Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Unit Dose Services
GABAPENTIN
GABAPENTIN 600 mg
PRESCRIPTION DRUG
New Drug Application
GRALISE - GABAPENTIN TABLET, FILM COATED UNIT DOSE SERVICES ---------- 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 Les hele dokumentet