GABAPENTIN capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Epic Pharma, LLC

INN (Internationale Bezeichnung):

GABAPENTIN

Zusammensetzung:

GABAPENTIN 100 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Gabapentin capsules are indicated for: Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Gabapentin is not a scheduled drug. 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 prescribing gabapentin carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., development of tolerance, self-dose escalation, and drug-seeking behavior). There are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended

Produktbesonderheiten:

Gabapentin Capsules, USP are supplied as follows: 100 mg capsules: The 100 mg capsule is a #3 capsule with a white opaque cap, white opaque body, imprinted "Є509" in blue ink on cap and body, filled with white to off-white powder. They are supplied as: NDC 42806-509-30 Bottles of 30 NDC 42806-509-01 Bottles of 100 NDC 42806-509-10 Bottles of 1,000 300 mg capsules: The 300 mg capsule is a #1 capsule with a yellow opaque cap, yellow opaque body, imprinted "Є510" in blue ink on cap and body, filled with white to off-white powder. They are supplied as: NDC 42806-510-30 Bottles of 30 NDC 42806-510-01 Bottles of 100 NDC 42806-510-10 Bottles of 1,000 400 mg capsules: The 400 mg capsule is a #0 capsule with a orange opaque cap, orange opaque body, imprinted "Є511" in blue ink on cap and body, filled with white to off-white powder. They are supplied as: NDC 42806-511-30 Bottles of 30 NDC 42806-511-01 Bottles of 100 NDC 42806-511-10 Bottles of 1,000 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

GABAPENTIN- GABAPENTIN CAPSULE
Epic Pharma, LLC
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MEDICATION GUIDE
Gabapentin (GA-ba-PEN-tin) Capsules, USP
Rx Only
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 actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
2.
Changes in behavior and thinking – Using gabapentin in children 3 to
12 years of age can cause
emotional changes,

Fachinformation

GABAPENTIN- GABAPENTIN CAPSULE
EPIC PHARMA, LLC
----------
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
INDICATIONS AND USAGE
Gabapentin capsules are indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥8% and at least twice that
for placebo) were:
•
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)
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)
Capsules: 100 mg, 300 mg, and 400 mg (3)
Known hypersensitivity to gabapentin or its ingredients (4)
Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan
hypersensitivity): Discontinue if alternative
etiology is not established (5.1)
Anaphylaxis and Angioedema: discontinue and evaluate patient