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TEVA-CARBAMAZEPINE is a brand name for Carbamazepine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Epilepsy: Adults (> 18 years of age) TEVA-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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Geriatrics: Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of TEVA-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 Use in Epilepsy TEVA-CARBAMAZEPINE may be used alone or with other anticonvulsants. A low initial daily dosage of TEVA-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 Teva-Carbamazepine Page 8 of 48 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). TEVA- CARBAMAZEPINE should be taken with meals whenever possible. 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.
). Relapse and aggravation of the symptomatology on the 2nd or 3rd day after overdose, due to delayed absorption, should be anticipated.
Central Nervous System:
CNS depression, disorientation, depressed level of consciousness, tremor, restlessness, somnolence, agitation, hallucination, coma, blurred vision, nystagmus, mydriasis, slurred speech, dysarthria, ataxia, dyskinesia, abnormal reflexes (slowed/hyperactive), convulsions, psychomotor disturbances, myoclonus, opisthotonia, hypothermia/hyperthermia, flushed skin/cyanosis, EEG changes.
Respiratory System: respiratory depression, pulmonary edema. Cardiovascular System: tachycardia, hypotension/hypertension, conduction disturbance with widening of QRS complex, syncope in association with cardiac arrest. Teva-Carbamazepine Page 10 of 48 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 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. Vital signs, including electrocardiogram to detect any cardiac arrhythmias or conduction defects, should be watched and symptomatic treatment should be administered as required.
, Pregnancy 06/2025 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 ......................................................................
4 1 INDICATIONS ...................................................................................................................... 1 Pediatrics ............................................................................................................................
2 Geriatrics ............................................................................................................................ 5 2 CONTRAINDICATIONS .........................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................................... 6 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations ........................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................... 5 Missed Dose .......................................................................................................................
9 5 OVERDOSAGE ..................................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................................ 10 7 WARNINGS AND PRECAUTIONS.........................................................................................
TEVA-CARBAMAZEPINE is contraindicated in: • Patients who are hypersensitive to carbamazepine or to any of the components of the tablets. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. g. amitriptyline, trimipramine, imipramine, or their analogues or metabolites).
• 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. Teva-Carbamazepine Page 6 of 48 • 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 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 TEVA-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. TEVA-CARBAMAZEPINE is not authorized for pediatric use in trigeminal neuralgia. Use in Mania and Bipolar (Manic-Depressive) Disorders (Adults >18 years of age) Teva-Carbamazepine Page 9 of 48 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.
TEVA-CARBAMAZEPINE is not authorized for pediatric use in acute mania and prophylaxis in bipolar (manic-depressive) disorders. 5 Missed Dose If a scheduled dose is missed, TEVA-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.
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 Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Teva-Carbamazepine Page 11 of 48 Oral Tablets; 200mg magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate and sodium starch glycolate.
Availability of Dosage Forms TEVA-CARBAMAZEPINE is a white, round, flat faced bevel-edged compressed tablet engraved C20 on one side and quadrisect on the reverse. Available in bottles of 100 and 500. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General TEVA-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 nonnucleoside 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 TEVA-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 Teva-Carbamazepine Page 12 of 48 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 TEVA-CARBAMAZEPINE to individual patients.
Cardiovascular TEVA-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 be performed before administering TEVA-CARBAMAZEPINE, in order to exclude patients with atrioventricular block. Dependence/Tolerance A tolerance may develop to the action of carbamazepine after a few months of treatment and should be watched for.
See 14 CLINICAL TRIALS. Driving and Operating Machinery Patients’ ability to react may be impaired by their medical condition resulting in seizures and adverse reactions reported with carbamazepine, including dizziness, drowsiness, ataxia, diplopia, impaired accommodation and blurred vision.
Patients should be advised not to drive or use complex machines, or engage in other hazardous activities, until they have gained sufficient experience on carbamazepine to gauge whether it affects their mental and/or motor performance adversely.
Endocrine and Metabolism Hyponatremia Hyponatremia is known to occur with […]
1 Special Populations........................................................................................................... 1 Pregnant Women ......................................................................................................
2 Breast-feeding........................................................................................................... 3 Pediatrics ..................................................................................................................
4 Geriatrics ................................................................................................................... 21 8 ADVERSE REACTIONS ........................................................................................................
1 Adverse Reaction Overview ............................................................................................. 2 Clinical Trial Adverse Reactions ........................................................................................
5 Post-Market Adverse Reactions ....................................................................................... 24 9 DRUG INTERACTIONS ........................................................................................................
1 Serious Drug Interactions ................................................................................................. 2 Drug Interactions Overview..............................................................................................
3 Drug-Behavioural Interactions ......................................................................................... 4 Drug-Drug Interactions .....................................................................................................
5 Drug-Food Interactions .................................................................................................... 6 Drug-Herb Interactions .....................................................................................................
7 Drug-Laboratory Test Interactions ................................................................................... 30 10 CLINICAL PHARMACOLOGY..............................................................................................
1 Mechanism of Action...................................................................................................... 2 Pharmacodynamics ........................................................................................................
3 Pharmacokinetics ........................................................................................................... 31 11 STORAGE, STABILITY AND DISPOSAL ................................................................................
32 Teva-Carbamazepine Page 3 of 48 PART II: SCIENTIFIC INFORMATION....................................................................................... 33 13 PHARMACEUTICAL INFORMATION ..................................................................................
33 14 CLINICAL TRIALS .............................................................................................................. 1 Trial Design and Study Demographics ............................................................................
2 Study Results .................................................................................................................. 3 Comparative Bioavailability Studies ...............................................................................
34 15 MICROBIOLOGY .............................................................................................................. 35 16 NON-CLINICAL TOXICOLOGY ............................................................................................
35 17 SUPPORTING PRODUCT MONOGRAPHS .......................................................................... 37 […]