TEGRETOL SYRUP; carbamazepine, anticonvulsants .
ACTIVE-INGREDIENT OF TEGRETOL SYRUP
Each 5 ml of Tegretol oral Suspension contains: 100 mg carbamazepine.
INDICATION OF TEGRETOL SYRUP
Epilepsy – Complex or simple partial seizures ( with or without loss of consciousness ) with or without secondary generalization. – Generalized tonic-clonic seizures, Mixed forms of seizures. Tergretol is suitable for both monotherapy and combination therapy. Tergretol is usually not effective in absences (petit mal) and myoclonic seizures ( see section warnings and precautions). Acute mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence. Alcohol-withdrawal syndrome. Idiopathic glossopharyngeal neuralgia. Painful diabetic neuropathy. Diabetes insipidus centralis. Polyuria and polydipsla of neurohormonal origin.
DOSAGE OF TEGRETOL SYRUP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Epilepsy: When possible, Tegretol should be prescribed as monotherapy. Treatment should be initiated with a low daily dosage, to be slowly increased untile an optimal effect is obtained. The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimun dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma-carbamazepine concentrations of about 4 to 12 micrograms/ml. (17 to 50 micromoles/litre)( see section warnings and precautions). When Tegretol is added to existing antiepileptic therapy, this should be done gradually while maintaining, or if necessary, adapting the dosage of the other antiepileptic(s) (see section interactions and clinical pharmacology – pharmacokinetics). Oral forms : Initially, 100 to 200 mg once or twice daily; the dosage should be slowly raisd until – generally at 400 mg 2 to 3 times daily – an optimum response is obtained. In some patients 1600 mg or even 2000 mg daily may be appropriate. Dosage in acute mania and maintenance treatment of bipolar affective disorders: Dosage range: about 400 to 1600 mg daily, the usual dosage being 400 to 6oo mg daily given in 2 to 3 divided doses. In acute mania, the dosage should be increased rather quickly, wheras small dosage increments are recommended for maintenance therapy of bipolar disorders in order to ensure optimal tolerability. Dosage in Alcohol-withdrawal syndrome: Average dosage: 200 mg 3 times daily. In severe cases, it can be raised during the first few days (e.g. to 400 mg 3 times daily0. At the start of treatment for severe withdrawal manifestations, Tegretol should be given in comination with sedative-hypnotic drugs (e.g. clomethiazole, chlordiazepoxide). After the acute stage has abated, Tegretol can be continued as monotherapy. Dosage in Trigeminal neuralgia : The initial dosage of 200 to 400 mg should be slowly raised daily until freedom from pain is achieved (normally at 200 mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200 mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs. Dosage in painful diabetic neuropathy : Average dosage : 200mg 2 to 4 times daily. Dosage in Diabetes insipidus centralis: Average dosage for adults: 200 mg 2 to 3 times daily. In children the dosage should be reduced proportionally to the child’s age and body weight. Special populations: Renal impairments/hepatic impairment : No data are available on the pharmacokinetics of carbamazepine in parients with impaired hepatic or renal function. Pediatrics /Children and adolescents. Dosage in Epilepsy : Oral forms : For children aged 4 years or less, a starting dose of 20 to 60 mg/day, increasing by 20 to 60 mg every second day, is recommended. For children over the age of 4 years, therapy may begin with 100 mg/day, increasing at weekly intervals by 100 mg. Maintenance dosage : 10 to 20 mg/kg body weight daily in divided doses, e.g. – Up to 1 year of age : 100 to 200 mg daily (= 5 to 10 ml = 1-2 measures of oral suspension). 1 to 5 years of age : 200 to 400 mg daily (= 10 to 20 ml = 2 ₓ 1-2 measures of oral suspension). 6 to 10 years of age : 400 to 600 mg daily (= 20 to 30 ml =2-3ₓ 2 measures of oral suspension). 11 to 16 years of age : 600 to 1000 mg daily (= 30 to 50 ml = 3ₓ 2-3 measures of oral suspension)(plus an extra measure of 5 ml in case of administration of 1000 mg) . >15 years of age : 800 to 1200 mg daily (same as adult dose). Maximum recommended dose : Up to 6 years of age: 35 mg/kg/day. 6-15 years of age : 1000 mg/day. >15 years of age : 1200 mg/day.
OVER-DOSAGE OF TEGRETOL SYRUP
Signs and symptoms : The presenting signs and symptoms of overdosage usually involve the central nervous, cardiovascular, respiratory systems and the adverse drug reactions mentioned under section (Adverse drug reaction). Central nervous system: CNS depression; disorientation, depressed level of consciousness, somnoience, agitation, hallucination, coma; blurred vision, sturred speech, dysarthria, nyslagmus, ataxia, dyskinesis, initially hyper-reflexia, later hyporeflexia; convulsions, psychromotor disturbances, myoclonus, hypothermia, mydriasis. Respiratory system : Respiratory depression, pulmonary oedema. Cardiovascular system : Tachycardia, hypotension, at times hypertension, conduction disturbance with widening of QRS complex; syncope in association with cardiac arrest. Gastrointestinal system : Vomiting , delayed emptying, reduced bowel motility. Musculoskeletal system: There have been some cases which reported rhabdomyolysis in association with carbamazepine toxicity. Renal function: Retention of urine, oliguria or anuria; fluid retention, water intoxication due to an ADH-like effect of carbamazepine.
CONTRA-INDICATION OF TEGRETOL SYRUP
Known hypersensitivity to carbamazepine or structurally related drugs (e.g. tricyclic antidepressants) or any other component of the formulation. Patients with atrioventricular block. Patients with a history of bone-marrow depression. Patients with a history of hepatic porphyrias (e.g. acute intermittent porphyria, variegate porphyria, porphyria cutanea trada ). The use of Tegretol is contraindicated in comination with monoamine-oxidase inhibitors (MAOIs) (see section of interactions).
STORAGE OF TEGRETOL SYRUP
( see folding box.), Targetol should not be used after the data marked ʺEXPʺ on the pack.
PACK OF TEGRETOL SYRUP
TEGRETOL SYRUP MANUFACTURED BY
Novartis Pharma AG, Basel, Switzerland.( see folding box.)