Terbinafine tablets and hydroxypropyl-chitosan

Generic Name: terbinafine (TER-bin-a-feen/hye-DROX-ee-PROE-pil/KYE-toe-san)
Brand Name: Terbinex

Terbinafine tablets and hydroxypropyl-chitosan is used for:

Treating certain fungal infections of the fingernails or toenails. It may also be used for other conditions as determined by your doctor.

Terbinafine tablets and hydroxypropyl-chitosan is an antifungal agent. It works by killing sensitive fungi.

Do NOT use terbinafine tablets and hydroxypropyl-chitosan if:

  • you are allergic to any ingredient in terbinafine tablets and hydroxypropyl-chitosan
  • you have liver problems

Contact your doctor or health care provider right away if any of these apply to you.

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Before using terbinafine tablets and hydroxypropyl-chitosan:

Some medical conditions may interact with terbinafine tablets and hydroxypropyl-chitosan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney or liver problems, lupus, depression, psoriasis, alcohol abuse or dependence, or blood problems (eg, anemia)
  • if you have a weakened immune system or low white blood cell counts

Some MEDICINES MAY INTERACT with terbinafine tablets and hydroxypropyl-chitosan. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, cimetidine, fluconazole, or ketoconazole because they may increase the risk of terbinafine tablets and hydroxypropyl-chitosan's side effects
  • Rifampin because it may decrease terbinafine tablets and hydroxypropyl-chitosan's effectiveness
  • Antiarrhythmics (eg, flecainide, propafenone), beta-blockers (eg, metoprolol), dextromethorphan, monoamine oxidase type B (MAO-B) inhibitors (eg, selegiline), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, amitriptyline, desipramine) because the risk of their side effects may be increased by terbinafine tablets and hydroxypropyl-chitosan
  • Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by terbinafine tablets and hydroxypropyl-chitosan
  • Cyclosporine or tamoxifen because their effectiveness may be decreased by terbinafine tablets and hydroxypropyl-chitosan

This may not be a complete list of all interactions that may occur. Ask your health care provider if terbinafine tablets and hydroxypropyl-chitosan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use terbinafine tablets and hydroxypropyl-chitosan:

Use terbinafine tablets and hydroxypropyl-chitosan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • To use the tablets: Take by mouth with or without food.
  • The tablets are taken for different amounts of time depending on your condition. The full benefit may not be seen for several months after stopping treatment. This includes the time period necessary for healthy nails to grow.
  • To use the nail lacquer: Use at bedtime, unless your doctor tells you otherwise. Wash and dry the affected nails, then apply a thin coat of medicine.
  • Do not apply the nail lacquer to a wound, or to broken or damaged skin.
  • Use the nail lacquer until a new, healthy nail has grown, unless your doctor tells you otherwise. This usually takes 6 to 12 months, depending on your condition.
  • To clear up your infection completely, take terbinafine tablets and hydroxypropyl-chitosan for the full course of treatment. Keep taking it even if you begin to see improvement before the end of your therapy.
  • If you miss a dose of terbinafine tablets and hydroxypropyl-chitosan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use terbinafine tablets and hydroxypropyl-chitosan.

Important safety information:

  • If you experience dizziness while taking terbinafine tablets and hydroxypropyl-chitosan, use caution. Do not drive or perform other possibly unsafe tasks.
  • Terbinafine tablets and hydroxypropyl-chitosan only works against fungal infections; it does not treat bacterial or viral infections (eg, the common cold).
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Be sure to use terbinafine tablets and hydroxypropyl-chitosan for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Very bad skin reactions (eg, Stevens-Johnson syndrome/toxic epidermal necrolysis) that include skin rash with or without liver, lung, kidney, and/or heart problems have occurred in patients taking terbinafine tablets and hydroxypropyl-chitosan. These reactions can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have red, swollen, blistered, or peeling skin; fever; red or irritated eyes; sores in your mouth, throat, nose, or eyes; or swollen lymph glands (with or without other unusual side effects).
  • Terbinafine tablets and hydroxypropyl-chitosan may lower the ability of your body to fight infection. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Tell your doctor or dentist that you take terbinafine tablets and hydroxypropyl-chitosan before you receive any medical or dental care, emergency care, or surgery.
  • Before using terbinafine tablets and hydroxypropyl-chitosan, tell your doctor if you take a medicine that contains caffeine or if you consume large amounts of food or drink that contain caffeine (eg, coffee, tea, cocoa, cola, chocolate).
  • Taste changes (eg, taste loss) or changes in smell (eg, loss of smell) have been reported in patients taking terbinafine tablets and hydroxypropyl-chitosan. These effects may resolve after you stop taking terbinafine tablets and hydroxypropyl-chitosan, but may last for a long time (eg, more than 1 year), or may become permanent. Tell your doctor right away if you experience changes in smell, taste changes, poor appetite, unwanted weight loss, anxiety, or mood changes (eg, symptoms of depression).
  • Terbinafine tablets and hydroxypropyl-chitosan may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to terbinafine tablets and hydroxypropyl-chitosan. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Rarely, terbinafine tablets and hydroxypropyl-chitosan may cause severe or even fatal liver problems. If liver problems occur, they may be more severe in patients who have other active liver problems or a history of long-term liver problems. Discuss any questions or concerns with your doctor.
  • The nail lacquer is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.
  • You may apply nail polish on top of the nail lacquer.
  • Unless you are washing your hands, use gloves while using water or chemical substances to avoid accidentally washing the nail lacquer off. Wearing cotton under the gloves is preferred.
  • The nail lacquer is flammable. Do not store or use near an open flame or while smoking.
  • Lab tests, including liver function and complete blood cell counts, may be performed while you use terbinafine tablets and hydroxypropyl-chitosan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Terbinafine tablets and hydroxypropyl-chitosan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if terbinafine tablets and hydroxypropyl-chitosan can cause harm to the fetus. Do not start taking terbinafine tablets and hydroxypropyl-chitosan during pregnancy without talking with your doctor. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using terbinafine tablets and hydroxypropyl-chitosan while you are pregnant. Terbinafine tablets and hydroxypropyl-chitosan is found in breast milk. Do not breast-feed while taking terbinafine tablets and hydroxypropyl-chitosan.

Possible side effects of terbinafine tablets and hydroxypropyl-chitosan:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; gas; headache; indigestion; mild stomach pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; mental or mood changes (eg, depression, restlessness, sadness, worthlessness); new or worsening symptoms of lupus (eg, butterfly-shaped rash on the face, joint pain, seizures, skin color changes, unusual sensitivity to the sun); pale skin or nail beds; severe muscle or joint pain or tenderness; severe or persistent stomach pain (with or without nausea or vomiting); sleep problems; symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; unexplained, persistent nausea; vomiting; yellowing of the skin or eyes); unusual bruising or bleeding; unusual tiredness or weakness; vision or hearing changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; frequent urination; rash; severe headache or nausea; stomach pain; vomiting.

Proper storage of terbinafine tablets and hydroxypropyl-chitosan:

Store the tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Store the nail lacquer at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not store near an open flame. Keep terbinafine tablets and hydroxypropyl-chitosan out of the reach of children and away from pets.

General information:

  • If you have any questions about terbinafine tablets and hydroxypropyl-chitosan, please talk with your doctor, pharmacist, or other health care provider.
  • Terbinafine tablets and hydroxypropyl-chitosan is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take terbinafine tablets and hydroxypropyl-chitosan or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about terbinafine tablets and hydroxypropyl-chitosan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to terbinafine tablets and hydroxypropyl-chitosan. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using terbinafine tablets and hydroxypropyl-chitosan.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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