Qualitative And Quantitative Composition

Terbinafine Hydrochloride, IP ………. 1.0% w/w

Preservative

Bezyl Alcohol, BP………. 1.0% w/w

Cream base………. q.s.

Dosage Form(S) and Strength(S)

Cream, 1% w/w

Clinical Particulars

Therapeutic Indications

• Fungal infections of the skin such as tinea pedis (interdigital/plantar type), tinea cruris and tinea corporis caused by dermatophytes like 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).

Posology and Method of Administration

TERBICIP Cream can be applied once or twice daily.

Duration of Treatment

Tinea corporis, tinea cruris: 1 to 2 weeks

Tinea pedis: 1 to 2 weeks

Cutaneous candidiasis: 1 to 2 weeks

Pityriasis versicolor: 2 weeks

Clean and dry the affected areas thoroughly before application of TERBICIP 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 (sub-mammary, 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 a history of hypersensitivity to terbinafine or any of the excipients contained in this cream.

Special Warnings and Precautions for Use

• Keep out of the reach of children.
• TERBICIP Cream is for external use only.
• Do not use on nails or scalp, in or near the mouth or for vaginal yeast infecions.
• If applied to face keep away from eyes.
• Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.
• Infants must not be allowed to come into contact with any treated skin, including the breast.
• Good general hygiene is necessary in conjunction with the use of TERBICIP Cream in order to prevent re-infection (e.g. from underwear, socks, shoes, etc.).

Drug Interactions

There are no known drug interactions with terbinafine cream.

Use in Special Populations

Pregnant Women

Foetal toxicity and fertility studies in animals suggest no adverse effects. Since, clinical experience in pregnant women is very limited, TERBICIP Cream should not be used during pregnancy unless the potential benefits outweigh any potential risks.

Lactating Women

Terbinafine is excreted in breast milk and, therefore, lactating mothers should not receive terbinafine cream. Infants should also not be allowed to come into contact with any treated skin, including the breasts.

Paediatric Patients

Not recommended for use in children below 12 years of age due to insufficient data on safety and efficacy.

Geriatric Patients

There is no evidence to suggest that elderly patients require different dosages or experience side effects different to those of younger patients.

Effects on Ability to Drive and Use Machines

TERBICIP Cream has no influence on the ability to drive and use machines.

Undesirable Effects

Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and 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 rare cases, the underlying fungal infection may be aggravated.

Adverse reactions are listed below by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Common

• Skin exfoliation, pruritus

Uncommon

• Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation
• Application site pain, irritation

Rare

• Eye irritation
• Dry skin, dermatitis contact, eczema
• Condition aggravated

Not known

• Adverse drug reaction such as Acute Generalised Exanthematous Pustulosis (AGEP) has been observed with the use of terbinafine formulations.
• Hypersensitivity
• Rash

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779. By reporting side-effects, you can help provide more information on the safety of this product.

Overdose

The low systemic absorption of topical terbinafine cream renders overdosage extremely unlikely.

Should a larger amount of terbinafine cream be inadvertently ingested, adverse effects similar to those observed with an overdosage of terbinafine tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.

The recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal and giving symptomatic supportive therapy, if needed.

Pharmacology Properties

Mechanism of Action

Terbinafine interferes specifically with fungal sterol biosynthesis at an early stage. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death.

Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme, squalene epoxidase, is not linked to the cytochrome (CY) P450 system.

Pharmacodynamic Properties

Terbinafine is an allylamine 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 , and yeasts of the genera Candida (e.g. C. albicans) and Pityrosporum. At low concentrations, terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. Its activity against yeasts is fungicidal or fungistatic, depending on the species.

Terbinafine does not influence the metabolism of hormones or other drugs. 

Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application in humans; systemic exposure is thus very less.

Nonclinical Properties

Animal Toxicology or Pharmacology

In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100 mg/kg a day. At high oral doses, the liver and possibly also the kidneys were identified as potential target organs.

In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69 mg/kg a day, an increased incidence of liver tumours was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys.

During the studies of high dose oral terbinafine in monkeys, refractile irregularities were observed in the retina at the higher doses (non-toxic effect level was 50 mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in ocular tissue and disappeared after drug discontinuation. They were not associated with histological changes.

A standard battery of in vitro and in vivo genotoxicity tests revealed no evidence of a mutagenic or clastogenic potential for the drug.

Description

TERBICIP Cream (terbinafine hydrochloride cream 1% w/w) contains the synthetic antifungal compound, terbinafine hydrochloride.

Pharmaceutical Particulars

Incompatibilities

Not applicable.

Shelf-Life

As on the pack

Packaging Information

TERBICIP Cream: Tube of 10 g

Storage and Handling Instructions

Store in a cool dry place.

Patient Counselling Information

What is TERBICIP Cream and what is it used for?

TERBICIP Cream contains the active ingredient terbinafine, which is an antifungal used to treat patients with fungal and certain yeast infections of the skin. It attacks and kills the fungus or yeast that is causing your infection.

Precautions to note before you use TERBICIP Cream

Do NOT use TERBICIP Cream if you

• are allergic (hypersensitive) to any of the ingredients in the product.

The cream is NOT recommended for use on children below 12 years of age.

Take special care with TERBICIP Cream

The cream is for external use only. In case of use on the face, avoid contact with the eyes. In case of accidental contact with the eyes, rinse thoroughly with running water.

Taking other medicines

Please tell your doctor if you are taking/used or have recently taken/used any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

Do not use the cream if you are pregnant or breastfeeding, unless advised to by your doctor. Ask your doctor for advice before taking any medicine.

Driving and using machines

TERBICIP Cream is not expected to affect your ability to drive or operate machinery.

How to use TERBICIP Cream

Your doctor will decide the right amount of TERBICIP Cream for you to use and will tell you for how long to use your medication.

Apply the cream once or twice a day, for 1–2 weeks, but this will depend upon the type and area of infection. Infections usually appear to improve within a few days of starting to use TERBICIP Cream, but may reappear if the cream is not applied regularly or is stopped too early.

Directions for use:

• Cleanse and dry the affected areas thoroughly and wash your hands. Treatment can be helped by keeping the affected areas clean by regular washing and careful drying with your own clean towels and clothes, and not rubbing or scratching the skin.
• Unscrew the cap; then gently squeeze out a small amount of the cream onto your finger.
• Apply just enough cream to form a thin layer on the affected skin and surrounding areas.
• Rub in gently. When used between the toes, or on the buttocks or the groin, the treated area may be covered with a light, fresh gauze strip, especially at night.
• Replace the cap on the tube and wash your hands. Even though you will not be using TERBICIP Cream during the second week for athlete’s foot, full skin healing after the infection has cleared will continue for up to 4 weeks. If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please seek advice from your doctor.

Children

Use in children below 12 years of age is NOT recommended, since there are no data to support use in this population.

If you accidently swallow TERBICIP Cream

Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed some cream. Take any remaining medicine and this leaflet with you, if possible. Symptoms of accidental ingestion include headache, nausea (feeling sick), dizziness and stomach pain.

If you forget to use TERBICIP Cream

If you miss an application, apply the cream as soon as possible then continue your treatment as before. If you only remember at the time of your next application, just apply the cream and carry on as normal. It is important to try to use the cream at the correct times as forgotten applications could put you at risk of the infection returning.

If you stop using TERBICIP Cream

Infections may come back if you do not use the cream regularly, or if you stop the treatment too early. If you have any further questions on the use of this product, ask your doctor.

Possible side effects

Like all medicines, TERBICIP Cream can cause side effects, although not everybody gets them.

STOP using the cream and seek medical help immediately if you have any of the following allergic reactions:

Very rare (may affect less than 1 user in 10,000):

• difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat (severe allergic reaction)
• severe itching of the skin, with red rash or raised lumps, hives or blisters

Common (may affect 1 to 10 users in 100): skin peeling, itching.

Uncommon (may affect 1 to 10 users in 1,000): skin lesions, scab, skin colour changes, redness, burning, pain and irritation at the site of application. These common and uncommon side effects are usually harmless and you can carry on using the spray.

Rare (may affect 1 to 10 users in 10,000):  eye irritation, dry skin, contact dermatitis, eczema, worsening of symptoms.

Not known (cannot to be estimated from available data): acute generalised exanthematous pustulosis (AGEP), hypersensitivity, rash.

Reporting of side effects

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779. By reporting side-effects, you can help provide more information on the safety of this product.

How to store TERBICIP Cream

Keep out of the sight and reach of children.

Keep the tube closed and in the carton.

Do not use this medicine after the expiry date shown on the box and tube.

What does TERBICIP Cream contain?

The active ingredient is terbinafine hydrochloride 1% w/w.

What are the contents of the pack?

TERBICIP Cream is a white-coloured cream, available in a lamitube of 10 g.

Details of Manufacturer

1. Metrocraft, Kh.No. 1874/450/1/1 & 2091/451/1, Phase IV,

Bhatoli Kalan, Baddi, Distt. Solan (H.P.) 173205

2. M/S Golden Cross Pharma Pvt. Limited, Tarpin

Block, Rorathang,Sikkim– 737133.

Details of Permission or License Number With Date

1. License No. MB/16/972 22/01/2018
2. License No. M/481/08

Date of Revision

05/12/2019