GABAPENTIN- gabapentin capsule
Amneal Pharmaceuticals of NY LLC
Gabapentin capsules, USP are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, USP.
The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1.
Mechanism of Action
The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats or mice (e.g. spinal nerve ligation models, streptozocin-induced diabetes model, spinal cord injury model, acute herpes zoster infection model). Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formalin test). Gabapentin did not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase, acetic acid abdominal constriction test, footpad heat irradiation test).
INDICATIONS AND USAGE
Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults.
Gabapentin Capsules, USP is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules, USP is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Gabapentin Capsules, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication
Neuropsychiatric Adverse Events-Pediatric Patients 3 to 12 years of age
Gabapentin use in pediatric patients with epilepsy 3 to 12 years of age is associated with the occurrence of central nervous system related adverse events.
Withdrawal Precipitated Seizure, Status Epilepticus
Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency.
In standard preclinical in vivo lifetime carcinogenicity studies, an unexpectedly high incidence of pancreatic acinar adenocarcinomas was identified in male, but not female, rats.
DOSAGE AND ADMINISTRATION
Gabapentin Capsules is given orally with or without food.
If Gabapentin Capsules dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
In adults with postherpetic neuralgia, Gabapentin Capsules therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). 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. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.
Gabapentin Capsules is recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.