GABAPENTIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gabapentin is indicated for the management of postherpetic neuralgia in adults. Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Controlled Substance Gabapentin is not a scheduled drug. Abuse Gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. A small number of postmarketing cases report gabapentin misuse and abuse. These individuals were taking higher than recommended doses of gabapentin for unapproved uses. Most of the individuals described in these reports had a history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances. When prescrib

Product summary:

Gabapentin Capsules, USP 300 mg are available for oral administration as hard gelatin capsules with a white opaque body and a yellow opaque cap. “APO 113” is imprinted on each capsule in black ink; supplied in: Bottles of 30 10544-436-30 Bottles of 45 10544-436-45 Bottles of 60 10544-436-60 Bottles of 84 10544-436-84 Bottles of 90 10544-436-90 Bottles of 100 10544-436-00 Bottles of 120 10544-436-02 Bottles of 180 10544-436-81 Gabapentin Capsules, USP 400 mg are available for oral administration as hard gelatin capsules with a white opaque body and an orange opaque cap. “APO 114” is imprinted on each capsule in black ink; supplied in: Bottles of 30 10544-447-30 Bottles of 60 10544-447-60 Bottles of 84 10544-447-84 Bottles of 90 10544-447-90 Bottles of 02 10544-447-02 Store 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 a tight, light resistant container [see USP]. * Maalox® is a registered trademark of Novartis Consumer Health Inc. BLENHEIM PHARMACAL, INC. GABAPENTIN CAPSULES, USP 300 mg and 400 mg Manufactured by:             Manufactured for: Packaged/ Marketed by: Apotex Inc.                     Apotex Corp. Blenheim Pharmacal, Inc Toronto, Ontario              Weston, Florida North Blenheim, NY Canada M9L 1T9             33326 12131 (USA) Revised: June 2013 Rev. 6

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN- GABAPENTIN CAPSULE
Blenheim Pharmacal, Inc.
----------
MEDICATION GUIDE
GABAPENTIN CAPSULES, USP
300 mg and 400 mg
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. 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:
1.
thoughts about suicide or dying
2.
attempts to commit suicide
3.
new or worse depression
4.
new or worse anxiety
5.
feeling agitated or restless
6.
panic attacks
7.
trouble sleeping (insomnia)
8.
new or worse irritability
9.
acting aggressive, being angry, or violent
10.
acting on dangerous impulses
11.
an extreme increase in activity and talking (mania)
12.
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
1.
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
2.
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.
1.
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
me

Summary of Product characteristics

GABAPENTIN- GABAPENTIN CAPSULE
BLENHEIM PHARMACAL, INC.
----------
GABAPENTIN CAPSULES, USP 100 MG, 300 MG AND 400 MG
DESCRIPTION
Gabapentin is described as 1-(aminomethyl) cyclohexaneacetic acid with
a molecular formula of
C H NO and a molecular weight of 171.24. Gabapentin is a white to
off-white crystalline solid with a
pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both
basic and acidic aqueous solutions.
The log of the partition coefficient (n-octanol/0.05M phosphate
buffer) at pH 7.4 is –1.25. It has the
following structural formula:
Each capsule for oral administration contains 100 mg, 300 mg and 400
mg of gabapentin. In addition,
each capsule contains the following inactive ingredients:
croscarmellose sodium and magnesium
stearate. The 100 mg, 300 mg and 400 mg capsule imprinting ink
contains the following inactive
ingredients: ammonium hydroxide; black iron oxide, bacteria controlled
EEC No. 172; n-butyl; ethyl
alcohol; isopropyl alcohol; potassium hydroxide; propylene glycol;
purified water and shellac.
The 300 mg capsule shell contains gelatin, yellow iron oxide and
titanium dioxide.
The 400 mg capsule shell contains gelatin, red iron oxide, yellow iron
oxide and titanium oxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The mechanism by which gabapentin exerts its analgesic action is
unknown, but in animal models of
analgesia, gabapentin prevents allodynia (pain-related behavior in
response to a normally innocuous
stimulus) and hyperalgesia (exaggerated response to painful stimuli).
In particular, gabapentin prevents
pain-related responses in several models of neuropathic pain in rats
or mice (e.g., spinal nerve ligation
models, streptozocin-induced diabetes model, spinal cord injury model,
acute herpes zoster infection
model). Gabapentin also decreases pain-related responses after
peripheral inflammation (carrageenan
footpad test, late phase of formalin test). Gabapentin did not alter
immediate pain-related behaviors (rat
tail flick test, formalin footpad acute phase, acetic acid