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Updated On: 18-11-2024

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Terbinafine hcl ( ** ) - @- Topical anti-infective- (Dec 1986)

Drug Name:
Terbinafine hcl ( ** ) - @- Topical anti-infective- (Dec 1986)

List Of Brands:

LAMISIL *
GRIS ODT
EXIFINE
TERBICIP CREAM

Indication Type Description:

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation

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.

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Disclaimer: Every effort has been made to ensure that the information provided in this Database is authentic and accurate. Commissions or omissions in the database, if any, are purely inadvertent and the site owner shall not accept any liability whatsoever for any adverse consequences of any nature arising to any individual or third party, as a result of usage of this information.