GRALISE gabapentin tablet film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Unit Dose Services

INN (International ime):

GABAPENTIN

Sastav:

GABAPENTIN 600 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

New Drug Application

Svojstava lijeka

GRALISE - GABAPENTIN TABLET, FILM COATED
UNIT DOSE SERVICES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRALISE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GRALISE.
GRALISE (GABAPENTIN) TABLETS
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
GRALISE is indicated for the management of Postherpetic Neuralgia
(PHN).
IMPORTANT LIMITATION: GRALISE IS NOT INTERCHANGEABLE WITH OTHER
GABAPENTIN PRODUCTS BECAUSE OF DIFFERING
PHARMACOKINETIC PROFILES THAT AFFECT THE FREQUENCY OF ADMINISTRATION
_(See Warnings and Precautions)_
DOSAGE AND ADMINISTRATION
GRALISE should be titrated to an 1800 mg dose taken orally,
once-daily, with the evening meal. GRALISE tablets
should be swallowed whole. Do not crush, split, or chew the tablets.
(2.1)
If GRALISE dose is reduced, discontinued, or substituted with an
alternative medication, this should be done gradually
over a minimum of 1 week or longer (at the discretion of the
prescriber). (2.1)
Renal impairment: Dose should be adjusted in patients with reduced
renal function. GRALISE should not be used in
patients with CrCl less than 30 or in patients on hemodialysis. (2.2)
DOSAGE FORMS AND STRENGTHS
300 and 600 mg tablets (3)
CONTRAINDICATIONS
GRALISE is contraindicated in patients who have demonstrated
hypersensitivity to the drug or its ingredients. (4)
WARNINGS AND PRECAUTIONS
GRALISE is not interchangeable with other gabapentin products
Antiepileptic drugs, including gabapentin, the active ingredient in
GRALISE, increase the risk of suicidal thoughts or
behavior (5.1)
Increased seizure frequency may occur in patients with seizure
disorders if GRALISE is rapidly discontinued. Withdraw
GRALISE gradually over a minimum of 1 week. (5.2)
ADVERSE REACTIONS
The most common adverse reaction (greater than or equal to 5% and
twice placebo) is dizziness. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DEPOMED, INC. AT
1-866-458-6389 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
A