Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Almatica Pharma LLC
ORAL
PRESCRIPTION DRUG
GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. GRALISE is contraindicated in patients with demonstrated hypersensitivity to the drug or its ingredients. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to gabapentin, including GRALISE, during pregnancy. Encourage women who are taking GRALISE during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting https://www.aedpregnancyregistry.org/. Risk Summary Available data from published prospective and retrospective cohort studies, and case reports over decades of use with gabapentin during pregnancy have not identified a drug-associated risk of major birth defects. The avai
GRALISE (gabapentin) Tablets are supplied as follows: • 300 mg tablets : GRALISE 300 mg tablets are white, oval, debossed with "SLV" on one side and "300" on the other side. NDC 52427-803-90 (Bottle of 90) • 450 mg tablets : GRALISE 450 mg tablets are red, oval, debossed with “ALM” on one side and “450” on the other side. NDC 52427-804-60 (Bottle of 60) • 600 mg tablets : GRALISE 600 mg tablets are beige, oval, debossed with "SLV" on one side and "600" on the other side. NDC 52427-806-90 (Bottle of 90) • 750 mg tablets : GRALISE 750 mg tablets are yellow, oval, debossed with “ALM” on one side and “750” on the other side. NDC 52427-850-60 (Bottle of 60) • 900 mg tablets : GRALISE 900 mg tablets are pink, oval, debossed with “ALM” on one side and “900” on the other side. NDC 52427-890-60 (Bottle of 60) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
New Drug Application
GRALISE- GABAPENTIN Almatica Pharma LLC ---------- MEDICATION GUIDE GRALISE® (gra leez') (gabapentin) Tablets Read this Medication Guide before you start taking GRALISE 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. If you have any questions about GRALISE, ask your healthcare provider or pharmacist. What is the most important information I should know about GRALISE? Do not stop taking GRALISE without first talking with your healthcare provider. Stopping GRALISE suddenly can cause serious problems. Like other antiepileptic drugs, gabapentin, the active ingredient in GRALISE, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. However, it is not known if GRALISE is safe and effective in people with seizure problems (epilepsy). Therefore, GRALISE should not be used in place of other gabapentin products. 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 • serious breathing problems • 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. Serious breathing problems • Serious breathing problems can occur when GRALISE is taken with other medicines that can cause severe sleepi Baca dokumen lengkap
GRALISE- GABAPENTIN TABLET, FILM COATED GRALISE- GABAPENTIN ALMATICA PHARMA LLC ---------- 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, FOR ORAL USE 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 1,800 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 Tablets: 300 mg, 450 mg, 600 mg, 750 mg, and 900 mg (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) Respiratory depression may occur with GRALISE when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. (5.2) Increased seizure frequency may occur in patients with seizure disorders if GRALISE is rapidly discontinued. Withdraw GRALISE gradually over a minimum of 1 week. (5.3) A Baca dokumen lengkap