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Mezacar

Mezacar

carbamazepine

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare
Concise Prescribing Info
Contents
Carbamazepine
Indications/Uses
Control secondarily generalized tonic-clonic & partial seizures. Trigeminal neuralgia, glossopharyngeal neuralgia & other severe pain syndromes associated w/ neurological disorders eg, tabes dorsalis & multiple sclerosis. Prophylaxis of manic depression (bipolar disorder) unresponsive to lithium.
Dosage/Direction for Use
Dose is given usually in 2 or 3 divided doses. Epilepsy Adult Initially 100-200 mg once daily or bid, gradually increase until best response is obtained, often 800-1,200 mg daily. Childn & adolescent 10-20 mg/kg daily in divided doses, >15 yr 800-1,200 mg daily (same as adult dose). Max daily dose: 1,200 mg, 10-15 yr 600-1,000 mg daily in divided doses, 5-10 yr 400-600 mg daily in divided doses. Max daily dose: 6-15 yr 1,000 mg, Up to 6 yr 35 mg/kg/day. Trigeminal neuralgia Gradually raise the initial dose 200-400 mg daily until freedom from pain is achieved. Max daily dose: 1,200 mg. Elderly Initially 100 mg bid. Max daily dose: 1,200 mg. Prophylaxis of manic depression Initially 400 mg daily in divided doses, may be increased gradually up to a max of 1,600 mg daily. Usual dosage range: 400-600 mg daily in divided doses.
Administration
Should be taken with food: May be taken during, after or between meals, w/ a little liqd eg, glass of water.
Contraindications
Hypersensitivity to carbamazepine or structurally related drugs (eg, TCAs). Patients w/ AV block; history of bone marrow depression, hepatic porphyria (eg, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). Combination w/ MAOIs; discontinue for a min of 2 wk or longer before administration.
Special Precautions
W/draw treatment if the patient develops symptoms suggestive of severe skin reactions (eg, SJS, Lyell's syndrome, & TEN); severe, progressive, or clinically manifested leucopenia, any evidence of significant bone marrow depression; aggravated liver dysfunction or acute liver disease. Agranulocytosis & aplastic anaemia. May exacerbate seizure; caution in patients w/ mixed seizures including typical or atypical absences. Abrupt w/drawal may precipitate seizures. History of cardiac, hepatic or renal damage; adverse haematological reactions to other drugs, or interrupted courses of therapy w/ carbamazepine. Monitor patients w/ increased IOP & urinary retention. Possibility of activation of a latent psychosis & in elderly patients, of confusion or agitation. Monitor patients for signs of suicidal ideation & behaviours. Closely monitor CBC if WBC or platelet count is definitely low or decreased during treatment. Perform LFTs before commencing treatment & periodically thereafter, particularly in patients w/ history of liver disease & in elderly patients. Measure serum Na levels prior to initiating therapy, after approx 2 wk, & then at mthly intervals for the 1st 3 mth during therapy, or according to clinical need. Obtain complete pre-treatment blood counts, including platelets & possibly reticulocytes & serum Fe, as baseline, & periodically thereafter. Monitor thyroid function to adjust the dosage of thyroid replacement therapy. Patients w/ ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment. Co-administration w/ CYP3A4 inhibitors/inducers. May impair ability to drive or operate machinery. Pregnancy due to increased risk of malformations. Pregnant women w/ epilepsy. Women of childbearing potential are advised to use alternative or additional birth control methods as the therapeutic effect of OCs containing oestrogen &/or progesterone may result in failure. Elderly.
Adverse Reactions
Leucopenia; ataxia, dizziness, somnolence; vomiting, nausea; urticaria; fatigue; increased γ-glutamyltransferase. Thrombocytopenia, eosinophilia; oedema, fluid retention, wt increase, hyponatraemia, decreased blood osmolarity due to antidiuretic hormone (ADH)-like effect; diplopia, headache; accommodation disorder (eg, blurred vision); dry mouth; increased blood alkaline phosphatase.
Drug Interactions
May raise plasma levels w/ analgesics, anti-inflammatory; androgens; antibiotics; antidepressants; antiepileptics; antifungals; antihistamines; antipsychotics; anti-TB; antivirals; carbonic anhydrase inhibitors; CV, GI drugs; grapefruit juice, nicotinamide (high dosage). May increase carbamazepine-10,11-epoxide plasma levels w/ quetiapine, primidone, progabide, valproic acid, valnoctamide & valpromide. May decrease plasma levels w/ antiepileptics; antineoplastics; anti-TB; bronchodilators; dermatological drugs; herbal prep containing St John's wort (Hypericum perforatum); anticoagulants; antiemetics; anthelmintics; anxiolytics; contraceptives; corticosteroids; drugs used in erectile dysfunction; immunosuppressants; thyroid agents; products containing oestrogens, tacrolimus &/or progesterones. Increased carbamazepine-induced toxicity w/ levetiracetam. Increased INH-induced hepatotoxicity w/ INH. May enhanced neurotoxicity w/ lithium. Increased neurological side-effects w/ metoclopramide or major tranquilizers eg, haloperidol & thioridazine. May lead to symptomatic hyponatraemia w/ diuretics (eg, hydrochlorothiazide, furosemide). May antagonise effects of non-depolarising muscle relaxants (eg, pancuronium). May reduce alcohol tolerance.
MIMS Class
Anticonvulsants / Drugs for Neuropathic Pain
ATC Classification
N03AF01 - carbamazepine ; Belongs to the class of carboxamide derivatives antiepileptic.
Presentation/Packing
Form
Mezacar tab 200 mg
Packing/Price
50's (P180/box)
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