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3k Cream

Kayhelt Pharmaceutical Ltd
2, Ninku Link, Secretatriat Junction, Jos Plateau State
Tel: 0803 856 6946; 0703 453 0021
Website: http://www.kayheltpharma.com

Brand Name

3k Cream

Manufacturer

Manufactured By: Ciron Drugs & Pharmaceuticals Pvt. Ltd. N-118/119. M.I.D.C" Tarapur, Boisar, Dist. Thane - 401 506. India. www.cironpharma.com

Therapeutic Class

Anti-infective/Corticosteroid combinations, Skin

Dosage Form, Composition & NAFDAC Registration Number (NRN)

CREAM (NRN: ): Composition: Each gm contains Clotrimazole BP 1.0% w/w Betamethasone, Dipropionate BP Eq. to Betamethasone 0.05% w/w Neomycin Sulphate BP 0.5% w/w Presentation: 15g/20gtube.

Pharmacology

CLINICAL PHARMACOLOGY PHARMACODYNAMICS: This Cream contains the dipropionate ester of betamethasone, a glucocorticosteroid exhibiting the general properties of corticosteroids, and clotrimazole which is an imidazole antifungal agent and Neomycin Sulphate which is antibacterial agent. Topical corticosteroids are effective in the treatment of a range of dermatoses because of their anti- inflammatory, anti-pruritic and vasoconstrictive actions. Clotrimazole is a broad-spectrum antifungal agent with activity against Trichomones, Staphylococci and Bacteroides. Neomycin sulphate is a broad-spectrum bactericidal antibiotic affective against the majority of bacteria commonly associated with skin infections. PHARMACOKINETICS: Clotrimazole Skin penetration and systemic absorption of clotrimazole following topical application of Clotrimazole and Betamethasone Dipropionate Cream have not been studied. The following information was obtained using 1% clotrimazole cream and solution formulations. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm3 in the stratum corneum, to 0.5 to 1 mcg/cm3 in the reticular dermis, and 0.1 mcg/cm3 in the subcutis. No measurable amount of radioactivity (<0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream. Only 0.5% or less of the applied radioactivity was excreted in the urine. Mechanism of Action: Clotrimazole is an imidazole antifungal agent. Imidazole inhibit 14-0- demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-a-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methyl sterols may affect the electron transport system, thereby inhibiting growth of fungi. Betamethasone Dipropionate Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Studies performed with Clotrimazole and Betamethasone Dipropionate Cream indicate that these topical combination anti-fungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high potency topical corticosteroids. Therefore, use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion. Neomycin Sulphate Actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30 S subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting. protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.

Indications

THERAPEUTIC INDICATIONS, 3K Cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tineapedis, tineacruris and tineacorporis due to Epidermophytonfloccosum, Trichophytorunentagrophytes, and Trichopbytonrubrurn. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporumcanis) has not been established. Several cases of treatment failure of cream in the treatment of infections caused by Microsporumcanis have been reported.

Contra-indications

CONTRAINDICATIONS, 3K cream is contraindicated in patients who are sensitive to c1otrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

Precautions/Warnings

Interactions

DRUG INTERACTIONS, Following significant systemic absorption, neomycin sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.

Adverse Effects

SIDE EFFECTS, Adverse reactions reported for Clotrimazole and Betamethasone Dipropionate, Neomycin Cream in clinical trials were paresthesia in 1.9% of patients, and rash, edema, and secondary infection, each in less than 1% of patients. The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy. striae, and miliaria. In the pediatric population, reported adverse events for Clotrimazole and Betamethasone Dipropionate Cream include growth retardation, benign intracranial hypertension, Cushing's syndrome (HPA axis suppression), and local cutaneous reactions, including skin atrophy. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary- adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging. blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.

Dosage & Administration

DOSAGE AND ADMINISTRATION, 3K cream should be thinly and evenly applied to the affected area two or three times a day with a gentle rub. To be used under medical supervision only. OVERDOSAGE, Amounts greater than 45 g/week of cream should not be used. Acute overdosage with topical application of cream is unlikely and would not be expected to lead to life-threatening situation cream should not be used for longer than the prescribed time period. Topically applied corticosteroids, such as the one contained in cream, can be absorbed in sufficient amounts to produce systemic-effects.

Storage/Handling Recommendations

STORAGE, Store in a cool & dry place. Keep out of reach of children. Puncture nozzle seal with piercing point of cap. FOR EXTERNAL USE ONLY

Review Date

2017-03-30 05:45:25