Diphenin tablets

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

phenytoin

Boleh didapati daripada:

Arpimed LLC

Kod ATC:

N03AB02

INN (Nama Antarabangsa):

phenytoin

Dos:

117mg

Borang farmaseutikal:

tablets

Unit dalam pakej:

(10) blister

Jenis preskripsi:

Prescription

Status kebenaran:

Registered

Tarikh kebenaran:

2017-07-31

Ciri produk

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