Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Gabapentin capsules are indicated for: Gabapentin capsules are contraindicated in patients who have 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 antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Encourage women who are taking gabapentin 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 http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see Data] . In the U.S. general popula
Gabapentin Capsules, USP are supplied as follows: 400 mg capsules: Hard Gelatin Capsules size “0” with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; supplied in; Bottles of 30 (NDC 68788-7042-3) Bottles of 60 (NDC 68788-7042-6) Bottles of 90 (NDC 68788-7042-9) Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Abbreviated New Drug Application
GABAPENTIN- GABAPENTIN CAPSULE Preferred Pharmaceuticals Inc. ---------- MEDICATION GUIDE Gabapentin Capsules, USP (gab-ah-PEN-tin) 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 capsules in children 3 to 12 years of age can cause emot Baca dokumen lengkapnya
GABAPENTIN- GABAPENTIN CAPSULE PREFERRED PHARMACEUTICALS INC. ---------- 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 is 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 1,800 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 pati Baca dokumen lengkapnya