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|Phenytoin Extended-Release Capsules

Phenytoin Extended-Release Capsules

Phenytoin Extended-Release Capsules is used for:

Treating certain types of seizures. It may also be used for other conditions as determined by your doctor.

Phenytoin Extended-Release Capsules is an anticonvulsant. It works by stabilizing the threshold in the brain that controls excessive excitability caused by overstimulation.

Do NOT use Phenytoin Extended-Release Capsules if:

• you are allergic to any ingredient in Phenytoin Extended-Release Capsules

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

Before using Phenytoin Extended-Release Capsules:

Some medical conditions may interact with Phenytoin Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 or other substances
• if you have a blood disease (including porphyria) or liver disease

Some MEDICINES MAY INTERACT with Phenytoin Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acyclovir, antineoplastic agents (eg, cyclophosphamide), corticosteroids, diazoxide, alcohol, folic acid, loxapine, nitrofurantoin, pyridoxine, quinolones (eg, ciprofloxacin), rifampin, sucralfate, theophyllines, or vigabatrin because the effectiveness of Phenytoin Extended-Release Capsules may be decreased
• Allopurinol, amiodarone, benzodiazepines (eg, diazepam), chloramphenicol, chlorpheniramine, cimetidine, diltiazem, disulfiram, felbamate, fluconazole, fluorouracil, fluoxetine, fluvoxamine, gabapentin, isoniazid, immune globulins, macrolide immunosuppressants (eg, tacrolimus), miconazole, modafinil, nifedipine, nisoldipine, omeprazole, phenacemide, pheneturide, phenothiazine (eg, chlorpromazine), phenylbutazone, ranitidine, sulthiame, sertraline, stiripentol, sulfonamides (eg, sulfamethoxazole), trazodone, tamoxifen, ticlopidine, tizanidine, tricyclic antidepressants (eg, amitriptyline), trimethoprim, valproic acid, viloxazine, or voriconazole because the side effects and toxic effects of Phenytoin Extended-Release Capsules may be increased and dosage may need to be adjusted
• Anticoagulants (eg, warfarin), clozapine, corticosteroids (eg, prednisone), cyclosporine, digitalis glycosides (eg, digoxin), doxycycline, estrogens (eg, estradiol), felodipine, gefitinib, HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, itraconazole, ketoconazole, macrolide immunosuppressants, mexiletine, nisoldipine, non-depolarizing muscle relaxants (eg, atracurium), praziquantel, primidone, progestin, psoralens, quetiapine, quinidine, steroidal contraceptives (birth control pills), sympathomimetics, teniposide, tetracyclic antidepressants (eg, trazodone), theophylline, topiramate, topoisomerase inhibitors (eg, irinotecan), verapamil, or valproic acid because the effectiveness of these medicines may be decreased
• Anticoagulants (eg, warfarin), digitalis glycosides (eg, digoxin), disopyramide, immune globulins, risperidone, or sertraline because the side effects and toxic effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenytoin Extended-Release Capsules 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 Phenytoin Extended-Release Capsules:

Use Phenytoin Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Phenytoin Extended-Release Capsules with food if it upsets your stomach.
• To prevent seizures, continue taking Phenytoin Extended-Release Capsules on a regular schedule.
• Taking Phenytoin Extended-Release Capsules at the same time each day will help you to remember to take it.
• If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Phenytoin Extended-Release Capsules.

Important safety information:

• Phenytoin Extended-Release Capsules may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Phenytoin Extended-Release Capsules. Using Phenytoin Extended-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Do not take capsules that are discolored.
• Do not drink alcoholic beverages without talking with your health care provider.
• Do not stop taking Phenytoin Extended-Release Capsules without checking with your doctor. Seizures can recur.
• It is important to brush and floss your teeth and see your dentist regularly to reduce the risk of gum disease.
• Additional monitoring of your dose or condition may be necessary if you are presently taking capecitabine, isoniazid, methoxsalen, or trioxsalen.
• Diabetes patients - Phenytoin Extended-Release Capsules may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• LAB TESTS, including phenytoin levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Phenytoin Extended-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
• Phenytoin Extended-Release Capsules may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control while you are taking Phenytoin Extended-Release Capsules.
• Phenytoin Extended-Release Capsules has been shown to cause harm to the fetus. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Phenytoin Extended-Release Capsules during pregnancy. Phenytoin Extended-Release Capsules is excreted in breast milk. Do not breast-feed while taking Phenytoin Extended-Release Capsules.

Possible side effects of Phenytoin Extended-Release Capsules:

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:

Dizziness; drowsiness; mental confusion; nausea; rapid eye movement; shaky movements; slurred speech; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal muscle movements; back and forth eye movements; birth defects; bleeding; blurred or double vision; clumsiness or unsteadiness; enlargement of the lymph nodes; fever or sore throat; joint pain; liver damage; rash; slurred speech; staggering walk; stuttering; swollen glands; swollen or tender gums; unusual bruising or bleeding; yellowish discoloration of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; dizziness; drowsiness; loss of consciousness; nausea; slurred speech; tremor; unsteadiness; unusual eye movements.

Store Phenytoin Extended-Release Capsules below 86 degrees F (30 degrees C). Protect from light and moisture. Keep Phenytoin Extended-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Phenytoin Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider
• Phenytoin Extended-Release Capsules 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.

This information is a summary only. It does not contain all information about Phenytoin Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.