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Bioviderm

Biomedicine Sckivs Pharmaceuticals Nig. Ltd
3 Anionwu Street Odoakpu. P.O.Box 7846 Onitsha, Nigeria
Email: sckivspharm@yahoo.com
Tel: 234-0803-507-8844; 803-619-3742

Brand Name

Bioviderm

Manufacturer

Bharat Parenterals Ltd. VilI. Haripura, Ta. Savli, Dist. Vadodara. Gujarat. India.

Therapeutic Class

Anti-infective/Corticosteroid combinations, Skin

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Cream (NRN: A4-9754): Each gram contains: Beclometasone Dipropionate BP 0.25 mg Neomycin Sulphate BP e.q to Neomycin 5.00 mg Miconazole Nitrate BP 20 mg Chlorocresol BP (as preservative) 0.1% w/w In cream base qs.

Pack size: 30 gm tube Description: Beclometasone dipropionate, Neomycin Sulphate. and Miconazole Cream filled in a tube is intended for topical application

bioviderm

Pharmacology

PHARMACOLOGICAL ACTION:

The mechanism for the anti-inflammatory action of beclomethasone dipropionate is unknown. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. 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.

Corticosteroids are also thought to act by the induction of phospholipase A2 inhibitory proteins. Miconazole nitrate fungistatic, depending on concentration, inhibits biosynthesis of' ergosterol or other sterols, damaging the fungal cell wall membrane and altering its permeability, as a result, loss of essential intracellular elements may occur, also inhibits biosynthesis of triglycerides and phospholipids by fungi; in addition, inhibits oxidative and peroxidative enzyme activity, resulting in intracellular buildup of toxic concentrations of hydrogen peroxide, which may contribute to deterioration of subcellular organelles and cellular necrosis.

In Candida albicans, inhibits transformation of biastopores into invasive mycellular form. Neomycin acts on the bacteria by interfering with bacterial protein synthesis by binding to 30S ribosomes. The antibacterial spectrum of Neomycin includes specific organisms which are susceptible to it and generally includes all medically important aerobic gram negative bacilli except Pseudomonas aeruginosa. Anaerobic bacteria are resistant. Staphylococcus aureus and staphylococcus epidermidis are highly sensitive, but all streptococci are relatively resistant.

PHARMACOKINETICS:

Topical corticosteroids can be absorbed from normal intact skin The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Systemic absorption following use of topical Miconazole preparations is very low. Estimated bioavailability is less than 0.5%. Miconazole concentrations achieved in the epidermal layers exceed the minimal inhibitory concentrations (MICs) for almost all pathogenic fungi.

PHARMACODYNAMICS:

Beclomethasone 17, 21-dipropionate is a diester of beclomethasone which has potent glucocorticosteroid and weak mineral corticosteroid activity. Miconazole nitrate fungistatic, which may contribute to deterioration of subcellular organelles and cellular necrosis. The antibacterial spectrum of Neomycin includes specific organisms which are susceptible to it and generally includes all medically important aerobic gram negative bacilli except Pseudomonas aeruginosa.

Indications

Beclometasone dipropionate, Neomycin sulphate and Miconazole cream is indicated for the relief of the inflammatory manifestations of corticosteroid responsive dermatoses when complicated by secondary infection caused by organisms’ sensitive to the components of this dermatologic preparation or when the possibility of such infection is suspected.

Such disorders include: chronic dermatitis of the extremeties, balanoposthitis, eczematoid dermatitis, contact dermatitis, follicular dermatitis, parakeratosis, paronychia, anal pruritus, intertrigo, impetigo, neurodermatitis, angular stomatitis, photosensitivity dermatitis, lichenfied inquinal dermatophytosis and tinea infections such as tinea pedis, tinea cruris and tinea corporis.

Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Contra-indications

Beclometasone dipropionate, Neomycin Sulphate and Miconazole Cream is contraindicated in those patients with a history of sensitivity reactions to any of its components.

Precautions/Warnings

Treatment should not be continued for more than 7 days without medical supervision.

Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for-prolonged periods of time.

Interactions

Beclomethasone dipropionate: None well documented

Miconazole nitrate: Miconazole shows interaction with drugs like anticoagulant or suphonylurea, hypoglycaemic drugs, clomipranine, carbamazepine and phenytoin, latex products, rifampicin and ketoconazole (an imidazole) and cyclosporine A.

Neomycin sulphate: Concurrent topical and systemic use of Neomycin or related drugs is not recommended since hypersensitivity reactions may occur more frequently during concurrent use.

Adverse Effects

The most frequent adverse reactions reported were burning, irritation, itching and stinging sensation.

Less frequent adverse reactions were itching, skin atrophy, cracking and fissuring of the skin, stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy and telangiectasia.

ADVERSE REACTION:

The following additional local adverse reactions have been reported with topical corticosteroids-dryness, acneiform, eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and malaria.

Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have been reported. The reaction most frequently occurring is allergic sensitization.

Dosage & Administration

A small quantity of BIOVIDERM should be applied to cover completely the affected area two or three times daily or as prescribed by the physician. Frequency of application should be determined according to seventy of the condition.

Duration of therapy should be determined by patient response. In cases of tinea pedis, longer therapy (2 - 4 weeks) may be necessary.

OVERDOSAGE

Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism, including Cushing’s disease.

Excessive or prolonged use of topical antibiotics may lead to overgrowth of lesions by non-susceptible organisms.

Storage/Handling Recommendations

Store away from light and in a cool dry place.

Keep out of reach of children.

Review Date

2016-06-14 11:24:47