Phenytoin ER 100 mg Capsules

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PHENYTOIN EXTENDED CAPSULE - ORAL

(FEN-i-toyn)

COMMON BRAND NAME(S): Dilantin

USES: Phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). It works by reducing the spread of seizure activity in the brain.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to treat certain types of irregular heartbeats.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking phenytoin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth usually once a day or in divided doses as directed by your doctor. You may take it with food if stomach upset occurs. Take this medication with a full glass (8 ounces or 240 milliliters) of water unless your doctor directs you otherwise. Swallow the capsules whole. Do not use the capsules if discolored. Use this medication regularly in order to get the most benefit from it. It is important to take all doses on time to keep the amount of medicine in your body at a constant level. Remember to use it at the same time(s) each day. Dosage is based on your medical condition and response to therapy. Products that contain calcium (e.g., antacids, calcium supplements) and nutritional tube-feeding (enteral) products may decrease the absorption of phenytoin. Do not take these products at the same time as your phenytoin dose. Separate liquid nutritional products at least 1 hour before and 1 hour after your phenytoin dose, or as directed by your doctor. Do not stop taking this medication without consulting your doctor. Seizures may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Inform your doctor if your condition does not improve or worsens.

SIDE EFFECTS: Headache, nausea, vomiting, constipation, dizziness, drowsiness, trouble sleeping, or nervousness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Phenytoin may cause swelling and bleeding of the gums. Massage your gums and brush and floss your teeth regularly to minimize this problem. See your dentist regularly. 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: unusual eye movements, loss of coordination, slurred speech, confusion, muscle twitching, double or blurred vision, tingling of the hands/feet, facial changes (e.g., swollen lips, butterfly-shaped rash around the nose/cheeks), excessive hair growth, increased thirst or urination, unusual tiredness, bone or joint pain, easily broken bones. 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. For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur. Get medical help right away if any of these rare but very serious side effects occur: uncontrolled muscle movements, muscle weakness/pain, swollen glands (lymph nodes), stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, easy bruising/bleeding, signs of infection (e.g., persistent sore throat or fever), chest pain, trouble breathing, irregular heartbeat. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, high fever, 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 phenytoin, tell your doctor or pharmacist if you are allergic to it; or to other anti-seizure medications (e.g., carbamazepine, ethotoin, phenobarbital, ethosuximide, trimethadione); 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, certain blood conditions (porphyria), diabetes, liver disease, lupus, folate or vitamin B-12 deficiency (megaloblastic anemia). 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. Limit alcoholic beverages. Alcohol may also affect your blood levels of this drug. Tell your doctor you are using phenytoin prior to surgery or any procedure that makes you unable to take it by mouth. If you have diabetes, this drug may increase your blood sugar levels. Check your blood (or urine) glucose level frequently, as directed by your doctor. Promptly report any abnormal results as directed. Your medicine, exercise plan, or diet may need to be adjusted. Vitamin D supplements may be necessary to prevent weakening of the bones (osteomalacia). Discuss this with your doctor. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor. Phenytoin 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. See also How to Use section. This drug should not be used with the following medications because very serious interactions may occur: azapropazone, delavirdine, dofetilide, etravirine, nisoldipine, rilpivirine. If you are currently using any of these medications, tell your doctor or pharmacist before starting phenytoin. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: colesevelam, molindone, pyridoxine (vitamin B6), sucralfate, sulfa drugs, telithromycin, drugs affecting liver enzymes that remove phenytoin from your body (such as amiodarone, azole antifungals including itraconazole, cimetidine, macrolide antibiotics including erythromycin, estrogens, isoniazid, rifamycins including rifabutin, St. John's wort, other anti-seizure medicines including carbamazepine/phenobarbital/valproic acid). Phenytoin can speed up the removal of many other drugs from your body by affecting certain liver enzymes. This can affect how well these other drugs work. These other drugs include: some drugs to treat cancer (e.g., imatinib, irinotecan), corticosteroids (e.g., prednisone), cyclosporine, felodipine, quetiapine, quinidine, theophylline, vitamin D, warfarin. This is not a complete list. Tell your doctor or pharmacist of all other drugs you take. Also report the use of drugs which might increase seizure risk (decrease seizure threshold) such as: phenothiazines (e.g., thioridazine) or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details. 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. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. 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 your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe mental/mood changes, severe drowsiness, loss of consciousness, slowed breathing.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., phenytoin blood levels, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Do not change from one brand of this product to another, or to another dose form of this drug (e.g., immediate release capsule, liquid suspension, or chewable tablet) without consulting your doctor or pharmacist. Your dosage may have to be adjusted.

MISSED DOSE: If you miss your once daily dose, use it as soon as you remember. However, if you do not remember until the next day, skip the missed dose and resume your usual dosing schedule. If you take several doses daily and miss a dose, use it as soon as you remember unless it is within 4 hours of the next dose. In that case, skip the missed dose and resume your usual schedule. Check with your doctor if you miss doses for more than 2 days in a row. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. See packaging or ask your pharmacist for the exact temperature range. 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 enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.