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Lamisil Oral Granules

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Lamisil Oral Granules

PATIENT INFORMATION

See FDA-Approved Patient Labeling

Instructions for Use

Patients should be informed that Lamisil Oral Granules (terbinafine hydrochloride) should be taken once a day with food. Patients should sprinkle the contents of each packet on a spoonful of pudding or other soft, non-acidic food such as mashed potatoes and swallow the entire spoonful; applesauce or fruit-based foods should not be used. The combination of food and granules should be swallowed without chewing. If two packets are required with each dose, the patient may either sprinkle the content of both packets on one spoonful of non-acidic food, or the sprinkle the contents of both packets on two spoonfuls of non-acidic food as directed above.

Monitoring Laboratory Tests

Pre-treatment serum transaminases (ALT and AST) tests are advised for all patients taking Lamisil Oral Granules (terbinafine hydrochloride) .

Hepatotoxicity

Patients prescribed Lamisil Oral Granules (terbinafine hydrochloride) and/or their guardian should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine or pale stools.

Skin Rash

Patients should be informed that if a progressive skin rash occurs, treatment with Lamisil Oral Granules (terbinafine hydrochloride) should be discontinued.

Patient Labeling

Lamisil
(terbinafine hydrochloride) Oral Granules

Read the Patient Information that comes with Lamisil Oral Granules (terbinafine hydrochloride) before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your specific scalp condition or treatment.

What is Lamisil Oral Granules (terbinafine hydrochloride) ?

Lamisil Oral Granules (terbinafine hydrochloride) is indicated for the treatment of tinea capitis in patients 4 years of age and older.

What is tinea capitis?

Tinea capitis is a dermatophyte infection of the scalp hair follicles which occurs primarily in children.

How long will it take Lamisil Oral Granules (terbinafine hydrochloride) to work?

Treatment time for tinea capitis is 6 weeks.

How are Lamisil Oral Granules (terbinafine hydrochloride) taken?

Your physician will prescribe dosing based upon your body weight. One to two packets should be taken each day with a soft non-acidic food, (see patient instructions below). For best results the patient should take the complete course of prescribed medicine. If two packets are required with each dose, you may either sprinkle the content of both packets on one spoonful of non-acidic food, or sprinkle the contents of both packets on two spoonfuls of non-acidic food as directed below.

Patient instructions:

  1. Hold packet with cut line on top.
  2. Shake packet gently to settle contents.
  3. Tear packet open along cut line, or use scissors to cut across line.
  4. Carefully pour entire contents of packet onto a spoonful of a soft food, such as pudding or other soft, non-acidic food such as mashed potatoes (do not use applesauce or a fruit-based food).
  5. Make sure that no granules remain in the packet.
  6. Swallow combination of food and granules without chewing.

Who should not use Lamisil Oral Granules (terbinafine hydrochloride) ?

Lamisil Oral Granules (terbinafine hydrochloride) should not be taken by anyone allergic to any of its ingredients. Also, Lamisil Oral Granules (terbinafine hydrochloride) should not be taken by anyone who has problems with his or her liver or kidneys, or by pregnant or nursing women, unless directed by your doctor. Lamisil Oral Granules (terbinafine hydrochloride) has the potential to interact with other drugs, including some commonly prescribed antidepressants, beta-blockers, and antiarrhythmics. Tell your doctor if you are taking any of these or any other prescription or over-the-counter medications.

What are the possible side effects of Lamisil Oral Granules (terbinafine hydrochloride) ?

Serious side effects on the liver, including death and liver transplant, have occurred in people taking terbinafine. Because of the potential for liver damage, people with liver disease should not take Lamisil Oral Granules (terbinafine hydrochloride) .

How do I know if my liver is healthy?

It is recommended that your doctor conduct a blood test to check your liver before prescribing Lamisil Oral Granules (terbinafine hydrochloride) . You should watch for symptoms of liver problems while taking Lamisil Oral Granules (terbinafine hydrochloride) . If you experience persistent nausea, loss of appetite, fatigue, vomiting, right upper abdominal pain, yellowing of skin, dark urine or pale stools while taking Lamisil Oral Granules (terbinafine hydrochloride) , stop taking Lamisil Oral Granules (terbinafine hydrochloride) immediately and call your doctor right away.

Are there other possible side effects?

Lamisil Oral Granules (terbinafine hydrochloride) may cause some side effects in some people. Some commonly reported side effects in clinical studies were headache, fever, vomiting, upper respiratory tract infection, abdominal pain, diarrhea, nausea, and itching. Because some people have developed serious skin conditions while taking oral Lamisil, stop taking Lamisil Oral Granules (terbinafine hydrochloride) and tell your doctor if you develop a rash. Also, tell your doctor if you experience any other side effects.

What else should I know before taking Lamisil Oral Granules (terbinafine hydrochloride) ?

Decreases in white blood cell count have been reported. If you have problems with your immune system, your doctor may need to monitor your white blood cell count carefully if you take Lamisil Oral Granules (terbinafine hydrochloride) for more than 6 weeks. In some cases, Lamisil Oral Granules (terbinafine hydrochloride) therapy may need to be discontinued.

Prolonged taste disturbances have been reported, in some instances severe enough to result in decreased food intake leading to significant and unwanted weight loss. Tell your doctor if you notice these symptoms.

How should I store Lamisil Oral Granules (terbinafine hydrochloride) ?

Store Lamisil Oral Granules (terbinafine hydrochloride) at 59-86°F and keep this and all other medications away from children.

Lamisil Oral Granules (terbinafine hydrochloride) were prescribed only for you; do NOT share the medication with anyone else.

Last reviewed on RxList: 7/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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