Round, white uncoated tablet, bevel-edged, flat-faces; “HOVID” embossed on one face and scored on the other.
Carbamazepine 200 mg/tablet.
ACTIONS AND PHARMACOLOGY
Exact mechanism of action of carbamazepine as an anticonvulsant is unknown but it is believed to stabilize rather than elevate the seizure threshold and to limit the spread of seizure activity.
Oral absorption is slow but fairly complete and plasma protein binding is extensive. It undergoes hepatic metabolism and renal excretion.
For treatment of:
• Partial seizures with complex symptomatology (psychomotor, temporal Iobe).
• Generalized tonic-clonic seizures (grand mal).
• Mixed seizure patterns.
• Pain due to trigeminal neuralgia and glossopharyngeal neuralgia.
• Not recommended in patients with atrioventricular (AV) heart block, blood disorders, and history of bone marrow depression.
• Use in nursing mothers should generally be avoided.
WARNING AND PRECAUTIONS
• Caution in getriatic patients and in patients with coronary artery disease, diabetes mellitus, glaucoma, history of hematologic adverse reactions to other medications, urinary retention, cardiac, hepatic or renal disease.
• Abrupt discontinuation in a responsive epileptic patient may precipitate convulsions or status epilepticus; gradual withdrawal is recommended.
• Plasma carbamazepine concentration determinations is recommended periodically as a guide to efficacy and safety.
• Carbamazepine should be given with caution to patients who are hypersensitive to tricyclic antidepressants.
• This medication may cause drowsiness. Caution when driving or operating machinery. Avoid alcoholic beverages.
• Safety for use in pregnancy has not been established.
• Caution: Serious and sometimes fatal skin reactions, including toxic epidermal necrolysis (Lyell’s Syndrome) and Stevens-Johnson Syndrome, have been known to occur during treatment with carbamazepine. They are significantly more common in patients with a particular human leucocyte antigen (HLA) allele, HLA-B*1502, which occurs almost exclusively in patients with ancestry across broad areas of Asia. Patients should be screened for HLA-B*1502 allele prior to initiating treatment with carbamazepine. If a patient tests positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine.
Patients treated with carbamazepine should closely be monitored for sign of hypersensitivity reactions, particularly during the first month of therapy. Immediate discontinuation of therapy should be made when cutaneous reactions occur.
• Potential for an increase in risk of suicidal thoughts or behaviours.
MAIN SIDE/ADVERSE EFFECTS
Dizziness, drowsiness, ataxia, nausea or vomiting.
• Monoamine oxidase (MAO) Inhibitors should be discontinued at least 14 days before carbamazepine therapy is initiated.
• Dosage adjustments may be necessary when used concurrently with anticoagulants, coumarin or indandione derivative, doxycycline, or tricyclic antidepressants.
• Effects of oral contraceptives, barbiturates, benzodiazepines, hydantoins, primidone, succinimides or valproic acid may be decreased during concurrent therapy
• Co-administration of erythromycin, propoxyphene or troleandomycin may increase carbamazepine plasma levels and toxicity.
Clinical features: Dizziness, ataxia, nystagmus, abdominal discomfort, urinary retention, hyperreflexia.
Treat overdosage by emesis or gastric lavage, if appropriate; with the necessary supportive measures, if required.
DOSAGE AND ADMINISTRATION
• Initial: Oral, 200 mg two times a day on the first day, the dosage then being increased as needed.
• Maintenance: Oral, 800 mg to 1.2 gram a day, in 3 or 4 divided doses.
• Initial: Oral, 100 mg two times a day on the first day, the dosage then being increased as needed.
• Maintenance: Oral, 200 mg to 1.2 grams a day, in 3 or 4 divided doses.
Below 6 years:
• Initial: Oral, 5 mg per kg body weight per day, the dosage being increased as needed.
• Maintenance: Oral, 10 to 20 mg per kg body weight per day, in 3 or 4 divided doses.
6 to 12 years:
• Initial: Oral, 100 mg two times a day on the first day, the dosage being increased as needed.
• Maintenance: Oral, 400-800 mg a day in 3 or 4 divided doses, not exceeding 1 gram daily.
Store below 25oC. Protect from moisture.
Tablet 200 mg x 1000’s, 500’s, 100’s, 10 x 10’s
21, Jalan Tunku Abdul Rahman, 30010 lpoh, Malaysia.
Revision date: December 2016.