Should be taken with food. Avoid grapefruit juice.
Administration
Should be taken with food. Avoid grapefruit juice.
|
Contraindications
History of bone marrow depression, history of hepatic porphyria (e.g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda), atrioventricular (AV) block. Concomitant use with MAOIs (or within 14 days of use); nefazodone; delavirdine or other non-nucleoside reverse transcriptase inhibitors (NNRTIs) metabolised by CYP3A4.
|
Special Precautions
Patient with mixed seizure disorder, increased intraocular pressure, urinary retention, constipation; pre-existing cardiac damage, underlying ECG abnormalities, history of cardiac conduction disturbance (e.g. 2nd- and 3rd-degree AV heart block). HLA-B*15:02 or HLA-A*31:01 positive patients. Not effective for use in absence, myoclonic, or akinetic seizures. Avoid abrupt withdrawal. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause drowsiness, dizziness, or blurred vision; if affected, do not drive or operate machinery. Do not switch between dosage forms unless instructed by your doctor. Women of childbearing potential must use proven birth control methods during therapy and for at least 2 weeks after stopping the treatment. Consider using other reliable contraceptive methods recommended by the doctor as hormonal contraceptives may be ineffective. Monitoring Parameters Screen for HLA-B*15:02 alleles in patients at increased risk of developing SCARs before treatment initiation. Obtain CBC with platelet count and differential, serum Fe, reticulocytes, hepatic and renal function tests, urinalysis, BUN, and eye examination at baseline and periodically during treatment; lipid panel, thyroid function tests, serum Na and carbamazepine levels as clinically indicated. Monitor for emergence or worsening of depression, suicidal thoughts or behaviour, or any unusual changes in mood or behaviour. Closely monitor serum levels when a change in product is necessary.
|
Adverse Reactions
Significant: Leucopenia, thrombocytopenia, CNS depression, ataxia, dizziness, somnolence, sedation, hypotension, increased intraocular pressure, cardiac conduction abnormalities; elevated hepatic enzymes, hepatic failure, hyponatraemia, reduced serum levels of thyroid hormones; confusion, agitation, activation of latent psychosis, suicidal thoughts or behaviour, renal toxicity, isolated macular or maculopapular exanthema; exacerbated atypical absence or myoclonic seizures.
Blood and lymphatic system disorders: Eosinophilia.
Eye disorders: Diplopia, blurred vision.
Gastrointestinal disorders: Dry mouth, nausea, vomiting; rectal irritation (supp).
General disorders and administration site conditions: Fatigue, weakness.
Investigations: Increased weight, decreased blood osmolarity, increased LDL, HDL, total cholesterol, alkaline phosphatase and gamma-glutamyltransferase.
Metabolism and nutrition disorders: Oedema, fluid retention. Rarely, acute or non-acute porphyria.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Urticaria, pruritus, rash.
Vascular disorders: Hypertension.
Potentially Fatal: Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, acute generalised exanthematous pustulosis, multiorgan hypersensitivity (also known as DRESS), anaphylaxis and angioedema involving the glottis, larynx, lips and eyelids; aplastic anaemia, agranulocytosis, CV effects (e.g. CHF, thromboembolism, AV block). |
Drug Interactions
Increased plasma levels with CYP3A4 inhibitors (e.g. aprepitant, cimetidine, acetazolamide, azole antifungals, ciprofloxacin, danazol, diltiazem, erythromycin, clarithromycin, fluoxetine, trazodone, olanzapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, verapamil, ticlopidine, protease inhibitors). Decreased plasma levels with CYP3A4 inducers (e.g. cisplatin, doxorubicin, felbamate, rifampicin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline). May reduce the plasma concentrations of drugs metabolised by CYP1A2, 2B6, 2C9/19, and 3A4 (e.g. aripiprazole, tacrolimus, lapatinib, valproic acid). May increase the risk of cyclophosphamide toxicity. May increase the neurotoxic effects of lithium. May increase the risk of isoniazid-induced hepatotoxicity. May cause alteration of thyroid function when used with other anticonvulsants. May reduce the plasma levels and efficacy of hormonal contraceptives. May cause resistance to the neuromuscular blocking action of nondepolarising neuromuscular blockers (e.g. cisatracurium, pancuronium, vecuronium, rocuronium). May reduce the plasma concentrations of oral anticoagulants (e.g. dabigatran, warfarin, apixaban). May cause breakthrough bleeding in women taking hormonal contraceptives.
|
CIMS Class
|
ATC Classification
N03AF01 - carbamazepine ; Belongs to the class of carboxamide derivatives antiepileptic.
|