Carbamazepine
Tablet, Extended Release · Oral
Uses
Epilepsy Carbamazepine extended-release capsules are 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: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types. Generalized tonic-clonic seizures (grand mal). 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 extended-release capsules are 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.
Dosage and administration
Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests ). Dosage should be adjusted to the needs of the individual patients. A low initial daily dosage with gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Carbamazepine extended-release capsules may be taken with or without food. Carbamazepine extended-release capsules may be swallowed whole or may be opened and all the beads sprinkled on a teaspoon of soft food such as applesauce. Make sure all of the food and medicine mixture is swallowed. Do not crush or chew carbamazepine extended-release capsules or the sprinkled beads. Carbamazepine extended-release capsule is an extended-release formulation for twice a day administration. When converting patients from immediate release carbamazepine to carbamazepine extended-release capsules, the same total daily mg dose of carbamazepine should be administered. Following conversion to carbamazepine, patients should be closely monitored for seizure control. Depending on the therapeutic response after conversion, the total daily dose may need to be adjusted within the recommended dosing instructions. Epilepsy (see INDICATIONS AND USAGE ) Adults and children over 12 years of age. Initial: 200 mg twice daily. Increase at weekly intervals by adding up to 200 mg/day until the optimal response is obtained. Dosage generally should not exceed 1,000 mg per day in children 12 to 15 years of age, and 1,200 mg daily in patients above 15 years of age. Doses up to 1,600 mg daily have been used in adults. Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1,200 mg daily. Children under 12 years of age: Children taking total daily dosages of immediate-release carbamazepine of 400 mg or greater may be converted to the same total daily dosage of carbamazepine extended-release capsules, using a twice daily regimen. Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine extended-release capsules for use at doses above 35 mg/kg/24 hours can be made. Combination Therapy: Carbamazepine extended-release capsules may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions ). Trigeminal Neuralgia (see INDICATIONS AND USAGE ) Initial: On the first day, start with one 200 mg capsule. This daily dose may be increased by up to 200 mg/day every 12 hours only as needed to achieve freedom from pain. Do not exceed 1,200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.
Contraindications
Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline and nortriptyline. Likewise, on theoretical grounds its use with monoamine oxidase inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated. Coadministration of carbamazepine is contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
Warnings
Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Carbamazepine extended-release capsules should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. SJS/TEN and HLA-B*1502 Allele Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with carbamazepine treatment and the presence of an inherited variant of the HLA-B gene, HLA-B*1502. The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity. Across Asian populations, notable variation exists in the prevalence of HLA-B*1502. Greater than 15% of the population is reported positive in Hong Kong, Thailand, Malaysia, and parts of the Philippines, compared to about 10% in Taiwan and 4% in North China. South Asians, including Indians, appear to have intermediate prevalence of HLA-B*1502, averaging 2 to 4%, but higher in some groups. HLA-B*1502 is present in <1% of the population in Japan and Korea. HLA-B*1502 is largely absent in individuals not of Asian origin (e.g., Caucasians, African-Americans, Hispanics, and Native Americans). Prior to initiating carbamazepine extended-release capsules therapy, testing for HLA-B*1502 should be performed in patients with ancestry in populations in which HLA-B*1502 may be present. In deciding which patients to screen, the rates provided above for the prevalence of HLA-B*1502 may offer a rough guide, keeping in mind the limitations of these figures due to wide variability in rates even within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry. Carbamazepine extended-release capsules should not be used in patients positive for HLA-B*1502 unless the benefits clearly outweigh the risks. Tested patients who are found to be negative for the allele are thought to have a low risk of SJS/TEN (see WARNINGS and PRECAUTIONS/Laboratory Tests ). Over 90% of carbamazepine treated patients who will experience SJS/TEN have this reaction within the first few months of treatment. This information may be taken into consideration in determining the need for screening of genetically at-risk patients currently on carbamazepine extended-release capsules. The HLA-B*1502 allele has not been found to predict risk of less severe adverse cutaneous reactions from carbamazepine, such as maculopapular eruption [MPE] or to predict Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients of Chinese ancestry taking other anti-epileptic drugs associated with SJS/TEN, including phenytoin. Consideration should be given to avoiding use of other drugs associated with SJS/TEN in HLA-B*1502 positive patients, when alternative therapies are otherwise equally acceptable. Patients should be made aware that carbamazepine extended-release capsules contain carbamazepine and should not be used in combination with any other medications containing carbamazepine. Hypersensitivity Reactions and HLA-A*3101 Allele Retrospective case-control studies in patients of European, Korean, and Japanese ancestry have found a moderate association between the risk of developing hypersensitivity reactions and the presence of HLA-A*3101, an inherited allelic variant of the HLA-A gene, in patients using carbamazepine. These hypersensitivity reactions include SJS/TEN, maculopapular eruptions, and Drug Reaction with Eosinophilia and Systemic Symptoms (see DRESS/Multiorgan hypersensitivity below). HLA-A*3101 is expected to be carried by more than 15% of patients of Japanese, Native American, Southern Indian (e.g., Tamil Nadu) and some Arabic ancestry; up to about 10% in patients of Han Chinese, Korean, European, Latin American and other Indian ancestry; and up to about 5% in African-Americans and patients of Thai, Taiwanese, and Chinese (Hong Kong) ancestry. The risks and benefits of carbamazepine therapy should be weighed before considering carbamazepine in patients known to be positive for HLA-A*3101. General Information on HLA Genotyping and Hypersensitivity Application of HLA genotyping as a screening tool has important limitations and must never substitute for appropriate clinical vigilance and patient management. Many HLA-B*1502-positive and HLA-A*3101-positive patients treated with carbamazepine will not develop SJS/TEN or other hypersensitivity reactions, and these reactions can still occur infrequently in HLA-B*1502-negative and HLA-A*3101-negative patients of any ethnicity. The role of other possible factors in the development of, and morbidity from, SJS/TEN and other hypersensitivity reactions, such as AED dose, compliance, concomitant medications, co-morbidities, and the level of dermatologic monitoring have not been studied. Aplastic Anemia and Agranulocytosis Aplastic anemia and agranulocytosis have been reported in association with the use of carbamazepine. (See BOXED WARNING .) Patients with a history of adverse hematologic reaction to any drug may be particularly at risk of bone marrow depression. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, have occurred with carbamazepine.
Precautions
General Before initiating therapy, a detailed history and physical examination should be made. Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients carbamazepine has been associated with increased frequency of generalized convulsions (see INDICATIONS AND USAGE ). Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac conduction disturbance, including second- and third-degree atrioventricular (AV) block; cardiac, hepatic, or renal damage; adverse hematologic or hypersensitivity reaction to other drugs including reactions to other anticonvulsants; or interrupted courses of therapy with carbamazepine. AV block, including second- and third-degree block, has been reported following carbamazepine treatment. This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances. Hepatic effects, ranging from slight elevations in liver enzymes to rare cases of hepatic failure, have been reported (see ADVERSE REACTIONS and PRECAUTIONS , Laboratory Tests ). In some cases, hepatic effects may progress despite discontinuation of the drug. In addition, rare instances of vanishing bile duct syndrome have been reported. This syndrome consists of a cholestatic process with a variable clinical course ranging from fulminant to indolent, involving the destruction and disappearance of the intrahepatic bile ducts. Some, but not all, cases are associated with features that overlap with other immunoallergenic syndromes such as multiorgan hypersensitivity/ DRESS and serious dermatologic reactions. As an example, there has been a report of vanishing bile duct syndrome associated with Stevens-Johnson syndrome and in another case an association with fever and eosinophilia. Information for Patients Patients should be informed of the availability of a Medication Guide and they should be instructed to read the Medication Guide before taking carbamazepine extended-release capsules. Patients should be made aware of the early toxic signs and symptoms of potential hematologic, dermatologic, hypersensitivity, or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. Patients should be advised that, because these signs and symptoms may signal a serious reaction, they must report any occurrence immediately to their physicians. In addition, the patient should be advised that these signs and symptoms should be reported even if mild or when occurring after extended use. Patients should be advised that serious skin reactions have been reported in association with carbamazepine extended-release capsules. In the event a skin reaction should occur while taking carbamazepine extended-release capsules, patients should consult with their physician immediately (see WARNINGS ). Patients should be advised that anaphylactic reactions and angioedema may occur during treatment with carbamazepine extended-release capsules (see WARNINGS ). Advise patients to immediately report signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, or tongue, or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their healthcare provider. Patients, their caregivers, and families should be counseled that AEDs, including carbamazepine, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Carbamazepine extended-release capsules may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or nonprescription medications or herbal products. Caution should be exercised if alcohol is taken in combination with carbamazepine therapy, due to a possible additive sedative effect. Since dizziness and drowsiness may occur, patients should be cautioned about the hazards of operating machinery or automobiles or engaging in other potentially dangerous tasks. Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 (see Warnings-Usage in Pregnancy ). If necessary, the carbamazepine extended-release capsules can be opened and the contents sprinkled over food, such as a teaspoon of applesauce or other similar food products. Carbamazepine extended-release capsules or their contents should not be crushed or chewed. Carbamazepine extended-release capsules may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or non-prescription medication or herbal products. Patients, their caregivers, and families should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking carbamazepine extended-release capsules. See FDA approved Medication Guide. Laboratory Tests For genetically at-risk patients (see WARNINGS ), high-resolution ‘ HLA-B*1502 typing ’ is recommended. The test is positive if either one or two HLA-B*1502 alleles are detected and negative if no HLA-B*1502 alleles are detected. Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, should be obtained as a baseline.
Side effects
General : If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive patient with epilepsy may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions previously observed with carbamazepine were reported in the hemopoietic system and skin (see BOXED WARNING ), and the cardiovascular system. The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. The following additional adverse reactions were previously reported with carbamazepine: Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria. Skin: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOXED WARNING ), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, onychomadesis and hirsutism. In certain cases, discontinuation of therapy may be necessary. Cardiovascular System : Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism, and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds. Immune system disorders : Hypogammaglobulinemia. Liver : Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, and hepatic failure. Pancreatic : Pancreatitis. Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia. Genitourinary System : Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported. There have been rare reports of impaired male fertility and/or abnormal spermatogenesis. Testicular atrophy occurred in rats receiving carbamazepine orally from 4 to 52 weeks at dosage levels of 50 to 400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg/day and higher. Relevance of these findings to humans is unknown. Nervous System : Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, and hyperacusis. There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established. Isolated cases of neuroleptic malignant syndrome have been reported with concomitant use of psychotropic drugs. Digestive System : Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis. Eyes: Scattered punctate cortical lens opacities, as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes. Musculoskeletal System: Bone loss, aching joints and muscles, and leg cramps. Metabolism : Fever and chills, decreased levels of plasma calcium leading to osteoporosis, and hyperammonemia have been reported. Other: Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants. A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.
Drug interactions
Drug Interactions Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to the following: Agents Highly Bound to Plasma Protein: Carbamazepine is not highly bound to plasma proteins; therefore, administration of carbamazepine extended-release capsules to a patient taking another drug that is highly protein bound should not cause increased free concentrations of the other drug. Agents that Inhibit Cytochrome P450 Isoenzymes and/or Epoxide Hydrolase: Carbamazepine is metabolized mainly by cytochrome P450 (CYP) 3A4 to the active carbamazepine 10, 11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Therefore, the potential exists for interaction between carbamazepine and any agent that inhibits CYP3A4 and/or epoxide hydrolase. Agents that are CYP3A4 inhibitors that have been found, or are expected, to increase plasma levels of carbamazepine extended-release capsules include, for example, the following: Acetazolamide, aprepitant, azole antifungals (e.g., ketoconazole, itraconazole, fluconazole, voriconazole), cimetidine, ciprofloxacin, clarithromycin, dalfopristin, danazol, dantrolene, delavirdine, diltiazem, erythromycin, fluoxetine, fluvoxamine, grapefruit juice, ibuprofen, isoniazid, loratadine, macrolides, nefazodone, niacinamide, nicotinamide, olanzapine, omeprazole, oxybutynin, protease inhibitors, propoxyphene, quinine, quinupristin, ticlopidine, troleandomycin, valproate, verapamil, zileuton. Human microsomal epoxide hydrolase has been identified as the enzyme responsible for the formation of the 10,11-transdiol derivative from carbamazepine-10,11 epoxide. Coadministration of inhibitors of human microsomal epoxide hydrolase may result in increased carbamazepine-10,11 epoxide plasma concentrations. Accordingly, the dosage of carbamazepine extended-release capsules should be adjusted and/or the plasma levels monitored when used concomitantly with loxapine, quetiapine, or valproic acid. Thus, if a patient has been titrated to a stable dosage of carbamazepine extended-release capsules, and then begins a course of treatment with one of these CYP3A4 or epoxide hydrolase inhibitors, it is reasonable to expect that a dose reduction for carbamazepine extended-release capsules may be necessary. Agents that Induce Cytochrome P450 Isoenzymes : Carbamazepine is metabolized by CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent that induces CYP3A4. Agents that are CYP inducers that have been found, or are expected, to decrease plasma levels of carbamazepine extended-release capsules include, for example, the following: Aminophylline, cisplatin, doxorubicin HCL, felbamate, fosphenytoin, methsuximide, phenobarbital, phenytoin( 1 ), primidone, rifampin and theophylline. (1) Phenytoin plasma levels have also been reported to increase and decrease in the presence of carbamazepine, see below. Thus, if a patient has been titrated to a stable dosage on carbamazepine extended-release capsules, and then begins a course of treatment with one of these CYP3A4 inducers, it is reasonable to expect that a dose increase for carbamazepine extended-release capsules may be necessary. Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes: Carbamazepine is a potent inducer of hepatic CYP3A4 and is also known to be an inducer of CYP1A2, 2B6, 2C9/19 and may therefore reduce plasma concentrations of co-medications mainly metabolized by CYP 1A2, 2B6, 2C9/19 and 3A4, through induction of their metabolism. When used concomitantly with carbamazepine extended-release capsules, monitoring of concentrations or dosage adjustment of these agents may be necessary: When carbamazepine is added to aripiprazole, the aripiprazole dose should be doubled. Additional dose increases should be based on clinical evaluation. If carbamazepine is later withdrawn, the aripiprazole dose should be reduced. When carbamazepine is used with tacrolimus, monitoring of tacrolimus blood concentrations and appropriate dosage adjustments are recommended. The use of concomitant strong CYP3A4 inducers such as carbamazepine should be avoided with temsirolimus. If patients must be coadministered carbamazepine with temsirolimus, an adjustment of temsirolimus dosage should be considered. The use of carbamazepine with lapatinib should generally be avoided. If carbamazepine is started in a patient already taking lapatinib, the dose of lapatinib should be gradually titrated up. If carbamazepine is discontinued, the lapatinib dose should be reduced. Concomitant use of carbamazepine with nefazodone results in plasma concentrations of nefazodone and its active metabolite insufficient to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated (see CONTRAINDICATIONS ). Monitor concentrations of valproate when carbamazepine extended-release capsules are introduced or withdrawn in patients using valproic acid. In addition, carbamazepine causes, or would be expected to cause, decreased levels of, for example, the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: Acetaminophen, albendazole, alprazolam, aprepitant, buprenorphine, apixaban( 6 ), bupropion, buspirone, citalopram, clobazam, clonazepam, clozapine, corticosteroids (e.g.
Pregnancy
Usage in Pregnancy (See WARNINGS )
Pediatric use
Pediatric Use Substantial evidence of carbamazepine effectiveness for use in the management of children with epilepsy (see INDICATIONS for specific seizure types) is derived from clinical investigations performed in adults and from studies in several in vitro systems which support the conclusion that (1) the pathogenic mechanisms underlying seizure propagation are essentially identical in adults and children, and (2) the mechanism of action of carbamazepine in treating seizures is essentially identical in adults and children. Taken as a whole, this information supports a conclusion that the generally acceptable therapeutic range of total carbamazepine in plasma (i.e., 4 to 12 mcg/mL) is the same in children and adults. The evidence assembled was primarily obtained from short-term use of carbamazepine. The safety of carbamazepine in children has been systematically studied up to 6 months. No longer term data from clinical trials is available.
Geriatric use
Geriatric Use No systematic studies in geriatric patients have been conducted.
Overdosage
Acute Toxicity Lowest known lethal dose: adults, >60 g (39-year-old man). Highest known doses survived: adults, 30 g (31-year-old woman); children, 10 g (6-year-old boy); small children, 5 g (3-year-old girl). Oral LD 50 in animals (mg/kg): mice, 1100 to 3750; rats, 3850 to 4025; rabbits, 1500 to 2680; guinea pigs, 920. Signs and Symptoms The first signs and symptoms appear after 1 to 3 hours. Neuromuscular disturbances are the most prominent. Cardiovascular disorders are generally milder, and severe cardiac complications occur only when very high doses (>60 g) have been ingested. Respiration: Irregular breathing, respiratory depression. Cardiovascular System: Tachycardia, hypotension or hypertension, shock, conduction disorders. Nervous System and Muscles: Impairment of consciousness ranging in severity to deep coma. Convulsions, especially in small children. Motor restlessness, muscular twitching, tremor, athetoid movements, opisthotonos, ataxia, drowsiness, dizziness, mydriasis, nystagmus, adiadochokinesia, ballism, psychomotor disturbances, dysmetria. Initial hyperreflexia, followed by hyporeflexia. Gastrointestinal Tract: Nausea, vomiting. Kidneys and Bladder: Anuria or oliguria, urinary retention. Laboratory Findings: Isolated instances of overdosage have included leukocytosis, reduced leukocyte count, glycosuria, and acetonuria. ECG may show dysrhythmias. Combined Poisoning: When alcohol, tricyclic antidepressants, barbiturates, or hydantoins are taken at the same time, the signs and symptoms of acute poisoning with carbamazepine may be aggravated or modified. Treatment For the most up to date information on management of carbamazepine overdose, please contact the poison center for your area by calling 1-800-222-1222. The prognosis in cases of carbamazepine poisoning is generally favorable. Of 5,645 cases of carbamazepine exposures reported to US poison centers in 2002, a total of 8 deaths (0.14% mortality rate) occurred. Over 39% of the cases reported to these poison centers were managed safely at home with conservative care. Successful management of large or intentional carbamazepine exposures requires implementation of supportive care, frequent monitoring of serum drug concentrations, as well as aggressive but appropriate gastric decontamination. Elimination of the Drug: The primary method for gastric decontamination of carbamazepine overdose is use of activated charcoal. For substantial recent ingestions, gastric lavage may also be considered. Administration of activated charcoal prior to hospital assessment has the potential to significantly reduce drug absorption. There is no specific antidote. In overdose, absorption of carbamazepine may be prolonged and delayed. More than one dose of activated charcoal may be beneficial in patients that have evidence of continued absorption (e.g., rising serum carbamazepine levels). Measures to Accelerate Elimination: The data on use of dialysis to enhance elimination in carbamazepine is scarce. Dialysis, particularly high flux or high efficiency hemodialysis, may be considered in patients with severe carbamazepine poisoning associated with renal failure or in cases of status epilepticus, or where there are rising serum drug levels and worsening clinical status despite appropriate supportive care and gastric decontamination. For severe cases of carbamazepine overdose unresponsive to other measures, charcoal hemoperfusion may be used to enhance drug clearance. Respiratory Depression: Keep the airways free; resort, if necessary, to endotracheal intubation, artificial respiration, and administration of oxygen. Hypotension, Shock: Keep the patient's legs raised and administer a plasma expander. If blood pressure fails to rise despite measures taken to increase plasma volume, use of vasoactive substances should be considered. Convulsions: Diazepam or barbiturates. Warning: Diazepam or barbiturates may aggravate respiratory depression (especially in children), hypotension, and coma. However, barbiturates should not be used if drugs that inhibit monoamine oxidase have also been taken by the patient either in overdosage or in recent therapy (within 1 week). Surveillance: Respiration, cardiac function (ECG monitoring), blood pressure, body temperature, pupillary reflexes, and kidney and bladder function should be monitored for several days. Treatment of Blood Count Abnormalities: If evidence of significant bone marrow depression develops, the following recommendations are suggested: (1) stop the drug, (2) perform daily CBC, platelet, and reticulocyte counts, (3) do a bone marrow aspiration and trephine biopsy immediately and repeat with sufficient frequency to monitor recovery. Special periodic studies might be helpful as follows: (1) white cell and platelet antibodies, (2) 59 Fe-ferrokinetic studies, (3) peripheral blood cell typing, (4) cytogenetic studies on marrow and peripheral blood, (5) bone marrow culture studies for colony-forming units, (6) hemoglobin electrophoresis for A2 and F hemoglobin, and (7) serum folic acid and B 12 levels. A fully developed aplastic anemia will require appropriate, intensive monitoring and therapy, for which specialized consultation should be sought.
Description
Carbamazepine extended-release capsules are an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is: Carbamazepine extended-release capsules are a multi-component capsule formulation consisting of extended-release granules. Inactive ingredients: colloidal silicon dioxide, ethylcellulose, and stearic acid. The 100 mg, 200 mg and 300 mg capsule shells contain FD&C Blue #2, gelatin, iron oxide yellow, titanium dioxide and are imprinted with black ink (S-1-8114 and S-1-8115) contain FD&C BLUE #2, FD&C RED #40, FD&C BLUE #1, D&C YELLOW #10 and shellac. carbamazepine-figure-1
How supplied
Carbamazepine extended-release capsules 100 mg are hard gelatin capsules with white opaque body and blue-green opaque cap, imprinted “APO C100” in black ink with white to off-white granule fill. They are supplied as follows: Bottles of 30s (NDC 60505-2805-3) Bottles of 120s (NDC 60505-2805-7) Bottles of 1000s (NDC 60505-2805-8) Carbamazepine extended-release capsules 200 mg are hard gelatin capsules with white opaque body and blue-green opaque cap, imprinted “APO C200” in black ink with white to off-white granule fill. They are supplied as follows: Bottles of 30s (NDC 60505-2806-3) Bottles of 120s (NDC 60505-2806-7) Bottles of 1000s (NDC 60505-2806-8) Carbamazepine extended-release capsules 300 mg are hard gelatin capsules with white opaque body and blue-green opaque cap, imprinted “APO C300” in black ink with white to off-white granule fill. They are supplied as follows: Bottles of 30s (NDC 60505-2807-3) Bottles of 120s (NDC 60505-2807-7) Bottles of 500s (NDC 60505-2807-5) Store at 20˚C to 25°C (68˚F to 77°F); excursions permitted to 15˚C to 30°C (59˚F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Dispense with Medication Guide available at https://www.apotex.com/products/us/mg.asp APOTEX INC. CARBAMAZEPINE EXTENDED-RELEASE CAPSULES 100 mg, 200 mg and 300 mg Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida USA 33326 Rev. 11
Patient information
Information for Patients Patients should be informed of the availability of a Medication Guide and they should be instructed to read the Medication Guide before taking carbamazepine extended-release capsules. Patients should be made aware of the early toxic signs and symptoms of potential hematologic, dermatologic, hypersensitivity, or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. Patients should be advised that, because these signs and symptoms may signal a serious reaction, they must report any occurrence immediately to their physicians. In addition, the patient should be advised that these signs and symptoms should be reported even if mild or when occurring after extended use. Patients should be advised that serious skin reactions have been reported in association with carbamazepine extended-release capsules. In the event a skin reaction should occur while taking carbamazepine extended-release capsules, patients should consult with their physician immediately (see WARNINGS ). Patients should be advised that anaphylactic reactions and angioedema may occur during treatment with carbamazepine extended-release capsules (see WARNINGS ). Advise patients to immediately report signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, or tongue, or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their healthcare provider. Patients, their caregivers, and families should be counseled that AEDs, including carbamazepine, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Carbamazepine extended-release capsules may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or nonprescription medications or herbal products. Caution should be exercised if alcohol is taken in combination with carbamazepine therapy, due to a possible additive sedative effect. Since dizziness and drowsiness may occur, patients should be cautioned about the hazards of operating machinery or automobiles or engaging in other potentially dangerous tasks. Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 (see Warnings-Usage in Pregnancy ). If necessary, the carbamazepine extended-release capsules can be opened and the contents sprinkled over food, such as a teaspoon of applesauce or other similar food products. Carbamazepine extended-release capsules or their contents should not be crushed or chewed. Carbamazepine extended-release capsules may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or non-prescription medication or herbal products. Patients, their caregivers, and families should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking carbamazepine extended-release capsules. See FDA approved Medication Guide.
Label text from the FDA structured product label by Apotex Corp. (revised Sep 10, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Carbamazepine in 140 products
Carbamazepine NDC products (140)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-0384 | Carbamazepine 200 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5740 | Carbamazepine 200 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 27241-233 | Carbamazepine 400 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-232 | Carbamazepine 200 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-231 | Carbamazepine 100 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 62332-731 | Carbamazepine 200 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-422 | Carbamazepine 400 mg/1 Tablet, Film Coated, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-420 | Carbamazepine 100 mg/1 Tablet, Film Coated, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-421 | Carbamazepine 200 mg/1 Tablet, Film Coated, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-420 | Carbamazepine 100 mg/1 Tablet, Film Coated, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-421 | Carbamazepine 200 mg/1 Tablet, Film Coated, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-422 | Carbamazepine 400 mg/1 Tablet, Film Coated, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-731 | Carbamazepine 200 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 60687-973 | Carbamazepine 100 mg/1 Tablet, Extended Release | American Health Packaging | ANDA |
| 60687-594 | Carbamazepine 400 mg/1 Tablet, Extended Release | American Health Packaging | ANDA |
| 68084-444 | Carbamazepine 200 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-583 | Carbamazepine 200 mg/1 Tablet, Extended Release | American Health Packaging | ANDA |
| 60687-479 | Carbamazepine 100 mg/1 Tablet, Chewable | American Health Packaging | ANDA |
| 62559-486 | Carbamazepine 300 mg/1 Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA |
| 62559-485 | Carbamazepine 200 mg/1 Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA |
| 62559-484 | Carbamazepine 100 mg/1 Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-240 | Carbamazepine 100 mg/5mL Suspension | ANI Pharmaceuticals, Inc. | ANDA |
| 71610-782 | Carbamazepine 200 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-953 | Carbamazepine 200 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 60505-2807 | Carbamazepine 300 mg/1 Capsule, Extended Release | Apotex Corp. | ANDA |
| 60505-2806 | Carbamazepine 200 mg/1 Capsule, Extended Release | Apotex Corp. | ANDA |
| 60505-2805 | Carbamazepine 100 mg/1 Capsule, Extended Release | Apotex Corp. | ANDA |
| 60505-0183 | Carbamazepine 200 mg/1 Tablet | Apotex Corp. | ANDA |
| 67877-797 | Carbamazepine 100 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-798 | Carbamazepine 200 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-799 | Carbamazepine 400 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 17856-4047 | Carbamazepine 100 mg/5mL Suspension | Atlantic Biologicals Corps | ANDA |
| 50268-160 | Carbamazepine 200 mg/1 Tablet | AvPAK | ANDA |
| 50268-170 | Carbamazepine 100 mg/1 Capsule, Extended Release | AvPAK | ANDA |
| 50268-171 | Carbamazepine 200 mg/1 Capsule, Extended Release | AvPAK | ANDA |
| 50268-172 | Carbamazepine 300 mg/1 Capsule, Extended Release | AvPAK | ANDA |
| 69452-312 | Carbamazepine 200 mg/1 Tablet | Bionpharma Inc., | ANDA |
| 63629-5914 | Carbamazepine 100 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1708 | Carbamazepine 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8753 | Carbamazepine 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0461 | Carbamazepine 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-3077 | Carbamazepine 100 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-3002 | Carbamazepine 200 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1715 | Carbamazepine 300 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-2572 | Carbamazepine 100 mg/1 Tablet, Chewable | Bryant Ranch Prepack | ANDA |
| 71335-3001 | Carbamazepine 300 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2921 | Carbamazepine 100 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2707 | Carbamazepine 300 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2706 | Carbamazepine 200 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1730 | Carbamazepine 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0691 | Carbamazepine 200 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 55154-1396 | Carbamazepine 200 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 68999-867 | Carbamazepine 200 mg/10mL Suspension | Chartwell Governmental & Specialty RX, LLC. | ANDA |
| 68999-802 | Carbamazepine 100 mg/5mL Suspension | Chartwell Governmental & Specialty RX, LLC. | ANDA |
| 62135-802 | Carbamazepine 100 mg/5mL Suspension | Chartwell RX, LLC | ANDA |
| 62135-867 | Carbamazepine 200 mg/10mL Suspension | Chartwell RX, LLC | ANDA |
| 67046-1559 | Carbamazepine 200 mg/1 Capsule, Extended Release | Coupler LLC | ANDA |
| 67046-1558 | Carbamazepine 100 mg/1 Capsule, Extended Release | Coupler LLC | ANDA |
| 67046-1455 | Carbamazepine 300 mg/1 Capsule, Extended Release | Coupler LLC | ANDA |
| 67046-0753 | Carbamazepine 100 mg/1 Tablet, Chewable | Coupler LLC | ANDA |
| 67046-0707 | Carbamazepine 200 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1534 | Carbamazepine 400 mg/1 Tablet, Extended Release | Coupler, LLC | ANDA |
| 72189-157 | Carbamazepine 200 mg/1 Tablet | direct rx | ANDA |
| 42806-274 | Carbamazepine 100 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 42806-275 | Carbamazepine 200 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 42806-276 | Carbamazepine 400 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 60429-032 | Carbamazepine 200 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-897 | Carbamazepine 400 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-896 | Carbamazepine 200 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-895 | Carbamazepine 100 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-215 | Carbamazepine 200 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 60429-934 | Carbamazepine 100 mg/1 Tablet, Chewable | Golden State Medical Supply, Inc. | ANDA |
| 50742-259 | Carbamazepine 400 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-257 | Carbamazepine 100 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-258 | Carbamazepine 200 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 59746-789 | Carbamazepine 100 mg/1 Tablet, Extended Release | Jubilant Cadista Pharmaceuticals Inc. | ANDA |
| 59746-790 | Carbamazepine 200 mg/1 Tablet, Extended Release | Jubilant Cadista Pharmaceuticals Inc. | ANDA |
| 59746-791 | Carbamazepine 400 mg/1 Tablet, Extended Release | Jubilant Cadista Pharmaceuticals Inc. | ANDA |
| 0904-6885 | Carbamazepine 200 mg/1 Capsule, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-6172 | Carbamazepine 200 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-3854 | Carbamazepine 100 mg/1 Tablet, Chewable | Major Pharmaceuticals | ANDA |
| 0615-8545 | Carbamazepine 200 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8125 | Carbamazepine 100 mg/1 Tablet, Chewable | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 75834-221 | Carbamazepine 200 mg/1 Tablet | NIVAGEN PHARMACEUTICALS, INC. | ANDA |
| 75834-220 | Carbamazepine 100 mg/1 Tablet | NIVAGEN PHARMACEUTICALS, INC. | ANDA |
| 72603-888 | Carbamazepine 400 mg/1 Tablet, Extended Release | Northstar Rx LLC | ANDA |
| 72603-887 | Carbamazepine 200 mg/1 Tablet, Extended Release | Northstar Rx LLC | ANDA |
| 72603-886 | Carbamazepine 100 mg/1 Tablet, Extended Release | Northstar Rx LLC | ANDA |
| 16714-064 | Carbamazepine 200 mg/1 Tablet, Extended Release | Northstar Rx LLC | ANDA |
| 16714-063 | Carbamazepine 100 mg/1 Tablet, Extended Release | Northstar Rx LLC | ANDA |
| 68071-3988 | Carbamazepine 200 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 72516-020 | Carbamazepine 200 mg/1 Tablet, Extended Release | Oryza Pharmaceuticals Inc. | ANDA |
| 72516-021 | Carbamazepine 400 mg/1 Tablet, Extended Release | Oryza Pharmaceuticals Inc. | ANDA |
| 43063-328 | Carbamazepine 200 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-7210 | Carbamazepine 200 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7825 | Carbamazepine 200 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 71205-025 | Carbamazepine 200 mg/1 Tablet | Proficient Rx LP | ANDA |
| 70518-4167 | Carbamazepine 200 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4682 | Carbamazepine 200 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4492 | Carbamazepine 300 mg/1 Capsule, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-3911 | Carbamazepine 400 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-3773 | Carbamazepine 100 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-3699 | Carbamazepine 200 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-3146 | Carbamazepine 200 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2841 | Carbamazepine 200 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2242 | Carbamazepine 200 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-1433 | Carbamazepine 100 mg/1 Tablet, Chewable | REMEDYREPACK INC. | ANDA |
| 70518-2426 | Carbamazepine 100 mg/1 Tablet, Chewable | REMEDYREPACK INC. | ANDA |
| 16571-682 | Carbamazepine 400 mg/1 Tablet, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 16571-680 | Carbamazepine 100 mg/1 Tablet, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 16571-681 | Carbamazepine 200 mg/1 Tablet, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 51672-4125 | Carbamazepine 400 mg/1 Tablet, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4050 | Carbamazepine 200 mg/1 Tablet, Chewable | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4123 | Carbamazepine 100 mg/1 Tablet, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4124 | Carbamazepine 200 mg/1 Tablet, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4047 | Carbamazepine 100 mg/5mL Suspension | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4041 | Carbamazepine 100 mg/1 Tablet, Chewable | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4005 | Carbamazepine 200 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 13668-268 | Carbamazepine 200 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 13668-271 | Carbamazepine 100 mg/1 Tablet, Chewable | Torrent Pharmaceuticals Limited | ANDA |
| 13668-284 | Carbamazepine 100 mg/1 Tablet, Extended Release | Torrent Pharmaceuticals Limited | ANDA |
| 13668-285 | Carbamazepine 200 mg/1 Tablet, Extended Release | Torrent Pharmaceuticals Limited | ANDA |
| 13668-286 | Carbamazepine 400 mg/1 Tablet, Extended Release | Torrent Pharmaceuticals Limited | ANDA |
| 60290-034 | Carbamazepine 100 mg/1 Tablet | Umedica Laboratories USA Inc. | ANDA |
| 60290-008 | Carbamazepine 200 mg/1 Tablet | Umedica Laboratories USA Inc. | ANDA |
| 60290-058 | Carbamazepine 100 mg/1 Tablet, Extended Release | Umedica Laboratories USA Inc. | ANDA |
| 60290-059 | Carbamazepine 200 mg/1 Tablet, Extended Release | Umedica Laboratories USA Inc. | ANDA |
| 60290-060 | Carbamazepine 400 mg/1 Tablet, Extended Release | Umedica Laboratories USA Inc. | ANDA |
| 29300-382 | Carbamazepine 200 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 0832-6024 | Carbamazepine 400 mg/1 Tablet, Extended Release | Upsher-Smith Laboratories, LLC | ANDA |
| 0832-6022 | Carbamazepine 100 mg/1 Tablet, Extended Release | Upsher-Smith Laboratories, LLC | ANDA |
| 70771-1470 | Carbamazepine 400 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1469 | Carbamazepine 200 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1468 | Carbamazepine 100 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 68382-557 | Carbamazepine 400 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-555 | Carbamazepine 100 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-556 | Carbamazepine 200 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 66828-0268 | Carbamazepine 400 mg/1 Tablet, Extended Release | Novartis Pharma Produktions GmbH | DRUG FOR FURTHER PROCESSING |
| 66828-0261 | Carbamazepine 200 mg/1 Tablet, Extended Release | Novartis Pharma Produktions GmbH | DRUG FOR FURTHER PROCESSING |
| 66828-0324 | Carbamazepine 100 mg/1 Tablet, Extended Release | Novartis Pharma Produktions GmbH | DRUG FOR FURTHER PROCESSING |
Carbamazepine recalls
- D-0771-2026 Aug 26, 2026 · Class II · Ongoing
CGMP deviations: tablets with black specks. - D-0675-2025 Oct 8, 2025 · Class II · Ongoing
Failed Dissolution Specifications. - D-0365-2022 Jan 19, 2022 · Class II · Terminated
Failed Dissolution Specifications - D-0807-2021 Sep 29, 2021 · Class II · Terminated
Failed Dissolution Specifications - D-1317-2020 Jun 10, 2020 · Class II · Terminated
Failed Dissolution Specifications
Frequently asked questions
What is Carbamazepine used for?
Epilepsy Carbamazepine extended-release capsules are 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: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater…
What are the side effects of Carbamazepine?
General : If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive patient with epilepsy may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions previously observed with carbamazepine were reported in the hemopoietic… See the full label for the complete list.
Who makes Carbamazepine?
Carbamazepine is listed by 42 labelers in the FDA NDC directory, including A-S Medication Solutions, Ajanta Pharma USA Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited.
Has Carbamazepine been recalled?
The FDA enforcement database lists 5 recalls for Carbamazepine, most recently D-0771-2026 (class ii): CGMP deviations: tablets with black specks.