Taro-CarBAMazepine CR

Carbamazepine is a prescription medication used to treat epilepsy and trigeminal neuralgia (a condition that causes facial nerve pain). Carbamazepine belongs to a group of drugs called anticonvulsants, which work by decreasing abnormal electrical activities in the brain that cause seizures. It also works by blocking nerve signals that cause pain in trigeminal neuralgia.

Carbamazepine comes in the form of an immediate-release tablet, an extended-release tablet, extended-release capsules, a chewable immediate-release tablet, and an oral suspension form. Carbamazepine may be taken 2 to 4 times daily, with or without food.

Carbamazepine is a prescription medicine used to treat certain types of seizures (partial, tonic-clonic, mixed), as well as certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).  

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight (children)
• your age

The recommended dose range of carbamazepine is 400-1200 mg/day.

The recommended initial dose range of carbamazepine in children under 6 years of age is 10 to 20 mg/kg/day and can be increased to a maximum dose of 35 mg/kg.

The number of times you take carbamazepine will depend on the formulation you are taking.

SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE

• SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH Carbamazepine. 
• THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. 
• HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH Carbamazepine. 
• PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH Carbamazepine UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK.

APLASTIC ANEMIA AND AGRANULOCYTOSIS

• APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF Carbamazepine. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5-8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA.
• ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF Carbamazepine, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
• BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON Carbamazepine ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY. DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT BONE MARROW DEPRESSION DEVELOPS.

Carbamazepine can cause serious side effects, including:

1.   Rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking carbamazepine within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take carbamazepine to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include: 

• skin rash
• hives
• sores in your mouth
• blistering or peeling of the skin

2. Rare but serious blood problems. Symptoms may include: 

• fever, sore throat or other infections that come and go or do not go away
• easy bruising
• red or purple spots on your body
• bleeding gums or nose bleeds
• severe fatigue or weakness

3.   Like other antiepileptic drugs, carbamazepine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. 

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: 

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Watch for early symptoms of suicidal thoughts and actions:

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Carbamazepine may cause other serious side effects. These include:
Irregular heartbeat - symptoms include:

• Fast, slow, or pounding heartbeat 
• Shortness of breath 
• Feeling lightheaded 
• Fainting 

Liver problems - symptoms include: 

• yellowing of your skin or the whites of your eyes 
• dark urine 
• pain on the right side of your stomach area (abdominal pain) 
• easy bruising 
• loss of appetite 
• nausea or vomiting 

Get medical help right away if you have any of the symtoms listed above.

Do not take carbamazepine if you:

• have a history of bone marrow depression. 
• are allergic to carbamazepine or any of the ingredients in carbamazepine. 
• take nefazodone. 
• are allergic to medicines called tricyclic antidepressants (TCAs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. 
• have taken a medicine called a Monoamine Oxidase Inhibitor (MAOI) in the last 14 days. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking carbamazepine until you talk to your healthcare provider. Carbamazepine taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how carbamazepine affects you. Carbamazepine may slow your thinking and motor skills.

Serious side effects have been reported. See "Precautions".

The most common side effects of carbamazepine include:

• dizziness 
• drowsiness 
• problems with walking and coordination (unsteadiness) 
• nausea 
• vomiting 

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking:

• cimetidine, danazol, diltiazem, macrolides, erythromycin, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, nefazodone, trazodone, loxapine, olanzapine, quetiapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azoles (e.g., ketaconazole, itraconazole, fluconazole, voriconazole), acetazolamide, verapamil, ticlopidine, grapefruit juice, protease inhibitors, valproate.

The medicines listed above may inhibit the metabolism of carbamazepine, thereby increasing the levels of carbamazepine in your body.

There are other medicines that may increase the rate of metabolism of carbamazepine, thereby decreasing the amount of carbamazepine available in your body. They include:

• cisplatin, doxorubicin HCl, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline.

Carbamazepine may cause an increase in the metabolism of other medicines. In doing so, carbamazepine causes, or would be expected to cause, decreased levels of the following:

• acetaminophen, alprazolam, bupropion, dihydropyridine calcium channel blockers (e.g., felodipine), citalopram, cyclosporine, corticosteroids (e.g., prednisolone, dexamethasone), clonazepam, clozapine, dicumarol, doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, midazolam, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, theophylline, tiagabine, topiramate, tramadol, trazodone, tricyclic antidepressants (e.g., imipramine, amitriptyline, nortriptyline), valproate, warfarin, ziprasidone, zonisamide.

If you must take one of the above medicines along with carbamazepine, your doctor may adjust your dosage.

Other medicines that may interact with carbamazepine include:

• nefazodone
• lithium
• isoniazid
• diuretics (hydrochlorothiazide, furosemide)
• pancuronium
• hormonal contraceptives

This is not a complete list of carbamazepine interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Category D medicines have been shown to present a risk to the fetus in studies of pregnant women, but may be given to a pregnant woman the benefits to the woman outweigh the possible risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. Carbamazepine is excreted in human breast milk. You and your doctor should discuss whether you should take carbamazepine or breastfeed; you should not do both.

This medication may make you feel drowsy or dizzy, especially when you first start taking it. Avoid alcohol while taking carbamazepine. It will worsen drowsiness.

Speak to your doctor if you are taking birth control pills. Carbamazepine may decrease the effectiveness of birth control.

Talk to your doctor about your medications (especially medications for mood disorders or seizures like lamotrigine) before starting or stopping carbamazepine.