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

Fluocinolone Ear Drops

Dosage Form: otic oil
Fluocinolone Acetonide Oil 0.01%

Ear Drops

For Otic Use Only-

Not for Ophthalmic Use

DESCRIPTION

Fluocinolone Acetonide Oil 0.01% Ear Drops contain fluocinolone acetonide {(6α, 11β, 16α) - 6,9 - difluoro - 11,21 - dihydroxy - 16,17[(1 - methylethylidene)bis(oxy)] - pregna - 1,4 - diene - 3,20 - dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide is C24 H30 F2O6 anhydrous. It has the following structural formula:

Fluocinolone acetonide in Fluocinolone Acetonide Oil 0.01% has a molecular weight of 452.49. It is a white crystalline powder that is odorless, stable in light, and melts at 270ºC with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of Fluocinolone Acetonide Oil 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF.

CLINICAL PHARMACOLOGY

Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics:

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.

Fluocinolone Acetonide Oil 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.

CLINICAL STUDIES

Efficacy in a placebo-controlled study for the treatment of chronic eczematous external otitis on 154 patients (adults and children 2 years of age and older) treated with five drops per ear of fluocinolone acetonide oil 0.01% twice daily, after 7 days of treatment, showed Fluocinolone Acetonide Oil 0.01% to be superior to placebo in clearing the signs and symptoms of eczematous external otitis.

Clinical safety studies were conducted on the same formulation of fluocinolone acetonide oil 0.01%, marketed as Fluocinolone Acetonide 0.01% Topical Oil. Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 4 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 mcg/dL; normal: cortisol > 7mcg/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18 mcg/dL).

A clinical study was conducted to assess the safety of Fluocinolone Acetonide 0.01% Topical Oil, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing peanut oil NF, Fluocinolone Acetonide 0.01% Topical Oil and histamine/saline controls on the 13 individuals. These subjects were also treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Fluocinolone Acetonide 0.01% Topical Oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of Fluocinolone Acetonide 0.01% Topical Oil use. Importantly, the bulk peanut oil NF, used in fluocinolone acetonide oil is heated at 475° F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.

INDICATIONS AND USAGE

Fluocinolone Acetonide Oil 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years old and older.

CONTRAINDICATIONS

Fluocinolone Acetonide Oil 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

This product contains refined peanut oil NF (See PRECAUTIONS).

PRECAUTIONS

General:

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS-Pediatric use)

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic testing.

If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, fluocinolone acetonide oil 0.01% should be discontinued immediately and appropriate therapy instituted.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of fluocinolone acetonide oil 0.01% should be discontinued until the infection has been adequately controlled.

Fluocinolone acetonide oil 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Oil 0.01% for peanut-sensitive individuals.

Information for Patients:

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external ear use only. Do not use occlusive dressings.

2. Avoid contact with the eyes. In case of contact, wash eyes liberally with water.

3. This medication should not be used for any disorder other than that for which it was prescribed.

4. Patients should promptly report to their physician any worsening of their skin condition.

5. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests:

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, mutagenesis, and impairment of fertility:

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of fluocinolone acetonide oil 0.01%. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in fluocinolone acetonide oil 0.01%. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay).

Pregnancy:

Teratogenic effects:

Pregnancy category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide oil 0.01%. Therefore, fluocinolone acetonide oil 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide oil 0.01% is administered to a nursing woman.

Pediatric Use:

Fluocinolone acetonide oil 0.01% may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis.

Fluocinolone acetonide oil 0.01% is not recommended for use on the face (See ADVERSE REACTIONS section).

Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA-axis-suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS).

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Fluocinolone acetonide oil 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Oil 0.01% for peanut-sensitive individuals.

ADVERSE REACTIONS

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

OVERDOSAGE

Topically applied fluocinolone acetonide oil 0.01% can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION

For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil 0.01% into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil 0.01% into the ear. Keep head tilted for about a minute to allow fluocinolone acetonide oil 0.01% to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

HOW SUPPLIED

Fluocinolone Acetonide Oil 0.01% Ear Drops is supplied in 1 fluid ounce bottles with a net contents of 20 mL (Dropper Included) (NDC # 65162-702-94).

Keep tightly closed. Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86°F) [See USP Controlled Room Temperature]

Caution: Rx only

Manufactured by:

Amneal Pharmaceuticals

Branchburg, NJ 08876

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 09-2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLUOCINOLONE ACETONIDE  fluocinolone acetonide  oil

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65162-702 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE 0.11 mg  in 20 mL

Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL   ISOPROPYL MYRISTATE   LIGHT MINERAL OIL   OLETH-2   PEANUT OIL

Product Characteristics Color YELLOW Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65162-702-94 1 BOTTLE In 1 CARTON contains a BOTTLE 1 20 mL In 1 BOTTLE This package is contained within the CARTON (65162-702-94)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091306	10/17/2011

Labeler - Amneal Pharmaceuticals, LLC (123797875)

Registrant - Identi Pharmaceuticals LLC (832355189)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals, LLC		963900878	MANUFACTURE, ANALYSIS

Revised: 11/2011Amneal Pharmaceuticals, LLC

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• Fluocinolone Ear Drops Support Group
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• Eczema

Ethacrynate Sodium

Pronunciation: eth-a-KRIN-ate soe-DEE-um
Generic Name: Ethacrynate Sodium
Brand Name: Sodium Edecrin

Ethacrynate Sodium is a strong "water pill" (diuretic). Using too much of Ethacrynate Sodium can lead to serious water and mineral loss. Therefore, it is important that you be monitored by your doctor. Promptly notify your doctor if you become very thirsty, have a dry mouth, become confused, or develop muscle cramps/weakness.

Ethacrynate Sodium is used for:

Treating swelling due to congestive heart failure, liver problems, and severe kidney problems. It may also be used for other conditions as determined by your doctor.

Ethacrynate Sodium is a loop diuretic. It works by making the kidneys eliminate larger amounts of electrolytes (especially sodium and potassium salts) and water than normal (diuretic effect). It is useful for treating many conditions in which salt and water retention (eg, edema, swelling) is a problem.

Do NOT use Ethacrynate Sodium if:

• you are allergic to any ingredient in Ethacrynate Sodium or to sulfonamides


• you are unable to urinate


• you are taking an aminoglycoside antibiotic (eg, gentamicin) or cephalosporin (eg, cephalexin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ethacrynate Sodium:

Some medical conditions may interact with Ethacrynate Sodium. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have fluid in your abdomen, hearing problems, liver disease, diabetes, low urine output, high blood uric acid levels or gout, a blood disorder, kidney disease, lupus, heart problems or you have had a heart attack, or you are dehydrated

Some MEDICINES MAY INTERACT with Ethacrynate Sodium. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin) because the effectiveness of Ethacrynate Sodium may be decreased


• Angiotensin converting enzyme (ACE) inhibitors (eg, captopril), aminoglycosides (eg, gentamicin), cephalosporin (eg, cephalexin), or salicylates (eg, aspirin) because serious side effects to the kidneys (decreased ability to urinate) and ears (hearing loss) may occur


• Chloral hydrate or corticosteroids (eg, prednisone) because the risk of side effects, such as excessive sweating, rapid heart beat, stomach bleeding, and changes in blood pressure may be increased


• Anticoagulants (eg, warfarin), digoxin, or lithium because the side effects may be increased by Ethacrynate Sodium

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ethacrynate Sodium may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ethacrynate Sodium:

Use Ethacrynate Sodium as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Ethacrynate Sodium is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Ethacrynate Sodium at home, carefully follow the injection procedures taught to you by your health care provider.


• If Ethacrynate Sodium contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Ethacrynate Sodium, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ethacrynate Sodium.

Important safety information:

• Ethacrynate Sodium may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ethacrynate Sodium. Using Ethacrynate Sodium alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Ethacrynate Sodium may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.


• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


• Patients being treated for high blood pressure often feel tired or rundown for a few weeks after beginning therapy. Continue using your medicine even though you might not feel quite "normal." Contact your health care provider or pharmacist about any new symptoms.


• Patients being treated for high blood pressure should avoid using nonprescription medicines that contain stimulants, such as products used for dieting (appetite suppressants) or relieving cold symptoms (eg, pseudoephedrine).


• Ethacrynate Sodium may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Ethacrynate Sodium. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• Diabetes patients - Ethacrynate Sodium may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.


• LAB TESTS, including complete blood cell counts and blood pressure monitoring, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.


• Use Ethacrynate Sodium with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Ethacrynate Sodium in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ethacrynate Sodium during pregnancy. It is unknown if Ethacrynate Sodium is excreted in breast milk. Do not breast-feed while taking Ethacrynate Sodium.

Possible side effects of Ethacrynate Sodium:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; lightheadedness; loss of appetite; nausea; restlessness; tiredness or weakness; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; diarrhea; drowsiness; dry mouth; excessive urination; fever; hearing loss; loss of appetite; muscle pain/cramps/weakness; muscle spasm; rapid or irregular heartbeat; restlessness; ringing in the ears; seeing a yellow color; seizures; severe dizziness; sudden joint pain; unusual bleeding or bruising; unusual thirst; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ethacrynate Sodium side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dehydration; electrolyte imbalance (weakness; drowsiness; dizziness; muscle pain or cramps; thirst; dry mouth; unusual tiredness; racing heartbeat; excessive urination; restlessness; muscle tiredness; irregular heart rhythms; nausea; vomiting); severe diarrhea.

Proper storage of Ethacrynate Sodium:

Ethacrynate Sodium is usually handled and stored by a health care provider. If you are using Ethacrynate Sodium at home, store Ethacrynate Sodium as directed by your pharmacist or health care provider. Keep Ethacrynate Sodium out of the reach of children and away from pets.

General information:

• If you have any questions about Ethacrynate Sodium, please talk with your doctor, pharmacist, or other health care provider.


• Ethacrynate Sodium is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ethacrynate Sodium. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ethacrynate Sodium resources

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

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• Ascites
• Edema
• Nonobstructive Oliguria
• Pulmonary Edema
• Renal Failure

Natural Ice

Generic Name: topical emollients (TOP i kal ee MOL i ents)

Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care

What are Natural Ice (topical emollients)?

Emollients are substances that moisten and soften your skin.

Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.

There are many brands and forms of topical emollients available and not all are listed on this leaflet.

Topical emollients may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Natural Ice (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.

What should I discuss with my healthcare provider before using Natural Ice (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  deep wounds or open sores;

  
  


• 
  

  swelling, warmth, redness, oozing, or bleeding;

  
  


• 
  

  large areas of skin irritation;

  
  


• 
  

  any type of allergy; or

  
  


• if you are pregnant or breast-feeding.

How should I use Natural Ice (topical emollients)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.

Shake the product container if recommended on the label.

Apply a small amount of topical emollient to the affected area and rub in gently.

If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.

Do not use this product over large area of skin. Do not apply a topical emollient to a deep puncture wound or severe burn without medical advice.

If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.

Some forms of topical emollient may be flammable and should not be used near high heat or open flame, or applied while you are smoking.

Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.

What happens if I miss a dose?

Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Natural Ice (topical emollients)?

Avoid getting topical emollients in your eyes, nose, or mouth. If this does happen, rinse with water. Avoid exposure to sunlight or tanning beds. Some topical emollients can make your skin more sensitive to sunlight or UV rays.

Natural Ice (topical emollients) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using the topical emollient and call your doctor if you have severe burning, stinging, redness, or irritation where the product was applied.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Natural Ice (topical emollients)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied products. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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• Natural Ice Use in Pregnancy & Breastfeeding
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• Campral Monograph (AHFS DI)


• Camptosar Monograph (AHFS DI)


• Diabinese Monograph (AHFS DI)


• Kinerase Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Neosalus Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Promiseb Cream MedFacts Consumer Leaflet (Wolters Kluwer)

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• Dry Skin

Where can I get more information?

• Your pharmacist can provide more information about topical emollients.

Efudex Occlusion Pack

Generic Name: fluorouracil topical (flore oh YER a sill)

Brand Names: Carac, Efudex, Efudex Occlusion Pack, Fluoroplex

What is Efudex Occlusion Pack (fluorouracil topical)?

Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.

Fluorouracil topical is used to treat scaly overgrowths of skin (actinic or solar keratoses). Fluorouracil topical may also be used in the treatment of superficial basal cell carcinoma.

Fluorouracil topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Efudex Occlusion Pack (fluorouracil topical)?

Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical. Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical.

Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.

What should I discuss with my healthcare provider before using Efudex Occlusion Pack (fluorouracil topical)?

Before using fluorouracil topical, tell your doctor if you:

• 
  

  have ever had an allergic reaction to another form of fluorouracil topical (Carac, Efudex, Fluoroplex) or injectable fluorouracil (Adrucil, 5-FU); or

  
  


• 
  

  have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

  
  

You may not be able to use fluorouracil topical, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical. It is not known whether fluorouracil topical passes into breast milk. Do not use fluorouracil topical without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of fluorouracil topical in patients younger than 18 years of age have not been established.

How should I use Efudex Occlusion Pack (fluorouracil topical)?

Use fluorouracil topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

Clean the area where you will apply fluorouracil topical. Rinse well and dry the area with a towel and wait ten minutes before applying the medication.

Wash your hands before and immediately after applying this medication, unless it is being used to treat a hand condition.

Apply fluorouracil topical to the affected area with the finger tips or a non-metal applicator, smoothing it gently onto the affected skin. Use enough to cover the entire area with a thin film.

Fluorouracil topical should not be applied on the eyelids or in the eyes, nose, or mouth. Use caution when applying fluorouracil topical around the eyes, nose, or mouth. Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical.

Do not cover the area after applying fluorouracil topical. This could cause too much medicine to be absorbed by the body and could be harmful. If a covering is needed, ask your doctor if a porous gauze dressing may be used.

A moisturizer or sun screen may be applied 2 hours after fluorouracil topical has been applied. Do not use any other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor.

The reaction of the skin treated with fluorouracil topical may be unsightly during treatment, and sometimes, for several weeks after completion of therapy.

Store fluorouracil topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not apply a double dose of this medication.

What happens if I overdose?

An overdose of fluorouracil topical is unlikely to occur. If you do suspect an overdose, or if fluorouracil topical has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using Efudex Occlusion Pack (fluorouracil topical)?

Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with the treatment or increase irritation of the skin. Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.

Efudex Occlusion Pack (fluorouracil topical) side effects

Serious side effects are not likely to occur. Stop using fluorouracil topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Efudex Occlusion Pack (fluorouracil topical)?

Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with treatment or increase irritation to the skin.

Drugs other than those listed here may also interact with fluorouracil topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Efudex Occlusion Pack resources

• Efudex Occlusion Pack Side Effects (in more detail)
• Efudex Occlusion Pack Use in Pregnancy & Breastfeeding
• Efudex Occlusion Pack Support Group
• 0 Reviews for Efudex Occlusion Pack - Add your own review/rating

• Carac Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carac Prescribing Information (FDA)


• Carac Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Efudex Prescribing Information (FDA)


• Fluoroplex Prescribing Information (FDA)

Compare Efudex Occlusion Pack with other medications

• Actinic Keratosis
• Basal Cell Carcinoma
• Skin Cancer

Where can I get more information?

• Your pharmacist has additional information about fluorouracil topical written for health professionals that you may read.

See also: Efudex Occlusion Pack side effects (in more detail)

Plan B Oral, Implantation, Parenteral

Generic Name: progestin contraceptives (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Aygestin


• Camila


• Errin


• Jolivette


• Next Choice


• Nora-BE


• Nor-QD


• Ortho Micronor


• Ovrette


• Plan B


• Plan B One-Step


• Provera

Available Dosage Forms:

• Tablet

Uses For Plan B

Progestins are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman's egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner's sperm to reach the egg. The fertilization of the woman's egg with her partner's sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.

Progestin contraceptives are available only with your doctor's prescription.

Importance of Diet

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using Plan B

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast Feeding

Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

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 any of these medicines, 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 medicines in this class 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.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Epilepsy, or history of or


• Heart or circulation problems or


• Kidney disease, severe or


• Migraine headaches—May cause fluid buildup and make these conditions worse.

• Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult.

• Breast disease (e.g., breast lumps or cysts), history of—May make this condition worse in certain types of diseases that do not react to progestins in a positive way.

• Central nervous system (CNS) disorders (e.g., depression), or history of or


• High blood cholesterol or


• Osteoporosis (brittle bones), or a family history of—May cause these conditions to occur or make these conditions worse.

• Diabetes mellitus—May cause a mild increase in blood sugar and a need to monitor blood sugar more often.

• Liver disease—The effects of some progestins may be increased. May make this condition worse.

Proper Use of progestin contraceptives

This section provides information on the proper use of a number of products that contain progestin contraceptives. It may not be specific to Plan B. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using this medicine.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using levonorgestrel tablet dosage form for emergency contraception:

• The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

• Your injection is given by a health care professional every 3 months.


• To stop using medroxyprogesterone injection for contraception, simply do not have another injection.


• Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

• Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.


• Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.


• When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.


• Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.

Dosing

The dose medicines in this class 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 these medicines. 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 levonorgestrel


• For oral dosage form (tablets):
  
  • For emergency contraception for preventing pregnancy:
    
    • Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.
    
    
  
  

• For medroxyprogesterone


• For muscular injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
    
    
  
  


• For subcutaneous injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).
    
    
  
  

• For norethindrone


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

• For norgestrel


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

• When you miss 1 day's dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

• If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.


• If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Plan B

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

• If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.

Progestins may cause dizziness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

It is possible that certain doses of progestins may cause a temporary thinning of the bones by changing your hormone balance. It is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:

• If vaginal bleeding continues for an unusually long time.


• If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately.

If you are scheduled for any laboratory tests, tell your doctor that you are taking a progestin. Progestins can change certain test results.

The following medicines might reduce the effectiveness of progestins for contraception:

• Aminoglutethimide (e.g., Cytadren®)


• Carbamazepine (e.g., Tegretol®)


• Phenobarbital


• Phenytoin (e.g., Dilantin®)


• Rifabutin (e.g., Mycobutin®)


• Rifampin (e.g., Rifadin®)

Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.

If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

Plan B 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:

More common

• Changes in uterine bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods


• heavier uterine bleeding between regular monthly periods


• lighter uterine bleeding between menstrual periods


• or stopping of menstrual periods

Less common

• Mental depression


• skin rash


• unexpected or increased flow of breast milk

Incidence not known - for patients taking Depo-Provera Contraceptive Injection

• Cough


• decrease in height


• difficulty swallowing


• fast heartbeat


• hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue


• pain in back, ribs, arms, or legs


• pain or swelling in arms or legs without any injury


• shortness of breath


• skin rash


• tightness in chest


• wheezing

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

• Abdominal pain or cramping


• diarrhea


• dizziness


• fatigue


• mild headache


• mood changes


• nausea


• nervousness


• pain or irritation at the injection site


• swelling of face, ankles, or feet


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Acne


• breast pain or tenderness


• brown spots on exposed skin, possibly long-lasting


• hot flashes


• loss or gain of body, facial, or scalp hair


• loss of sexual desire


• trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

• Delayed return to fertility


• stopping of menstrual periods


• unusual menstrual bleeding (continuing)

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.

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