Carbamazepine

(kar ba maz' e peen)

PCI  : Contraindicated in pregnancy

LCaution when used during lactation : Caution when used during lactation

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |
WARNING

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 TEGRETOL. 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 TEGRETOL. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH TEGRETOL UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK.

APLASTIC ANEMIA AND AGRANULOCYTOSIS

APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF TEGRETOL. 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 TEGRETOL, 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 TEGRETOL 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.

Indication(s) & Dosage

Oral route
Epilepsy
Adult: Initially, 100-200 mg once or bid gradually increased by increments of 100-200 mg every 2 wk. Maintenance: 0.8-1.2 g daily in divided doses. Max dose: 2 g daily. 
Child: â‰¤1 yr: 100-200 mg daily, 1-5 yr: 200-400 mg daily, 5-10 yr: 400-600 mg daily, 10-15 yr: 0.6-1 g daily. Alternatively, 10-20 mg/kg daily in divided doses.

Trigeminal neuralgia
Adult: Initially, 100 mg once or bid gradually increased as necessary. Maintenance: 400-800 mg daily in 2-4 divided doses. Max: 1.2 g daily.

Prophylaxis of bipolar disorder
Adult: Initially, 400 mg daily in divided doses gradually increased if necessary. Maintenance: 400-600 mg daily. Max: 1.6 g daily.

Rectal route
Epilepsy
Adult: 250 mg every 6 hr for patients incapable of oral treatment.

Administration Should be taken with food. Avoid grapefruit juice.
Contraindications Hypersensitivity; bone marrow depression; porphyria, pregnancy.
Special Precautions Lactation; CV disease, hepatic or renal disorders, history of blood disorders or haematological reactions to other drugs; glaucoma; skin disorders; elderly, patients on MAO inhibitors; abrupt withdrawal of treatment.
Adverse Drug Reaction(s) Dizziness, drowsiness, ataxia; dry mouth, abdominal pain, nausea, vomiting, anorexia; leucopenia, proteinuria, renal failure, heart failure and hyponatraemia.
Potentially Fatal: Agranulocytosis, aplastic anaemia, hepatic failure, severe exfoliative dermatitis and Stevens-Johnson syndrome.
Drug Interactions Reduces tolerance to alcohol; shortens T1/2 of doxycycline. Decreased efficacy of oral contraceptives when used with carbamazepine. Increased plasma concentrations of carbamazepine by propoxyphene. Serum level decreases with phenytoin, phenobarbital, primidone.
Potentially Fatal: Neurotoxic reactions when combined with lithium. Please consult detailed drug interactions before prescribing.
Lab Interference False-positive result in urine sugar, elevated serum alkaline phosphatase and serum bilirubin values.
Pregnancy Category (FDA) Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Pharmacology Carbamazepine reduces polysynaptic responses and blocks post-tetanic potentiation. It is effective in partial and generalised convulsions as well as in mixed types but not in petit mal seizures. It reduces or abolishes pain in trigeminal and glossopharyngeal neuralgia.
Absorption: Slowly and irregularly absorbed from the GI tract (oral).
Distribution: Crosses the placenta; enters breast milk. Protein-binding: 75%. Well distributed in the body.
Metabolism: Hepatic; converted to its metabolites.
Excretion: Urine (as metabolites), faeces; 5-26 hr (elimination half-life).
ATC Classification N03AF01 - carbamazepine; Belongs to the class of carboxamide derivatives antiepileptic. Used in the management of epilepsy.

Brand/Product Info


Total Products : 19                   
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ANLEPTIC Square Pharmaceuticals Ltd. Carbamazepine 200mg Tablet 5x10's: 276.00 MRP
ANLEPTIC CR Square Pharmaceuticals Ltd. Carbamazepine 200mg CR Tablet 5x10's: 301.00 MRP
ANLEPTIC SUSP Square Pharmaceuticals Ltd. Carbamazepine 100mg/5 ml Suspension 100 ml: 300.90 MRP
CABRETOL Renata Limited Carbamazepine 200mg Tablet 50's: 195.50 MRP
CABRETOL CR Renata Limited Carbamazepine 200mg Tablet (controlled release) 50's: 195.00 MRP
CABRETOL Syrup Renata Limited Carbamazepine 100mg/5ml Syrup 100ml: 301.13 MRP
CARBAZIN Eskayef Bangladesh Ltd Carbamazepine BP 200mg Tablet 50's MRP: 200.00
CARBAZIN CR Eskayef Bangladesh Ltd Carbamazepine USP 200mg (CRT) Tablet(controlled release) 50's MRP: 203.00
Carmapine 200 Incepta Pharmaceuticals Limited Carbamazepine 200mg Tablet 10x5's:MRP 200 Tk
Carmapine CR Incepta Pharmaceuticals Limited Carbamazepine 200mg Tablet 10x5's:MRP 250 Tk
Carmapine Suspension Incepta Pharmaceuticals Limited Carbamazepine 100mg/5ml Suspension 100ml:MRP 250 Tk
CAZEP Opsonin Pharma Limited Carbamazepine 200mg Tablet 50's: 200.00 MRP
EPILEP Beximco Pharmaceuticals Ltd Carbamazepine 200mg Tablet 50's: 175.50 MRP
EPILEP CR Beximco Pharmaceuticals Ltd Carbamazepine 200mg Tablet 50's: 226.00 MRP
TEGRETOL Novartis (Bangladesh) Ltd. Carbamazepine BP 200mg Tablet 50's: MRP 326.50
TEGRETOL CR Novartis (Bangladesh) Ltd. Carbamazepine BP 200mg Tablet (Controlled Release) 50's: MRP 351.50
TEGRETOL SYRUP Novartis (Bangladesh) Ltd. Carbamazepine BP 100mg/5ml Syrup 100ml: MRP 371.25
ZEPTOL Sun Pharmaceutical (Bangladesh) Ltd. Carbamazepine 200mg Tablet 100's: 500.00 MRP
ZEPTOL CR Sun Pharmaceutical (Bangladesh) Ltd. Carbamazepine 200mg & 400mg Tablet (controlled release) 200mg x100's, 400mg x50's: 550.00 & 375.00 MRP

Gen. MedInfo

IMPORTANT WARNING:

Carbamazepine may cause life-threatening allergic reactions called Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). These allergic reactions may cause severe damage to the skin and internal organs. The risk of SJS or TEN is highest in people of Asian ancestry who have a genetic (inherited) risk factor. If you are Asian, your doctor will usually order a test to see if you have the genetic risk factor before prescribing carbamazepine. If you do have this risk factor, your doctor will probably prescribe another medication that is less likely to cause SJS or TEN. If you do not have this genetic risk factor, your doctor may prescribe carbamazepine, but there is still a slight risk that you will develop SJS or TEN. Call your doctor immediately if you develop a rash, blisters, or a fever during your treatment with carbamazepine.

Stevens-Johnson syndrome or toxic epidermal necrolysis usually occurs during the first few months of treatment with carbamazepine. If you have taken carbamazepine for several months or longer, you probably will not need to be tested, even if you are Asian.

Carbamazepine may decrease the number of blood cells produced by your body. In rare cases, the number of blood cells may decrease enough to cause serious or life-threatening health problems. Tell your doctor if you have ever had a decreased number of blood cells, especially if it was caused by another medication. If you experience any of the following symptoms, call your doctor immediately: sore throat, fever, chills, or other signs of infection; unusual bleeding or bruising; tiny purple dots or spots on the skin; mouth sores; or rash.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to carbamazepine.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with carbamazepine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

 

Why is Carbamazepine prescribed?

Carbamazepine is used alone or in combination with other medications to control certain types of seizures in patients with epilepsy. It is also used to treat trigeminal neuralgia (a condition that causes facial nerve pain). Carbamazepine extended-release capsules (Equetro brand only) are used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or mixed episodes (symptoms of mania and depression that happen at the same time) in patients with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Carbamazepine is in a class of medications called anticonvulsants. It works by reducing abnormal electrical activity in the brain.

How should Carbamazepine be used?

Carbamazepine comes as a tablet, a chewable tablet, an extended-release (long-acting) tablet, an extended-release capsule, and a suspension (liquid) to take by mouth. The regular tablet, chewable tablet, and liquid are usually taken two to four times a day with meals. The extended-release tablet is usually taken twice a day with meals. The extended-release capsule is usually taken twice a day with or without meals. To help you remember to take carbamazepine, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take carbamazepine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them. The extended-release capsules may be opened and the beads inside sprinkled over food, such as a teaspoon of applesauce or similar food. Do not crush or chew the extended-release capsules or the beads inside them.

Shake the liquid well before each use to mix the medication evenly.

Your doctor will start you on a low dose of carbamazepine and gradually increase your dose.

Carbamazepine may help control your condition, but will not cure it. It may take a few weeks or longer before you feel the full benefit of carbamazepine. Continue to take carbamazepine even if you feel well. Do not stop taking carbamazepine without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you have a seizure disorder and you suddenly stop taking carbamazepine, your seizures may become worse. Your doctor will probably decrease your dose gradually.

Other uses for Carbamazepine 

Carbamazepine is also sometimes used to treat mental illnesses, depression, posttraumatic stress disorder, drug and alcohol withdrawal, restless legs syndrome, diabetes insipidus, certain pain syndromes, and a disease in children called chorea. Talk to your doctor about the possible risks of using Carbamazepine for your condition.

Carbamazepine may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions to follow? 

Before taking carbamazepine, 

  • inform your doctor if you are allergic to carbamazepine, amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, other medications for seizures such as phenobarbital  or phenytoin, protriptyline, trimipramine, or any other medications.
  • you should know that carbamazepine is the active ingredient in several products that have different names and may be prescribed to treat different conditions. Check the list of brand names at the beginning of this document carefully. All of the products listed contain carbamazepine and you should not take more than one of them at the same time.
  • do not take carbamazepine if you are taking monoamine oxidase  inhibitors, including isocarboxazid, phenelzine, selegiline, and tranylcypromine, or have stopped taking them within the past 2 weeks.
  • inform your doctor what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: acetaminophen; acetazolamide; alprazolam; anticoagulants  such as warfarin; antidepressants such as amitriptyline, bupropion, buspirone, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, mirtazapine, nortriptyline; antifungals such as itraconazole  and ketoconazole; cimetidine; cisplatin; clarithromycin; clonazepam; clozapine; cyclosporine; dalfopristin and quinupristin; danazol; delavirdine; diltiazem; doxorubicin; doxycycline; erythromycin; felodipine; haloperidol; HIV protease inhibitors including atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, and saquinavir; isoniazid; levothyroxine; lithium; loratadine; lorazepam; certain medications to treat malaria such as chloroquine  and mefloquine; medications for anxiety or mental illness; other medications for seizures such as ethosuximide, felbamate, lamotrigine, methsuximide, oxcarbazepine, phenobarbital, phensuximide , phenytoin, primidone, tiagabine,topiramate, and valproic acid; methadone; nefazodone; niacinamide; propoxyphene; praziquantel; quinine; rifampin; sedatives; sleeping pills; terfenadine ; theophylline; tramadol; tranquilizers; troleandomycin; verapamil; and zileuton . Many other medications may also interact with carbamazepine, so be sure to inform your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • if you are taking any other liquid medications, do not take them at the same time as carbamazepine liquid.
  • inform your doctor what herbal products you are taking, especially St. John's wort.
  • inform your doctor if you have or have ever had glaucoma; psychosis; or heart, kidney, thyroid, or liver disease.
  • you should know that carbamazepine may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, injections, implants, or intrauterine devices). Use another form of birth control while taking carbamazepine. Tell your doctor if you have unexpected vaginal bleeding or think you may be pregnant while you are taking carbamazepine.
  • inform your doctor if you are pregnant or plan to become pregnant. Carbamazepine may harm the fetus. If you become pregnant while taking carbamazepine, call your doctor immediately.
  • do not breast-feed while you are taking carbamazepine.
  • if you are having surgery, including dental surgery, inform the doctor or dentist that you are taking carbamazepine.
  • you should know that carbamazepine may make you drowsy. Do not drive a car or operate machinery until you know how Carbamazepine affects you.
  • remember that alcohol can add to the drowsiness caused by Carbamazepine.
  • you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking carbamazepine for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as carbamazepine to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as carbamazepine, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What special dietary instructions to follow?

Talk to your doctor about drinking grapefruit juice while taking Carbamazepine.

What to do if I forget a dose? 

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can Carbamazepine cause?

 Carbamazepine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness

  • dizziness

  • unsteadiness

  • nausea

  • vomiting

  • headache

  • anxiety

  • memory problems

  • diarrhea

  • constipation

  • heartburn

  • dry mouth

  • back pain

 Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • confusion

  • loss of contact with reality

  • chest pain

  • yellowing of the skin or eyes

  • vision problems

Carbamazepine may cause other side effects. Call your doctor if you have any unusual problems while taking Carbamazepine.

What to know about storage and disposal of Carbamazepine? 

Keep Carbamazepine in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose 

In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include: 

  • unconsciousness

  • seizures

  • restlessness

  • muscle twitching

  • abnormal movements

  • shaking of a part of your body that you cannot control

  • unsteadiness

  • drowsiness

  • dizziness

  • blurred vision

  • irregular or slowed breathing

  • rapid or pounding heartbeat

  • nausea

  • vomiting

  • difficulty urinating

What other information to know?

Before having any laboratory test, inform your doctor and the laboratory personnel that you are taking carbamazepine.

Carbamazepine can interfere with the results of home pregnancy tests. Talk to your doctor if you think you might be pregnant while you are taking carbamazepine. Do not try to test for pregnancy at home.

The extended-release tablet does not dissolve in the stomach after swallowing. It slowly releases the medicine as it passes through your digestive system. You may notice the tablet coating in your stool.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

What other information to know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Carbamazepine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref: MedlinePlus, U.S. National Library of Medicine.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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| Latest mph edition: 09 Dec 2013 |
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