Psoriasin

coal tar

Dosage Form: topical liquid
Drug Facts

Active ingredient

Coal tar, 0.66% (from coal tar topical solution, USP)...........Psoriasis/Seborrheic Dermatitis Treatment

Uses

For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irritation of the skin.  Helps prevent recurrence.

Warnings

For external use only. 

Ask a doctor before use

• for prolonged periods


• if condition covers a large area of the body


• around the rectum or in the genital area or groin


• with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.

When using this product avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• condition worsens


• does not improve after regular use of this product as directed.

Use caution in exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application.


Warning:  This product contains chemicals known to the State of California to cause cancer.

Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

Directions

• Read all package directions and warnings before using.


• Use only as directed.


• Apply a small amount of Psoriasin Liquid to affected areas (if desired, massage in gently with finger tips).


• Apply one to four times daily or as directed by a doctor.


• Apply to thoroughly dry skin.


• The active ingredient, coal tar, in Psoriasin Liquid may affect very light hair color; test first on a few strands of hair before broader application to areas where light colored hair is present.


• Avoid applying to severely cracked or irritated areas.


• Wash or shampoo affected area at least daily with mild soap or shampoo and warm water and dry thoroughly.


• Intended for use by normally healthy adults only.


• Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.

Other information

Serious side effects associated with the use of this product may be reported to the phone number provided below.

Inactive ingredients

Ethanol, fragrance, isopropyl alcohol (96%), and polysorbate 80.

Questions?  1-800-792-2582

Psoriasin Liquid

Multi-Symptom Psoriasis Relief for Skin and Scalp

• Fast Drying


• Itch Relief


• Quick Absorbing


• Not Oily


• No Unpleasant Odor

A WORD ABOUT Psoriasin Liquid

Psoriasin Multi-Symptom Psoriasis Relief Liquid for skin and scalp represents an important advance in the relief and control of psoriasis and seborrheic dermatitis. Unlike medicated soaps or shampoos which are rinsed away, Psoriasin Liquid offers complete multi-symptom relief in a "leave-on" skin and scalp treatment application. Psoriasin Liquid gets to work quickly to help eliminate the itching, flaking, redness, scaling and related discomforts often associated with psoriasis and seborrheic dermatitis. Psoriasin Liquid's active ingredient is formulated in a unique, oil-free, fast drying, vanishing liquid base which is easy to apply...dries almost instantly...absorbs thoroughly and virtually disappears, leaving no greasy/oily "tell-tale" appearance or lingering unpleasant odor. With Psoriasin Liquid, a little goes a long way. You can use Psoriasin Liquid with confidence on skin, scalp and hairline during the day or night. Psoriasin Liquid locks in effective medication at the affected site which starts to work immediately...keeps working hour after hour...resists rubbing off on bedding or clothing. With normal use as directed, Psoriasin Liquid helps stop even the most intense itching and flaking including dandruff...helps restore a more healthy natural appearance...plus helps prevent recurrence.


WHAT IS PSORIASIS AND SEBORRHEIC DERMATITIS?


PSORIASIS is a non-contagious skin disorder which afflicts millions of men and women of all ages. Normal skin cells multiply, mature and shed on a regular basis. In those afflicted with psoriasis, skin cells appear to multiply much faster than normal with excessive skin cells accumulating on the skin surface. In its most common form, these cells form scaly, reddish patches which are often unsightly, uncomfortable, and are frequently irritating, itchy and painful. While the exact causes of psoriasis are still unknown, it is reported that a susceptibility to psoriasis may be inherited...passed along from one generation to another genetically within families. First visible outbreaks of psoriasis may be prompted by a stress such as surgery, a major Infection, or a minor skin injury such as a burn or cut. After the first outbreak, psoriasis flare-ups tend to come and go without any specific regularity or frequency. Symptoms appear to diminish during warm summer months and increase during cold winter months. Some studies have shown a relationship between psoriasis flare-ups and periods of emotional stress.


The number of flare-ups and their intensity may differ from case to case. Although there is no known cure for psoriasis, the active ingredient in Psoriasin Liquid has been proven to help effectively relieve and control the symptoms of psoriasis, as well as prevent recurrences.


SEBORRHEIC DERMATITIS is a distinctly different condition, though sometimes confused with psoriasis. Seborrheic dermatitis is an inflammation affecting areas of the skin rich in sebaceous (oil producing) glands, commonly occurring on the hairy areas of the body, such as the trunk of the body, hairline, scalp, and face including the brows and especially around the nose. This troublesome skin disorder tends to be marked by skin cell proliferation and heightened sebaceous gland activity...skin cells shed and become scaly or itchy, red and irritated. Affected areas tend to display oily looking, yellowing scaly patches. People who tend toward oily skin are more likely to be affected. While seborrheic dermatitis and psoriasis are different disorders, troublesome symptoms of seborrheic dermatitis, such as intense itching and flaking (the appearance of dandruff) respond well (as do psoriasis symptoms) to the active ingredient In Psoriasin Liquid. As such, these symptoms can be effectively relieved and controlled as well as recurrences prevented, with regular use of Psoriasin Liquid as directed.


HOW DO YOU KNOW IF YOU HAVE PSORIASIS OR SEBORRHEIC DERMATITIS?


In its most common form, known as plaque psoriasis, the condition is characterized by sharply defined raised reddish areas of skin or patches typically covered with overlapping, rough, dry silvery scales, most often occurring on body extensions such as elbows and knees. Often times outbreaks are accompanied by itching and flaking at the affected site. In many cases, skin is cracked, irritated and burning. When soft tissue areas are affected, such as the palm of the hand, constant movement may cause skin to break and crack, causing pain and discomfort.


Seborrheic dermatitis tends to occur most often on the face and trunk. Both seborrheic dermatitis and psoriasis can and do affect the scalp. Seborrheic dermatitis tends to show up as thick, greasy, yellowish scales.


If you experience any type of unusual skin eruption(s) including those described here, contact your doctor to make the correct diagnosis and obtain professional advice. You may wish to show him/her Psoriasin Liquid and discuss its use for relief and prevention.


HOW Psoriasin LIQUID CAN HELP; PRODUCT DESCRIPTION AND ACTION:


Psoriasin Liquid is a convenient and highly effective treatment for relief of symptoms of psoriasis and seborrheic dermatitis affecting the skin and scalp. Unlike soaps and shampoos that are rinsed away, Psoriasin Liquid is a "leave-on" treatment application which is not rinsed away, thus allowing the active ingredient to remain at work hour after hour...to achieve optimal effective relief. Coal tar, the active ingredient in Psoriasin Liquid, slows down the excessive skin cell production that is the root cause of psoriasis symptoms. No other FDA compliant non-prescription drug ingredient works this way. Psoriasin Liquid is formulated in a unique quick drying, vanishing liquid base which won't promote clogging of hair follicles. Unlike commonly available creams and ointments, Psoriasin Liquid will not leave skin, hairline, scalp or hair looking oily or greasy...and with Psoriasin's convenient "Dab-On" applicator, fingers need never touch affected areas.


After application, Psoriasin Liquid starts to work immediately to help relieve suffering three ways:

• Psoriasin Liquid helps calm and normalize skin/scalp affected by psoriasis flare-ups,


• Psoriasin Liquid helps remove scaling and roughness,


• Psoriasin Liquid helps relieve related itching, irritation and discomfort...helps promote healing.

With regular use, Psoriasin Liquid can help prevent recurrence of symptoms of psoriasis and seborrheic dermatitis. Should symptoms recur, don't hesitate to again use Psoriasin Liquid for prompt relief and to help restore affected areas to their healthier looking appearance.


USES For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irritation of the skin. Helps prevent recurrence.


WARNINGS:


For external use only.


Ask a doctor before use • for prolonged periods • if condition covers a large area of the body • around the rectum or in the genital area or groin • with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.


When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.


Stop use and ask a doctor if • condition worsens • does not improve after regular use of this product as directed.


Use caution in exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application.


Warning: This product contains chemicals known to the State of California to cause cancer.


Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.


DIRECTIONS • Read all package directions and warnings before using.• Use only as directed. • Apply a small amount of Psoriasin Liquid to affected areas (If desired, massage in gently with finger tips). • Apply one to four times daily or as directed by a doctor. • Apply to thoroughly dry skin. • The active ingredient, coal tar, in Psoriasin Liquid may affect very light hair color; test first on a few strands of hair before broader application to areas where light colored hair is present. • Avoid applying to severely cracked or irritated areas. • Wash or shampoo affected area at least daily with mild soap or shampoo and warm water and dry thoroughly. • Intended for use by normally healthy adults only. • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.


OTHER INFORMATION Serious side effects associated with the use of this product may be reported to the phone number provided below.


QUESTIONS? 1-800-792-2582


HOW SUPPLIED: As a topical liquid, net contents 60ml (2 fl.oz.) in a bottle container.


STORAGE: Keep tightly closed when not in use. Store away from excessive heat and cold.


Coal tar, the active ingredient in Psoriasin LIQUID, slows down the excessive skin cell production that is the root cause of psoriasis symptoms. No other FDA compliant non-prescription drug ingredient works this way.

Psoriasin   coal tar  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 52389-169 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Coal tar (Coal tar) Coal tar 6.6 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Ethanol   isopropyl alcohol   Polysorbate 80

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52389-169-60 60 mL In 1 BOTTLE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358	01/20/2002

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 05/2010Alva-Amco Pharmacal Companies, Inc.

More Psoriasin resources

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• Psoriasin Support Group
• 1 Review for Psoriasin - Add your own review/rating

• Psoriasin Concise Consumer Information (Cerner Multum)


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Compare Psoriasin with other medications

• Dermatitis
• Psoriasis
• Seborrheic Dermatitis

Pulmicort Turbuhaler

Generic Name: budesonide (Inhalation route)

bue-DES-oh-nide

Commonly used brand name(s)

In the U.S.

• Pulmicort


• Pulmicort Flexhaler


• Pulmicort Respules


• Pulmicort Turbuhaler

In Canada

• Pulmicort Nebuamp


• Rhinocort Turbuhaler

Available Dosage Forms:

• Suspension


• Powder


• Solution


• Aerosol Powder


• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Pulmicort Turbuhaler

Budesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled budesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Budesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

This medicine is available only with your doctor's prescription.

Before Using Pulmicort Turbuhaler

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving inhaled budesonide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir


• Bupropion


• Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin


• Itraconazole


• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute—Should not be used in patients with this condition.

• Bone problems (e.g., osteoporosis) or


• Cataracts or


• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox, including recent exposure or


• Measles or


• Herpes simplex virus infection of the eye or


• Infections (virus, bacteria, or fungus) or


• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Milk protein allergy, severe—Use with caution. The Pulmicort Flexhaler™ contains lactose (milk sugar with milk protein), which may cause side effects for patients with this condition.

Proper Use of budesonide

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Pulmicort Turbuhaler. Please read with care.

Inhaled budesonide is used to prevent asthma attacks. It is not used to stop an attack that has already started. For relief of an asthma attack that has already started, you or your child should use another medicine. If you do not have another medicine to use for an acute asthma attack or if you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. This medicine usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

Do not change your dose or stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

When using the Pulmicort Flexhaler™:

• This medicine comes as a powder that you breathe into the lungs with a special inhaler that is placed in the mouth. It is used by adults, teenagers, and children who are 6 years of age and older.


• The medicine comes with patient instructions. Read the instructions carefully before using this medicine. If you or your child do not understand the instructions or are not sure how to use the inhaler, check with your doctor.


• When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Before using this medicine, test or prime it.


• Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip, then twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time.


• You do not have to prime it again after this, even if you have not used it for a long time.


• After the inhaler is primed, twist the cover and lift it off.


• To load a dose, hold the inhaler in the upright position, then twist the grip fully in one direction as far as it will go, and then fully back again in the other direction. You will hear a click.


• Turn your head away from the inhaler and breathe out. Do not shake the inhaler.


• Place the mouthpiece between your lips and breathe in deeply and forcefully. You may not taste or feel the medicine.


• Do not chew or bite on the mouthpiece.


• Remove the inhaler from your mouth and breathe out. Do not blow or breathe into the inhaler.


• Repeat these steps if more than one dose is needed.


• When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water and spit out the water. Do not swallow the water. This helps prevent hoarseness, throat irritation, and infections in the mouth.


• Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.


• Do not use a spacer with the Pulmicort Flexhaler™.


• Keep the inhaler clean and dry at all times. Follow the patient directions for cleaning and storing the inhaler.


• The inhaler has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.


• Discard the whole device when all doses have been used. The inhaler is empty when the number zero appears in the middle of the dose indicator window. You will be given a new inhaler each time you refill your prescription.

When using the Pulmicort Respules® liquid:

• This medicine comes as a liquid that you breathe into the lungs with a special breathing machine called a jet nebulizer. The nebulizer has a face mask or mouthpiece. It is used by children who are 12 months to 8 years of age.


• Your doctor will tell you which type of nebulizer to use with this medicine and will show you how to use the nebulizer. The medicine and nebulizer come with patient instructions. Read the instructions carefully before using the medicine or the machine. If you or your child do not understand the instructions or are not sure how to use the nebulizer, check with your doctor.


• Use this medicine at the same time each day, unless your child's doctor tells you otherwise.


• Do not mix this liquid with other medicines.


• Open the sealed aluminum foil envelope containing the medicine. Remove one container from the strip of five plastic containers with sealed caps. Write the current date on the back of the envelope when you open the foil pouch.


• Each container has one dose of medicine.


• Place the unused containers back in the foil pouch. This will protect the medicine from light.


• Shake the container in a circular motion before using it.


• Hold the container upright and open it by twisting off the cap.


• Slowly squeeze out all of the contents of the container into the nebulizer cup. Throw the empty container away.


• If your child is using a face mask, make sure that the mask fits tightly on the face to avoid getting the medicine in the eyes.


• Turn on the compressor to begin nebulizing the medication. The nebulizer turns the medicine into a fine mist that the child breathes into the lungs using the mouthpiece or mask.


• After the dose is completed, wash your child's face to prevent skin irritation.


• Rinsing your child's mouth with water after each dose may help prevent hoarseness, throat irritation, and infections in the mouth. Do not allow your child to swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For preventing an asthma attack:
  
  • For inhalation dosage form (powder inhaler):
    
    • Adults and children 6 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose as needed.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For inhalation dosage form (suspension in a nebulizer):
    
    • Children 12 months to 8 years of age—0.5 to 1 milligram (mg) in a nebulizer once a day, or divided and given twice a day. Each container of liquid has one dose and a new container is used for each dose.
    
    
    • Infants younger than 12 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Pulmicort Flexhaler™ in a dry place at room temperature with the cover tightly in place.

Store the unused Pulmicort Respules® in an upright position at room temperature. Keep the medicine containers in the foil pouch until you are ready to use them. Do not freeze the containers. Once you have opened a foil pouch, the containers will only be good for 2 weeks. Throw away any unused containers if it has been longer than 2 weeks since you opened the pouch.

Precautions While Using Pulmicort Turbuhaler

It is very important that your doctor check you or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by this medicine.

You or your child should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor if you have any questions about this.

If your or your child's symptoms do not improve within one to two weeks, or if they become worse, check with your doctor.

This medicine may weaken your immune system. Avoid being around people who are sick or who have infections such as chickenpox or measles. Tell your doctor right away if you think you or your child have been exposed to chickenpox or measles.

If you or your child develop a skin rash, hives, or any type of allergic reaction (including anaphylaxis) to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child have any signs of a throat infection.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child to not gain weight or get taller. Talk with your child's doctor if you think this is a problem or if you have any concerns.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist knows that you or your child are using this medicine. You might need to stop using this medicine several days before having surgery.

Your doctor may want you or your child to carry a medical identification card that says this medicine is being used. You or your child may need additional medicine during an emergency, a severe asthma attack, an illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pulmicort Turbuhaler Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain


• chills


• congestion


• cough


• diarrhea


• dryness or soreness of the throat


• fever


• general feeling of discomfort or illness


• headache


• hoarseness


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• pain or tenderness around the eyes and cheekbones


• shivering


• shortness of breath or troubled breathing


• sneezing


• sore throat


• stuffy or runny nose


• sweating


• tender, swollen glands in the neck


• tightness of the chest or wheezing


• trouble with sleeping


• trouble with swallowing


• unusual tiredness or weakness


• voice changes


• vomiting

Less common

• Bruising


• darkening of the skin


• depression


• dizziness


• earache


• excessive muscle tone


• fainting


• fractures


• large, flat, blue, or purplish patches in the skin


• lower back or side pain


• muscle stiffness


• muscle tension or tightness


• painful or difficult urination


• redness or swelling in the ear


• skin rash


• sore mouth or tongue


• white patches in the mouth or on the tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain

Less common

• Acid or sour stomach


• belching


• change in taste or bad, unusual, or unpleasant (after) taste


• difficulty with breathing


• difficulty with moving


• dry mouth


• ear congestion


• headache, severe and throbbing


• heartburn


• indigestion


• muscle cramping


• neck pain


• sleeplessness


• stomach discomfort, upset, or pain


• swollen joints


• unable to sleep


• unexplained runny nose or sneezing


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Pulmicort Turbuhaler side effects (in more detail)

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More Pulmicort Turbuhaler resources

• Pulmicort Turbuhaler Side Effects (in more detail)
• Pulmicort Turbuhaler Use in Pregnancy & Breastfeeding
• Pulmicort Turbuhaler Drug Interactions
• Pulmicort Turbuhaler Support Group
• 3 Reviews for Pulmicort Turbuhaler - Add your own review/rating

• Pulmicort Turbuhaler Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• budesonide Concise Consumer Information (Cerner Multum)


• Budesonide Professional Patient Advice (Wolters Kluwer)


• Budesonide Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Budesonide Monograph (AHFS DI)


• Entocort EC Prescribing Information (FDA)


• Entocort EC Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Pulmicort Flexhaler Prescribing Information (FDA)


• Pulmicort Flexhaler Concise Consumer Information (Cerner Multum)


• Pulmicort Respules Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pulmicort Turbuhaler with other medications

• Asthma, Maintenance

Pyri-500

Generic Name: pyridoxine (Oral route, Injection route)

pir-i-DOX-een

Commonly used brand name(s)

In the U.S.

• Aminoxin


• Pyri-500


• Rodex


• Vitabee 6

Available Dosage Forms:

• Injectable


• Solution


• Tablet


• Capsule


• Tablet, Extended Release


• Tablet, Enteric Coated

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B

Uses For Pyri-500

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Pyridoxine (vitamin B 6) is necessary for normal breakdown of proteins, carbohydrates, and fats.

Some conditions may increase your need for pyridoxine. These include:

• Alcoholism


• Burns


• Diarrhea


• Dialysis


• Heart disease


• Intestinal problems


• Liver disease


• Overactive thyroid


• Stress, long-term illness, or serious injury


• Surgical removal of stomach

In addition, infants receiving unfortified formulas such as evaporated milk may need additional pyridoxine.

Increased need for pyridoxine should be determined by your health care professional.

Lack of pyridoxine may lead to anemia (weak blood), nerve damage, seizures, skin problems, and sores in the mouth. Your doctor may treat these problems by prescribing pyridoxine for you.

Claims that pyridoxine is effective for treatment of acne and other skin problems, alcohol intoxication, asthma, hemorrhoids, kidney stones, mental problems, migraine headaches, morning sickness, and menstrual problems, or to stimulate appetite or milk production have not been proven.

Injectable pyridoxine is given by or under the supervision of a health care professional. Other forms of pyridoxine are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Pyridoxine is found in various foods, including meats, bananas, lima beans, egg yolks, peanuts, and whole-grain cereals. Pyridoxine is not lost from food during ordinary cooking, although some other forms of vitamin B 6 are.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of pyridoxine needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for pyridoxine are generally defined as follows:

• Infants and children—
  
  • Birth to 3 years of age: 0.3 to 1 milligram (mg).
  
  
  • 4 to 6 years of age: 1.1 mg.
  
  
  • 7 to 10 years of age: 1.4 mg.
  
  


• Adolescent and adult males—1.7 to 2 mg.


• Adolescent and adult females—1.4 to 1.6 mg.


• Pregnant females—2.2 mg.


• Breast-feeding females—2.1 mg.

Before Using Pyri-500

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Altretamine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of pyridoxine

This section provides information on the proper use of a number of products that contain pyridoxine. It may not be specific to Pyri-500. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, tablets, oral solution):
  
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    
    • Adult and teenage males—1.7 to 2 milligrams (mg) per day.
    
    
    • Adult and teenage females—1.4 to 1.6 mg per day.
    
    
    • Pregnant females—2.2 mg per day.
    
    
    • Breast-feeding females—2.1 mg per day.
    
    
    • Children 7 to 10 years of age—1.4 mg per day.
    
    
    • Children 4 to 6 years of age—1.1 mg per day.
    
    
    • Children birth to 3 years of age—0.3 to 1 mg per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.
    
    
  
  

To use the extended-release capsule form of this dietary supplement:

• Swallow the capsule whole.


• Do not crush, break, or chew before swallowing.


• If the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

To use the extended-release tablet form of this dietary supplement:

• Swallow the tablet whole.


• Do not crush, break, or chew before swallowing.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Pyri-500 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With large doses

• Clumsiness


• numbness of hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Pyri-500 side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Pyri-500 resources

• Pyri-500 Side Effects (in more detail)
• Pyri-500 Use in Pregnancy & Breastfeeding
• Pyri-500 Drug Interactions
• Pyri-500 Support Group
• 1 Review for Pyri-500 - Add your own review/rating

Compare Pyri-500 with other medications

• Anemia
• Dietary Supplementation
• Drug Induced Vitamin/Mineral Deficiency
• Nausea/Vomiting
• Seizures

pyridoxine Oral, Injection

pir-i-DOX-een

Commonly used brand name(s)

In the U.S.

• Aminoxin


• Pyri-500


• Rodex


• Vitabee 6

Available Dosage Forms:

• Injectable


• Solution


• Tablet


• Capsule


• Tablet, Extended Release


• Tablet, Enteric Coated

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B

Uses For pyridoxine

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Pyridoxine (vitamin B 6) is necessary for normal breakdown of proteins, carbohydrates, and fats.

Some conditions may increase your need for pyridoxine. These include:

• Alcoholism


• Burns


• Diarrhea


• Dialysis


• Heart disease


• Intestinal problems


• Liver disease


• Overactive thyroid


• Stress, long-term illness, or serious injury


• Surgical removal of stomach

In addition, infants receiving unfortified formulas such as evaporated milk may need additional pyridoxine.

Increased need for pyridoxine should be determined by your health care professional.

Lack of pyridoxine may lead to anemia (weak blood), nerve damage, seizures, skin problems, and sores in the mouth. Your doctor may treat these problems by prescribing pyridoxine for you.

Claims that pyridoxine is effective for treatment of acne and other skin problems, alcohol intoxication, asthma, hemorrhoids, kidney stones, mental problems, migraine headaches, morning sickness, and menstrual problems, or to stimulate appetite or milk production have not been proven.

Injectable pyridoxine is given by or under the supervision of a health care professional. Other forms of pyridoxine are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Pyridoxine is found in various foods, including meats, bananas, lima beans, egg yolks, peanuts, and whole-grain cereals. Pyridoxine is not lost from food during ordinary cooking, although some other forms of vitamin B 6 are.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of pyridoxine needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for pyridoxine are generally defined as follows:

• Infants and children—
  
  • Birth to 3 years of age: 0.3 to 1 milligram (mg).
  
  
  • 4 to 6 years of age: 1.1 mg.
  
  
  • 7 to 10 years of age: 1.4 mg.
  
  


• Adolescent and adult males—1.7 to 2 mg.


• Adolescent and adult females—1.4 to 1.6 mg.


• Pregnant females—2.2 mg.


• Breast-feeding females—2.1 mg.

Before Using pyridoxine

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pyridoxine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Altretamine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of pyridoxine

Dosing

The dose of pyridoxine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pyridoxine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, tablets, oral solution):
  
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    
    • Adult and teenage males—1.7 to 2 milligrams (mg) per day.
    
    
    • Adult and teenage females—1.4 to 1.6 mg per day.
    
    
    • Pregnant females—2.2 mg per day.
    
    
    • Breast-feeding females—2.1 mg per day.
    
    
    • Children 7 to 10 years of age—1.4 mg per day.
    
    
    • Children 4 to 6 years of age—1.1 mg per day.
    
    
    • Children birth to 3 years of age—0.3 to 1 mg per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.
    
    
  
  

To use the extended-release capsule form of this dietary supplement:

• Swallow the capsule whole.


• Do not crush, break, or chew before swallowing.


• If the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

To use the extended-release tablet form of this dietary supplement:

• Swallow the tablet whole.


• Do not crush, break, or chew before swallowing.

Missed Dose

If you miss a dose of pyridoxine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

pyridoxine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With large doses

• Clumsiness


• numbness of hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pyridoxine Oral, Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More pyridoxine Oral, Injection resources

• Pyridoxine Oral, Injection Side Effects (in more detail)
• Pyridoxine Oral, Injection Use in Pregnancy & Breastfeeding
• Pyridoxine Oral, Injection Drug Interactions
• Pyridoxine Oral, Injection Support Group
• 1 Review for Pyridoxine Oral, Injection - Add your own review/rating

Compare pyridoxine Oral, Injection with other medications

• Anemia
• Dietary Supplementation
• Drug Induced Vitamin/Mineral Deficiency
• Nausea/Vomiting
• Seizures

Pulmicort Nebuamp

Generic Name: budesonide (Inhalation route)

bue-DES-oh-nide

Commonly used brand name(s)

In the U.S.

• Pulmicort


• Pulmicort Flexhaler


• Pulmicort Respules


• Pulmicort Turbuhaler

In Canada

• Pulmicort Nebuamp


• Rhinocort Turbuhaler

Available Dosage Forms:

• Suspension


• Powder


• Solution


• Aerosol Powder


• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Pulmicort Nebuamp

Budesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled budesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Budesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

This medicine is available only with your doctor's prescription.

Before Using Pulmicort Nebuamp

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving inhaled budesonide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir


• Bupropion


• Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin


• Itraconazole


• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute—Should not be used in patients with this condition.

• Bone problems (e.g., osteoporosis) or


• Cataracts or


• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox, including recent exposure or


• Measles or


• Herpes simplex virus infection of the eye or


• Infections (virus, bacteria, or fungus) or


• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Milk protein allergy, severe—Use with caution. The Pulmicort Flexhaler™ contains lactose (milk sugar with milk protein), which may cause side effects for patients with this condition.

Proper Use of budesonide

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Pulmicort Nebuamp. Please read with care.

Inhaled budesonide is used to prevent asthma attacks. It is not used to stop an attack that has already started. For relief of an asthma attack that has already started, you or your child should use another medicine. If you do not have another medicine to use for an acute asthma attack or if you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. This medicine usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

Do not change your dose or stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

When using the Pulmicort Flexhaler™:

• This medicine comes as a powder that you breathe into the lungs with a special inhaler that is placed in the mouth. It is used by adults, teenagers, and children who are 6 years of age and older.


• The medicine comes with patient instructions. Read the instructions carefully before using this medicine. If you or your child do not understand the instructions or are not sure how to use the inhaler, check with your doctor.


• When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Before using this medicine, test or prime it.


• Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip, then twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time.


• You do not have to prime it again after this, even if you have not used it for a long time.


• After the inhaler is primed, twist the cover and lift it off.


• To load a dose, hold the inhaler in the upright position, then twist the grip fully in one direction as far as it will go, and then fully back again in the other direction. You will hear a click.


• Turn your head away from the inhaler and breathe out. Do not shake the inhaler.


• Place the mouthpiece between your lips and breathe in deeply and forcefully. You may not taste or feel the medicine.


• Do not chew or bite on the mouthpiece.


• Remove the inhaler from your mouth and breathe out. Do not blow or breathe into the inhaler.


• Repeat these steps if more than one dose is needed.


• When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water and spit out the water. Do not swallow the water. This helps prevent hoarseness, throat irritation, and infections in the mouth.


• Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.


• Do not use a spacer with the Pulmicort Flexhaler™.


• Keep the inhaler clean and dry at all times. Follow the patient directions for cleaning and storing the inhaler.


• The inhaler has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.


• Discard the whole device when all doses have been used. The inhaler is empty when the number zero appears in the middle of the dose indicator window. You will be given a new inhaler each time you refill your prescription.

When using the Pulmicort Respules® liquid:

• This medicine comes as a liquid that you breathe into the lungs with a special breathing machine called a jet nebulizer. The nebulizer has a face mask or mouthpiece. It is used by children who are 12 months to 8 years of age.


• Your doctor will tell you which type of nebulizer to use with this medicine and will show you how to use the nebulizer. The medicine and nebulizer come with patient instructions. Read the instructions carefully before using the medicine or the machine. If you or your child do not understand the instructions or are not sure how to use the nebulizer, check with your doctor.


• Use this medicine at the same time each day, unless your child's doctor tells you otherwise.


• Do not mix this liquid with other medicines.


• Open the sealed aluminum foil envelope containing the medicine. Remove one container from the strip of five plastic containers with sealed caps. Write the current date on the back of the envelope when you open the foil pouch.


• Each container has one dose of medicine.


• Place the unused containers back in the foil pouch. This will protect the medicine from light.


• Shake the container in a circular motion before using it.


• Hold the container upright and open it by twisting off the cap.


• Slowly squeeze out all of the contents of the container into the nebulizer cup. Throw the empty container away.


• If your child is using a face mask, make sure that the mask fits tightly on the face to avoid getting the medicine in the eyes.


• Turn on the compressor to begin nebulizing the medication. The nebulizer turns the medicine into a fine mist that the child breathes into the lungs using the mouthpiece or mask.


• After the dose is completed, wash your child's face to prevent skin irritation.


• Rinsing your child's mouth with water after each dose may help prevent hoarseness, throat irritation, and infections in the mouth. Do not allow your child to swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For preventing an asthma attack:
  
  • For inhalation dosage form (powder inhaler):
    
    • Adults and children 6 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose as needed.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For inhalation dosage form (suspension in a nebulizer):
    
    • Children 12 months to 8 years of age—0.5 to 1 milligram (mg) in a nebulizer once a day, or divided and given twice a day. Each container of liquid has one dose and a new container is used for each dose.
    
    
    • Infants younger than 12 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Pulmicort Flexhaler™ in a dry place at room temperature with the cover tightly in place.

Store the unused Pulmicort Respules® in an upright position at room temperature. Keep the medicine containers in the foil pouch until you are ready to use them. Do not freeze the containers. Once you have opened a foil pouch, the containers will only be good for 2 weeks. Throw away any unused containers if it has been longer than 2 weeks since you opened the pouch.

Precautions While Using Pulmicort Nebuamp

It is very important that your doctor check you or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by this medicine.

You or your child should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor if you have any questions about this.

If your or your child's symptoms do not improve within one to two weeks, or if they become worse, check with your doctor.

This medicine may weaken your immune system. Avoid being around people who are sick or who have infections such as chickenpox or measles. Tell your doctor right away if you think you or your child have been exposed to chickenpox or measles.

If you or your child develop a skin rash, hives, or any type of allergic reaction (including anaphylaxis) to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child have any signs of a throat infection.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child to not gain weight or get taller. Talk with your child's doctor if you think this is a problem or if you have any concerns.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist knows that you or your child are using this medicine. You might need to stop using this medicine several days before having surgery.

Your doctor may want you or your child to carry a medical identification card that says this medicine is being used. You or your child may need additional medicine during an emergency, a severe asthma attack, an illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pulmicort Nebuamp Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain


• chills


• congestion


• cough


• diarrhea


• dryness or soreness of the throat


• fever


• general feeling of discomfort or illness


• headache


• hoarseness


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• pain or tenderness around the eyes and cheekbones


• shivering


• shortness of breath or troubled breathing


• sneezing


• sore throat


• stuffy or runny nose


• sweating


• tender, swollen glands in the neck


• tightness of the chest or wheezing


• trouble with sleeping


• trouble with swallowing


• unusual tiredness or weakness


• voice changes


• vomiting

Less common

• Bruising


• darkening of the skin


• depression


• dizziness


• earache


• excessive muscle tone


• fainting


• fractures


• large, flat, blue, or purplish patches in the skin


• lower back or side pain


• muscle stiffness


• muscle tension or tightness


• painful or difficult urination


• redness or swelling in the ear


• skin rash


• sore mouth or tongue


• white patches in the mouth or on the tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain

Less common

• Acid or sour stomach


• belching


• change in taste or bad, unusual, or unpleasant (after) taste


• difficulty with breathing


• difficulty with moving


• dry mouth


• ear congestion


• headache, severe and throbbing


• heartburn


• indigestion


• muscle cramping


• neck pain


• sleeplessness


• stomach discomfort, upset, or pain


• swollen joints


• unable to sleep


• unexplained runny nose or sneezing


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Pulmicort Nebuamp side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Pulmicort Nebuamp resources

• Pulmicort Nebuamp Side Effects (in more detail)
• Pulmicort Nebuamp Use in Pregnancy & Breastfeeding
• Pulmicort Nebuamp Drug Interactions
• Pulmicort Nebuamp Support Group
• 0 Reviews for Pulmicort Nebuamp - Add your own review/rating

• budesonide Concise Consumer Information (Cerner Multum)


• Budesonide Professional Patient Advice (Wolters Kluwer)


• Budesonide Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Budesonide Monograph (AHFS DI)


• Entocort EC Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Entocort EC Prescribing Information (FDA)


• Pulmicort Flexhaler Prescribing Information (FDA)


• Pulmicort Flexhaler Concise Consumer Information (Cerner Multum)


• Pulmicort Respules Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Pulmicort Turbuhaler Powder MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pulmicort Nebuamp with other medications

• Asthma, Maintenance

Pimecrolimus

Class: Skin and Mucous Membrane Agents, Miscellaneous
VA Class: DE900
Chemical Name: (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS) - 3 - [(1E) - 2 - [(1R,3R,4S) - 4 - Chloro - 3 - methoxycyclohexyl] - 1 - methyl - ethenyl] - 8 - ethyl - 5,6,8,11,12,13,14,15,16,17,18,19,24,26,26a - hexadecahydro - 5,19 - dihydroxy - 14,16 - dimethoxy - 4,10,12,18 - tetramethyl - 15,19 - epoxy - 3H - pyrido[2,1 - c][1,4]oxaazacyclotricosine - 1,17,20,21(4H,23H) - tetrone
Molecular Formula: C₄₃H₆₈ClNO₁₁
CAS Number: 137071-32-0
Brands: Elidel

• 
  

  Long-term safety of topical pimecrolimus not established.^{a c}

  
  


• 
  

  Malignancies (e.g., skin cancers, lymphoma) reported rarely in patients treated with topical calcineurin inhibitors, including pimecrolimus; causal relationship not established.^{a c}

  
  


• 
  

  Avoid continuous long-term use of topical pimecrolimus; limit application to areas affected by atopic dermatitis.^{a c} (See Carcinogenicity under Cautions.)

  
  


• 
  

  Not indicated for use in children <2 years of age.^{a c}

  
  

Introduction

Immunosuppressive agent; derivative of ascomycin (a macrolactam); structurally related to tacrolimus.^{1 3 4 6 7}

Uses for Pimecrolimus

Atopic Dermatitis

Second-line therapy for short-term treatment and noncontinuous chronic treatment of mild to moderate atopic dermatitis (eczema) in immunocompetent adults and children ≥2 years of age who are unable to tolerate or have not responded to first-line therapies (e.g., corticosteroids) or for whom first-line therapies are inadvisable.^{3 5 6 12 a c} (See Carcinogenicity under Cautions.)

Not indicated for use in children <2 years of age.^{a c}

Pimecrolimus Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 1% cream.¹ For external use only; do not use in the eyes or ingest.¹

Apply in thin layers to affected areas of skin.^a

Use minimum amount required to control symptoms;¹² limit application to areas affected with atopic dermatitis.^a (See Carcinogenicity under Cautions.)

Do not use occlusive dressings or wrappings.¹

Dosage

Pediatric Patients

Atopic Dermatitis

Topical

Children ≥2 years of age: Apply to affected areas twice daily.¹

Treatment effects usually evident within 15 days; erythema and infiltration or papulation generally reduced within 8 days.^{1 3 4} Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema).^a If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.^a

Adults

Atopic Dermatitis

Topical

Apply to affected areas twice daily.¹

Treatment effects usually evident within 15 days; erythema and infiltration or papulation generally reduced within 8 days.^{1 3 4} Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema).^a If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.^a

Prescribing Limits

Pediatric Patients

Atopic Dermatitis

Topical

For short-term and intermittent use only; avoid continuous long-term use.^{12 a} Safety of noncontinuous use for >1 year not established.^{12 a c} (See Carcinogenicity under Cautions.)

Adults

Atopic Dermatitis

Topical

For short-term and intermittent use only; avoid continuous long-term use.^{12 a} Safety of noncontinuous use for >1 year not established.^{12 a c} (See Carcinogenicity under Cautions.)

Cautions for Pimecrolimus

Contraindications

• 
  

  Known hypersensitivity to pimecrolimus or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Carcinogenicity

Possible increased risk of malignancies.^{12 13 14 a} (See Boxed Warning.)

Malignancies (including lymphoma and skin cancers) reported rarely in children and adults receiving topical pimecrolimus.^{12 13 14 a} Concerns also based on case reports of malignancies (including lymphoma and skin cancers) in patients (including transplant patients) receiving prolonged systemic treatment with calcineurin inhibitors (e.g., cyclosporine, tacrolimus);^a animal studies indicating dose-related increases in the risk of lymphoma and other malignancies with pimecrolimus and other calcineurin inhibitors;^{12 13 14 a} and known pharmacologic effects of these immunosuppressants.^{a 12 13 14}

Animal studies using topically or orally administered pimecrolimus in 3 species (mouse, rat, monkey) indicate increased risk of lymphoma and other malignancies (possibly due to immunosuppression^{10 12 14} );^a risk appears to be related to dose and duration of exposure.^{12 13 14 a}

Risk associated with systemic therapy is related to intensity and duration of immunosuppression.^a The potential for systemic immunosuppression with topical pimecrolimus and the drug’s role in the development of malignancies in humans have not been established.^{12 13 14 a} Long-term studies in humans are needed to determine whether topical pimecrolimus is associated with an increased risk of malignancies.^{12 13} Until such data are available, FDA recommends limiting use to the labeled indication, reserving the drug for use as a second-line agent for short-term and intermittent treatment.^{12 13} (See Atopic Dermatitis under Uses, see Immunocompromised Patients under Cautions, and see Dosage and Administration.) Carefully evaluate potential risks and benefits of therapy.^{12 13}

Avoid use for malignant or premalignant skin conditions (e.g., cutaneous T-cell lymphoma [CTCL]), which may appear clinically similar to dermatitis.^a

General Precautions

Lymphadenopathy

Lymphadenopathy reported; usually related to infections and resolves following appropriate anti-infective therapy.¹ Also reported in association with malignancy.¹⁴ Investigate etiology if lymphadenopathy develops.¹ Discontinue pimecrolimus in the absence of a clear etiology or in the presence of acute infectious mononucleosis.^a Monitor patients with lymphadenopathy to ensure that it resolves.¹

Netherton’s Syndrome

Not recommended for use in patients with Netherton’s syndrome because of the potential for increased systemic absorption of pimecrolimus.¹

Generalized Erythroderma

Safety in patients with generalized erythroderma has not been established.^a

Dermatologic Reactions

Mild to moderate sensation of warmth and/or burning, stinging, soreness, and pruritus at the treatment site may occur within 1–5 days of initiating therapy.^{a b} Reactions usually last no more than 5 days and improve as the lesions of atopic dermatitis resolve.¹

Infectious Complications

Clinical infections (e.g., bacterial, viral) at treatment sites should be resolved before initiating pimecrolimus therapy.¹ Safety and efficacy not established for treatment of clinically infected atopic dermatitis.¹

Possible increased risk of varicella-zoster infections (chickenpox or shingles), herpes simplex virus infection, or eczema herpeticum.¹

Skin papilloma and/or warts may occur.¹ If skin papilloma worsens or is unresponsive to conventional therapy, consider discontinuing pimecrolimus until complete resolution of the warts is achieved.¹

Septic arthritis reported in infants ≤1 year of age during clinical trials; however, causality not established.^a

Phototoxicity

Although phototoxicity not reported in humans, it may be prudent to minimize or avoid natural or artificial sunlight exposure during pimecrolimus therapy (including periods when no drug is on skin).¹ Potential effects on skin response to ultraviolet (UV) damage are not known.^a

Animal photocarcinogenicity studies indicate shortened time to skin tumor formation following chronic topical pimecrolimus dosing with concurrent UV radiation exposure.¹

Immunocompromised Patients

Safety and efficacy not established and not recommended for use in immunocompromised adults or children.^{1 12 13 14 a}

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established and not recommended for use in children <2 years of age.^{1 12 a c}

Increased incidence of upper respiratory tract infections in infants <24 months of age receiving pimecrolimus compared with those receiving placebo.¹² Possible increased incidence of upper respiratory symptoms and/or infections in infants 3–23 months of age compared with older children; relationship to treatment not known.¹

Long-term effects on the developing immune system in infants and children are not known.^{12 13 14 a}

Not recommended for use in immunocompromised children.^{1 12 13 14}

Geriatric Use

Experience insufficient to determine whether patients ≥65 years of age respond differently than younger adults.¹

Common Adverse Effects

Upper respiratory tract infection,^{1 3 b} cough,^{1 3 b} nasopharyngitis,^{1 b} application site reactions (e.g., sensation of burning or warmth),^{1 3 b} headache.^{1 3 b}

Interactions for Pimecrolimus

No formal drug interaction studies have been performed.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction with inhibitors of CYP3A4 in patients with widespread and/or erythrodermic disease.¹

Specific Drugs

Drug	Interaction	Comments
Antifungals, azoles	Potential interaction (inhibition of pimecrolimus metabolism) in patients with widespread and/or erythrodermic disease (which may increase systemic absorption)1	Caution advised in patients with widespread and/or erythrodermic disease1
Calcium-channel blocking agents	Potential interaction (inhibition of pimecrolimus metabolism) in patients with widespread and/or erythrodermic disease (which may increase systemic absorption)1	Caution advised in patients with widespread and/or erythrodermic disease1
Cimetidine	Potential interaction (inhibition of pimecrolimus metabolism) in patients with widespread and/or erythrodermic disease (which may increase systemic absorption)1	Caution advised in patients with widespread and/or erythrodermic disease1
Erythromycin	Potential interaction (inhibition of pimecrolimus metabolism) in patients with widespread and/or erythrodermic disease (which may increase systemic absorption)1	Caution advised in patients with widespread and/or erythrodermic disease1

Pimecrolimus Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed into systemic circulation following multiple topical applications in adults or children 2–14 years of age with atopic dermatitis.^{1 2 3} Increased systemic absorption occurs following topical application in infants 3–23 months of age with atopic dermatitis compared with older children, possibly because of the larger surface area to body mass ratio.^{1 14}

Occlusive dressings or wrappings may promote systemic exposure.¹

Distribution

Extent

Crosses placenta in rats and rabbits following oral administration.¹

Plasma Protein Binding

74–87% bound to plasma proteins in vitro.¹

Elimination

Metabolism

Studies using oral pimecrolimus indicate absorbed drug is metabolized in the liver principally via demethylation by CYP3A isoenzymes.^{1 3}

No evidence of skin-mediated metabolism.¹

Elimination Route

Studies using oral pimecrolimus indicated absorbed drug is eliminated principally in feces as metabolites.¹

Stability

Storage

Topical

Cream

25°C (may be exposed to 15–30°C).¹ Do not freeze.¹

ActionsActions

• 
  

  Exact mechanism(s) of immunosuppressive action in the treatment of atopic dermatitis not known; appears to involve inhibition of T cell activation.^{1 3 7}

  
  


• 
  

  Not genotoxic and does not interact directly with DNA; however, may impair local immunosurveillance.¹⁴

  
  

• 
  

  In vitro studies indicate pimecrolimus prevents release of inflammatory mediators from mast cells.^{1 3 7 11}

  
  

Advice to Patients

• 
  

  Importance of reading the patient information (medication guide) provided by the manufacturer before initiating therapy and each time the prescription is refilled.^b

  
  


• 
  

  Importance of informing clinicians of other medical conditions, including Netherton’s syndrome, skin infections (e.g., chicken pox, herpes), or weakened immune system.^b

  
  


• 
  

  Advise patients that pimecrolimus is for external use on affected areas of the skin only.^a Importance of patients or caregivers washing their hands before and after application if hands are not an area for treatment.¹

  
  


• 
  

  Importance of ensuring that the skin is completely dry before applying the drug.^a Advise patients not to bathe, shower, or swim immediately after application.^b

  
  


• 
  

  Importance of avoiding contact with the eyes; irrigate eyes with copious amounts of cool water if contact occurs.^a

  
  


• 
  

  Importance of following the clinician’s advice regarding use of other topical preparations; importance of maintaining good skin care practices; apply moisturizers (if used) after pimecrolimus.^a

  
  


• 
  

  Advise patients to discontinue pimecrolimus when the signs and symptoms (e.g., itching, rash, redness) of atopic dermatitis (eczema) resolve, or as directed by clinician.^a Importance of following the clinician’s advice if symptoms recur after a course of treatment.^a

  
  


• 
  

  Importance of not using the drug in children <2 years of age.^a

  
  


• 
  

  Importance of avoiding use of bandages, dressings, or wrappings on treated skin.^b

  
  


• 
  

  Importance of not using the drug for any disorder other than that for which it was prescribed.¹

  
  


• 
  

  Importance of using pimecrolimus exactly as prescribed and of not using the drug continuously for a long period of time.^{a 1} Importance of using the minimum amount required to control signs and symptoms of atopic dermatitis; importance of using the drug for short-term or intermittent therapy (e.g., courses repeated after treatment-free intervals) only.^{12 13 a}

  
  


• 
  

  Importance of reporting persistently swollen glands or any other adverse reactions to clinician.^{1 b} Importance of notifying clinician if reaction at treatment site (e.g., warmth and/or burning) is severe or persists >1 week.¹

  
  


• 
  

  Importance of notifying clinician if the signs and symptoms of atopic dermatitis do not improve after 6 weeks of therapy or at any time become noticeably worse.¹

  
  


• 
  

  Importance of notifying clinician if a skin infection develops during treatment with pimecrolimus.^a

  
  


• 
  

  Importance of avoiding or limiting exposure of unprotected skin to natural or artificial sunlight (tanning beds or UVA/B light) while using pimecrolimus cream (even when the drug is not on the skin); wear protective clothing and use a broad-spectrum sunscreen with a high protection factor.^{1 a}

  
  


• 
  

  Importance of not swallowing pimecrolimus; contact clinician if swallowed.^a

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription or OTC drugs, dietary supplements, herbal supplements, any other skin product, or any form of phototherapy (UVA or UVB).^{1 b}

  
  


• 
  

  Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pimecrolimus

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Cream	1%	Elidel	Novartis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Elidel 1% Cream (NOVARTIS): 100/$311.99 or 200/$596.95

Elidel 1% Cream (NOVARTIS): 30/$109.99 or 90/$300.96

Elidel 1% Cream (NOVARTIS): 60/$203.09 or 180/$586.63

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis Pharmaceutical Corp. Elidel (pimecrolimus) cream 1% prescribing information. East Hanover, NJ; 2004 Jul.

2. Harper J, Green A, Scott G et al. First experience of topical SDZ ASM 981 in children with atopic dermatitis. Br J Dermatol. 2001; 144:781-7. [IDIS 462842] [PubMed 11298537]

3. Novartis Pharmaceutical Corp., East Hanover, NJ: Personal communication.

4. Hebert AA, Warken KA, Cherill R. Pimecrolimus cream 1%: a new development in nonsteroid topical treatment of inflammatory skin diseases. Semin Cutan Med Surg. 2001; 20:260-7. [PubMed 11770913]

5. Van Leent EJM, Graber M, Thurston M et al. Effectiveness of the ascomycin macrolactam SDZ ASM 981 in the topical treatment of atopic dermatitis. Arch Dermatol. 1998; 134:805-9. [IDIS 409267] [PubMed 9681343]

6. Luger T, Van Leent EJM, Graeber M et al. SDZ ASM 981: an emerging safe and effective treatment for atopic dermatitis. Br J Dermatol. 2001; 144:788-94. [IDIS 462843] [PubMed 11298538]

7. Stuetz A, Grassberger M, Meingassner JG. Pimecrolimus (Elidel, SDZ ASM 981)—preclinical pharmacologic profile and skin selectivity. Semin Cutan Med Surg. 2001; 20:233-41. [PubMed 11770910]

8. Lucky A, Marshall K, Bush C et al. Efficacy and safety of SDZ ASM 981 1% cream in the treatment of paediatric atopic dermatitis. J Eur Acad Dermatol Venereol. 2000; 14(Suppl 1):318.

9. Lucky A, Marshall K, Bush C et al. SDZ ASM 981: efficacy and safety in children with atopic dermatitis. J Eur Acad Dermatol Venereol. 2000; 14(Suppl 1):91. [PubMed 10972092]

10. Robinson N, Singri P, Gordon KB. Safety of the new macrolide immunomodulators. Semin Cutan Med Surg. 2001; 20:242-9. [PubMed 11770911]

11. Fujisawa Healthcare, Inc. Protopic (tacrolimus) ointment prescribing information. Deerfield, IL; 2000 Dec.

12. Anon. FDA issues public health advisory informing health care providers of safety concerns associated with the use of two eczema drugs, Elidel and Protopic. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2005 March 10. From the FDA website: . Accessed on May 20, 2005.

13. Food and Drug Administration (FDA). FDA Public Health Advisory regarding potential cancer risk from use of Elidel (pimecrolimus) cream and Protopic (tacrolimus) ointment. From FDA website: . 2005 Mar 10. Accessed on May 20, 2005

14. Food and Drug Administration (FDA). FDA alert for healthcare professionals regarding potential cancer risk from use of pimecrolimus (marketed as Elidel). From FDA website: . Accessed on May 20, 2005.

a. Novartis Pharmaceutical Corp. Elidel (pimecrolimus) cream 1% prescribing information. East Hanover, NJ; 2006 Jan.

b. Novartis Pharmaceutical Corp. Elidel (pimecrolimus) cream 1% medication guide. East Hanover, NJ; 2006 Jan.

c. Bess AL, Cunningham SR. Dear health care provider letter regarding important safety information regarding Elidel and rare cases of malignancy reported in patients treated with topical calcineurin inhibitors. East Hanover, NJ;2006 Jan 27.

x. space

More Pimecrolimus resources

• Pimecrolimus Side Effects (in more detail)
• Pimecrolimus Dosage
• Pimecrolimus Use in Pregnancy & Breastfeeding
• Pimecrolimus Drug Interactions
• Pimecrolimus Support Group
• 6 Reviews for Pimecrolimus - Add your own review/rating

Compare Pimecrolimus with other medications

• Atopic Dermatitis
• Eczema
• Perioral Dermatitis