Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
phenytoin
Arpimed LLC
N03AB02
phenytoin
117mg
tablets
(10/1x10/) blister
Prescription
Registered
2022-09-23
SUMMARY OF PRODUCT CHARACTERISTICS DIPHENIN 117 MG TABLETS 1.1 NAME OF THE MEDICAL PRODUCT - DIPHENIN 1.2 INTERNATIONAL NON-PROPERTY NAME - PHENYTOIN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 117 mg of phenytoin For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. White or white-off biconvex scored tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination of these, and for the prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury. Diphenin has also been employed in the treatment of trigeminal neuralgia but it should only be used as second line therapy if carbamazepine is ineffective or patients are intolerant to carbamazepine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. _Dosage:_ Dosage should be individualised as there may be wide interpatient variability in phenytoin serum levels with equivalent dosage. Diphenin should be introduced in small dosages with gradual increments until control is achieved or until toxic effects appear. In some cases serum level determinations may be necessary for optimal dosage adjustments - the clinically effective level is usually 10 mcg/mL- 20 mcg/mL (40-80 micromoles/l) although some cases of tonic-clonic seizures may be controlled with lower serum levels of phenytoin. With recommended dosage a period of 7 to 10 days may be required to achieve steady state serum levels with Diphenin and changes in dosage should not be carried out at intervals shorter than 7 to 10 days. Maintenance of treatment should be the lowest dose of anticonvulsant consistent with control of seizures. Posology _Adult Dosage for Seizures:_ Initially 3 to 4 mg/kg/day with subsequent dosage adjustment if necessary. For most adults a satisfactory maintenance dose will be 200 mg to 500 mg daily in single or divided doses. Exceptionally, a daily dose outside this ra Прочитать полный документ