Gabapentin capsules

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

gabapentin

Доступна с:

Arpimed LLC

код АТС:

N03AX12

ИНН (Международная Имя):

gabapentin

дозировка:

300mg

Фармацевтическая форма:

capsules

Штук в упаковке:

(30/3x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-12-22

Характеристики продукта

SUMMARY PRODUCT CHARACTERISTIC (S
M
PC)
GABAPENTIN
300 MG CAPSULES
1. NAME OF THE MEDICAL PRODUCT- GABAPENTIN
1.2 INTERNATIONAL NON-PROPERTY NAME - GABAPENTIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg of gabapentin
Excipients with known effect:
Each hard capsule contains 34 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard
Hard gelatin capsule (size 1), with yellow body and yellow cap,
containing a white to
off-white granules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of
partial seizures with
and without secondary generalization in adults and children aged 6
years and above (see
section 5.1).
Gabapentin is indicated as monotherapy in the treatment of partial
seizures with and
without secondary generalization in adults and adolescents aged 12
years and above.
Treatment of peripheral neuropathic pain
Gabapentin is indicated for the treatment of peripheral neuropathic
pain such as painful
diabetic neuropathy and post-herpetic neuralgia in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all indications a titration scheme for the initiation of therapy
is described in Table 1,
which is recommended for adults and adolescents aged 12 years and
above. Dosing
instructions for children under 12 years of age are provided under a
separate sub-
heading later in this section.
Table 1
DOSING CHART – INITIAL TITRATION
Day 1
Day 2
Day 3
300 mg once a day
300 mg two times a day
300 mg three times a day
Discontinuation of gabapentin
In accordance with current clinical practice, if gabapentin has to be
discontinued it is
recommended this should be done gradually over a minimum of 1 week
independent of
the indication.
Epilepsy
Epilepsy typically requires long-term therapy. Dosage is determined by
the treating
physician according to individual tolerance and efficacy.
_Adults and adolescents:_
In clinical trials, the effective dosing range was