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Begecin

JB Pharmaceuticals Ltd
JB House, 40B Commercial Avenue, Sabo-Yaba, Lagos State, Nigeria
Email: jbpharma@hotmail.com
Tel: 01-793-8369, 234-806-905-5837, 234-803-662-6117
Fax: 01-3425272
Website: http://jbpharma.com

Brand Name

Begecin

Manufacturer

Rhydburg Pharmaceuticals Ltd. C-2 & 3, S.I.E.L, Selaqui, Dehradun, Uttarakhand, INDIA

Therapeutic Class

Anti-infective/Corticosteroid combinations, Skin

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Cream (NRN:B4-0174): Anhydrous Beclometasone Dipropionate BP 0.025% w/w Gentamicin Sulphate BP eq. to Gentamicin 0.2% w/w Clotrimazole BP 1.0% w/w Iodochlorhydroxyquinoline BP 2.0% w/w Exciplents

Pack Size: 30 gm

Begecin

Pharmacology

Description:

White thick soft mass.

Pharmacodynamics

Beclometasone dipropionate is a glucocorticoid which has anti-inflammatory, antipruritic and vasoconstrictive properties.
Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc. Under appropriate test conditions, the minimum inhibitory concentration (MIC) values for these types of fungi are in the region of less than 0.062-4 (-8) mg/mL substrate. The mode of action of clotrimazole is primarily fungistatic.

In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive. In addition to its antimycotic action, clotrimazole also acts on Trichomonas vaginalis, gram-positive microorganisms (Streptococci/Staphylococci) and gram-negative microorganisms (Bacteroides/Gardnerella vaginalis).

In vitro clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci-with the exception of Enterococci in concentrations of 0.5 - 10 mg/mL substrate and exerts a trichomonacidal action at 100 mg/mL. Primary resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions. 

Iodochlorohydroxyquinoline: Broad-spectrum antibacterial with antifungal properties. Iodochlorohydroxyquinoline is bacteriostatic, however, the precise mechanism of its action is unknown.

Pharmacokinetics:

Absorption of clotrimazole is less than 0.5% after application to skin/topical application Iodochlorohydroxyquinoline: Topical absorption is rapid and extensive, especially when the skin is covered with an occlusive dressing or if the medication is applied to extensive or eroded areas of the skin.

Iodochlorhydroxyquinoline is absorbed through the skin in sufficient amounts to affect thyroid function tests. Application of Iodochlorohydroxyquinoline to extensive or eroded areas of the skin may lead to Increased protein-bound iodine (PBI) levels within 1 week. In addition, elevated PBI levels may occur when relatively small areas of the skin are treated with lodochlorohydroxyquinoline for more than 1 week.

Indications

BEGECIN is indicated for the relief from Impetigo, Furunculosis, secondary Infected dermatoses, Napkin rashes, Otitis externa, Intertringinous eruptions, Atopic and discoid eczema, dermatitis, psoriasis, lichen simplex, discoid lupus erythematosus.

BEGECIN is commonly used for the treatment and prevention of the symptoms of discomfort of many types of skin problems.

BEGECIN is also used for the treatment of a variety of skin conditions such as contact dermatitis, atopic dermatitis, eczema, lichen planus, bug bites, bums, psoriasis, severe diaper rash, chronic discoid lupus erythematosus, alopecia areata, mycosis fungoides, dermatophyte and fungus or yeast infections.

BEGECIN reduces or inhibits the actions of chemicals in the body that cause Inflammation, redness, and swelling.

BEGECIN works by reducing irritation and itching on the affected areas of the skin.

Contra-indications

Hypersensitivity to any of the ingredients of the cream. Rosacea, acne, pert-oral dermatitis, tuberculosis of the skin and varicose ulcers. Skin lesions caused by infection with viruses (e.g. herpes simplex vaccinia or varicella), fungi (e.g. candida, tinea) or bacteria (e.g. impetigo). Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded.

Therefore, cream should not be used during pregnancy & during breast feeding. Not using for more than 1 week; checking with physician if skin infection does not improve in 1 week, or If it becomes worse. Not using on extensive areas of the skin or eroded, open skin lesions, because of the possibility of increased protein-bound iodine levels. Iodochlorohydroxyquinoline may turn yellow in color when exposed to air and may stain fabrics, skin, hair, and nails yellow; bleaching may not remove stain.

Pregnancy and Breastfeeding:

This medicine should not be used during pregnancy unless considered essential by your doctor. If It is prescribed by your doctor it should not be used on large areas of skin, underneath airtight dressings, or for prolonged periods of time. Consult your doctor for further information.

This medicine should not be used during breastfeeding unless considered essential by your doctor. If it is prescribed by your doctor it should not be used on large areas of skin, underneath airtight dressings or for prolonged periods of time. lf it is applied to the breasts it should be washed off carefully before breastfeeding and then reapplied afterwards.

Precautions/Warnings

BEGECIN should be used for short courses only, as prolonged and intensive treatment may cause local atrophic changes in the skill such as stria, thinning, loss of elasticity, dilatation of the superficial blood vessels, telangiectasia and ecchymosis. These changes are particularly likely to occur on the face, where occlusive dressings are used, or where skin folds are involved.

Prolonged use, use of large amounts, treatment extensive areas. or application to damaged skin, when cream is used and when the occlusive dressing technique is applied can result in sufficient systemic absorption to produce the features of hypercortisonsim such as depression of the hypothalamic pituitary-adrenal axis with consequent suppression of the adrenal gland. These effects are most likely to be severe in infants and children. Growth may be retarded and a Cushingoid state may be produced.

Benign intracranial hypertension has been reported less frequently. In infants the napkin may act as an occlusive dressing, and hence these preparations should not be used in the nappy area for flexural eruptions. Ideally they should not be used in infants and young children at all. Regular review should be made of the necessity for continuing therapy. Treatment of psoriasis with cream (or its withdrawal) may provoke the pustular form of the disease.

If signs of hypersensitivity appear, application should stop immediately. The least potent corticosteroids should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacea-like facies may be produced. This must be borne in mind when treating such conditions as psoriasis, discold lupus erythematosus, and severe eczema with cream.

Topical corticosteroids preparations should be used with caution near the eyes; application to the eyelids may cause glaucoma. Corticosteroids should never be used in the presence of infection except in conjunction with effective chemotherapy. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.

Iodochlorohydroxyquinoline: Skin sensitization

Clotrimazole: Local reactions include irritation, burning sensation, contact dermatitis, blister, edema, erythema, peeling of skin, pruritus, urticaria and stinging of skin

Gentamicin Sulphate: The use of topical antibiotics occasionally allows overgrowth of nonsusceptible organism, including fungi. If this condition occurs or if irritation, sensitization or superinfection develops, treatment with gentamicin sulfate should be discontinued and appropriate therapy instituted

Interactions

Adverse Effects

Gentamicin Sulphate:

In patients with dermatoses treated with gentamicin sulfate, irritation (erythema and pruritis) that did not usually require discontinuance of treatment has been reported in a small percentage of cases. There was no evidence of irritation or sensitization, however, in any of these patients patch-tested subsequently with gentamicin sulfate on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin sulfate followed by exposure to ultraviolet radiation.

Clotrimazole:

Nausea. vomiting, unpleasant mouth sensations and pruritus.

Dosage & Administration

General:

The affected area should be washed and thoroughly dried. Thin layer of cream Is evenly rubbed into the affected area twice daily. Treatment should continue for 2 - 4 weeks after the disappearance of all signs of infection to ensure mycological cure and prevent relapse.

• Adult & Paediatric: dosing based on type of infection

• Candidiasis (topical): twice daily for up to 4 weeks

• Pityriasis versicolor (tinea versicolor): twice daily for upto 4 weeks

• Tinea corporis: twice daily for up to 4 weeks

• Tinea cruris: Cream/solution; twice daily for upto 4 weeks

• Tinea cruris (2 years and older): Lotion; twice daily for 2 weeks

• Tlnea pedis: twice daily for upto 4 weeks

Overdose:

Excessive or prolonged use of cream may result in systemic absorption of steroid and complications of steroid therapy, especially growth retardation in children, suppression of pituitary adrenal function, Increased susceptibility to refection, hyperglycaemia, Cushingoid state and benign intracranial hypertension. Cessation of treatment with appropriate symptomatic and supportive treatment is indicated.

Storage/Handling Recommendations

Keep in a cool place. Protect from light.

Do not freeze.

KEEP OUT OF REACH OF CHILDREN

Shelf Life: 2 years

Review Date

2016-06-23 05:22:23