Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Akron Pharma Inc
GABAPENTIN
GABAPENTIN 100 mg
ORAL
PRESCRIPTION DRUG
Gabapentin is 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 mg/kg/day, 1,000 mg/kg/day, or 3,000 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 3,600 mg/kg on a body surface area (mg/m2 ) basis. In studies in which rats received oral
Gabapentin capsules, USP are supplied as follows: 100 mg capsules: White to off-white powder filled in size “3” hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted SG on cap and 179 on body with black ink, available in: Bottles of 500: NDC 71399-0551-5 300 mg capsules: White to off-white powder filled in size “1” hard gelatin capsules with opaque yellow colored cap and opaque yellow colored body imprinted SG on cap and 180 on body with black ink, available in: Bottles of 500: NDC 71399-0553-5 400 mg capsules: White to off-white powder filled in size “0” hard gelatin capsules with opaque orange colored cap and opaque orange colored body imprinted SG on cap and 181 on body with black ink, available in: Bottles of 500: NDC 71399-0554-5 Store gabapentin capsules 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 CAPSULE Akron Pharma Inc ---------- MEDICATION GUIDE Gabapentin Capsules, USP (gab″ a pen′ tin) Read the Medication Guide before you start taking gabapentin 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? Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems. Gabapentin can cause serious side effects including: 1.Suicidal Thoughts. Like other antiepileptic drugs, gabapentin 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 without first talking to a healthcare provider. •Stopping gabapentin 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 provi Izlasiet visu dokumentu
GABAPENTIN - GABAPENTIN CAPSULE AKRON PHARMA 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 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 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: 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) 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: •Epilepsy in patients >12 years of age: somnolence, dizziness, ataxia, fatigue, and nystagmus (6.1)•Epilepsy in patients 3 to 12 years of age: viral infection, fever, nausea and/or vomiting, somnolence, and hostility (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AKRON PHARMA, INC. AT 1-973-227-2000 OR FDA AT 1- 800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ DRUG INTERACTIONS Morphine increases gabapentin concentrations; dose adjustment may be needed (5.4, 7.2) 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 i Izlasiet visu dokumentu