Phenytoin Capsules

GENERIC NAME: PHENYTOIN (FEN-i-toin)

COMMON USES: This medicine is an anticonvulsant used for treating tonic-clonic (grand mal) and partial seizures. It is also used to prevent and treat seizures that may occur during or after brain or nervous system surgery. It may also be used for other conditions as determined by your doctor.

BEFORE USING THIS MEDICINE: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking medicines used for asthma, blood thinning, diabetes, infections, inflammation, aches and pains, high blood pressure, heart problems, high cholesterol, birth control, hormone replacement, mental or mood problems, sleep, or seizures, multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzym Q10, garlic, ginseng, ginkgo, St. John's wort). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including blood disease (eg, porphyria), liver disease, diabetes, very poor health, a history of mental or mood problems (eg, depression), or suicidal thoughts or attempts, allergies, pregnancy, or breast-feeding . Tell your doctor if you drink alcohol, have a history of alcohol abuse, or if you have a history of lymph gland problems. Tell your doctor if you have been tested and know whether or not you have a gene type called HLA-B* 1502. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

HOW TO USE THIS MEDICINE: Follow the directions for taking this medicine provided by your doctor. Take this medicine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. SWALLOW THIS MEDICINE WHOLE. Do not break, crush, or chew before swallowing. DO NOT TAKE capsules that are discolored. IF YOU TAKE CALCIUM PRODUCTS (eg, antacids), ask your doctor or pharmacist how to take them with this medicine. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. DO NOT SUDDENLY STOP TAKING THIS MEDICINE. You may have an increased risk of side effects (eg, seizures). If you need to stop this medicine or add a new medicine, your doctor will gradually lower your dose. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. TAKING THIS MEDICINE at the same time each day will help you remember to take it. IF YOU MISS A DOSE of this medicine, 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.

CAUTIONS: DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine or to another hydantoin (eg, fosphenytoin). DO NOT take more than the recommended dose without checking with your doctor. LAB TES IS may be performed while you use this medicine to monitor your condition or check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS. This medicine may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking this medicine. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. CHECK WITH YOUR DOCTOR BEFORE you drink alcohol while you are taking this medicine. PATIENTS WHO TAKE THIS MEDICINE MAY BE AT INCREASED RISK FOR SUICIDAL THOUGHTS OR ACTIONS. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take this medicine closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood, anxious, restless, or irritable behavior panic attacks, or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. THIS MEDICINE MAY raise your blood sugar. High blood sugar may make you feel confused, drowsy or thirsty. It can also make you flush, breathe faster or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. T'HERE HAVE BEEN REPORTS OF lymph node problems including cancer, in patients who take this medicine. It is not known if this medicine may be the cause. Contact your doctor right away if you develop swollen lymph nodes, fever, rash, dark urine, stomach pain, or yellowing of the eyes or skin. TELL YOUR DOCTOR OR DEN1TIST THAT YOU TAKE THIS MEDICINE before you receive any medical or dental care, emergency care, or surgery. HORMONAL BIRTH CONTROL (eg, birth control pills) may not work as well while you are using this medicine. To prevent pregnancy, use an extra form of birth control (eg, condoms). PATIENTS WHO HAVE A CERTAIN GENE TYPE called HLA-B*1502 may have an increased risk for serious skin reactions from this medicine. Tell your doctor if you have been tested and know whether or not you have the HLA-B* 1502 gene type. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. Use this medicine with caution in the ELDERLY; they may be more sensitive to its effects. FOR WOMEN: Women who take this medicine may experience an increase in seizure activity if they become pregnant. Discuss any questions or concerns with your doctor. This medicine may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. This medicine is found in breast milk. Do not breast-feed while taking this medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include constipation, dizziness, headache, mild nervousness, nausea, trouble sleeping, or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bone pain, butterfly-shaped rash on the face, clumsiness or unsteadiness, confusion, dark urine, delirium, high blood sugar (flushing, fruit-like breath odor, increased thirst, hunger, or urination, rapid breathing), new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes, suicidal thoughts or attempts), new or worsening seizures, numbness or tingling of the hands or feet, red, swollen, blistered, or peeling skin, signs of infection (eg, chills, fever, sore throat), slurred speech, stomach pain, swollen lymph nodes, swollen or tender gums, tremor, unusual bruising or bleeding, unusual eye movements, unusual muscle movements, or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, hives, itching, difficulty breathing, tightness in the chest, or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms may include confusion, decreased coordination, joint pain, loss of consciousness, severe dizziness or drowsiness, severe or persistent nausea or vomiting, slow or difficult breathing, slurred speech, tremor, or unusual eye movements.

ADDITIONAL INFORMATION: Carry an identification card at all times that says you are taking this medication. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. DO NOT CHANGE BRANDS OR DOSE FORMS (eg, tablets, suspension, injection) of this medicine without talking with your doctor. KEEP THIS MEDICINE out of the reach of children and pets. PROPER DENTAL CARE is important while you are taking this medicine. Brush and floss your teeth and visit the dentist regularly. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.