Dermotel

Clobetasol Propionate:

• Dermotel information
• Dermotel indications
• Dermotel warnings
• Dermotel intake guidelines
• Dermotel dosage
• Dermotel overdose
• Dermotel missed dose
• Dermotel side effects
• Dermotel drug reactions
• Dermotel (Clobetasol Propionate) reviews

Dermotel information

Dermotel (Clobetasol Propionate) (also known as Clobevate, Cormax, Cormax Scalp Application, Embeline, Olux, and Temovate) is a strong corticosteroid, used to treat a variety of skin conditions such as dermatitis, allergies, rashes and eczema.

Dermotel indications

Dermotel (Clobetasol Propionate) is a popular medicine that is generally prescribed in the treatment of the patients with skin diseases in order to reduce the itching, redness and swelling of the affected parts of the body. Dermotel (Clobetasol Propionate) is meant only for external use. Patients should not allow the medication to get into their eyes, nose and mouth. Patients should also avoid putting dressings, other skin medications or bandages on the area which is treated with Dermotel (Clobetasol Propionate) Pharmaniaga.

Dermotel warnings

Before beginning the treatment with Dermotel (Clobetasol Propionate) the patients should inform their doctor or personal healthcare provider if they are allergic to any of this drug's components or to any other corticosteroids such as Prednisone or hydrocortisone. Patients should also tell the doctor if they have other allergies. Before using Dermotel (Clobetasol Propionate) patients must tell their PD about their medical history, especially if they have immune system problems, poor blood circulation or other skin conditions such as dermatitis. In very rare cases this medicine might be absorbed into the bloodstream and this condition will require treatment also based on corticosteroids. This may happen in children who are using it or in the case of individuals who have been using it for long periods of time. Pregnant women should not use Dermotel (Clobetasol Propionate) Pharmaniaga, unless it is clearly needed; however, they should discuss with their personal healthcare provider the benefits and risks of such a treatment.

Dermotel intake guidelines

Patients should use Dermotel (Clobetasol Propionate) only on the skin and not on the groin, underarms, face, unless their doctor or personal healthcare provider advises them to do so. You should wash and dry your hands very well and thoroughly clean the affected area before applying Dermotel (Clobetasol Propionate) Pharmaniaga. This medicine should be applied in a thin film to the affected area and then rubbed. This process should be done by patients two times a day, except the cases when the doctor has prescribed them other instructions. When the patients must apply this medicine near the eyes, they should be extra careful not to put it in their eyes because this can lead to a medical condition known as glaucoma.

Dermotel dosage

Dermotel (Clobetasol Propionate) should be applied directly on the affected skin areas at least twice a day. The treatment should not last longer than four weeks, as this medicine contains a very strong topical corticosteroid. Usually the dose should not be more than 50g a week.

You should not use a medicine which looks discolored or that contains any sort of particle. Do not stop your treatment with Dermotel (Clobetasol Propionate) without your physician's approval, even if you feel that your condition has not improved at all. If you feel that your treatment with this medicine is not working properly, you should alert your personal health care provider.

Dermotel overdose

In most of the cases that involve an overdose of Dermotel (Clobetasol Propionate) Pharmaniaga, the medicine is absorbed in an abnormally high amount in the patient's blood stream; this can lead to systemic effects. The systemic absorption usually cases reversible adrenal suppression which may eventually lead to an insufficiency of corticosteroids in the organism. In other cases the patients may experience symptoms of Cushing's syndrome, glucosuria and even hyperglycemia which are also due to the systemic absorption.

Dermotel missed dose

It is important to try to take each of your scheduled doses of Dermotel (Clobetasol Propionate) at their due time. However, if you happen to miss taking one of your prescribed doses of this product you should use it as soon as you recall. If it is already time for another dose, we advise you to forget about the one that you have missed and to proceed with your regular dosing schedule. Do not apply double doses of Dermotel (Clobetasol Propionate) without your personal physician's approval.

Dermotel side effects

The most common side effects that patients who are under treatment with Dermotel (Clobetasol Propionate) may experience are the following: burning, stinging, dryness, redness, itching, and so on. These side effects usually appear when the product is applied to the skin for the first time, but they should pass in a few days; in case these side effects do not go away the patients should contact their pharmacist or personal healthcare provider.

Individuals should alert their doctor or health care specialist if they develop any of the following side effects: stretch marks, acne, hair bumps (also known as follicullitis), skin thinning, skin discoloration, extreme hair growth and unwanted hair growth. Patients should also inform their doctor if the redness, irritation and swelling do not improve. Serious allergic reactions are very rare in patients who are using Dermotel (Clobetasol Propionate) Pharmaniaga, but in case the patients experience rash, swelling, itching, breathing problems, severe dizziness, they should inform their physician as quickly as they can. This is not a complete list with the side effects that the intake of this medicine can lead to; this is why it is very important to discuss with your doctor in the case in which you develop other symptoms than those listed above.

Dermotel drug reactions

Generally it is improbable for Dermotel (Clobetasol Propionate) to interact with other drugs. However, it is well known that many drugs harmfully interact among each other and this is why it is very important to inform your doctor about all the other medicines that you are taking during your therapy with this drug (including vitamins, minerals, over-the-counter medications or herbal products). It is also important to not start taking a new drug without consulting with your personal healthcare provider.

Miconazole Nitrate:

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Dermotel (Miconazole Nitrate) reviews

1 INDICATIONS AND USAGE

• Dermotel Ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older. (1)
• Dermotel (Miconazole Nitrate) Ointment should not be used as a substitute for frequent diaper changes. (1)
• Dermotel (Miconazole Nitrate) Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. (1)

1.1 Indication

Dermotel (Miconazole Nitrate) Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicansis not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.

Dermotel (Miconazole Nitrate) should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.

Dermotel (Miconazole Nitrate) should not be used as a substitute for frequent diaper changes. Dermotel (Miconazole Nitrate) should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.

1.2 Limitations of Use

The safety and efficacy of Dermotel (Miconazole Nitrate) have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).

The safety and efficacy of Dermotel (Miconazole Nitrate) have not been evaluated in incontinent adult patients. Dermotel (Miconazole Nitrate) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

2 DOSAGE AND ADMINISTRATION

Dermotel (Miconazole Nitrate) is not for oral, ophthalmic, or intravaginal use.

Before applying Dermotel (Miconazole Nitrate), gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area.

Apply Dermotel (Miconazole Nitrate) to the affected area at each diaper change for 7 days. Continue treatment for the full 7 days, even if there is improvement. The safety of Dermotel (Miconazole Nitrate) when used for longer than 7 days is not known. Do not use Dermotel (Miconazole Nitrate) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.

Gently apply a thin layer of Dermotel (Miconazole Nitrate) to the diaper area with the fingertips. Do not rub Dermotel (Miconazole Nitrate) into the skin as this may cause additional irritation. Thoroughly wash hands after applying Dermotel (Miconazole Nitrate).

• Dermotel (Miconazole Nitrate) Ointment is for topical use only. Dermotel (Miconazole Nitrate) Ointment is not for oral, ophthalmic, or intravaginal use. (2)
• Dermotel (Miconazole Nitrate) Ointment should be applied as a thin layer to the affected area at each diaper change for 7 days. (2)
• Dermotel (Miconazole Nitrate) Ointment should be used as part of a treatment regimen that includes gentle cleansing of the diaper area and frequent diaper changes. (2)

3 DOSAGE FORMS AND STRENGTHS

White ointment containing 0.25% Dermotel (Miconazole Nitrate) nitrate, 15% zinc oxide, and 81.35% white petrolatum.

• Ointment with 0.25% Dermotel (Miconazole Nitrate) nitrate, 15% zinc oxide, and 81.35% white petrolatum. (3)

4 CONTRAINDICATIONS

None

• None

5 WARNINGS AND PRECAUTIONS

If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.

The safety and efficacy of Dermotel (Miconazole Nitrate) have not been evaluated in incontinent adult patients. Dermotel (Miconazole Nitrate) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

• If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. (5)

6 ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Prestium Pharma, Inc. at 1-866-897-5002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the Dermotel group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with Dermotel (Miconazole Nitrate) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

6.2 Post-marketing Experience

The following adverse reactions have been identified during post approval use of Dermotel (Miconazole Nitrate).

GASTROINTESTINAL DISORDERS: vomiting

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: burning sensation, condition aggravated, inflammation, pain

INJURY, POISONING AND PROCEDURAL COMPLICATIONS: accidental exposure

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

7 DRUG INTERACTIONS

Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a Dermotel (Miconazole Nitrate) intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and Dermotel (Miconazole Nitrate) is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Dermotel in pregnant women. Therefore, Dermotel (Miconazole Nitrate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Dermotel (Miconazole Nitrate) nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day, which are 28 and 45 times the maximum possible topical exposure of caregivers, respectively, assuming 100% absorption.

8.3 Nursing Mothers

Safety and efficacy of Dermotel (Miconazole Nitrate) have not been established in nursing mothers. It is not known if the active components of Dermotel (Miconazole Nitrate) may be present in milk.

8.4 Pediatric Use

Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants.

Dermotel should not be used to prevent diaper dermatitis.

The safety of Dermotel (Miconazole Nitrate) when used for longer than 7 days is not known. Do not use more than 7 days.

8.5 Geriatric Use

Safety and efficacy in a geriatric population have not been evaluated.

11 DESCRIPTION

Dermotel (Miconazole Nitrate) contains the synthetic antifungal agent, Dermotel (Miconazole Nitrate) nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.

The chemical name of Dermotel (Miconazole Nitrate) nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C₁₈H₁₄Cl₄N₂O-HNO₃ and molecular weight of 479.15. The structural formula of Dermotel (Miconazole Nitrate) nitrate is as follows:

The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.

The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula C_nH_2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.

Each gram of Dermotel (Miconazole Nitrate) contains 2.5 mg of Dermotel (Miconazole Nitrate) nitrate USP, 150 mg of zinc oxide USP, and 813.5 mg of white petrolatum USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm^® 1001/B fragrance.¹

Dermotel (Miconazole Nitrate) is a smooth, uniform, white ointment.

Structural formula of Dermotel (Miconazole Nitrate) nitrate

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The Dermotel component of Dermotel (Miconazole Nitrate) is an antifungal agent. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.

12.2 Pharmacodynamics

The human pharmacodynamics of Dermotel (Miconazole Nitrate) is unknown.

12.3 Pharmacokinetics

The topical absorption of Dermotel from Dermotel (Miconazole Nitrate) was studied in immunocompetent male and female infants and children (n=17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of Dermotel (Miconazole Nitrate) were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of Dermotel (Miconazole Nitrate) were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.

12.4 Microbiology

The Dermotel (Miconazole Nitrate) nitrate component in this product has been shown to have in vitro activity against Candida albicans, an organism that is associated with diaper dermatitis. The activity of Dermotel (Miconazole Nitrate) nitrate against C. albicans is based on the inhibition of the ergosterol biosynthesis in the cell membrane. The accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell. In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Clinical Study 1 (see Clinical Studies (14)) does not appear to indicate that resistance to Dermotel (Miconazole Nitrate) nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of Dermotel (Miconazole Nitrate) nitrate against C. albicans in the setting of diaper dermatitis is unclear.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Dermotel (Miconazole Nitrate) in animals has not been evaluated.

Dermotel (Miconazole Nitrate) nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.

Dermotel (Miconazole Nitrate) nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day, which is 89 times the maximum possible topical exposure of caregivers, assuming 100% absorption.

14 CLINICAL STUDIES

Study 1 was a double-blind, multicenter study in which Dermotel (Miconazole Nitrate) was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated psuedohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.

The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.

Study results are shown in the following table.

Two additional studies provided supportive evidence of the clinical efficacy of Dermotel (Miconazole Nitrate) in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Dermotel is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:

50g (NDC 40076-002-50)

16.2 Storage Conditions

Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

Patients using Dermotel (Miconazole Nitrate) should be informed about the following information:

• Dermotel (Miconazole Nitrate) is to be used only for diaper dermatitis that is complicated by documented candidiasis (i.e. documented by microscopic testing).
• Dermotel (Miconazole Nitrate) should not be used as a substitute for frequent diaper changes.
• Dermotel (Miconazole Nitrate) should not be used to prevent diaper dermatitis.
• Dermotel (Miconazole Nitrate) should not be used long term.
• Dermotel (Miconazole Nitrate) should be used only as directed by the health care provider.
• Dermotel (Miconazole Nitrate) is for external use only. It is not for oral, ophthalmic, or intravaginal use.
• Gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying Dermotel (Miconazole Nitrate).
• Gently apply Dermotel (Miconazole Nitrate) to the diaper area with the fingertips after each diaper change. Do not rub Dermotel (Miconazole Nitrate) into the skin as this may cause additional irritation.
• Thoroughly wash hands after applying Dermotel (Miconazole Nitrate).
• Treatment should be continued for 7 days, even if there is improvement. Do not use Dermotel (Miconazole Nitrate) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
• Dermotel (Miconazole Nitrate) should not be used on children for whom it is not prescribed.

Manufactured for:

Prestium Pharma, Inc.

Newtown, PA 18940

Manufactured by:

GlaxoSmithKline

Mississauga, ON, Canada

Made in Canada

© 2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.

Revised Oct 2013 VSN:3PI

FDA-Approved Patient Labeling

Dermotel (Miconazole Nitrate)^® (Vu-sion) Ointment

(0.25% Dermotel (Miconazole Nitrate) nitrate, 15% zinc oxide and 81.35% white petrolatum)

IMPORTANT: For Skin Use Only. Do not use in the mouth, eyes, or vagina.

Read the Patient Information that comes with Dermotel (Miconazole Nitrate) before you use it on your child. This leaflet does not take the place of talking to your health care provider about your child’s medical condition or treatment. If you have any questions or if you are not sure about any of the information on Dermotel (Miconazole Nitrate), ask your health care provider, or pharmacist.

What is Dermotel (Miconazole Nitrate)?

Dermotel (Miconazole Nitrate) is a prescription skin medicine used to treat diaper rash that also has a yeast infection in children who are at least 4 weeks old and who have a normal immune system. Dermotel (Miconazole Nitrate) contains medicines that will help treat the yeast infection and the diaper rash, but you must also change your child’s diapers very often so that your child is not wearing a wet or soiled diaper. Even if you use Dermotel (Miconazole Nitrate), diaper rash will not go away if you do not keep your child’s diaper area clean and dry. You should use water or a very mild cleanser to clean your child’s diaper area. Dermotel (Miconazole Nitrate) is not to be used to prevent diaper rash or to be used for more than 7 days.

Your health care provider will need to do a special test to tell if your child’s diaper rash also has a yeast infection. Do not use Dermotel (Miconazole Nitrate) on your child’s diaper rash unless your health care provider tells you that there is also a yeast infection.

Who should not use Dermotel (Miconazole Nitrate)?

Dermotel (Miconazole Nitrate) is not for treatment of all cases of diaper rash. Dermotel (Miconazole Nitrate) is only for diaper rash that also has a yeast infection. Most cases of diaper rash do not need the yeast medicine that is in Dermotel (Miconazole Nitrate) because most cases of diaper rash do not also have a yeast infection.

Do not use Dermotel (Miconazole Nitrate) on any other children or other family member.

Do not use Dermotel (Miconazole Nitrate) on your child’s diaper rash if they are allergic to anything in it. See the end of this leaflet for a list of ingredients in Dermotel (Miconazole Nitrate).

Do not use on infants less than 4 weeks of age.

Do not use in infants or children who do not have a normal immune system.

How should I use Dermotel (Miconazole Nitrate) on my child?

Dermotel (Miconazole Nitrate) is applied to the skin on your child’s diaper area at each diaper change for 7 days.

Apply Dermotel (Miconazole Nitrate) for the full 7 days even if the diaper rash starts to go away. Call your child’s health care provider if the diaper rash gets worse or does not go away with 7 days of treatment with Dermotel (Miconazole Nitrate). Dermotel (Miconazole Nitrate) should not be used for more than 7 days.

To apply Dermotel (Miconazole Nitrate):

• Gently, clean the skin on your child’s diaper area with warm ( not hot ) water. You may also use a very mild soap. Pat the area dry with a soft towel.
• Use your fingertips and gently apply a thin layer of Dermotel (Miconazole Nitrate) to your child’s diaper area at each diaper change. Do not rub Dermotel (Miconazole Nitrate) into your child’s skin. Rubbing the skin can cause more irritation.
• Wash your hands after applying Dermotel (Miconazole Nitrate) on your child.

Dermotel (Miconazole Nitrate) is for skin use only.

Call your child’s health care provider or poison control center right away if any Dermotel (Miconazole Nitrate) is swallowed. Call your child’s health care provider if Dermotel (Miconazole Nitrate) gets in the eye.

Keep out of reach of children.

What other steps will help diaper rash go away?

• Check your child’s diaper often. Change the diaper at the first sign of wetness.
• Clean your child’s diaper area after each diaper change. Gently wipe the diaper area from the front to back using warm ( not hot )water. You may also use a mild soap. Rinse the diaper area well. Pat dry with a soft towel.
• Keep the diaper area open to air when possible.
• Even if you use Dermotel (Miconazole Nitrate), diaper rash will not go away if you do not keep your child’s diaper area clean and dry.

What are the possible side effects of Dermotel (Miconazole Nitrate)?

Dermotel (Miconazole Nitrate) may cause irritation. You should call your child’s health care provider if irritation appears or if the diaper rash gets worse.

How should I store Dermotel (Miconazole Nitrate)?

• Keep Dermotel (Miconazole Nitrate) out of the reach of children to avoid the risk of accidental ingestion.
• Store Dermotel (Miconazole Nitrate) at room temperature between 68°F to 77°F (20°C to 25°C).

General information about Dermotel (Miconazole Nitrate)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use Dermotel (Miconazole Nitrate) for a condition for which it was not prescribed. Do not give Dermotel (Miconazole Nitrate) to other children or family members, even if they have the same symptoms your child has. It may harm them.

This leaflet summarizes the most important information about Dermotel (Miconazole Nitrate). If you would like more information, talk to your child’s health care provider. You can ask your child’s health care provider or pharmacist for information about Dermotel (Miconazole Nitrate) that is written for healthcare professionals.

Side effects may be reported to Prestium Pharma, Inc. at 1-866-897-5002 or the FDA at 1-800-FDA-1088.

What are the ingredients in Dermotel (Miconazole Nitrate)?

Active Ingredients: Dermotel (Miconazole Nitrate) nitrate, zinc oxide, and white petrolatum

Inactive Ingredients: trihydroxystearin, butylated hydroxyltoluene (BHT), and Chemoderm^® 1001/B fragrance

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

The Patient Information leaflet was last revised: October 2013

Manufactured for:

Prestium Pharma, Inc.

Newtown, PA 18940

Manufactured by:

GlaxoSmithKline

Mississauga, ON, Canada

Made in Canada

© 2013 Delcor Asset Corporation, an affiliate of

Prestium Pharma, Inc.

Revised Oct 2013

VSN:3PIL

Principal Display Panel

NDC 40076-002-50

Dermotel (Miconazole Nitrate)^®

(miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP)

Ointment

50 grams

R_x only

Principal Display Panel NDC 40076-002-50 Vusion® (miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP) Ointment 50 grams Rx only

Neomycin:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Dermotel (Neomycin) reviews

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dermotel (Neomycin) sulfate tablets and other antibacterial drugs, Dermotel (Neomycin) sulfate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Suppression of Intestinal Bacteria

Dermotel (Neomycin) sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).

Hepatic Coma (Portal-Systemic Encephalopathy)

Dermotel (Neomycin) sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.

CONTRAINDICATIONS

Dermotel (Neomycin) sulfate oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to Dermotel (Neomycin). Dermotel (Neomycin) sulfate oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of Dermotel (Neomycin).

WARNINGS

Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.

The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of Dermotel (Neomycin) have not been conducted. If Dermotel (Neomycin) is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS

General

Prescribing Dermotel sulfate tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antibiotics, use of oral Dermotel (Neomycin) may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

Dermotel (Neomycin) is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of Dermotel (Neomycin).

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered Dermotel (Neomycin) are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of Dermotel (Neomycin). If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral Dermotel (Neomycin) dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered Dermotel (Neomycin) increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for The Patient

Patients should be counseled that antibacterial drugs including Dermotel (Neomycin) sulfate tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Dermotel (Neomycin) sulfate tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Dermotel (Neomycin) sulfate tablets or other antibacterial drugs in the future.

Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.

Laboratory Tests

Patients with renal insufficiency may develop toxic Dermotel blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve (eighth cranial nerve) function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Drug Interactions

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of Dermotel (Neomycin) (see boxed WARNINGS ).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate Dermotel (Neomycin) sulfate’s neuromuscular blocking effects.

Oral Dermotel (Neomycin) inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral Dermotel (Neomycin) sulfate may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Dermotel sulfate to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

See WARNINGS section.

Nursing Mothers

It is not known whether Dermotel is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of oral Dermotel (Neomycin) sulfate in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, Dermotel (Neomycin) should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

ADVERSE REACTIONS

The most common adverse reactions to oral Dermotel (Neomycin) sulfate are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).

OVERDOSAGE

Because of low absorption, it is unlikely that acute overdosage would occur with oral Dermotel (Neomycin) sulfate. However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Dermotel (Neomycin) sulfate from the blood.

DOSAGE AND ADMINISTRATION

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:

• Withdraw protein from diet. Avoid use of diuretic agents.
• Give supportive therapy, including blood products, as indicated.
• Give Dermotel (Neomycin) sulfate tablets in doses of 4 to 12 grams of Dermotel (Neomycin) sulfate per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.
• If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, Dermotel (Neomycin) in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS ). Also, Dermotel (Neomycin) serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of Dermotel (Neomycin) in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.

Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Dermotel (Neomycin) sulfate (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.

Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

HOW SUPPLIED

Dermotel (Neomycin) sulfate tablets USP, 500 mg (equivalent to 350 mg of Dermotel (Neomycin) base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:

Bottles of 100 (NDC 0527-1210-01)

Store at 20° to 25°C (68° to 77°F).

Dispense in tight containers as defined in the USP/NF.

Distributed By:

Lannett Company, Inc.

Philadelphia, PA 19154

Made in the USA

Rev. 01/17

CIB71710A