국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Akorn
GABAPENTIN
GABAPENTIN 250 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Gabapentin oral solution is indicated for: Gabapentin oral solution is 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 oral solution, during pregnancy. Encourage women who are taking gabapentin oral solution 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 oral solution 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 clinic
Gabapentin Oral Solution is supplied as follows: 250 mg/5 mL oral solution; Clear, colorless to slightly yellow solution; each 5 mL of oral solution contains 250 mg of gabapentin; available in: Bottles containing 470 mL, 5 mL unit dose, and 6 mL unit dose in trays of ten cups. Storage Store refrigerated, 2° - 8°C (36° - 46°F) Rx Only
Abbreviated New Drug Application
GABAPENTIN- gabapentin solution Akorn ---------- Medication Guide Gabapentin Oral Solution (GA-ba-PEN-tin) What is the most important information I should know about Gabapentin Oral Solution? Do not stop taking Gabapentin Oral Solution without first talking to your healthcare provider. Stopping Gabapentin Oral Solution suddenly can cause serious problems. Gabapentin Oral Solution can cause serious side effects including: 1. Suicidal Thoughts. Like other antiepileptic drugs, Gabapentin Oral Solution 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 Oral Solution without first talking to a healthcare provider. • Stopping Gabapentin Oral Solution 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. • Changes in behavior and thinking - Using Gabapentin Oral Solution in children 3 to 12 years of ag 전체 문서 읽기
GABAPENTIN- GABAPENTIN SOLUTION AKORN ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GABAPENTIN ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN ORAL SOLUTION. GABAPENTIN ORAL SOLUTION INITIAL U.S. APPROVAL: 1993 RECENT MAJOR CHANGES Warnings and Precautions, Respiratory Depression (5.7) 4/2020 INDICATIONS AND USAGE Gabapentin oral solution is indicated for: (1) • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS 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) Oral Solution: 250 mg/5 mL (3) Known hypersensitivity to gabapentin oral solution 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 patient immed 전체 문서 읽기