RiteMED Carbamazepine

RiteMED Carbamazepine

carbamazepine

Manufacturer:

RiteMED

Distributor:

RiteMED
Full Prescribing Info
Contents
Carbamazepine.
Description
Each tablet contains: Carbamazepine 200 mg.
Action
Carbamazepine is an anticonvulsant and specific analgesic for trigeminal neuralgia.
Indications/Uses
Trigeminal Neuralgia: For the symptomatic relief of pain of trigeminal neuralgia only in periods of exacerbation of true or primary 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.
Epilepsy: Management of psychomotor epilepsy, as an adjunct with other anti-epileptic drugs for partial seizures with complex symptomatology, as an alternative medication in patients with generalized tonic-clonic seizures.
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 intolerant of conventional antimanic drugs.
Dosage/Direction for Use
Epilepsy: Adults: Initial oral dose is 100 mg to 200 mg once or twice daily gradually increased at weekly intervals by increments of 200 mg to a usual maintenance dose of 0.8 to 1.2 g daily in 2 to 4 divided doses; up to 1.6 g or more daily may occasionally be necessary.
Children: The usual oral dosage in children is 10 to 20 mg per kilogram body-weight daily and suggested daily doses for children are: up to 1 year of age, 100 to 200 mg; 1 to 5 years, 200 to 400 mg; 5 to 10 years, 400 to 600 mg; 10 to 15 years, 600 mg to 1 g.
Oral doses are divided and usually given 2 to 4 times daily. A twice daily regimen may be associated with improved compliance but may produce widely fluctuating plasma-carbamazepine concentrations leading to intermittent side effects.
However, twice daily administration may be suitable for patients receiving carbamazepine as monotherapy, and without peak-related side-effects.
Also, slow-release formulations can minimize fluctuations in plasma concentration and may allow twice-daily administration.
The initial dose of carbamazepine in the treatment of trigeminal neuralgia is 100 mg once or twice daily increased gradually; the usual maintenance dose is 400 to 800 mg daily in 2 to 4 divided doses but up to 1.6 g daily may be required. When pain relief has been obtained, attempts should be made to reduce and ultimately discontinue the therapy, until another attack occurs. Carbamazepine is usually given in daily divided doses of 400 to 600 mg for the prophylaxis of bipolar disorder.
Overdosage
Neuromuscular disturbance are the most prominent symptom. Irregular breathing, tachycardia, hypotension or hypertension, impairment of consciousness, coma, tremor, muscular twitching. Treat this by evacuating the stomach with an emetic or by gastric lavage, then take appropriate steps to diminish absorption. If these measures cannot be implemented on the spot, the patient should be transferred at once to a hospital, while ensuring that vital functions are safeguarded.
Contraindications
Should not be administered in patients with a history of hepatic disease, serious blood disorder hypersensitivity to the drug, or any of the tricyclic compounds, such as amitriptyline, imipramine, nortriptyline, trimipramine, etc. RiteMED Carbamazepine should not be used immediately before, in conjunction with, or immediately after an MAO inhibitor. MAO inhibitors should be discontinued for a minimum of fourteen days or longer if the clinical condition allows.
Warnings
Should there be any signs or symptoms suggest severe dermatologic reactions such as toxic epidermal necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, Carbamazepine should be withdrawn at once.
Special Precautions
Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since its use has been associated with increased frequency of generalized convulsions.
Use In Pregnancy & Lactation
Pregnancy: Carbamazepine should be prescribed as monotherapy, because the incidence of congenital abnormalities in the offspring of women treated with more than one antiepileptic drug is greater than in those of women receiving a single antiepileptic.
Lactation: Carbamazepine passes into breast milk in concentrations of 25% to 60% of the plasma level. The benefits of breast-feeding should be weighed against the possible risk to the infant.
Adverse Reactions
The most frequent adverse reactions reported, particularly during the initial phase of therapy, are drowsiness, dizziness, unsteadiness on the feet, nausea and vomiting, as well as allergic skin reactions. These reactions can be minimized by initiating treatment at a low dosage.
The more severe adverse reactions observed are the skin, hepatic, cardiovascular and hematologic reactions, which require discontinuation of therapy.
The following additional adverse reactions have been reported: Skin: Lyell's syndrome, Stevens-Johnson syndrome, urticaria, photosensitivity reactions, exfoliative dermatitis.
Hematologic: Leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia, leukocytosis, acute intermittent porphyria.
Cardiovascular: Hypertension or hypotension, arrhythmias, bradycardia, congestive heart failure aggravation of coronary artery disease.
Respiratory: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis or pneumonia.
Gastrointestinal: Nausea, vomiting, diarrhea, constipation, anorexia, glossitis, stomatitis.
Musculoskeletal: Muscle pain or cramp, arthralgia.
Storage
Protect from moisture.
Store at temperatures not exceeding 25°C.
MIMS Class
Anticonvulsants / Drugs for Neuropathic Pain
ATC Classification
N03AF01 - carbamazepine ; Belongs to the class of carboxamide derivatives antiepileptic.
Presentation/Packing
Form
RiteMed Carbamazepine tab 200 mg
Packing/Price
100's (P892.86/box, P8.93/tab)
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