Dermovate-NN

Clobetasol Propionate:

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

Dermovate-NN information

Dermovate-NN (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.

Dermovate-NN indications

Dermovate-NN (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. Dermovate-NN (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 Dermovate-NN (Clobetasol Propionate) Pharmaniaga.

Dermovate-NN warnings

Before beginning the treatment with Dermovate-NN (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 Dermovate-NN (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 Dermovate-NN (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.

Dermovate-NN intake guidelines

Patients should use Dermovate-NN (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 Dermovate-NN (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.

Dermovate-NN dosage

Dermovate-NN (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 Dermovate-NN (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.

Dermovate-NN overdose

In most of the cases that involve an overdose of Dermovate-NN (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.

Dermovate-NN missed dose

It is important to try to take each of your scheduled doses of Dermovate-NN (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 Dermovate-NN (Clobetasol Propionate) without your personal physician's approval.

Dermovate-NN side effects

The most common side effects that patients who are under treatment with Dermovate-NN (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 Dermovate-NN (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.

Dermovate-NN drug reactions

Generally it is improbable for Dermovate-NN (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.

Neomycin Sulfate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Dermovate-NN (Neomycin Sulfate) reviews

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dermovate-NN (Neomycin Sulfate) tablets and other antibacterial drugs, Dermovate-NN (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

Dermovate-NN (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)

Dermovate-NN (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

Dermovate-NN (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 neomycin. Dermovate-NN (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of 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 neomycin have not been conducted. If 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 Dermovate-NN 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 neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

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 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 neomycin are absorbed through intact intestinal mucosa.

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

An oral 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 neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for The Patient

Patients should be counseled that antibacterial drugs including Dermovate-NN (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Dermovate-NN (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 Dermovate-NN (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 neomycin 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 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 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 neomycin sulfate’s neuromuscular blocking effects.

Oral 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 Dermovate-NN (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 Dermovate-NN to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

See WARNINGS section.

Nursing Mothers

It is not known whether neomycin 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 Dermovate-NN (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, 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 Dermovate-NN (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 Dermovate-NN (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Dermovate-NN (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 Dermovate-NN (Neomycin Sulfate) tablets in doses of 4 to 12 grams of Dermovate-NN (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, 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, 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 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. Dermovate-NN (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

Dermovate-NN (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of 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

Nystatin:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Dermovate-NN (Nystatin) reviews

DESCRIPTION

Dermovate-NN (Nystatin), USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

• C₄₇H₇₅NO₁₇ M.W. 926.13

Dermovate-NN (Nystatin) Tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.

Structural formula for Dermovate-NN (Nystatin)

CLINICAL PHARMACOLOGY

Pharmacokinetics

Gastrointestinal absorption of Dermovate-NN is insignificant. Most orally administered Dermovate-NN (Nystatin) is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Dermovate-NN (Nystatin) may occasionally occur.

Microbiology

Dermovate-NN (Nystatin) is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to Dermovate-NN (Nystatin) in vitro on repeated subculture in increasing levels of Dermovate-NN (Nystatin); other Candida species become quite resistant. Generally, resistance does not develop in vivo. Dermovate-NN (Nystatin) acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Dermovate-NN (Nystatin) exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

Dermovate-NN (Nystatin) tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

CONTRAINDICATIONS

Dermovate-NN (Nystatin) tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Dermovate-NN. It is also not known whether Dermovate-NN (Nystatin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dermovate-NN (Nystatin) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Dermovate-NN (Nystatin) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dermovate-NN (Nystatin) is administered to a nursing woman.

ADVERSE REACTIONS

Dermovate-NN is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).

Gastrointestinal

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

OVERDOSAGE

Oral doses of Dermovate-NN (Nystatin) in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units Dermovate-NN (Nystatin)) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

HOW SUPPLIED

Dermovate-NN (Nystatin) Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets (NDC 0093-0983-01).

Store at 20° to 25°C (68° to 77°F).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured By:

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. N 2/2016

NDC 0093-0983-01

Dermovate-NN (Nystatin)

Tablets USP

500,000 units (oral)

Rx only

100 TABLETS

TEVA