|
















































































































































































| |
Lamisil Oral®
(terbinafine hydrochloride) Tablets

Drug Uses
Lamisil Tablets are indicated for the
treatment of onychomycosis of the toenail or fingernail due to dermatophytes.
How Taken
Lamisil comes as a tablet to take orally.
It is usually taken once a day for 6 weeks for fingernail fungus and once a day
for 12 weeks for toenail fungus. Take Lamisil exactly as directed. Do not take
more or less of it or take it more often than prescribed by your doctor. Your
fungus may not be completely cured until a few months after you finish taking
Lamisil. This is because it takes time for a healthy nail to grow in.
Warnings/Precautions
Do not take Lamisil without first talking
to your doctor if you have ever had an allergic reaction to it, liver disease,
kidney disease, problems with your immune system, or blood problems. You may not
be able to take Lamisil, or you may require a dosage adjustment or special
monitoring if you have any of the conditions listed above. Lamisil is in the FDA
pregnancy category B. This means that it is not expected to harm an unborn baby.
Do not take Lamisil without first talking to your doctor if you are pregnant.
Lamisil passes into breast milk and may affect a nursing baby. Do not take this
medication without first talking to your doctor if you are breast-feeding a
baby.
Missed Dose
Take the missed dose as soon as you
remember. However, if it is almost time for the next regularly scheduled dose,
skip the missed dose and take the next one as directed. Do not take a double
dose of this medication.
Possible Side Effects
If you experience any of the following
serious side effects, stop taking Lamisil and seek emergency medical attention:
an allergic reaction (difficulty breathing; closing of your throat; swelling of
your lips, tongue, or face; or hives); a rash; changes in vision; or blood
problems (detected by blood tests). In rare cases, Lamisil has caused severe
liver damage, sometimes resulting in liver transplant or death. Notify your
doctor immediately if you develop nausea, vomiting, abdominal pain, unusual
fatigue, loss of appetite, yellow skin or eyes, itching, dark urine, or clay
colored stools. These symptoms may be early signs of liver damage. Other, less
serious side effects may be more likely to occur. Continue to take Lamisil and
talk to your doctor if you experience nausea, upset stomach, or heartburn;
diarrhea or flatulence; headache; or taste disturbances or a loss of taste. Side
effects other than those listed here may also occur. Talk to your doctor about
any side effect that seems unusual or that is especially bothersome.
Storage
Store tablets below 25o C (77o F); in a
tight container. Protect from light.
Overdose
Clinical experience regarding overdose
with Lamisil Tablets is limited. The symptoms of overdose included nausea,
vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
Seek emergency medical attention.
More Information
Avoid alcohol or use it in moderation
while taking Lamisil. Alcohol and Lamisil can both affect the liver. Lamisil
Tablets are contraindicated if you have a hypersensitivity to Lamisil.
LAMISIL® (terbinafine hydrochloride tablets) Tablets contain the synthetic
allylamine antifungal compound terbinafine hydrochloride.
Chemically, terbinafine hydrochloride is
(E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl -1-
naphthalenemethanamine hydrochloride.
The empirical formula C21H26CIN with a molecular
weight of 327.90.
Terbinafine hydrochloride is a white to off-white fine crystalline powder. It is
freely soluble in methanol and methylene chloride, soluble in ethanol, and
slightly soluble in water.
Each tablet contains:
Active Ingredients: terbinafine hydrochloride (equivalent to 250 mg base)
Inactive Ingredients: colloidal silicon dioxide, NF; hydroxypropyl
methylcellulose, USP; magnesium stearate, NF; microcrystalline cellulose, NF;
sodium starch glycolate, NF
|