Lamisil (terbinafine hydrochloride) is an antifungalantibiotic used to treat infections caused by fungus that affect the fingernails or toenails (onychomycosis). Oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old. Lamisil is available in generic form.
temporary unusual or unpleasant taste or loss of taste in your mouth.
Dosage for Lamisil
To treat fingernail onychomycosis the dose of Lamisil is one 250 mg tablet once daily for 6 weeks. For toenail onychomycosis, take one 250 mg tablet once daily for 12 weeks.
What Drugs, Substances, or Supplements Interact with Lamisil?
Lamisil may interact with cimetidine, rifampin, other antifungal antibiotics, blood thinners, heart rhythm medications, antidepressants, MAO inhibitors (MAOIs), or beta-blockers. Tell your doctor all medications you use.
Lamisil During Pregnancy and Breastfeeding
During pregnancy, Lamisil should be used only when prescribed. Fungal nail infectiontreatment can usually wait until after you have had your baby. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.
Additional Information
Our Lamisil (terbinafine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Lamisil Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using terbinafine.
Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.
Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.
Also call your doctor if you have:
changes in your sense of taste or smell;
depressed mood, sleep problems, lack of interest in daily activity, feeling anxious or restless;
pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
swelling, rapid weight gain, little or no urinating;
blood in your urine or stools;
weight loss due to taste changes or loss of appetite; or
skin sores, butterfly-shaped skin rash on your cheeks and nose (worsens in sunlight).
Common side effects may include:
diarrhea, nausea, gas, stomach pain or upset;
rash;
headache;
abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Because clinical trials are conducted under widely
varying conditions, adverse reaction rates in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and
may not reflect the rates observed in practice.
The most frequently reported adverse events observed in
the 3 US/Canadian placebo-controlled trials are listed in the table below. The
adverse events reported encompass gastrointestinal symptoms (including
diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes,
urticaria, pruritus, and taste disturbances. Changes in the ocularlens and
retina have been reported following the use of Lamisil Tablets in controlled
trials. The clinical significance of these changes is unknown. In general, the
adverse events were mild, transient, and did not lead to discontinuation from
study participation.
Adverse Event
Discontinuation
Lamisil Tablets (%)
n=465
Placebo (%)
n=137
Lamisil Tablets (%)
n=465
Placebo (%)
n=137
Headache
12.9
9.5
0.2
0.0
Gastrointestinal Symptoms:
Diarrhea
5.6
2.9
0.6
0.0
Dyspepsia
4.3
2.9
0.4
0.0
Abdominal Pain
2.4
1.5
0.4
0.0
Nausea
2.6
2.9
0.2
0.0
Flatulence
2.2
2.2
0.0
0.0
Dermatological Symptoms:
Rash
5.6
2.2
0.9
0.7
Pruritus
2.8
1.5
0.2
0.0
Urticaria
1.1
0.0
0.0
0.0
Liver Enzyme Abnormalities*
3.3
1.4
0.2
0.0
Taste Disturbance
2.8
0.7
0.2
0.0
Visual Disturbance
1.1
1.5
0.9
0.0
*Liver enzyme abnormalities ≥ 2x the upper limit of
normal range.
Postmarketing Experience
The following adverse events have been identified during
postapproval use of Lamisil Tablets. Because these events are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure.
Psychiatric disorders: Anxiety and depressive
symptoms independent of taste disturbance have been reported with use of
Lamisil Tablets. In some cases, depressive symptoms have been reported to subside
with discontinuance of therapy and to recur with reinstitution of therapy [see
WARNINGS AND PRECAUTIONS].
Nervous system disorders: Cases of taste
disturbance, including taste loss, have been reported with the use of Lamisil
Tablets. It can be severe enough to result in decreased food intake, weight
loss, anxiety, and depressive symptoms. Cases of smell disturbance, including
smell loss, have been reported with the use of Lamisil Tablets [see WARNINGS
AND PRECAUTIONS]. Cases of paresthesia and hypoesthesia have been reported
with the use of Lamisil Tablets.
Hepatobiliary disorders: Cases of liver failure
some leading to liver transplant or death [see WARNINGS AND PRECAUTIONS],
idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis,
and increased hepatic enzymes [see WARNINGS AND PRECAUTIONS] have been
seen with the use of Lamisil Tablets.
General disorders and administration site conditions:Malaise, fatigue, influenza-like illness, pyrexia
Investigations: Altered prothrombin time
(prolongation and reduction) in patients concomitantly treated with warfarin
and increased blood creatine phosphokinase have been reported
&Copy; Lamisil Patient Information is supplied by Cerner Multum, Inc. and Lamisil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
