LAMISIL DERMGEL 1% Gel (Emulsion)
Terbinafine
10mg/g
Novartis Pharma AG
| Pack size | 15g Tube |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 14.50 AED |
Available as:
Indications
LAMISIL DERMGEL 1% Gel (Emulsion) is used for:
Tinea pedis, Tinea cruris, Tinea corporis, Dermatophytosis, Nail infections
Adult Dose
Oral
Onychomycosis
Adult: 250 mg once daily for 6 weeks (fingernail) or 12 weeks (toenail)
Tinea Pedis, Tinea Corporis, Tinea Cruris
Adult: 250 mg/day PO in single dose or divided q12hr
2-4 wk in tinea cruris, tinea corporis
2-6 wk for tinea pedis
Hepatic impairment: Use not recommended in chronic or active liver disease
Child Dose
Tinea Capitis
>4 years (<25 kg): 125 mg/day PO for 6 weeks
>4 years (25-35 kg): 187.5 mg/day PO for 6 weeks
>4 years (>35 kg): 250 mg/day PO for 6 weeks
Renal Dose
Renal impairment: Use not recommended if CrCl <50 mL/min
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity, active or chronic liver disease, lactation.
Precautions
Preexisting liver or renal impairment, pregnancy. Perform liver function tests prior to oral therapy.
Lactation: Drug excreted in breast milk; do not use
Pregnancy-Lactation
Pregnancy
Available data from postmarketing cases in pregnant women are insufficient to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
In animal reproduction studies, the drug did not cause malformations or any harm to fetus when administered to pregnant rabbits and rats during period of organogenesis at oral doses up to 12 and 23 times the maximum recommended human dose (MRHD) of 250 mg/day, respectively
Because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that oral terbinafine not be initiated during pregnancy
Lactation
After oral administration, terbinafine is present in human milk; however, there are no data on effects on breastfed child or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy; tablets and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Interactions
Possible increase in levels in drugs metabolised by CYP450 2D6. Decreased terbinafine concentration with rifampicin; increased terbinafine concentration with cimetidine.
Adverse Effects
Side effects of Terbinafine :
>10%
Headache (13%)
1-10%
Rash (6%), Pruritus (3%), Nausea (3%), Diarrhea (6%), Dyspepsia (4%), Abdominal pain (2%), Taste disturbance (3%), Elevated liver function test results (3%), Visual disturbance (1%)
Potentially Fatal: Liver failure, Stevens-Johnson syndrome, neutropaenia.
Mechanism of Action
Terbinafine causes fungal cell death by inhibiting squalene epoxidase, the main enzyme in sterol biosynthesis, resulting in ergosterol deficiency within fungal cell walls. It has fungicidal activity against dermatophytes and some yeast.
Note
LAMISIL DERMGEL 1% 10mg/g Gel (Emulsion) manufactured by Novartis Pharma AG. Its generic name is Terbinafine. LAMISIL DERMGEL 1% is availble in United Arab Emirates.
Farmaco UAE drug index information on LAMISIL DERMGEL 1% Gel (Emulsion) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.