GABAPENTIN capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

RxChange Co.

INN (International Name):

GABAPENTIN

Sammensætning:

GABAPENTIN 300 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Gabapentin capsules, USP 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, USP are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. Gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. The no-effec

Produkt oversigt:

Gabapentin capsules, USP are supplied as follows: 100 mg capsules: White-White, opaque hard gelatin capsules printed with “IP 101” on both cap and body. They are available as follows: Bottles of 30: NDC 65162-101-03 Bottles of 100: NDC 65162-101-10 Bottles of 500: NDC 65162-101-50 Bottles of 1000: NDC 65162-101-11 300 mg capsules: Buff-Buff, opaque hard gelatin capsules printed with “IP 102” on both cap and body. They are available as follows: Bottles of 30: NDC 65162-102-03 Bottles of 100: NDC 65162-102-10 Bottles of 500: NDC 65162-102-50 Bottles of 1000: NDC 65162-102-11 400 mg capsules: Light caramel-Light caramel, opaque hard gelatin capsules printed with “IP 103” on both cap and body. They are available as follows: Bottles of 30: NDC 65162-103-03 Bottles of 100: NDC 65162-103-10 Bottles of 500: NDC 65162-103-50 Bottles of 1000: NDC 65162-103-11 Store gabapentin capsules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight (USP), child-resistant containers.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

RxChange Co.
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MEDICATION GUIDE
Gabapentin (GA-be-PEN-tin) Capsules
Read the Medication Guide before you start taking gabapentin capsules
and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or treatment.
What is the most important information I should know aboutgabapentin
capsules? Do not stop taking
gabapentin capsuleswithout first talking to your healthcare provider.
Stopping gabapentin capsules suddenly can cause serious problems.
Gabapentin capsulescan cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin
capsulesmay cause suicidal thoughts or
actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
Do not stop taking gabapentin capsuleswithout first talking to a
healthcare provider.
•
Stopping gabapentin capsules suddenly can cause serious problems.
Stopping a seizure medicine
suddenly in a patient who has epilepsy can cause seizures that will
not stop (status epilepticus).
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have

Produktets egenskaber

GABAPENTIN- GABAPENTIN CAPSULE
RXCHANGE CO.
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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, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin capsules are 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)
Dose can be titrated up as needed to a dose of 1800 mg/day
Day 1: Single 300 mg dose
Day 2: 600 mg/day (i.e., 300 mg two times a day)
Day 3: 900 mg/day (i.e., 300 mg three times a day)
Epilepsy with Partial Onset Seizures (2.2)
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
Patients 3 to 11 years of age: starting dose range is 10 to 15
mg/kg/day, given in three divided doses; the effective
dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three
divided doses; the effective dose in patients 5 to
11 years of age is 25 to 35 mg/kg/day, given in three divided doses.
The effective 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)
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)
_Driving impairment:_ warn patients not to drive until they have
gained sufficient experience with gabapentin to assess
whether it will impair their ability to drive (5.2)
_Somnolence/Sedation and Dizziness:_ gabapentin may impair the
pa