Country: United States
Language: English
Source: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Solco Healthcare U.S., LLC
GABAPENTIN
GABAPENTIN 600 mg
ORAL
PRESCRIPTION DRUG
Gabapentin tablets are indicated for: Gabapentin is 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, 1000, 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 received oral doses of gabap
600 mg tablets: White to off -White, film-coated, oval-shaped tablets, deep scoring on both the sides and debossed with “NT”and “150” on one side. Bottles of 100: NDC 43547-332-10 Bottles of 500: NDC 43547-332-50. 800 mg tablets: White to off -White, film-coated, oval-shaped tablets, deep scoring on both the sides and debossed with “NT”and “151” on one side. Bottles of 100: NDC 43547-333-10 Bottles of 500: NDC 43547-333-50 Store gabapentin tablets at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
GABAPENTIN- GABAPENTIN TABLET, FILM COATED Solco Healthcare U.S., LLC ---------- MEDICATION GUIDE GABAPENTIN (GAB-a-PEN-tin) Tablets 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 Read the complete document
GABAPENTIN- GABAPENTIN TABLET, FILM COATED SOLCO HEALTHCARE U.S., LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GABAPENTIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN TABLETS. GABAPENTIN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1993 INDICATIONS AND USAGE Gabapentin tablets are 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 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) Tablets: 600 mg, and 800 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 pa Read the complete document