Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Preferred Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Gabapentin Tablets, USP are indicated for: Gabapentin Tablets, USP are 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 mg, 1000 mg, 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 rec
Gabapentin Tablets, USP are supplied as follows: Gabapentin Tablets, USP 600 mg : White colored film coated, Modified Capsule shaped, biconvex tablets de-bossed with '1' on the left side of the bisect and '2' on the right side of the bisect on one side and bisect on other. Bottle of 30 - 68788-9299-3 Bottle of 60 - 68788-9299-6 Bottle of 90 - 68788-9299-9 Bottle of 100 - 68788-9299-1 Bottle of 120 - 68788-9299-8 Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Abbreviated New Drug Application
GABAPENTIN- GABAPENTIN TABLET Preferred Pharmaceuticals, Inc. ---------- 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 be caused by things other than medicines. If you have suicid Læs hele dokumentet
GABAPENTIN- GABAPENTIN TABLET PREFERRED PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GABAPENTIN TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN TABLETS, USP. GABAPENTIN TABLETS, USP FOR ORAL USE, INITIAL U.S. APPROVAL: 1993 RECENT MAJOR CHANGES • INDICATIONS AND USAGE Gabapentin is indicated for: • • DOSAGE AND ADMINISTRATION • 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) DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥8% and at least twice that for placebo) were: • • Warnings and Precautions: Anaphylaxis and Angioedema: discontinue gabapentin and evaluate patient immediately (5.2) 9/2015 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) Tablets: 600 mg, and 800 mg (3) Known hypersensitivity to gabapentin or its ingredients (4) Drug Reaction with Eosinophilia and Systemic Læs hele dokumentet