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PMS-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: AND CLINICAL USE Epilepsy: pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR (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…
Verbatim from this product's HC label. Tap a section to expand.
Use in Epilepsy (see Indications) pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR (carbamazepine) may be used alone or with other anticonvulsants. A low initial daily dosage of pms-CARBAMAZEPINE or pms- CARBAMAZEPINE-CR 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 (see Clinical Pharmacokinetics and Warnings - Pregnancy and Nursing ).
pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR should be taken with meals whenever possible. pms-CARBAMAZEPINE Tablets and Chewable Tablets should be taken in 2 to 4 divided doses daily. pms-CARBAMAZEPINE Chewable Tablets are particularly suitable for patients who have difficulty swallowing tablets or who need initial careful adjustment of dosage.
The controlled release characteristics of pms-CARBAMAZEPINE-CR reduce the daily fluctuations of plasma carbamazepine. pms-CARBAMAZEPINE-CR tablets (either whole or, if so prescribed, only half a tablet) should be swallowed unchewed with a little liquid during or after a meal.
These controlled release tablets should be prescribed as a twice-daily dosage. If necessary, three divided doses may be prescribed. Some patients have been reported to require a dosage increase when switching from tablets to CR tablets.
Dosage adjustments should be individualized based on clinical response and, if necessary, plasma carbamazepine levels. 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 pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph Page 34 of 51 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 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.
pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR (carbamazepine) should not be administered to 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.
pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR should not be administered immediately before, in conjunction with, or immediately after a monoamine oxidase (MAO) inhibitor (see Precautions, Drug Interactions). Coadministration of pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR and voriconazole is contraindicated, until data become available from drug interactions studies.
CYP3A4 is one of the enzymes thought to be involved in the metabolism of voriconazole. Therefore, coadministration of pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR, a potent inducer of CYP3A4, could diminish the therapeutic effect of voriconazole (see Precautions, Drug Interactions, Effects of pms-CARBAMAZEPINE and pms- CARBAMAZEPINE-CR on plasma levels of concomitant agents).
pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR should not be administered to patients presenting atrioventricular heart block (see Actions and Clinical Pharmacology and Precautions). pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR should not be administered to patients with known hypersensitivity to carbamazepine, to any of the components of the tablets (see Pharmaceutical Information) or to any of the tricyclic compounds, such as: amitriptyline, trimipramine, imipramine, or their analogues or metabolites, because of the similarity in chemical structure.
pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph Page 7 of 51 WARNINGS HEMATOLOGIC: Although reported infrequently, serious adverse effects have been observed during the use of carbamazepine. Agranulocytosis and aplastic anemia, with a fatal outcome, have occurred very rarely.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 (see Precautions, Drug Interactions and Warnings, Pregnancy and Nursing).
Use in Trigeminal Neuralgia 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 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 pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR 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. Use in Mania and Bipolar (Manic-Depressive) Disorders 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 pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph Page 35 of 51 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.
Special populations Geriatrics Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of pms- CARBAMAZEPINE or pms-CARBAMAZEPINE-CR should be selected with caution in elderly patients. Renal impairment / Hepatic impairment No data are available on the pharmacokinetics of carbamazepine in patients with any degree of hepatic or renal impairment.
27 g/mol Description: White to off-white powder Solubility: Practically insoluble in water and in acetone Stability and Storage Recommendations See Following Table Keep out of reach of children. Availability of Dosage Forms See Following Table N CONH2 pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph Page 37 of 51 pms- CARBAMAZEPINE Tablets 200 mg pms- CARBAMAZEPINE Tablets (Chewable) 100 mg pms- CARBAMAZEPINE Tablets (Chewable) 200 mg pms- CARBAMAZEPINE-CR CR Tablets (Controlled Release) 200 mg pms- CARBAMAZEPINE-CR CR Tablets (Controlled Release) 400 mg Colour White White with red specks White with red specks Beige-orange Brown-orange Shape Round, flat-faced and bevel-edged […]
Leucopenia, thrombocytopenia, hepatocellular and cholestatic jaundice, and hepatitis have also been reported. However, in the majority of cases, leucopenia and thrombocytopenia were transient and did not signal the onset of either aplastic anemia or agranulocytosis.
It is important that pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR be used carefully and close clinical and frequent laboratory supervision should be maintained throughout treatment in order to detect as early as possible signs and symptoms of a possible blood dyscrasia.
pms- CARBAMAZEPINE or pms-CARBAMAZEPINE-CR should be discontinued if any evidence of significant bone marrow depression appears (see Precautions).
DERMATOLOGIC:
Steven’s-Johnson Syndrome and Toxic Epidermal Necrolysis: Serious and sometimes fatal dermatologic reactions, including Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported with carbamazepine. , Taiwan, Malaysia and the Philippines) the risk is estimated to be about 10 times higher.
Human Leukocyte Antigens (HLA)-A*3101 and HLA-B*1502 may be risk factors for the development of serious cutaneous adverse drug reactions. Retrospective genome-wide studies in Japanese and Northern European populations reported an association between severe skin reactions (SJS, TEN, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP) and maculopapular rash) associated with carbamazepine use and the presence of the HLA-A*3101 allele in these patients.
Similarly, in studies that included small samples of patients of Han Chinese ancestry, a strong association was found between the risk of developing SJS/TEN and the presence of the HLA-B*1502 allele. The HLA-B*1502 allele is found almost exclusively in pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph Page 8 of 51 individuals with ancestry across broad areas of Asia†.
It is therefore, recommended that physicians consider HLA-A*3101 and HLA-B*1502 genotyping as a screening tool in genetically at-risk populations (see Warnings - Ancestry and Allelic Variations in the HLA- A Gene and Ancestry and Allelic Variations in the HLA-B Gene).
Until further information is available, the use of pms-CARBAMAZEPINE, pms-CARBAMAZEPINE- CR and other anti-epileptic drugs associated with SJS/TEN should be avoided in patients who test positive for the HLA-A*3101 or HLA-B*1502 alleles (see Warnings - Ancestry and Allelic Variations in the HLA-A Gene; Warnings- Ancestry and Allelic Variation in the HLA-B Gene and Warnings- Important Limitations of HLA-A and HLA-B Genotyping).
Treatment recommendations for dermatological reactions: pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR 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.
The use of other anti- epileptic drugs associated with SJS/TEN should be avoided in patients who have shown severe dermatological reactions during pms-CARBAMAZEPINE or pms- CARBAMAZEPINE-CR treatment.
CARCINOGENICITY:
Long-term toxicity studies in rats indicated a potential carcinogenic risk (see TOXICOLOGY). Therefore, the possible risk of the drug must be weighed against the potential benefits before prescribing pms-CARBAMAZEPINE or pms- CARBAMAZEPINE-CR to individual patients.
† The following provide a rough estimate of the frequency of HLA-B*1502 allele in various populations: from 2 to 12% in Han Chinese populations, about 8% in Thai populations, and above 15% in the Philippines and some Malaysian populations.
Allele frequencies up to about 2% and 6% have been reported in Korea and India, respectively. The frequency of the HLA-B*1502 allele is negligible in persons from European descent, several African populations, indigenous peoples of the Americas, Hispanic populations sampled and in Japanese (< 1%).
The estimated […]