GABAPENTIN- gabapentin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gabapentin capsules, USP are indicated for: 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 mg, 1000 mg, 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-effect dose for embryo-fetal developmental toxicity in mice was 500 mg/kg/day or approximately ½ of the maximum recommended human dose (MRHD) of 3600 mg/kg on a body surface area (mg/m2 ) basis. In studies in which rats r

Product summary:

Gabapentin Capsules, USP are supplied as follows: 100 mg capsules: Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder; supplied in bottles of: Bottle of 30 - 68788-9026-3 Bottle of 60 - 68788-9026-6 Bottle of 90 - 68788-9026-9 Bottle of 100 - 68788-9026-0 Bottle of 120 - 68788-9026-8 300 mg capsules: Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; supplied in bottles of: Bottle of 20 - 68788-9027-2 Bottle of 28 - 68788-9027-4 Bottle of 30 - 68788-9027-3 Bottle of 60 - 68788-9027-6 Bottle of 90 - 68788-9027-9 Bottle of 100 - 68788-9027-0 Bottle of 120 - 68788-9027-8 Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN- GABAPENTIN CAPSULE
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Gabapentin Capsules, USP
(gab-ah-PEN-tin)
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 about gabapentin
capsules?
Do not stop taking gabapentin capsules without first talking to your
healthcare provider.
Stopping gabapentin capsules suddenly can cause serious problems.
Gabapentin capsules can cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin
capsules may 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 capsules without 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 acti

Summary of Product characteristics

GABAPENTIN- GABAPENTIN CAPSULE
PREFERRED PHARMACEUTICALS, INC.
----------
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
RECENT MAJOR CHANGES
•
INDICATIONS AND USAGE
Gabapentin is indicated for:
•
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 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, 400 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to gabapentin or its ingredients (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥8% and at least twice that
for placebo) were:
•
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CAMBER PHARMACEUTICALS,
INC. AT 1-866-495-8330 OR
Warnings and Precautions: Anaphylaxis and Angioedema: discontinue
gabapentin capsules and evaluate patient
immediat