Product Code: AZ-02
Composition: Terbinafine HCL IP 1.0 % W/W Preservative:
Benzyl Alcohol IP 1.0 % W/W cream base
Dosage Form: Cream Base Tube
INFORMATION FOR THE USER
Terbinafine 1% Cream
Read all of this information carefully before you start taking this medicine because it contains important information for you.
- Keep this information. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.
- COMPOSITION:
Each tube contains:
Terbinafine – 1% w/w
For external use only.
2. DESCRIPTION:
Terbinafine is an anti-fungal medication that inhibit an enzyme responsible for ergosterol synthesis.
3. PHARMACOLOGICAL ACTION:
Terbinafine is an allylamine. It has a broad spectrum of antifungal activity. At low concentrations it is fungicidal against dermatophytes, moulds & certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending on the species. Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. It acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. When given orally, the drug concentrates in skin at levels associated with fungicidal activity.
4. CLINICAL PHARMACOKINETICS:
Less than 5% of the dose is absorbed after topical application to humans; systemic exposure is therefore very slight.
5. INDICATIONS:
Terbinafine cream is indicated for the treatment of:
- Fungal infections of the skin caused by Trichophyton, Microsporum and Epidermophyton.
- Yeast infections of the skin, principally those caused by the genus Candida.
- Pityriasis (tinea) versicolor due to Pityrosporum orbiculare.
6. CONTRAINDICATIONS:
Terbinafine cream is contraindicated in:
- Known hypersensitivity to terbinafine or to any of the excipients.
- WARNINGS AND PRECAUTIONS:
- For external use only. Contact with the eyes should be avoided. May be irritating to the eyes. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.
- Contains cetyl alcohol & stearyl alcohol, which may cause local skin reactions.
7. ADVERSE EFFECTS:
Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema & scab may occur at the site of application.
These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritis, rash, bullous eruptions and hives which are reported in sporadic cases but require discontinuation.
In case of accidental contact with the eyes terbinafine hydrochloride may be irritating to the eyes.
In rare cases, the underlying fungal infection may be aggravated.
8. DRUG INTERACTIONS:
There are no known drug interactions with terbinafine Cream.
9. DOSAGE:
Can be applied once or twice daily.
10. ADMINISTRATION:
For cutaneous use.
Cleanse and dry the affected areas thoroughly before application of LAMISIL. Apply the cream to the affected skin and surrounding area in a thin layer 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.
11. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.
12. MANUFACTURED BY:
13. MARKETED BY:
Last revised on May 2019.