CARBAMAZEPINE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

CARBAMAZEPINE (UNII: 33CM23913M) (CARBAMAZEPINE - UNII:33CM23913M)

Beszerezhető a:

direct rx

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). Trigeminal Neuralgia Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. Carbamazepine should not be used in patients

Termék összefoglaló:

Carbamazepine Tablets USP, 100 mg- Pink Colored, round flat beveled edge, uncoated single scored tablet debossed with ‘CAR’ on one side and ‘100’ on the scored side and other side plain, free from physical defects: Carbamazepine Tablets USP, 200 mg - Pink colored, capsule-shaped biconvex, uncoated tablet, debossed ‘CAR’ on one side and ‘200’ on the partially scored side, free from physical defects: Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container. *The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt. Ltd. The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Ltd. or its products. Revised: April 2020, V-05 MEDICATION GUIDE CARBAMAZEPINE (kar-bah-MAZ-eh-peen) TABLETS USP, 100 mg and 200 mg Read this Medication Guide before you start taking carbamazepine. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about carbamazepine? Do not stop taking carbamazepine without first talking to your healthcare provider. Stopping carbamazepine suddenly can cause serious problems. Carbamazepine can cause serious side effects, including: 1. Carbamazepine may cause 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. Carbamazepine may cause 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. Carbamazepine may cause allergic reactions or serious problems, which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following: • swelling of your face, eyes, lips, or tongue • a skin rash • painful sores in the mouth or around your eyes • unusual bruising or bleeding • frequent infections or infections that do not go away • fever, swollen glands, or sore throat that do not go away or come and go • trouble swallowing or breathing • hives • yellowing of your skin or eyes • severe fatigue or weakness • an extreme increase in activity and talking (mania) • severe muscle pain 4. 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 How can I 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. Do not stop carbamazepine without first talking to a healthcare provider. Stopping carbamazepine suddenly can cause serious problems. You should talk to your healthcare provider before stopping. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. What is carbamazepine? Carbamazepine is a prescription medicine used to treat: • certain types of seizures (partial, tonic-clonic, mixed) • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia) Carbamazepine is not a regular pain medicine and should not be used for aches or pains. Who should not take carbamazepine? Do not take carbamazepine if you: • have a history of bone marrow depression. • are allergic to carbamazepine or any of the ingredients in Carbamazepine Tablets. See the end of this Medication Guide for a complete list of ingredients in Carbamazepine Tablets. • 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. What should I tell my healthcare provider before taking carbamazepine? Before you take carbamazepine, tell your healthcare provider if you: • have or have had suicidal thoughts or actions, depression, or mood problems • have or ever had heart problems • have or ever had blood problems • have or ever had liver problems • have or ever had kidney problems • have or ever had allergic reactions to medicines • have or ever had increased pressure in your eye • have any other medical conditions • drink grapefruit juice or eat grapefruit • use birth control. Carbamazepine may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and carbamazepine. • are pregnant or plan to become pregnant. Carbamazepine may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking carbamazepine. You and your healthcare provider should decide if you should take carbamazepine while you are pregnant. ▪ If you become pregnant while taking carbamazepine, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334. • are breastfeeding or plan to breastfeed. Carbamazepine passes into breast milk. You and your healthcare provider should discuss whether you should take carbamazepine or breastfeed; you should not do both. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking carbamazepine with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take carbamazepine? • Do not stop taking carbamazepine without first talking to your healthcare provider. Stopping carbamazepine suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus). • Take carbamazepine exactly as prescribed. Your healthcare provider will tell you how much carbamazepine to take. • Your healthcare provider may change your dose. Do not change your dose of carbamazepine without talking to y

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CARBAMAZEPINE- CARBAMAZEPINE TABLET
DIRECT RX
----------
CARBAMAZEPINE
WARNINGS
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 (SEE WARNINGSAND PRECAUTIONS,
LABORATORY TESTS).
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 TO 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 AGRANULOCYTOSI