16, Oguntona Crescent Phase 1, Gbagada, Lagos, Nigeria
Tel: 0810-540-6002; 0814-503-9010
Lincoin Pharmaceuticals Ltd.
Trimul Estate, At. & Post- Khatraj, Tal. KaIol, Dist- Gandhinagar, Gujarat India
GB PHARMA LIMITED
65 Chatsworth Road, London NW2 4BG, United Kingdom
Tel.: +44 (0) 20 8830 1057, Fax: +44 (0) 20 6830 4807, E-mail: email@example.com
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Cream (NRN: ): Each gm contains: Betamethasone Valerate BP 0.61 mg; Gentamicin Sulphate SP 1 mg; Tolnaftate BP 10 mg
Clioquinol BP 10 mg; Cream Base Q.S.
Pack Size: Tube Pack
Betamethasone valerate is a potent topical corticosteroid which exhibits anti-inflammatory and anti-allergic properties when applied to the skin and mucosa. The mechanism of action is related to causing vasoconstriction, stabilizing lysosomal membranes, suppressing cell division and suppressing the immune response.
Gentamicin works by binding 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.
Tolnaftate is a potent fungicidal agent against Trichophyton mentagrophytes, Trichophyton rubrum, Microsporum canis, Epidermophyton floccosum and Malassezia furfur. Tolnaftate works by distort the hyphae and to stunt mycelial growth in susceptible organisms. Clioquinol is a topical antifungal and antibacterial agent. Clioquinol inhibit certain enzymes related to DNA replication.
Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Topical gentamicin is readily absorbed from large denuded, burned, or granulating areas. Betamethasone is metabolized largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are excreted with the urine.
AMIDERM 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: inguinal dermatosis, chronic dermatitis of the extremities, erythrasma, balanoposthitis, herpes zoster, eczematiod dermatitis, contact dermtitis, follicular dermatitis, dyshidrosis, paronychia, anal pruritus, seborrheic eczema, intertrigo, seborrheic
dermatitis, pustular acne, impetigo, neurodermatitis, angular stomatitis, photosensitivity dermatitis, lichenified inguinal dermatophytosis and tinea infections such as tinea pedis, tinea cruris and tinea corporis
AMIDERM Cream is contraindicated in those patients with a history of sensitivity reactions to any of its components.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long term use is anticipated, particularly in infants and children.
Prolonged use of topical antibiotics occasionally may result in overgrowth of non-susceptible organisms. If this occurs or if irritation, sensitization or super infection develops, treatment with AMIDERM Cream should be discontinued and appropriate therapy instituted.
Systemic absorption of clioquinol may interfere with thyroid function tests. Therapy should be discontinued one month before these tests are conducted.
AMIDERM Cream is not for ophthalmic use.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
AMIDERM Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
BCG: Antibiotics may diminish the therapeutic effect of BCG.
Tacrolimus: May enhance the adverse/toxic effect of Immunosuppressant.
Local adverse reactions reported with the use of topical corticosteroids, include:
Burning, itching, irritation, dryness, acne form eruptions, maceration of the skin, skin atrophy.
Rash, irritation and hypersensitivity have been reported with the topical usage of gentamicin sulfate, clioquinol and rarely with tolnaftate.
Dosage & Administration
AMIDERM Cream 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 severity of the condition.
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 over-growth of lesions by non-susceptible organisms.
Store below 30°C.
Protect from light.
Do not freeze.