GABAPENTIN tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Solco Healthcare U.S., LLC

SNN (starptautisko nepatentēto nosaukumu):

GABAPENTIN

Kompozīcija:

GABAPENTIN 600 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Gabapentin tablets are indicated for: Gabapentin is 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-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 received oral doses of gabap

Produktu pārskats:

600 mg tablets: White to off -White, film-coated, oval-shaped tablets, deep scoring on both the sides and debossed with “NT”and “150” on one side. Bottles of 100: NDC 43547-332-10 Bottles of 500: NDC 43547-332-50. 800 mg tablets: White to off -White, film-coated, oval-shaped tablets, deep scoring on both the sides and debossed with “NT”and “151” on one side. Bottles of 100: NDC 43547-333-10 Bottles of 500: NDC 43547-333-50 Store gabapentin tablets at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
Solco Healthcare U.S., LLC
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MEDICATION GUIDE
GABAPENTIN (GAB-a-PEN-tin)
Tablets
Read the Medication Guide before you start taking gabapentin tablets
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
tablets?
Do not stop taking gabapentin tablets without first talking to your
healthcare provider. Stopping gabapentin
tablets suddenly can cause serious problems.
Gabapentin tablets can cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin
tablets 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 tablets without first talking to a
healthcare provider.
•
Stopping gabapentin tablets 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

Produkta apraksts

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
SOLCO HEALTHCARE U.S., LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN TABLETS.
GABAPENTIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin tablets 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)
Tablets: 600 mg, and 800 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 pa