Drug Interaction:
Interacting drugs- summary
+Terbinafine-
Cimetidine
terbinafine clearance decreased by 3% by cimetidine
Rifampin
terbinafine clearance is increased by 100% by rifampin
Terbinafine +
Terfenadine
terbinafine clearance decreased 16% by terfenadine
Warfarin
oral terbinafine does not affect the clearance of warfarin
Caffeine
terbinafine decreases the clearance of IV caffeine by 19%
Cyclosporine
terbinafine increases the clearance of cyclosporine by 15%
Indication:
Skin and nail infections
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Terbinafine Antibiotics& Novartis Group 29-12-2006
Antifungals
Adverse Reaction:
Irritation, burning, itching, dryness.
Oral- Severe neutropenia, allergic reactions( including anaphylaxis), taste disturbance.
Contra-Indications:
Hypersen. Patients with pre-existing liver disease or renal impairment.
Special precautions:
Monitor CBC in immunodefiency patients receiving treatment for more than 6 weeks .
Dosages/ Overdosage Etc:
Approved by FDA on December 30,1992
Skin and nail infections
Dosage:
Oral- Onychomycosis- Fingernail - 250mg/day for 6 weeks.
Toenail- 250mg/day for 12 weeks.
Storage: store between 5 and 30C(4 and 86F). Store tablets below 25C.
Protect from light
Patient Information:
1. Avoid contact with eyes, nose, mouth or other mucous membranes.
2. Use the medication for the recommended treatment time.
3. Avoid the use of occulsive dressings unless otherwise directed
4. Inform physician if the area of application shows signs of increased
irritation or possible sensitisation (redness, itching, burning, blistering,
swelling or oozing)
Ref - USP PDI Vol II 17th Edition (1997)
TERBINAFINE - TOPICAL
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
terbinafine. Also tell your healthcare care professional if you are allergic
to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Studies have not been done in pregnant women. However, terbinafine
has not shown to cause birth defects or other problems in animal studies
3. Breast-feeding-
Terbinafine passes into breast milk. it is not known whether topical
terbenafine passes into breast milk.
Mothers who are taking this medicine and who wish to breast feed should
discuss this with their doctor.
4.Children-
Studies of this medicine has been done only in adult patients and there
is no specific information comparing use of terbinafine in children
with use in other age groups.
5.Older adults-
Although there is no specific information comparing use of terbenafine
in the elderly with use in other age groups, this medicine is not likely
to cause different side effects or problems in older people.
6. Other medicines-
Tell your doctor if you are using any other prescription or
non-prescription (Over-the counter) OTC medicine applied
to the same area as the skin.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Terbinafine is a synthetic allylamine derivative, which exerts fungal effect by inhibiting squalene epioxidase, a key enzyme in sterol biosynthesis in fungi.
Pharmacokinetics:
Terbinafine is well absorbed and peak plasma concentration of 1mcg/ml appear within 2 hour of after a single 250mg dose. Pror to excretion, terbinafine is extensively metabolised. Approximately 70% of the administerd drug is eliminated in the urine.
Pregnancy and lactation:
Pregnancy:
No adequte and well controlled studies in pregnant women available. Use only if clearly indicated during pregnancy
Lactation:
Excreted in breast milk. Decide whether to continue the drug or discontinue nursing, taking into account the importance of the drug to the mother.
Manufacturer Details