GABAPENTIN capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Clinical Solutions Wholesale, LLC

INN (International Adı):

GABAPENTIN

Kompozisyon:

GABAPENTIN 300 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

GABAPENTIN- GABAPENTIN CAPSULE
CLINICAL SOLUTIONS WHOLESALE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN CAPSULES.
GABAPENTIN CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions: Anaphylaxis and Angioedema: discontinue
Gabapentin and evaluate patient immediately
(5.2) 9/2015
INDICATIONS AND USAGE
Gabapentin is indicated for:
· Postherpetic neuralgia in adults (1)· 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 (1)
DOSAGE AND ADMINISTRATION
· Postherpetic Neuralgia ( 2.1)
o Dose can be titrated up as needed to a dose of 1800 mg/day
o Day 1: Single 300 mg dose
o Day 2: 600 mg/day (i.e., 300 mg two times a day)
o Day 3: 900 mg/day (i.e., 300 mg three times a day)
· Epilepsy with Partial Onset Seizures (2.2)
o Patients 12 years of age and older: starting dose is 300 mg three
times daily; may be titrated up to 600 mg three times
daily
o Patients 3 to 11 years of age: starting dose range is 10 to 15
mg/kg/day, given in three divided doses; recommended
dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three
divided doses; the recommended dose in patients 5 to
11 years of age is 25 to 35 mg/kg/day, given in three divided doses.
The recommended dose is reached by upward titration
over a period of approximately 3 days
· Dose should be adjusted in patients with reduced renal function (
2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
· Capsules: 100 mg, 300 mg, and 400 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to gabapentin or its ingredients (4)
WARNINGS AND PRECAUTIONS
· Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan
hypersensitivity): discontinue gabapentin if an
alternative etiology cannot be established (5.1)
· Anaphylaxis and Angioedema: discontinue gabape