GABAPENTIN capsule GABAPENTIN tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)

Pieejams no:

DIRECTRX

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Gabapentin capsules are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was dev

Produktu pārskats:

Gabapentin Tablets USP are supplied as follows: Gabapentin Tablets USP, 600 mg are white to off white film-coated, oval shaped, biconvex scored tablets debossed with “G” and “31” on one side. They are available as: Bottles of 100 NDC 68462-126-01 Bottles of 500 NDC 68462-126-05 Gabapentin Tablets USP, 800 mg are white to off white film-coated, oval shaped, biconvex scored tablets debossed with “G” and “13” on one side. They are available as: Bottles of 100 NDC 68462-127-01 Bottles of 500 NDC 68462-127-05 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

GABAPENTIN- GABAPENTIN TABLET
DIRECTRX
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Revised: 4/2019
Document Id: 8643d513-86d0-cea3-e053-2991aa0a0ddd
34391-3
Set id: 76b30316-37f4-62ed-e053-2a91aa0aa572
Version: 2
Effective Time: 20190411
DIRECTRX

Produkta apraksts

GABAPENTIN- GABAPENTIN CAPSULE
GABAPENTIN- GABAPENTIN TABLET
DIRECTRX
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GABAPENTIN 400MG
Gabapentin capsules are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with
and without secondary generalization,
in adults and pediatric patients 3 years and older with epilepsy
2.1 Dosage for Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin may be initiated on
Day 1 as a single 300 mg dose, on
Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900
mg/day (300 mg three times a day).
The dose can subsequently be titrated up as needed for pain relief to
a dose of 1,800 mg/day (600 mg
three times a day). In clinical studies, efficacy was demonstrated
over a range of doses from 1,800
mg/day to 3,600 mg/day with comparable effects across the dose range;
however, in these clinical
studies, the additional benefit of using doses greater than 1,800
mg/day was not demonstrated.
2.2 Dosage for Epilepsy with Partial Onset Seizures
Patients 12 years of age and above
The starting dose is 300 mg three times a day. The recommended
maintenance dose of gabapentin
Capsules is 300 mg to 600 mg three times a day. Dosages up to 2,400
mg/day have been well tolerated
in long-term clinical studies. Doses of 3,600 mg/day have also been
administered to a small number of
patients for a relatively short duration, and have been well
tolerated. Administer gabapentin capsules
three times a day using 300 mg or 400 mg capsules. The maximum time
between doses should not
exceed 12 hours.
Pediatric Patients Age 3 to 11 years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in
three divided doses, and the
recommended maintenance dose reached by upward titration over a period
of approximately 3 days. The
recommended maintenance dose of gabapentin in patients 3 to 4 years of
age is 40 mg/kg/day, given in
three divided doses. The recommended maintenance dose of gabapentin in
patients 5 to 11 years of age
is 25 mg/kg/day to 35 mg/kg