|
Product
Anti-asthmatic Products (Aerocort Inhaler)
|
Terbifin 1% Cream
|
|
| |
 |
Terbifin 1% Cream
COMPOSITION
• Terbinafine Hydrochloride……………1% w/w
Preservative:
• Benzyl Alcohol IP………………...1% w/w
In a cream base
PHARMACOLOGY
Pharmacodynamics
√ Terbinafine is an allylamine (an organic amine with molecular formula C3H7N ) with a broad spectrum of activity against fungal pathogens of the skin, hair and nails, including dermatophytes such as
|
»Trichophyton (e.g., T. rubrum, T. mentagrophytes, T.
verrucosum, T. tonsurans, T. violaceum )
»Microsporum (e.g., M. canis )
»Epidermophyton floccosum
»Yeasts of the genera Candida (e.g., C. albicans )
»Pityrosporum
»The second generation fungicide
»At low concentrations, terbinafine is fungicidal against dermatophytes (a parasitic fungus that infects the skin) , moulds and certain dimorphic fungi.
»Its activity against yeasts is fungicidal or fungistatic, depending on the species.
»Terbinafine interferes specifically with fungal sterol biosynthesis at an early stage and resulting in fungal cell death.
Pharmacokinetics
√ In one study involving 20 volunteers, the C max of terbinafine was reached 4 hours after a single application of terbinafine cream 1%.
√ Extending the treatment duration from 1 to 7 days caused a 3 fold increase in the elimination half-life of terbinafine.
√ Penetration of terbinafine into the systemic circulation is minimal after topical administration.
INDICATIONS
√ Fungal infections of the skin caused by dermatophytes such as
»Trichophyton (e.g., T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum ),
»Microsporum canis and Epidermophyton floccosum .
√ Yeast infections of the skin, principally those caused by the genus Candida (e.g., Candida albicans ).
√ Pityriasis (tinea) versicolor, due to Pityrosporum orbiculare (also known as Malassezia furfur ).
DOSAGE & ADMINISTRATION
√ It can be applied once or twice daily.
Duration of Treatment
»Tinea pedis, tinea corporis, tinea cruris ……….1 week
cutaneous candidiasis:
»Pityriasis versicolor……………………………………..2 weeks
√ Clean and dry the affected areas thoroughly before application of TERBIFIN Cream .
√ Apply a thin layer of the cream to the affected skin and surrounding areas and rub in lightly.
»In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal), the application may be covered with a gauze strip, especially at night.
»Relief of clinical symptoms occurs within a few days.
»Irregular use or premature discontinuation of treatment carries the risk of recurrence.
»If there are no signs of improvement after 2 weeks, the diagnosis should be verified.
CONTRAINDICATIONS
• TERBICIP Cream is contraindicated in patients with history of hypersensitivity to terbinafine or any of the excipients contained in this cream.
WARNINGS & PRECAUTIONS
√ Keep out of reach of children.
√ TERBIFIN Cream is for external use only.
√ Contact with the eyes should be avoided.
√ Good general hygiene is necessary in conjunction with the use of TERBIFIN Cream in order to prevent reinfection (e.g., from underwear, socks, shoes, etc.).
Pregnancy
√ Foetal toxicity and fertility studies in animals suggest no adverse effects.
√ It should not be used during pregnancy unless the potential benefits outweigh any potential risks.
Loctation
√ Terbinafine is excreted in breast milk.
√ However, with TERBIFIN Cream treatment, the small amounts absorbed through the skin are unlikely to affect the infant.
Paediatric Use
√ Experience in children is limited.
Geriatric Use
√ There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.
UNDESIRABLE EFFECTS
√ Redness, itching or stinging occasionally occur at the site of application of TERBICIP Cream .
√ However, treatment rarely has to be discontinued for this reason.
√ These harmless symptoms must be distinguished from allergic reactions, which are rare but require discontinuation.
PACKAGING INFORMATION
TERBIFIN Cream ………. tube of 10 gm
|
|
