Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Direct_Rx
ORAL
PRESCRIPTION DRUG
Gabapentin Capsules, USP are indicated for: Management of postherpetic neuralgia in adults 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 Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. 8.1 Pregnancy 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 toxi
Gabapentin Capsules USP are supplied as follows: 100 mg capsules: Hard gelatin capsules with white opaque body with white opaque cap,imprinted with “AHD” on cap and “100” on body in black ink and filled with white to off-white powder; available in: Bottles of 100: NDC 71093-120-04 Bottles of 500: NDC 71093-120-05. 300 mg capsules: Hard gelatin capsules with yellow opaque body with caramel opaque cap, imprinted with “AHD” on cap and “300” on body in black ink and filled with white to off-white powder; available in: Bottles of 100: NDC 71093-121-04 Bottles of 500: NDC 71093-121-05. 400 mg capsules: Hard gelatin capsules with orange opaque body with caramel opaque cap, imprinted with “AHD” on cap and “400” on body in black ink and filled with white to off-white powder; available in: Bottles of 100: NDC 71093-122-04 Bottles of 500: NDC 71093-122-05.
Abbreviated New Drug Application
GABAPENTIN- GABAPENTIN CAPSULE Direct_Rx ---------- Gabapentin (GAB-a-PEN-tin) Capsules, USP 100 mg, 300 mg and 400 mg Rx Only 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 emotional changes, aggressive behavior, problems with concentration, restl Прочитать полный документ
GABAPENTIN- GABAPENTIN CAPSULE DIRECT_RX ---------- GABAPENTIN Gabapentin Capsules, USP are indicated for: Management of postherpetic neuralgia in adults 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 2.1 Dosage for Postherpetic Neuralgia In adults with postherpetic neuralgia, Gabapentin may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated 2.2 Dosage for Epilepsy with Partial Onset Seizures Patients 12 years of age and above The starting dose is 300 mg three times a day. The recommended maintenance dose of Gabapentin is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer Gabapentin three times a day using 300 mg or 400 mg capsules. The maximum time between doses should not exceed 12 hours. Pediatric Patients Age 3 to 11 years The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of Gabapentin in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of Gabapentin in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin may be a Прочитать полный документ