felbamate - oral, Felbatol
GENERIC NAME: FELBAMATE - ORAL (fel-BAM-ate)
BRAND NAME(S): Felbatol
WARNING: Severe (sometimes fatal) blood disorders (aplastic anemia, pancytopenia) and liver problems have occurred with felbamate. Felbamate should be used only in people with severe seizures (epilepsy) that cannot be controlled with other medications. This drug should not be used if you have liver problems. Discuss the risks and benefits with your doctor before starting felbamate.
Immediately tell your doctor if you have symptoms of infection (fever, chills, persistent sore throat), anemia (tiredness, pale skin/fingernails, fast heartbeat), liver problems (e.g., severe stomach/abdominal pain, unusual weakness/tiredness, pale stools, dark urine, yellowing eyes/skin) or if you have unusual bleeding/bruising. Usually, people who have liver problems while taking this drug should not start taking it again.
Your doctor will perform certain blood tests (e.g., liver function, complete blood count) and may have you see a doctor who treats blood problems (hematologist) before you start felbamate and while you use this drug. Aplastic anemia may occur after you stop taking the drug. Therefore, blood tests may be needed for some time after you stop taking it. Keep all medical/laboratory appointments.
USES: This medication is used alone or with other medications to treat severe seizures (epilepsy). This medication should be used only when you cannot take other medications or when other medications have not been able to control your seizures.
HOW TO USE: Read the Medication Guide provided by your pharmacist. Read and sign the Informed Consent form provided by your doctor. If you have any questions, ask your doctor or pharmacist before starting felbamate.Take this medication with or without food, usually 3-4 times a day or as directed by your doctor. Take with food or milk if stomach upset occurs. Follow the dosing schedule carefully.If you are using the liquid form of this medication, shake the container well before pouring each dose. Measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.The dosage is based on your medical condition and response to therapy. Your doctor may direct you to take a low dose at first, gradually increasing the dose to lower the chance of side effects such as upset stomach and drowsiness. Your doctor will adjust your dose to find the best dose for you. Follow your doctor's directions carefully. The usual maximum dose for adults is 3600 milligrams each day.Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. Do not skip doses.If you are already taking another anti-seizure drug, follow your doctor's directions carefully for stopping or continuing the old drug and starting felbamate.Do not stop taking this medication or any anti-seizure medication without consulting your doctor. Your seizures may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: See also Warning section.Drowsiness, dizziness, nausea, vomiting, diarrhea, trouble sleeping, loss of coordination, headache, hiccups, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: ear pain, vision changes (e.g., blurred vision, double vision).A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.Tell your doctor immediately if any of these rare but very serious side effects occur: fast/irregular/pounding heartbeat, fainting.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking felbamate, tell your doctor or pharmacist if you are allergic to it; or to meprobamate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood problems (e.g., anemia), liver disease.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.Older adults may be more sensitive to the side effects of this drug, especially dizziness, loss of coordination, or fainting. These side effects can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other anti-seizure medications (e.g., phenytoin, valproate).This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.Also report the use of drugs which might increase seizure risk such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., complete blood count, kidney/liver tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.
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