Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Epilepsy – generalised tonic-clonic and partial seizures.
Note: Storilat is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences.
The paroxysmal pain of trigeminal neuralgia.
For the prophylaxis of manic-depressive psychoses in patients unresponsive to lithium therapy.
Storilat is given orally usually in two or three divided doses. Storilat may be taken during, after or between meals with a little liquid e.g. a glass of water.
Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated SJS (See information on genetic testings and cutaneous reactions in section 4.4).
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 optimum 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 warnings and precautions).
It is advised that with all formulations of Storilat, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. It may be helpful to monitor the plasma concentration of carbamazepine to establish the optimum dose (see Pharmacokinetics, Precautions and Interactions).
Storilat should be taken in a number of divided doses although initially 100-200mg once or twice daily is recommended. This may be followed by a slow increase in dosage until the best response is obtained, often 800-1200mg daily. In some instances, 1600mg or even 2000mg daily may be necessary.
Due to the potential for drug interactions, the dosage of Storilat should be selected with caution in elderly patients.
No data are available on the pharmacokinetics of carbamazepine in patients with impaired hepatic or renal function.
Children and adolescents with hypertension from 6 years to 17 years of age:
It is advised that with all formulations of Storilat, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. It may be helpful to monitor the plasma concentration of carbamazepine to establish the optimum dose (see Pharmacokinetics, Precautions and Interactions).
Usual dosage 10-20mg/kg bodyweight daily taken in several divided doses.
Storilat Tablets are not recommended for very young children.
5-10 years: 400-600mg daily, to be taken in divided doses.
10-15 years: 600-1000mg daily, to be taken in several divided doses.
>15 years of age: 800 to 1200mg daily (same as adult dose).
Maximum recommended dose:
Up to 6 years of age: 35mg/kg/day
6-15 years of age: 1000mg/day
>15 years of age: 1200mg/day.
Wherever possible, anti-epileptic agents should be prescribed as the sole anti-epileptic agent but if used in polytherapy, the same incremental dosage pattern is advised.
When Storilat 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 4.5 Interaction with other Medicaments and other forms of Interaction).
Slowly raise the initial dosage of 200-400mg daily (100mg twice daily in elderly patients) until freedom from pain is achieved (normally at 200mg 3-4 times daily). In the majority of patients a dosage of 200mg 3 or 4 times a day is sufficient to maintain a pain free state. In some instances, doses of 1600mg Storilat daily may be needed. However, once the pain is in remission, the dosage should be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.
Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Storilat should be selected with caution in elderly patients.
In elderly patients, an initial dose of 100mg twice daily is recommended. The initial dosage of 100mg twice daily should be slowly raised daily until freedom from pain is achieved (normally at 200mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.
Initial starting dose of 400mg daily, in divided doses, increasing gradually until symptoms are controlled or a total of 1600mg given in divided doses is reached. The usual dosage range is 400-600mg daily, given in divided doses.
Oral administration.
The presenting signs and symptoms of overdosage involve the central nervous, cardiovascular, respiratory systems and the the adverse drug reactions mentioned under section 4.8.
Central nervous system: CNS depression; disorientation, depressed level of consciousness, somnolence, agitation, hallucination, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, initially hyperreflexia, later hyporeflexia; convulsions, psychomotor disturbances, myoclonus, hypothermia, mydriasis.
Respiratory system: Respiratory depression, pulmonary oedema.
Cardiovascular system: Tachycardia, hypotension and at times hypertension, conduction disturbance with widening of QRS complex; syncope in association with cardiac arrest.
Gastro-intestinal system: Vomiting, delayed gastric 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 ADH-like effect of carbamazepine.
Laboratory findings: Hyponatraemia, possibly metabolic acidosis, possibly hyperglycaemia, increased muscle creatinine phosphokinase.
There is no specific antidote.
Management should initially be guided by the patient’s clinical condition; admission to hospital. Measurement of the plasma level to confirm carbamazepine poisoning and to ascertain the size of the overdose.
Evacuation of the stomach, gastric lavage, and administration of activated charcoal. Delay in evacuating the stomach may result in delayed absorption, leading to relapse during recovery from intoxication. Supportive medical care in an intensive care unit with cardiac monitoring and careful correction of electrolyte imbalance.
Hypotension: Administer dopamine or dobutamine i.v.
Disturbances of cardiac rhythm: To be handled on an individual basis.
Convulsions: Administer a benzodiazepine (e.g. diazepam) or another antiepileptic, e.g. phenobarbitone (with caution because of increased respiratory depression) or paraldehyde.
Hyponatraemia (water intoxication): Fluid restriction and slow and careful NaCl 0.9% infusion i.v. These measures may be useful in preventing brain damage.
Charcoal haemoperfusion has been recommended. Forced diuresis, haemodialysis, and peritoneal dialysis have been reported not to be effective.
Relapse and aggravation of symptomatology on the 2nd and 3rd day after overdose, due to delayed absorption, should be anticipated.
5 years.
Store below 25°C. Protect from light and moisture.
PVC/Aluminium blisters. Pack sizes of 50 and 100 tablets.
PP containers with PE closure. Pack sizes of 100, 500 and 1000 tablets.
Not all pack sizes may be marketed.
No special requirements.
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