Concise Prescribing Info
Epilepsy; generalized tonic clonic & partial seizures. Paroxysmal pain of trigeminal neuralgia. Prophylaxis of manic depressive psychosis in patients unresponsive to lithium therapy.
Dosage/Direction for Use
Epilepsy Individualized dosage. Adult Initially, 100-200 mg/day in divided doses; may be increased to 1,600 or 2,000 mg/day. Childn & adolescent Adjust dosage at gradually increasing scheme. Usual dose: 10-20 mg/kg/day in divided doses; >15 yr 800-1,200 mg/day; 10- 15 yr 600-1,000 mg/day (3-5 tab/day in divided doses); 5-10 yr 400-600 mg/day (2-3 tab/day in divided doses). Max recommended dose: Childn >15 yr 1,200 mg/day; 6-15 yr 1,000 mg/day; ≤6 yr 35 mg/kg/day. Trigeminal neuralgia Initially, 200-400 mg/day, slowly increasing until freedom from pain is achieved (usual dose: 200 mg tds-qds). In some instances, 1,600 mg/day doses may be needed. Max recommended dose: 1,200 mg/day. Elderly Initially, 100 mg bd, slowly increase until freedom from pain is achieved. Prophylaxis of manic depressive psychosis in patients unresponsive to lithium therapy Initially, 400 mg/day, in divided doses increasing gradually until symptoms are controlled or max 1,600 mg in divided doses.
Should be taken with food: May be taken during, after or between meals w/ a glass of water.
Hypersensitivity to carbamazepine or structurally-related drugs (eg, TCAs). AV block, history of bone marrow depression or of hepatic porphyrias (eg, acute intermittent porphyria cutanea tarda). Concomitant use w/ MAOIs.
Special Precautions
Hypersensitivity, including exacerbation of seizures. Obtain complete pre-treatment blood counts including platelets & possibly reticulocytes & serum Fe as baseline & periodically thereafter. Immediate medical attention is necessary in the occurrence of toxic signs & symptoms of a potential haematological problem & dermatological or hepatic reactions. Closely monitor the patient & complete blood count if decreased or definitely low WBC or platelet count during treatment. Discontinue use if patient develops leucopenia [severe progressive or accompanied by clinical manifestations (eg, fever or sore throat)]. Perform liver function tests before treatment & periodically thereafter in patients w/ liver disease history & in the elderly; immediately w/draw treatment in aggravated liver dysfunction or acute liver disease. Monitor for signs of suicidal ideation & behavior. W/draw treatment & consider alternative therapy if signs & symptoms of severe skin reactions eg, Stevens-Johnson syndrome, toxic epidermal necrolysis occur. Strong association of HLA*1502 allele in individuals of Han Chinese & Thai origin to the risk of Stevens-Johnson syndrome development; screen for this allele prior to treatment in these individuals, also consider presence of HLA*1502 in Filipino & Malaysian patients. W/draw gradually as abrupt w/drawal may precipitate seizures. Concomitant use w/ hormonal contraceptives; consider alternative forms of birth control. Monitor plasma levels during dramatic seizure frequency increase; patient compliance verification; pregnancy; childn & adolescents; suspected absorption disorders; in suspected toxicity w/ concomitant use of >1 drug. Closely monitor patients w/ history of cardiac, hepatic or renal damage, adverse haematological reaction to other drugs, or interrupted courses of therapy; baseline & periodic complete urinalysis & BUN determinations. Hyponatremia w/ preexisting renal conditions; measure serum Na levels prior to initiation of therapy & thereafter, after approx 2 wk & mthly intervals for the 1st 3 mth during therapy or according to clinical need. May reduce thyroid hormone serum conc. Closely observe patient w/ increased IOP & urinary retention during therapy. Activation of a latent psychosis. May affect ability to drive & operate machinery. Select dosage cautiously in the elderly. Risk of hyponatremia & confusion or agitation in the elderly. Particular care in the 1st 3 mth of pregnancy; do not interrupt effective antiepileptic treatment during pregnancy. Lactation. Not recommended for very young childn.
Adverse Reactions
Leucopenia; ataxia, dizziness, somnolence; vomiting, nausea; urticaria; fatigue; increased γ-glutamyltransferase. Thrombocytopenia, eosinophilia; oedema, fluid retention, increased wt, hyponatremia & decreased blood osmolarity leading to water intoxication accompanied by lethargy, headache, confusional state, neurological disorders; diplopia, headache; accommodation disorders (eg, blurred vision); dry mouth; increased blood alkaline phosphatase.
Drug Interactions
Contraindicated w/ MAOIs (discontinue use ≥2 wk prior to carbamazepine therapy). Agents that may raise carbamazepine plasma levels (eg, dextropropoxyphene; danazol; macrolide antibiotics, ciprofloxacin; fluoxetine, fluvoxamine, paroxetine, trazodone; vigabatrin, azole antifungals; loratadine; olanzapine; isoniazid; HIV protease inhibitors; acetazolamide; diltiazem, verapamil; possibly cimetidine, omeprazole; grapefruit juice, high dose nicotinamide). Agents that may raise plasma levels of active metabolite carbamazepine 10-11 epoxide (eg, quetiapine, pyrimidine, progabide, valproic acid, valnoctamide & valpromide). Agents that may decrease carbamazepine plasma levels (eg, oxcarbazepine, phenobarbital, phenytoin, fosphenytoin, primidone, possibly clonazepam); cisplatin, doxorubicin; rifampicin; theophylline, aminophylline; isotretinoin; herbal prep containing St. John's wort. Decreased plasma level, diminished or abolished activity of buprenorphine, methadone, paracetamol, tramadol; doxycycline, rifabutin; oral anticoagulants; bupropion, citalopram, mianserin, sertraline, trazodone, TCAs; aprepitant; clobazam, eslicarbazepine, clonazepam, ethosuximide, lamotrigine, oxcarbazepine, primidone, tiagabine, topiramate, valproic acid, zonisamide; increase plasma mephenytoin levels; itraconazole, voriconazole; albendazole; imatinib, cyclophosphamide, lapatinib, temsirolimus; clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, aripiprazole, paliperidone; PIs; alprazolam; theophylline, hormonal contraceptives; dihydropyridine Ca channel blockers (eg, felodipine, digoxin, simvastatin, atorvastatin, lovastatin, cerivastatin, ivabradine); corticosteroids; tadalafil; ciclosporin, everolimus, tacrolimus, sirolimus; levothyroxine; oestrogen- & progesterone-containing products. Increased induced toxicity w/ levetiracetam; induced hepatotoxicity w/ isoniazid. Enhanced neurotoxicity w/ lithium, haloperidol, thioridazine. Symptomatic hyponatraemia w/ diuretics (hydrochlorothiazide, furosemide). May antagonize effects of non-depolarizing muscle relaxants eg, pancuronium. Reduced alcohol tolerance. May result in false +ve perphenazine conc in high-performance liquid chromatography (HPLC); TCA conc in fluorescence polarized immunoassay (for carbamazepine & 10, 11 epoxide metabolite). Breakthrough bleeding in women concomitantly using hormonal contraceptives.
MIMS Class
ATC Classification
N03AF01 - carbamazepine ; Belongs to the class of carboxamide derivatives antiepileptic.
Mezacar tab 200 mg
5 × 10's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in