Plain-language summary, compiled from the cited regulatory records
Carbamazepine is an anticonvulsant drug belonging to the carboxamide derivatives class [1]. It is approved for the treatment of epilepsy, specifically for patients experiencing partial seizures with complex symptomatology (psychomotor, temporal lobe) and generalized tonic-clonic seizures (grand mal) [1]. Studies have indicated that patients with complex partial seizures may show greater improvement with carbamazepine compared to those with other seizure types [1].
Carbamazepine is available under various brand names [N]. In the past 12 months, there have been 2383 adverse event reports associated with carbamazepine [2]. The most frequently reported issues include off-label use, perceived drug ineffectiveness, drug interactions, nausea, and seizures [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 28, 2026[1]
Epilepsy - generalised tonic-clonic and partial seizures.
Note:
Carbamazepine is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences. The paroxysmal pain of trigeminal neuralgia.
For the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy.
How to take
CACanada· Health Canada
16 products
Uses
CAOfficial regulatory label· revised January 6, 2026[2]
Epilepsy:
Adults (>18 years of age) TARO-CARBAMAZEPINE (carbamazepine) is indicated for use as an anticonvulsant drug either alone or in combination with other anticonvulsant drugs. Carbamazepine is not effective in controlling absence, myoclonic or atonic seizures, and does not prevent the generalization of epileptic discharge.
Moreover, exacerbation of seizures may occasionally occur in patients with atypical absences.
Trigeminal Neuralgia:
Adults (>18 years of age) TARO-CARBAMAZEPINE is indicated for the symptomatic relief of pain of trigeminal neuralgia only during periods of exacerbation of true or primary trigeminal neuralgia (tic douloureux). It should not be used preventively during periods of remission.
In some patients, carbamazepine has relieved glossopharyngeal neuralgia. For patients who fail to respond to TARO-CARBAMAZEPINE, or who are sensitive to the drug, recourse to other accepted measures must be considered. Carbamazepine is not a simple analgesic and should not be used to relieve trivial facial pains or headaches.
USUnited States· FDA
6 products
Uses
USOfficial regulatory label· revised February 18, 2026[3]
INDICATIONS AND USAGE
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: Partial seizures with complex symptomatology (psychomotor, temporal lobe).
Patients with these seizures appear to show greater improvement 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 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.
Drug interactions
Known interactions involving Carbamazepine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02244403 · revised January 6, 2026
[3]FDA DailyMed · 1922a7cd-6a43-da… · revised February 18, 2026 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 28, 2026[1]
Carbamazepine Suspension is given orally, usually in two or three divided doses. Carbamazepine Suspension (the suspension should be shaken before use) may be taken during, after or between meals. After taking this medicine, a full glass of water (approximately 240 ml) should be taken.
This medicinal product must not be administered via enteral feeding tubes. Administer only by the oral route. Since a given dose of Carbamazepine Suspension will produce higher peak levels than the same dose in tablet form, it is advisable to start with low doses of the liquid and to increase them slowly so as to avoid adverse effects on the central nervous system such as dizziness and lethargy.
When switching a patient from tablets to liquid the same overall dose may be used but in smaller, more frequent, doses. 4).
Epilepsy:
The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma-carbamazepine concentrations of about 4 to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and precautions).
Adults:
It is advised that with all formulations of Carbamazepine, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. Carbamazepine should be taken in a number of divided doses although initially 100-200 mg once to twice daily is recommended.
This may be followed by a slow increase until the best response is obtained, often 800-1200 mg daily. Adult patients who require doses exceeding 1200 mg up to 2000 mg/day of Carbamazepine, should be switched to alternative oral formulations of Carbamazepine, such as immediate release and prolonged release tablets.
Elderly population (65 years or above):
Due to the potential for drug interactions, the dosage of Carbamazepine should be selected with caution in elderly patients.
Children (4 weeks of age or above) and adolescents:
It is advised that with all formulations of Carbamazepine, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. Usual dosage 10-20 mg/kg bodyweight daily in several divided doses.
Age up to 1 year: 1-5 years: 5-10 years: 10-15 years: >15 years of age: 100 to 200 mg daily (5-10 ml liquid per day). 200 to 400 mg daily (10-20 ml liquid per day). 400 to 600 mg daily (20-30 ml liquid per day to be taken in divided doses).
600 to 1000 mg daily (30-50 ml liquid per day to be taken in several divided doses). 800 to 1200 mg daily (same as adult dose). Maximum recommended dose From ≥ 4 weeks up to 6 years of age: 35 mg/kg/day 6 to 15 years of age: 1000 mg/day >15 years of age: 1200 mg/day.
Caution is advised when administering to infants under 1 year of age due to the presence of propylene glycol (25 mg/ml). The maximum recommended daily dose (10 ml) results in an exposure of 250 mg/day, equivalent to 50 mg/kg/day in a 5 kg infant – the EMA safety threshold would be exceeded in infants of weights lower than 5 kg.
Consider alternative formulations or monitor closely if use is clinically justified. Wherever possible anti-epileptic agents should be prescribed as the sole drug anti-epileptic agent but if used in polytherapy, the same incremental dosage pattern is advised.
5 Interaction with other medicinal products and other forms of interaction).
Trigeminal neuralgia:
Slowly raise the initial dosage of 200-400 mg daily until freedom from pain is achieved (normally at 200 mg 3-4 times daily). In the majority of patients a dosage of 200 mg 3 or 4 times a day is sufficient to maintain a pain free state.
The dosage should be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200 mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.
Elderly population (65 years of age or above):
Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Carbamazepine should be selected with caution in elderly patients. Dosage in Trigeminal neuralgia In elderly patients, an initial dose of 100 mg twice daily is recommended.
The initial dosage of 100 mg twice daily should be slowly raised daily until freedom from pain is achieved (normally at 200 mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level.
Maximum recommended dose is 1200 mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs. For the prophylaxis of manic depressive psychosis in patients unresponsive to lithium therapy: Initial starting dose of 400 mg daily, in divided doses, increasing gradually until symptoms are controlled or a total of 1200 mg given in divided doses is reached.
The usual dosage range is 400-600 mg daily, given in divided doses. Adult patients who require doses exceeding 1200 mg up to 1600 mg/day of Carbamazepine, should be switched to alternative oral formulations of Carbamazepine, such as immediate release and prolonged release tablets.
Special populations Renal impairment / Hepatic impairment No data are available on the pharmacokinetics of carbamazepine in patients with impaired hepatic or renal function.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 28, 2026[1]
). g. fever or sore throat. Carbamazepine should also be discontinued if any evidence of significant bone marrow depression appears. Liver function tests should also be performed before commencing treatment and periodically thereafter, particularly in patients with a history of liver disease and in elderly patients.
The drug should be withdrawn immediately in cases of aggravated liver dysfunction or acute liver disease. Some liver function tests in patients receiving carbamazepine may be found to be abnormal, particularly gamma glutamyl transferase.
This is probably due to hepatic enzyme induction. Enzyme induction may also produce modest elevations in alkaline phosphatase. These enhancements of hepatic metabolising capacity are not an indication for the withdrawal of carbamazepine.
Severe hepatic reactions to carbamazepine occur very rarely. The development of signs and symptoms of liver dysfunction or active liver disease should be urgently evaluated and treatment with Carbamazepine suspended pending the outcome of the evaluation.
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for carbamazepine. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Serious dermatological reactions, including toxic epidermal necrolysis (TEN: also known as Lyell's syndrome) and Stevens Johnson syndrome (SJS) have been reported very rarely with Carbamazepine.
Patients with serious dermatological reactions may require hospitalization, as these conditions may be life-threatening and may be fatal. Most of the SJS/TEN cases appear in the first few months of treatment with Carbamazepine. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly Caucasian populations.
g. SJS, Lyell's syndrome/TEN) appear, Carbamazepine should be withdrawn at once and alternative therapy should be considered. Cutaneous reactions Serious and sometimes fatal cutaneous 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 1-6 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. 2). HLA-B*1502 allele - in Han Chinese, Thai and other Asian populations HLA-B*1502 in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing Stevens-Johnson syndrome (SJS) when treated with carbamazepine.
The prevalence of HLA- B*1502 carrier is about 10% in Han Chinese and Thai populations. 2). If these individuals test positive, carbamazepine should not be started unless there is no other therapeutic option. Tested patients who are found to be negative for HLA- B*1502 have a low risk of SJS, although the reactions may still very rarely occur.
There are some data that suggest an increased risk of serious carbamazepine- associated TEN/SJS in other Asian populations. g. above 15% in the Philippines and Malaysia), testing genetically at risk populations for the presence of HLA- B*1502 may be considered.
g. European descent, African, Hispanic populations sampled, and in Japanese and Koreans (< 1%). 8) in people of European descent and the Japanese. The frequency of the HLA-A*3101 allele varies widely between ethnic populations. HLA-A*3101 allele has a prevalence of 2 to 5% in European populations and about 10% in Japanese population.
8%. There are insufficient data supporting a recommendation for HLA-A*3101 screening before starting carbamazepine treatment. If patients of European descent or Japanese origin are known to be positive for HLA-A*3101 allele, the use of carbamazepine may be considered if the benefits are thought to exceed risks.
, isolated macular or maculopapular exanthema, can also occur and are mostly transient and not hazardous. They usually disappear within a few days or weeks, either during the continued course of treatment or following a decrease in dosage.
However, since it may be difficult to differentiate the early signs of more serious skin reactions from mild transient reactions, the […]
GBOfficial regulatory label· Warnings and precautions· revised May 28, 2026[1]
Warnings Agranulocytosis and aplastic anaemia have been associated with Carbamazepine; however, due to the very low incidence of these conditions, meaningful risk estimates for Carbamazepine are difficult to obtain. 0 persons per million per year for aplastic anaemia.
Decreased platelet or white blood cell counts occur occasionally to frequently in association with the use of Carbamazepine. Nonetheless, complete pre- treatment blood counts, including platelets and possibly reticulocytes and serum iron, should be obtained as a baseline, and periodically thereafter.
Patients and their relatives should be made aware of early toxic signs and symptoms indicative of a potential haematological problem, as well as symptoms of dermatological or hepatic reactions. If reactions such as fever, sore throat, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage appear, the patient should be advised to consult the physician immediately.
8 Undesirable Effects). g. fever or sore throat. Carbamazepine should also be discontinued if any evidence of significant bone marrow depression appears. Liver function tests should also be performed before commencing treatment and periodically thereafter, particularly in patients with a history of liver disease and in elderly patients.
The drug should be withdrawn immediately in cases of aggravated liver dysfunction or acute liver disease. Some liver function tests in patients receiving carbamazepine may be found to be abnormal, particularly gamma glutamyl transferase.
This is probably due to hepatic enzyme induction. Enzyme induction may also produce modest elevations in alkaline phosphatase. These enhancements of hepatic metabolising capacity are not an indication for the withdrawal of carbamazepine.
Severe hepatic reactions to carbamazepine occur very rarely. The development of signs and symptoms of liver dysfunction or active liver disease should be urgently evaluated and treatment with Carbamazepine suspended pending the outcome of the evaluation.
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 28, 2026[1]
g. tricyclic antidepressants) or any other component of the formulation. g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). The use of Carbamazepine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs) (see section
This is not medical advice. Consult a qualified healthcare professional.
Treatment of Acute Mania and Prophylaxis in Bipolar (Manic-Depressive) Disorders:
Adults (>18 years of age) TARO-CARBAMAZEPINE may be used as a monotherapy or as an adjunct to lithium in the treatment of acute mania or prophylaxis of bipolar (manic-depressive) disorders in patients who are resistant to or are intolerant of conventional antimanic drugs.
Carbamazepine may be a useful alternative to neuroleptics in such patients. Patients with severe mania, dysphoric mania or rapid cycling who are non-responsive to lithium may show a positive response when treated with carbamazepine.
It is important to note that these recommendations are based on extensive clinical experience and some clinical trials versus active comparison agents. 2 Recommended Dose and Dosage Adjustment, Use in Epilepsy, Adults and Children Over 12 Years of Age and Children 6-12 Years of Age).
Trigeminal Neuralgia:
Pediatrics (< 18 years of age) The safety and efficacy of carbamazepine in pediatric patients (<18 years of age) have not been studied. TARO-CARBAMAZEPINE is not authorized for pediatric use in trigeminal neuralgia.
Treatment of Acute Mania and Prophylaxis in Bipolar (Manic-Depressive) Disorders:
Pediatrics (< 18 years of age) The safety and efficacy of carbamazepine in pediatric patients (<18 years of age) have not been studied. TARO-CARBAMAZEPINE is not authorized for pediatric use in acute mania and prophylaxis in bipolar (manic-depressive) disorders.
2 Geriatrics Geriatrics (> 65 years of age) For all indications, due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of TARO-CARBAMAZEPINE should be selected with caution in elderly patients. 1 Dosing Considerations, Geriatrics.
How to take
CAOfficial regulatory label· revised January 6, 2026[2]
1 Dosing Considerations • TARO-CARBAMAZEPINE (suspension) produces higher peak carbamazepine levels than the same dose in tablet form, it is therefore advisable to start with low doses and to increase slowly to avoid adverse reactions.
3 Pharmacokinetics. • Geriatrics: Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of TARO-CARBAMAZEPINE should be selected with caution in elderly patients. 2 Recommended Dose and Dosage Adjustment), reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.
3 Pharmacokinetics, Special Populations and Conditions. 2 Recommended Dose and Dosage Adjustment TARO-CARBAMAZEPINE <Carbamazepine Oral Suspension>, TARO-CARBAMAZEPINE CHEWABLE TABLETS <Carbamazepine Chewable Tablets> Page 8 of 52 Unclassified / Non classifié Use in Epilepsy TARO-CARBAMAZEPINE may be used alone or with other anticonvulsants.
A low initial daily dosage of TARO-CARBAMAZEPINE with a gradual increase in dosage is advised. To achieve adequate control of seizures, dosage should be adjusted to the needs of the individual patient. Determination of plasma levels may help in establishing the optimum dosage.
In the treatment of epilepsy, the dose of carbamazepine should be adjusted to maintain steady state plasma concentration of about 4 - 10 mcg/mL. See 10 CLINICAL PHARMACOLOGY. TARO-CARBAMAZEPINE should be taken with meals whenever possible.
TARO-CARBAMAZEPINE CHEWABLE TABLETS and TARO-CARBAMAZEPINE (suspension) should be taken in 2 to 4 divided doses daily. TARO-CARBAMAZEPINE CHEWABLE TABLETS and TARO-CARBAMAZEPINE (suspension) are particularly suitable for patients who have difficulty swallowing tablets or who need initial careful adjustment of dosage.
Adults and Children Over 12 Years of Age Initially, 100 to 200 mg once or twice a day depending on the severity of the case and previous therapeutic history. The initial dosage is progressively increased, in divided doses, until the best response is obtained.
The usual optimal dosage is 800 to 1200 mg daily. In rare instances some adult patients have received 1600 mg. As soon as disappearance of seizures has been obtained and maintained, dosage should be reduced very gradually until a minimum effective dose is reached.
Children 6-12 Years of Age Initially, 100 mg in 2 to 4 divided doses on the first day. Increase gradually by adding 100 mg per day until the best response is obtained. Dosage should generally not exceed 1000 mg daily. As soon as disappearance of seizures has been obtained and maintained, dosage should be reduced very gradually until a minimum effective dose is reached.
Combination Therapy When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except for phenytoin, which may be increased. 1 WARNINGS AND PRECAUTIONS, Special Populations: Pregnant Women and 9 DRUG INTERACTIONS.
Use in Trigeminal Neuralgia (Adults > 18 years of age) The initial daily dosage should be small; 200 mg taken in 2 doses of 100 mg each is recommended. The total daily dosage can be increased by 200 mg/day until relief of pain is obtained.
This is usually achieved at dosage between 200 and 800 mg daily, but occasionally up to 1200 mg/day may be necessary. Maximum recommended dose is 1200 mg/day. As soon as relief of pain has been obtained TARO-CARBAMAZEPINE <Carbamazepine Oral Suspension>, TARO-CARBAMAZEPINE CHEWABLE TABLETS <Carbamazepine Chewable Tablets> Page 9 of 52 Unclassified / Non classifié and maintained, progressive reduction in dosage should be attempted until a minimal effective dosage is reached.
Because trigeminal neuralgia is characterized by periods of remission, attempts should be made to reduce or discontinue the use of TARO-CARBAMAZEPINE at intervals of not more than 3 months, depending upon the individual clinical course.
Prophylactic use of the drug in trigeminal neuralgia is not recommended. TARO-CARBAMAZEPINE is not authorized for pediatric use in trigeminal neuralgia. Use in Mania and Bipolar (Manic-Depressive) Disorders (Adults >18 years of age) The initial daily dosage should be low, 200 to 400 mg/day, administered in divided doses, although higher starting doses of 400 to 600 mg/day may be used in acute mania.
This dose may be gradually increased until patient symptomatology is controlled or a total daily dose of 1600 mg is achieved. Increments in dosage should be adjusted to ensure optimal patient tolerability. The usual dose range is 400 to 1200 mg/day administered in divided doses.
Doses used to achieve optimal acute responses and tolerability should be continued during maintenance treatment. When given in combination with lithium and neuroleptics, the initial dosage should be low, 100 mg to 200 mg daily, and then increased gradually.
A dose higher than 800 mg/day is rarely required when given in combination with neuroleptics and lithium, or with other psychotropic drugs such as benzodiazepines. Plasma levels are probably not helpful for guiding therapy in bipolar disorders.
TARO-CARBAMAZEPINE is not authorized for pediatric use in acute mania and prophylaxis in bipolar (manic-depressive) disorders. 4 Administration TARO-CARBAMAZEPINE (suspension) should be well shaken before use since improper re-suspension may lead to administering an incorrect dose.
5 Missed Dose If a scheduled dose is missed, TARO-CARBAMAZEPINE should be administered as soon as possible unless nearing the time to administer the next dose in which case the missed dose should be skipped. Doses should not be doubled.
TARO-CARBAMAZEPINE <Carbamazepine Oral Suspension>, TARO-CARBAMAZEPINE CHEWABLE TABLETS <Carbamazepine Chewable Tablets> Page 10 of 52 Unclassified / Non classifié
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised January 6, 2026[2]
). Relapse and aggravation of the symptomatology on the 2nd or 3rd day after overdose, due to delayed absorption, should be anticipated.
Respiratory System: respiratory depression, pulmonary edema. Cardiovascular System: tachycardia, hypotension/hypertension, conduction disturbance with widening of QRS complex, syncope in association with cardiac arrest. Gastrointestinal System: nausea, vomiting, delayed gastric emptying, reduced bowel motility.
Musculoskeletal System:
There have been some cases which reported rhabdomyolysis in association with carbamazepine toxicity. Renal Function: urinary retention, oliguria or anuria; fluid retention, and water intoxication. Laboratory Findings: hyponatremia, hypokalemia, leukocytosis, reduced white cell count, metabolic acidosis, hyperglycemia, glycosuria, acetonuria, increased muscle creatine phosphokinase.
Treatment of Overdosage There is no known specific antidote to TARO-CARBAMAZEPINE. Evacuate the stomach, with an emetic or by gastric lavage and then administer activated charcoal. Delay in evacuating the stomach may result in delayed absorption, leading to relapse during recovery from intoxication.
Hemodialysis is the effective treatment modality in the management of the carbamazepine overdose. TARO-CARBAMAZEPINE <Carbamazepine Oral Suspension>, TARO-CARBAMAZEPINE CHEWABLE TABLETS <Carbamazepine Chewable Tablets> Page 11 of 52 Unclassified / Non classifié Vital signs, including electrocardiogram to detect any cardiac arrhythmias or conduction defects, should be watched and symptomatic treatment should be administered as required.
Hyperirritability or convulsions should be appropriately managed by standard medical care. Hyponatremia should be appropriately managed by standard medical care. Shock (circulatory collapse) should be treated with supportive measures, including intravenous fluids, oxygen, and corticosteroids.
Charcoal hemoperfusion has been recommended. For management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669). 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging.
40 Lake, Magnesium Stearate, Microcrystalline Cellulose, Natural Cherry Flavour, Pregelatinized Starch, Sorbitol suspension; 100 mg / 5mL Citric acid, FD&C Yellow # 6, Orange Flavour, Poloxamer 188, Potassium Sorbate, Propylene Glycol, Purified Water, Sucrose, Sorbitol Solution, Xanthan Gum Availability of Dosage Forms TARO-CARBAMAZEPINE CHEWABLE TABLETS 100 mg are white with pink speckles, cherry odour, round, flat.
Scored on one side, engraved “TARO” above the score and “16" under the score. Available in Bottles of 100's TARO-CARBAMAZEPINE CHEWABLE TABLETS 200 mg are white with pink speckles, cherry odour, oval, flat. Both sides scored, one side “T” engraved above the score line and “27" under the score line.
Available in Bottles of 100's TARO-CARBAMAZEPINE (suspension) 100 mg/5 mL is orange in colour. Available in bottles of 450 mL TARO-CARBAMAZEPINE <Carbamazepine Oral Suspension>, TARO-CARBAMAZEPINE CHEWABLE TABLETS <Carbamazepine Chewable Tablets> Page 12 of 52 Unclassified / Non classifié 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General TARO-CARBAMAZEPINE should not be used in conjunction with the antiretroviral agent delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
4 Drug-Drug Interactions. Anticholinergic effects Like other tricyclic compounds, carbamazepine has a moderate anticholinergic action which is responsible for some of its side effects. Because of its anticholinergic action, carbamazepine should be given cautiously, if at all, to patients with increased intraocular pressure or urinary retention.
5 Post-Market Adverse Reactions) which may lead to falls and, consequently fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete risk assessment of fall should be considered recurrently for patients on long-term TARO-CARBAMAZEPINE treatment.
Bone Disorders Long-term use of antiepileptics such as carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrigine and sodium valproate is associated with a risk of decreased bone mineral density that may lead to weakened or brittle bones.
Carcinogenesis and Mutagenesis Long-term toxicity studies in rats indicated a potential carcinogenic risk. See 16 NON-CLINICAL TOXICOLOGY. Therefore, the possible risk of the drug must be weighed against the potential benefits before prescribing TARO-CARBAMAZEPINE to individual patients.
Cardiovascular TARO-CARBAMAZEPINE should be used cautiously in patients with a history of coronary artery disease, organic heart disease, or congestive heart failure. Carbamazepine may suppress ventricular automaticity due to its membrane-depressant effect, similar to that of quinidine and procainamide, associated with suppression of phase 4 depolarization of the heart muscle fiber (see 14 CLINICAL TRIALS).
If a defective conductive system is suspected, an ECG should […]
CAOfficial regulatory label· Warnings and precautions· revised January 6, 2026[2]
, Pregnancy 04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .....................................................................................................
2 TABLE OF CONTENTS ....................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ...............................................................................
11 7 WARNINGS AND PRECAUTIONS ............................................................................................. 1 Special Populations ......................................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised January 6, 2026[2]
TARO-CARBAMAZEPINE is contraindicated in: • Patients who are hypersensitive to carbamazepine or to any of the components of the tablets or suspension. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
g. amitriptyline, trimipramine, imipramine, or their analogues or metabolites). TARO-CARBAMAZEPINE <Carbamazepine Oral Suspension>, TARO-CARBAMAZEPINE CHEWABLE TABLETS <Carbamazepine Chewable Tablets> Page 6 of 52 Unclassified / Non classifié • Patients with hepatic disease, a history of bone-marrow depression, a history of hepatic porphyria (acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda), or serious blood disorder.
• Conjunction with, or immediately after, a monoamine oxidase (MAO) inhibitor. See 9 DRUG INTERACTIONS. • Conjunction with itraconazole and voriconazole. See 9 DRUG INTERACTIONS. • Patients presenting atrioventricular heart block. See 7 WARNINGS AND PRECAUTIONS, Cardiovascular.
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised February 18, 2026[3]
DOSAGE AND ADMINISTRATION (SEE TABLE BELOW) Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs (see PRECAUTIONS, Drug Interactions ).
Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents. 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 patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level.
Medication should be taken with meals. Since a given dose of carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: ½ teaspoon (four times a day) and to increase slowly to avoid unwanted side effects.
, twice a day tablets to three times a day suspension). Carbamazepine extended-release tablets is an extended-release formulation for twice-a-day administration. When converting patients from carbamazepine conventional tablets to carbamazepine extended-release tablets, the same total daily mg dose of carbamazepine extended-release tablets should be administered.
Carbamazepine extended-release tablets must be swallowed whole and never crushed or chewed. Carbamazepine extended-release tablets should be inspected for chips or cracks. Damaged tablets should not be consumed. Epilepsy (see INDICATIONS AND USAGE ) Adults and children over 12 years of age-Initial Either 200 mg twice a day for tablets and extended-release tablets, or 1 teaspoon four times a day for suspension (400 mg/day).
Increase at weekly intervals by adding up to 200 mg/day using a twice a day regimen of carbamazepine extended-release tablets or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained.
Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.
Children 6 to 12 years of age-Initial Either 100 mg twice a day for tablets or extended-release tablets, or ½ teaspoon four times a day for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a twice a day regimen of carbamazepine extended-release tablets or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained.
Dosage generally should not exceed 1000 mg daily. Maintenance Adjust dosage to the minimum effective level, usually 400 to 800 mg daily. Children under 6 years of age-Initial 10 mg/kg/day to 20 mg/kg/day twice a day or three times a day as tablets, or four times a day as suspension.
Increase weekly to achieve optimal clinical response administered three times a day or four times a day Maintenance 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 for use at doses above 35 mg/kg/24 hours can be made. Combination Therapy Carbamazepine 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 , and Pregnancy ).
Trigeminal Neuralgia (see INDICATIONS AND USAGE ) Initial On the first day, either 100 mg twice a day for tablets or extended-release tablets, or ½ teaspoon four times a day for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or extended-release tablets, or 50 mg (½ teaspoon) four times a day for suspension, only as needed to achieve freedom from pain.
Do not exceed 1200 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.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 2,383 reports total. [4]
Off Label Use 234
Drug Ineffective 204
Drug Interaction 187
Nausea 148
Seizure 144
Toxicity To Various Agents 138
Vomiting 137
Somnolence 130
Drug Reaction With Eosinophilia And Systemic Symptoms 129
Dizziness 124
Condition Aggravated 113
Rash 93
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised February 18, 2026[3]
ADVERSE REACTIONS
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 epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.
The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING ), the liver, 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 have been reported:
TEN and 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. , pulmonary embolism), and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.
Liver:
Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of 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 and higher. Relevance of these findings to humans is unknown.
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 both with and without 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, increased intraocular pressure (see WARNINGS, General ) 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:
Aching joints and muscles, and leg cramps.
Metabolism:
Fever and chills. Hyponatremia (see WARNINGS, General ). Decreased levels of plasma calcium have been reported. Osteoporosis has been reported. 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.
, at 1-866-923-4914.
USOfficial regulatory label· Warnings and precautions· revised February 18, 2026[3]
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 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 less than 1% of the population in Japan and Korea. , Caucasians, African-Americans, Hispanics, and Native Americans). Prior to initiating carbamazepine 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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised February 18, 2026[3]
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, nortriptyline, etc.
Likewise, on theoretical grounds its use with monoamine oxidase (MAO) 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.
This is not medical advice. Consult a qualified healthcare professional.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for carbamazepine. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Serious dermatological reactions, including toxic epidermal necrolysis (TEN: also known as Lyell's syndrome) and Stevens Johnson syndrome (SJS) have been reported very rarely with Carbamazepine.
Patients with serious dermatological reactions may require hospitalization, as these conditions may be life-threatening and may be fatal. Most of the SJS/TEN cases appear in the first few months of treatment with Carbamazepine. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly Caucasian populations.
g. SJS, Lyell's syndrome/TEN) appear, Carbamazepine should be withdrawn at once and alternative therapy should be considered. Cutaneous reactions Serious and sometimes fatal cutaneous 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 1-6 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. 2). HLA-B*1502 allele - in Han Chinese, Thai and other Asian populations HLA-B*1502 in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing Stevens-Johnson syndrome (SJS) when treated with carbamazepine.
The prevalence of HLA- B*1502 carrier is about 10% in Han Chinese and Thai populations. 2). If these individuals test positive, carbamazepine should not be started unless there is no other therapeutic option. Tested patients who are found to be negative for HLA- B*1502 have a low risk of SJS, although the reactions may still very rarely occur.
There are some data that suggest an increased risk of serious carbamazepine- associated TEN/SJS in other Asian populations. g. above 15% in the Philippines and Malaysia), testing genetically at risk populations for the presence of HLA- B*1502 may be considered.
g. European descent, African, Hispanic populations sampled, and in Japanese and Koreans (< 1%). HLA-A*3101 allele - European descent and Japanese populations There are some data that suggest HLA-A*3101 is associated with an increased risk of carbamazepine induced cutaneous adverse drug reactions including SJS, TEN, Drug rash with eosinophilia (DRESS), or less severe acute generalized exanthematous pustulosis […]
1 Pregnant Women ................................................................................................................. 2 Breastfeeding .......................................................................................................................
26 9 DRUG INTERACTIONS............................................................................................................. 1 Serious Drug Interactions ............................................................................................................
2 Drug Interactions Overview ......................................................................................................... 3 Drug-Behavioural Interactions .....................................................................................................
32 11 STORAGE, STABILITY AND DISPOSAL ...................................................................................... 33 TARO-CARBAMAZEPINE <Carbamazepine Oral Suspension>, TARO-CARBAMAZEPINE CHEWABLE TABLETS <Carbamazepine Chewable Tablets> Page 3 of 52 Unclassified / Non classifié PART II: SCIENTIFIC INFORMATION ................................................................................................
34 13 PHARMACEUTICAL INFORMATION ........................................................................................ 34 14 CLINICAL TRIALS ....................................................................................................................
1 Trial Design and Study Demographics […]
Carbamazepine 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 BOXED WARNING 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.
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 antiepileptic 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.
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 (for example, 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. 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 antiepileptic drug (AED) dose, compliance, concomitant medications, comorbidities, 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. Some of these events have been fatal or life-threatening.
DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.
Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. , fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately.
Carbamazepine should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Hypersensitivity Hypersensitivity reactions to carbamazepine have been reported in patients who previously experienced this reaction to anticonvulsants including phenytoin, primidone, and phenobarbital.
If such history is present, benefits and risks should be carefully considered and, if carbamazepine is initiated, the signs and symptoms of hypersensitivity should be carefully monitored. Patients should be informed that about a third of patients who have had hypersensitivity reactions to carbamazepine also experience hypersensitivity reactions with oxcarbazepine (Trileptal ® ).
Anaphylaxis and Angioedema Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelids have been reported in patients after taking the first or subsequent doses of carbamazepine. Angioedema associated with laryngeal edema can be fatal.
If a patient develops any of these reactions after treatment with carbamazepine, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug. Propylene Glycol Toxicity Carbamazepine oral suspension contains propylene glycol (see DESCRIPTION).
Patients less than 5 years of age are at highest risk for propylene glycol toxicity, and a safe level for propylene glycol exposure with repeated administration has not been established for this age group. , less than 4 weeks of age (including full-term babies and preterm babies less than 44 post-menstrual weeks of age) are known to have immature metabolic and renal clearance of propylene glycol.
Therefore, carbamazepine oral suspension should only be used in neonates after careful risk-benefit assessment if no therapeutic alternatives are available. When carbamazepine oral suspension is administered at the maximum dose (35 mg/kg/day) for treatment of epilepsy, the exposure to propylene glycol will be 88 mg/kg/day.
The total daily intake of propylene glycol from all sources, including concomitant drugs, should be considered in managing the risk of propylene glycol toxicity. Monitor patients for signs of potential propylene glycol toxicity, including hemolysis, hyperosmolarity with anion gap metabolic acidosis, acute kidney injury, and central nervous system (CNS) toxicity.
Discontinue carbamazepine oral suspension if propylene glycol toxicity is suspected (see DESCRIPTION). Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including carbamazepine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. 7) of suicidal thinking or behavior compared to patients randomized to placebo.
24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication.
The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 1 shows absolute and relative risk by indication for all evaluated AEDs. 9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing carbamazepine or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.
Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. General Carbamazepine has shown mild anticholinergic activity that may be associated with increased intraocular pressure; therefore, patients with increased intraocular pressure should be closely observed during therapy.
Because of the relationship of the drug to other tricyclic compounds, the possibility of activation of a latent psychosis and, in elderly patients, of confusion or agitation should be borne in mind. , acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda).
Acute attacks have been reported in such patients receiving carbamazepine therapy. Carbamazepine administration has also been demonstrated to increase porphyrin precursors in rodents, a presumed mechanism for the induction of acute attacks of porphyria.
As with all antiepileptic drugs, carbamazepine should be withdrawn gradually to minimize the potential of increased seizure frequency. Hyponatremia can occur as a result of treatment with carbamazepine. In many cases, the hyponatremia appears to be caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
The risk of developing SIADH with carbamazepine treatment appears to be dose-related. Elderly patients and patients treated with diuretics are at greater risk of developing hyponatremia. Signs and symptoms of hyponatremia include headache, new or increased seizure frequency, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls.
Consider discontinuing carbamazepine in patients with symptomatic hyponatremia. Usage in Pregnancy Carbamazepine can cause fetal harm when administered to a pregnant woman. Epidemiological data suggest that there may be an association between the use of carbamazepine during pregnancy and congenital malformations, including spina bifida.
, craniofacial defects, cardiovascular malformations, and anomalies involving various body systems). Developmental delays based on neurobehavioral assessments have been reported. When treating or counseling women of childbearing potential, the prescribing physician will wish to weigh the benefits of therapy against the risks.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Retrospective case reviews suggest that, compared with monotherapy, there may be a higher prevalence of teratogenic effects associated with the use of anticonvulsants in combination therapy.
Therefore, if therapy is to be continued, monotherapy may be preferable for pregnant women. In humans, transplacental passage of carbamazepine is rapid (30 to 60 minutes), and the drug is accumulated in the fetal tissues, with higher levels found in liver and kidney than in brain and lung.
5 to 4 times the MHDD on a mg/m 2 basis. In rat teratology studies, 2 of 135 offspring showed kinked ribs at 250 mg/kg and 4 of 119 offspring at 650 mg/kg showed other anomalies (cleft palate, 1; talipes, 1; anophthalmos, 2). In reproduction studies in rats, nursing offspring demonstrated a lack of weight gain and an unkempt appearance at a maternal dosage level of 200 mg/kg.
There have been a few cases of neonatal seizures and/or respiratory depression associated with maternal carbamazepine and other concomitant anticonvulsant drug use. A few cases of neonatal vomiting, diarrhea, and/or decreased feeding have also been reported in association with maternal carbamazepine use.
These symptoms may represent a neonatal withdrawal syndrome. To provide information regarding the effects of in utero exposure to carbamazepine, physicians are advised to recommend that pregnant patients taking carbamazepine enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. org/. Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Epilepsy, with or without exposure to antiepileptic drugs, has been associated with several adverse outcomes during pregnancy, including preeclampsia, preterm labor, antepartum and postpartum hemorrhage, placental abruption, poor fetal growth, prematurity, fetal death, and maternal mortality.
The risk of maternal or fetal injury may be greatest for patients with untreated or poorly controlled convulsive seizures. Women with epilepsy who become pregnant should not abruptly discontinue antiepileptic drugs, including carbamazepine, due to the risk of status epilepticus or severe seizures, which may be life-threatening.