DrugindexOnline^{2nd edition}

Generic Name: Carbamazepine Sustained-Release Tablets 12-Hour (KAR-ba-MAZE-uh-peen)
Brand Name: Tegretol XR

Carbamazepine Sustained-Release Tablets 12-Hour may rarely cause serious bone marrow and blood problems (eg, aplastic anemia, agranulocytosis). If you develop symptoms such as fever, chills, sore throat, unusual fatigue, or unusual bruising or bleeding, contact your doctor immediately. Your doctor should perform blood tests before you start taking Carbamazepine Sustained-Release Tablets 12-Hour and periodically while you are taking Carbamazepine Sustained-Release Tablets 12-Hour to check for these effects.

Carbamazepine Sustained-Release Tablets 12-Hour is used for:

Controlling certain types of seizures and relieving pain in patients with nerve pain in the face, jaw, tongue, or throat.

Carbamazepine Sustained-Release Tablets 12-Hour is an anticonvulsant. It works by controlling abnormal nerve impulses in the brain. In trigeminal neuralgia, it reduces the activity of nerve impulses in the nerves to the face, decreasing pain.

Do NOT use Carbamazepine Sustained-Release Tablets 12-Hour if:

• you are allergic to any ingredient in Carbamazepine Sustained-Release Tablets 12-Hour
• you are allergic to tricyclic antidepressants (eg, amitriptyline, imipramine, desipramine) or similar medications
• you have a history of bone marrow depression, the blood disorder porphyria, or other serious blood disorders
• you have a heart condition known as atrioventricular block
• you are taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Carbamazepine Sustained-Release Tablets 12-Hour:

Some medical conditions may interact with Carbamazepine Sustained-Release Tablets 12-Hour. 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 are allergic to other seizure medicines (eg, phenytoin, phenobarbital)
• if you have a history of increased pressure in the eye (glaucoma), liver or kidney problems, blood problems, heart problems or congestive heart failure, mood or mental problems, seizures, multiple sclerosis, or severe skin reactions (eg, Stevens-Johnson syndrome)
• if you consume alcohol-containing beverages or have a history of alcoholism

Some MEDICINES MAY INTERACT with Carbamazepine Sustained-Release Tablets 12-Hour. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Androgens (eg, testosterone), cimetidine, clarithromycin, diltiazem, fluconazole, fluoxetine, fluvoxamine, HIV protease inhibitors (eg, ritonavir), isoniazid, itraconazole, ketoconazole, lamotrigine, loratadine, macrolide antibiotics (eg, erythromycin), nefazodone, niacinamide, progabide, propoxyphene, stiripentol, terfenadine, theophylline, tricyclic antidepressants (eg, amitriptyline), troleandomycin, valproic acid, verapamil, or viloxazine because the side effects of Carbamazepine Sustained-Release Tablets 12-Hour may be increased
• Lithium because the risk of severe nervous system side effects may be increased
• Antineoplastics (eg, cisplatin, doxorubicin), felbamate, hydantoins (eg, phenytoin), phenobarbital, primidone, rifampin, or theophylline because the effectiveness of Carbamazepine Sustained-Release Tablets 12-Hour may be decreased
• Acetaminophen, anticoagulants, (eg, warfarin), butyrophenones (eg, haloperidol), clozapine, trazadone, tricyclic antidepressants (eg, amitriptyline), or valproic acid because the side effects of these medicines may be increased by Carbamazepine Sustained-Release Tablets 12-Hour
• Anticoagulants (eg, warfarin), benzodiazepines (eg, alprazolam), birth control pills (eg, ethinyl estradiol/norethindrone) or any other hormone-type contraceptive (eg, levonorgestrel implant), butyrophenones (eg, haloperidol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxycycline, erlotinib, ethosuximide and its derivatives, etretinate, felbamate, felodipine, HIV protease inhibitors (eg, ritonavir), HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, itraconazole, lamotrigine, methylphenidate, nifedipine, nondepolarizing muscle relaxants (eg, vecuronium), praziquantel, quetiapine, sertraline, tiagabine, topirimate, tricyclic antidepressants (eg, amitriptyline), or voriconazole because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbamazepine Sustained-Release Tablets 12-Hour 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 Carbamazepine Sustained-Release Tablets 12-Hour:

Use Carbamazepine Sustained-Release Tablets 12-Hour as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Carbamazepine Sustained-Release Tablets 12-Hour may be taken with or without food.
• Swallow Carbamazepine Sustained-Release Tablets 12-Hour whole. Do not break, crush, or chew before swallowing.
• Take Carbamazepine Sustained-Release Tablets 12-Hour regularly to receive the most benefit from it.
• Taking Carbamazepine Sustained-Release Tablets 12-Hour at the same time each day will help you remember to take it.
• Eating grapefruit or drinking grapefruit juice may affect the amount of Carbamazepine Sustained-Release Tablets 12-Hour in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• If you miss a dose of Carbamazepine Sustained-Release Tablets 12-Hour, 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 Carbamazepine Sustained-Release Tablets 12-Hour.

Important safety information:

Important safety information about Carbamazepine Sustained-Release Tablets 12-Hour:

• Carbamazepine Sustained-Release Tablets 12-Hour 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 Carbamazepine Sustained-Release Tablets 12-Hour. Using Carbamazepine Sustained-Release Tablets 12-Hour alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Carbamazepine Sustained-Release Tablets 12-Hour may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Carbamazepine Sustained-Release Tablets 12-Hour. Use sunscreen or protective clothing if you must be outside for a prolonged period of time.
• Before you have any medical or dental surgery, tell your doctor or dentist that you are taking Carbamazepine Sustained-Release Tablets 12-Hour.
• Carbamazepine Sustained-Release Tablets 12-Hour may interfere with certain lab tests, including thyroid function tests. Be sure your doctor or laboratory personnel know you are taking Carbamazepine Sustained-Release Tablets 12-Hour.
• Carbamazepine Sustained-Release Tablets 12-Hour may interfere with some pregnancy test results. Check with your doctor or pharmacist if you are taking Carbamazepine Sustained-Release Tablets 12-Hour and have questions or concerns about the result of a pregnancy test.
• LAB TESTS, including blood cell counts, blood iron levels, liver function, kidney function, eye exams, and carbamazepine blood levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: Carbamazepine Sustained-Release Tablets 12-Hour has been shown to cause harm to the fetus. Avoid becoming pregnant while taking Carbamazepine Sustained-Release Tablets 12-Hour. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Carbamazepine Sustained-Release Tablets 12-Hour during pregnancy. Carbamazepine Sustained-Release Tablets 12-Hour is excreted in breast milk. Do not breast-feed while taking Carbamazepine Sustained-Release Tablets 12-Hour.

Possible side effects of Carbamazepine Sustained-Release Tablets 12-Hour:

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:

Blurred vision; confusion; dizziness; drowsiness; dry mouth or throat; headache; nausea; unsteadiness; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone, joint, or muscle pain; chills; fainting; fast or irregular heartbeat; fever; hair loss; hallucinations; involuntary muscle movements; pain, tenderness, or unusual swelling in the neck, groin, or under the arms; rapid eye movement; reddened, blistered, or swollen skin; ringing in the ears; seizures; severe sweating; shortness of breath; sore throat; stomach pain; swelling of ankles or fingers; ulcers or sores in the mouth; unusual bruising or bleeding; vision changes; yellowing of the eyes or skin.

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 fast or irregular heartbeat; inability to urinate; muscle twitching or tremor; seizures; severe dizziness; severe drowsiness or loss of consciousness; slow, shallow, or irregular breathing.

Proper storage of Carbamazepine Sustained-Release Tablets 12-Hour:

Store Carbamazepine Sustained-Release Tablets 12-Hour between 59 and 86 degrees F (15 and 30 degrees C). Protect from moisture. Keep in a tight container. Do not store in the bathroom. Keep Carbamazepine Sustained-Release Tablets 12-Hour out of the reach of children and away from pets.

General information:

• If you have any questions about Carbamazepine Sustained-Release Tablets 12-Hour, please talk with your doctor, pharmacist, or other health care provider.
• Carbamazepine Sustained-Release Tablets 12-Hour 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 Carbamazepine Sustained-Release Tablets 12-Hour. 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.