Lamisil Oral Granules

Name: Lamisil Oral Granules

What is the most important information i should know about terbinafine (lamisil)?

Before using terbinafine, tell your doctor if you have liver or kidney disease, or an autoimmune disorder such as lupus or psoriasis.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terbinafine will not treat a viral infection such as the common cold or flu.

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, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

To be sure this medicine is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

It may take several months for your nails to return to their normal appearance after your treatment with terbinafine.

Uses of Lamisil Oral Granules

  • It is used to treat fungal infections of the scalp.
  • It may be given to you for other reasons. Talk with the doctor.

How do I store and/or throw out Lamisil Oral Granules?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Indications and usage

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

Dosage and administration

      Assessment Prior to Initiation

Before administering Lamisil Oral Granules, evaluate patients for evidence of chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1)].

2.2       Dosage

Take LAMISIL (terbinafine hydrochloride) Oral Granules once a day for 6 weeks based upon body weight (see Table 1). Sprinkle the contents of each packet on a spoonful of pudding or other soft, nonacidic food such as mashed potatoes and swallow the entire spoonful (without chewing); do not use applesauce or fruit-based foods. Take with food. If 2 packets (250 mg) are required with each dose, either the content of both packets may be sprinkled on 1 spoonful, or the contents of both packets may be sprinkled on 2 spoonfuls of nonacidic food as directed above.

Table 1: Dosage by Body Weight
<25 kg 125 mg/day
25–35 kg 187.5 mg/day
>35 kg 250 mg/day

Contraindications

LAMISIL (terbinafine hydrochloride) Oral Granules are contraindicated in patients with: 

• History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2)]

• Chronic or active liver disease [see Warnings and Precautions (5.1)]

Adverse reactions

      Clinical Trials Experience

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.

LAMISIL (terbinafine hydrochloride) Oral Granules

The data described below reflect exposure to terbinafine including 1042 subjects exposed for a median of 42 days. Lamisil Oral Granules was studied in 2 active-controlled trials (n=1042). The population was children aged 4 to 12 years old, 64% male and 36% female, 21% Caucasian, 47% Black, and 32% Other. Baseline disease (dermatophyte) characteristics of subjects included 49% having T. tonsurans, 15% T. violaceum, 15% M. canis, 2% M. audouinii, and 1% others. Subjects received once daily, for 6 weeks, oral doses of Lamisil Oral Granules based on body weight: less than 25 kg 125 mg/day, 25-35 kg 187.5 mg/day, and greater than 35 kg 250 mg/day.

Adverse events reported in the 2 trials are listed in the table below.

Table 2: Adverse Events (Greater Than or Equal to 1%) in the Tinea Capitis Trials
LAMISIL 
Oral Granules (%)
N=1042
Griseofulvin Oral Suspension (%)
N=507
Nasopharyngitis 10 11
Headache 7 8
Pyrexia 7 6
Cough 6 5
Vomiting 5 5
Upper respiratory tract infection 5 5
Upper abdominal pain 4 4
Diarrhea 3 4
Influenza 2 1
Abdominal pain 2 1
Pharyngolaryngeal pain 2 2
Nausea 2 2
Rash 2 2
Rhinorrhea 2 0
Nasal congestion 2 1
Pruritus 1 1
Toothache 1 1

In the pooled pivotal trials, 2% (17/1042) of subjects in the terbinafine group and 2% (6/507) in the griseofulvin group experienced discontinuation of study drug due to adverse events. The most common categories of adverse events causing discontinuation in those exposed to terbinafine included gastrointestinal disorders, skin and subcutaneous disorders, and infections and infestations.

No ophthalmologic safety signal was identified in the pooled pivotal trials. Ophthalmologic assessments included dilated fundoscopy to assess for refractile bodies in the retina, visual acuity assessment, and color vision testing. Of the 940 subjects in the terbinafine group and 471 subjects in the griseofulvin group who completed dilated fundoscopy at posttreatment visits, none of the subjects were found to have refractile bodies of the retina at baseline or end of treatment. For visual acuity, 1% (11/837) of subjects treated with terbinafine and 2% (7/426) of subjects treated with griseofulvin showed a doubling of visual angle after 6 weeks of treatment, while 2% (15/837) treated with terbinafine and 3% (12/426) treated with griseofulvin showed a halving of the visual angle after 6 weeks of treatment. Of subjects who completed yellow-blue color vision assessment for acquired defects, 5% (13/262) of subjects treated with terbinafine and 6% (8/129) of subjects treated with griseofulvin had color confusion on more than 1 symbol at week 6 than at baseline, while 13% (33/262) of subjects treated with terbinafine and 13% (17/129) of subjects treated with griseofulvin identified more symbols correctly at week 6 than at baseline.

LAMISIL (terbinafine hydrochloride) Tablets

Adverse events reported in 3 US/Canadian placebo-controlled trials included diarrhea (6%), rashes (6%), dyspepsia (4%), nausea (3%), liver abnormalities (3%), pruritus (3%), taste disturbances (3%), abdominal pain (2%), and urticaria (1%).

Changes in the ocular lens and retina have been reported following the use of LAMISIL Tablets in clinical trials in adult subjects with onychomycosis. The clinical significance of these changes is unknown.

     Postmarketing Experience

The following adverse events have been identified during post-approval use of oral terbinafine. 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.

Blood and lymphatic system disorders: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia, thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome [see Warnings and Precautions (5.5, 5.8)]

Immune system disorders: Serious hypersensitivity reactions e.g., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus [see Warnings and Precautions (5.7)], serum sickness-like reaction

Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with oral terbinafine use. 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 (5.4)].

Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of oral terbinafine. 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 oral terbinafine [see Warnings and Precautions (5.2, 5.3)]. Cases of paresthesia and hypoesthesia have been reported with the use of oral terbinafine.

Eye disorders: Visual field defects, reduced visual acuity

Ear and labyrinth disorders: Hearing impairment, vertigo, tinnitus

Vascular disorders: Vasculitis

Gastrointestinal disorders: Pancreatitis, vomiting

Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death [see Warnings and Precautions (5.1)], idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes [see Warnings and Precautions (5.1)] have been seen with the use of oral terbinafine.  

Skin and subcutaneous tissue disorders: Serious skin reactions [e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome] [see Warnings and Precautions (5.6)], acute generalized exanthematous pustulosis, psoriasiform eruptions or exacerbation of psoriasis, photosensitivity reactions, hair loss

Musculoskeletal and connective tissue disorders: Rhabdomyolysis, arthralgia, myalgia

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

Overdosage

Clinical experience regarding overdose with oral terbinafine is limited. Doses up to 5 grams in adults (20 times the therapeutic daily adult dose) have been reported without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

Patient counseling information

Advise the patient to read the FDA-Approved Medication Guide and Instructions for Use.

Patients taking LAMISIL (terbinafine hydrochloride) Oral Granules should receive the following information and instructions:

•       Advise patients and/or their guardian to immediately report to their physician or get emergency help if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing. Lamisil Oral Granules treatment should be discontinued.      

•       Advise patients prescribed Lamisil Oral Granules and/or their guardian to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools. LAMISIL Oral Granules treatment should be discontinued.

•       Advise patients and/or their guardian to report to their physician any signs of taste disturbance, smell disturbance, and/or depressive symptoms, fever, skin eruption, lymph node enlargement, erythema, scaling, loss of pigment, and unusual photosensitivity that can result in a rash. LAMISIL Oral Granules treatment should be discontinued.

•       Advise patients and/or their guardian to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Lamisil Oral Granules.

•       Advise patients and/or their guardian to call their physician if they take too many Lamisil Oral Granules.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

© Novartis

T2017-08
January 2017

This Medication Guide has been approved by the U.S. Food and Drug Administration               Issued: January 2017
MEDICATION GUIDE
LAMISIL® (lam-i-sil)
(terbinafine hydrochloride) Oral Granules
What is the most important information I should know about Lamisil Oral Granules?
Lamisil Oral Granules may cause serious side effects, including:      
  • Liver problems that can lead to the need for a liver transplant, or death. This can happen in people who have liver problems and in people who have never had liver problems. Tell your doctor right away if you get any of these symptoms of a liver problem:
    ○ nausea
    ○ poor appetite
    ○ tiredness
    ○ vomiting
    ○ upper right stomach-area (abdomen) pain
    ○ yellowing of your skin or eyes (jaundice)
    ○ dark (tea-colored) urine
    ○ pale or light colored stools
Your doctor should do a blood test to check you for liver problems before you start treatment with Lamisil Oral Granules. Your doctor may also check you for liver problems during treatment, and tell you to stop taking Lamisil Oral Granules if you develop liver problems.
What is Lamisil Oral Granules?
Lamisil Oral Granules is a prescription medicine used to treat a fungal infection of the scalp (tinea capitis) in people 4 years of age and older.
Who should not take Lamisil Oral Granules?
Do not take Lamisil Oral Granules if you:
  • have had a severe allergic reaction to terbinafine hydrochloride when taken by mouth.
  • have had liver disease for a long time (chronic) or have active liver disease.
What should I tell my doctor before taking Lamisil Oral Granules?
Before taking Lamisil Oral Granules, tell your doctor about all of your medical conditions, including if you:
  • have or had liver problems
  • have a weakened immune system (immunocompromised)
  • have lupus (an autoimmune disease)
  • are pregnant or plan to become pregnant. It is not known if Lamisil Oral Granules will harm your unborn baby. You should not start taking LAMISIL during pregnancy.
  • are breastfeeding or plan to breastfeed. LAMISIL passes into your breast milk and may harm your baby. You should not breastfeed while taking Lamisil Oral Granules. Talk to your doctor about the best way to feed your baby if you take Lamisil Oral Granules.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Lamisil Oral Granules may affect the way other medicines work and other medicines may affect how Lamisil Oral Granules works.
How should I take Lamisil Oral Granules?
  • LAMISIL comes as oral granules that you sprinkle on food and take by mouth.
  • See the Instructions for Use that come with Lamisil Oral Granules for information about the correct way to prepare and take or give a dose.
  • Take Lamisil Oral Granules exactly as your doctor tells you to take it.
  • Take Lamisil Oral Granules 1 time each day with pudding or other soft, non-acidic food such as mashed potatoes. Do not use applesauce or a fruit-based food.
  • Your doctor will tell you how much Lamisil Oral Granules to take and when to take it.
  • If you take too much Lamisil Oral Granules call your doctor. You may have the following symptoms:
    ○ nausea
    ○ stomach-area (abdomen) pain
    ○ frequent urination
    ○ rash
    ○ headache
    ○ vomiting
    ○ dizziness
What should I avoid while taking Lamisil Oral Granules?
Avoid sunlight. Lamisil Oral Granules can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You can get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn.
What are the possible side effects of Lamisil Oral Granules?
Lamisil Oral Granules may cause serious side effects, including:
  • See “What is the most important information I should know about Lamisil Oral Granules?”
  • Change in your sense of taste or loss of taste may happen with Lamisil Oral Granules, but can also be severe. This may improve within several weeks after you stop taking Lamisil Oral Granules, but may last for a long time or may become permanent. Tell your doctor if you develop any of the following:
    ○ change in your sense of taste or loss of taste
    ○ poor appetite
    ○ weight loss
    ○ anxiousness
    ○ change in your mood or depressive symptoms. See the list of depressive symptoms below.
  • Change in your sense of smell or loss of smell may happen with Lamisil Oral Granules. This may improve after you stop taking Lamisil Oral Granules, but may last for a long time or may become permanent. Tell your doctor if you have a change in your sense of smell or loss of smell.
  • Depressive symptoms. Tell your doctor right away if you develop any of these signs or symptoms:
    ○ feel sad or worthless
    ○ change in sleep pattern
    ○ mood changes
    ○ loss of energy or interest in daily activities
    ○ restlessness
  • Low white blood cell count. Lamisil Oral Granules may decrease your white blood cells, especially neutrophils. You may have a higher risk of getting an infection when your white blood cell count is low.
  • Serious skin or allergic reactions, which may include problems with some of your body organs. Tell your doctor right away or get emergency medical help if you get any of these symptoms:
    ○ skin rash
    ○ hives
    ○ sores in your mouth, or your skin blisters and peels
    ○ swelling of your face, eyes, lips, tongue or throat
    ○ trouble swallowing or breathing
    ○ fever
    ○ swollen lymph nodes
    Also tell your doctor about any new symptoms, such as cough, chest pain, fast heartbeat, or blood in your urine.
  • New or worsening lupus. Stop taking Lamisil Oral Granules and tell your doctor if you get any of the following:
    ○ a skin rash that gets worse (progresses), is scaly, red, shows scarring, or loss of skin color
    ○ unusual sensitivity to the sun that can cause a rash
  • Blood clotting problems. When taking Lamisil Oral Granules, you may develop a blood clotting problem. Tell your doctor, if you get any unexplained bleeding or bruising.
The most common side effects of Lamisil Oral Granules include:
       ○ nasal congestion
       ○ headache
       ○ fever
       ○ cough
       ○ vomiting
       ○ upper respiratory infection
       ○ upper stomach-area (abdomen) pain
       ○ diarrhea
These are not all of the possible side effects of Lamisil Oral Granules.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store LAMISIL Oral Granules?
  • Store Lamisil Oral Granules at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Lamisil Oral Granules and all medicines out of the reach of children.
General information about the safe and effective use of Lamisil Oral Granules.
Medicines are sometimes prescribed for purposes other than those listed in Medication Guide. Do not use Lamisil Oral Granules for a condition for which it was not prescribed. Do not give Lamisil Oral Granules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Lamisil Oral Granules that is written for health professionals.
What are the ingredients in Lamisil Oral Granules?
Active ingredient: terbinafine hydrochloride
Inactive ingredients: basic butylated methacrylate copolymer, colloidal silicon dioxide, dibutyl sebacate, hypromellose, magnesium stearate, microcrystalline cellulose, nitrogen (filling gas), polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

© Novartis

T2017-09

INSTRUCTIONS FOR USE

LAMISIL® (Lam-i-sil)

(terbinafine hydrochloride) Oral Granules

  • Before taking or giving a dose of Lamisil Oral Granules, read this Instructions for Use to be sure you prepare, and take or give the Oral Granules correctly.
  • Follow your doctor’s instructions for the dose of Lamisil Oral Granules to take or give. The dose is based on your or your child’s body weight. The prescribed dose may be either 1 packet or 2 packets of Lamisil Oral Granules.
  • Ask your doctor or pharmacist if you are not sure how to prepare, take or give the prescribed dose of Lamisil Oral Granules.

Preparing and giving a dose of Lamisil Oral Granules for children and adults.

  1. Remove the prescribed number of packets (either 1 or 2) of Lamisil Oral Granules from the carton.
  2. Hold the packet with the cut line on top.
  3. Tear the packet open along cut line, or use scissors to cut across line.
  4. Prepare a small amount of soft food, such as pudding or other soft, non-acidic food such as mashed potatoes. Do not use applesauce or fruit-based foods.
    • Carefully pour the entire contents of the prescribed number of packets of Lamisil Oral Granules onto the soft food.
    • If your dose is 1 packet of Lamisil Oral Granules, use 1 spoonful of soft food for your dose.
    • If your dose is 2 packets of Lamisil Oral Granules, you can either sprinkle the contents of both packets onto 1 spoonful of soft food, or you can sprinkle each packet onto a separate spoonful of soft food.

  5. Make sure that no Lamisil Oral Granules remain in the packet.
  6. Take or give all of the soft food and Lamisil Oral Granules combination.
    • Swallow combination of food and Oral Granules without chewing.
    • Take with food.

How should I store Lamisil Oral Granules?

  • Store Lamisil Oral Granules at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Lamisil Oral Granules and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

Issued: August 2016

© Novartis

T2016-71
August 2016

PRINCIPAL DISPLAY PANEL

Package Label – 125 mg

Rx Only             NDC 0078-0499-58

Lamisil® (terbinafine hydrochloride)

Oral Granules

125 mg

terbinafine base equivalent per packet

Contains 14 packets

PRINCIPAL DISPLAY PANEL

Package Label – 187.5 mg

Rx Only             NDC 0078-0500-58

Lamisil® (terbinafine hydrochloride)

Oral Granules

187.5 mg

terbinafine base equivalent per packet

Contains 14 packets

LAMISIL 
terbinafine hydrochloride granule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0499
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
DIBUTYL SEBACATE  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
NITROGEN  
POLYETHYLENE GLYCOLS  
SODIUM LAURYL SULFATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND (round, biconvex) Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:0078-0499-58 14 PACKET in 1 CARTON
1 NDC:0078-0499-62 1 GRANULE in 1 PACKET
2 NDC:0078-0499-59 3 CARTON in 1 PACKAGE
2 NDC:0078-0499-58 14 PACKET in 1 CARTON
2 NDC:0078-0499-62 1 GRANULE in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022071 09/28/2007
LAMISIL 
terbinafine hydrochloride granule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0500
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE 187.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
DIBUTYL SEBACATE  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
NITROGEN  
POLYETHYLENE GLYCOLS  
SODIUM LAURYL SULFATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color WHITE (off white to yellowish) Score no score
Shape ROUND (round, biconvex) Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:0078-0500-58 14 PACKET in 1 CARTON
1 NDC:0078-0500-62 1 GRANULE in 1 PACKET
2 NDC:0078-0500-59 3 CARTON in 1 PACKAGE
2 NDC:0078-0500-58 14 PACKET in 1 CARTON
2 NDC:0078-0500-62 1 GRANULE in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022071 09/28/2007
Labeler - Novartis Pharmaceuticals Corporation (002147023)
Revised: 01/2017   Novartis Pharmaceuticals Corporation
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