GABAPENTIN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)

Tilgjengelig fra:

REMEDYREPACK INC.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Gabapentin tablets 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. 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 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 clinically [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal data When pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. The no-effect dose for embryofetal developmental toxicity in mice (500 mg/kg/day) is less than the maximum recommended human dose (MRHD) of 3600 mg on a body surface area (mg/m 2 ) basis. In studies in which rats received oral doses of gabapentin (500 to 2000 mg/kg/day) during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses. The lowest dose tested is similar to the MRHD on a mg/m 2 basis. When pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryofetal mortality was observed at all doses tested (60, 300, or 1500 mg/kg). The lowest dose tested is less than the MRHD on a mg/m 2 basis. In a published study, gabapentin (400 mg/kg/day) was administered by intraperitoneal injection to neonatal mice during the first postnatal week, a period of synaptogenesis in rodents (corresponding to the last trimester of pregnancy in humans). Gabapentin caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. Gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis. The clinical significance of these findings is unknown. Risk Summary Gabapentin is secreted in human milk following oral administration. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin and any potential adverse effects on the breastfed infant from gabapentin or from the underlying maternal condition. Safety and effectiveness of gabapentin in the management of postherpetic neuralgia in pediatric patients have not been established. Safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established [see Clinical Studies ( 14.2)] . The total number of patients treated with gabapentin in controlled clinical trials in patients with postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were 75 years of age and older. There was a larger treatment effect in patients 75 years of age and older compared to younger patients who received the same dosage. Since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment effect observed in patients ≥75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function. However, other factors cannot be excluded. The types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age. Clinical studies of gabapentin in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients [see Dosage and Administration ( 2.4), Adverse Reactions ( 6), and Clinical Pharmacology ( 12.3)] . Dosage adjustment in adult patients with compromised renal function is necessary [see Dosage and Administration ( 2.3) and Clinical Pharmacology ( 12.3)] . Pediatric patients with renal insufficiency have not been studied. Dosage adjustment in patients undergoing hemodialysis is necessary [see Dosage and Administration ( 2.3) and Clinical Pharmacology ( 12.3)] . Gabapentin is not a scheduled drug. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Gabapentin does not exhibit affinity for benzodiazepine, opioid (mu, delta or kappa), or cannabinoid 1 receptor sites. Gabapentin misuse and abuse have been reported in the postmarketing setting and published literature. Most of the individuals described in these reports had a history of polysubstance abuse. Some of these individuals were taking higher than recommended doses of gabapentin for unapproved uses. When prescribing gabapentin, carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., self-dose escalation, and drug-seeking behavior). The abuse potential of gabapentin has not been evaluated in human studies. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. There are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not approved. Such symptoms included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. The dependence potential of gabapentin has not been evaluated in human studies.

Produkt oppsummering:

Gabapentin Tablets USP, 600 mg are white to off-white, film-coated, oval shaped, biconvex scored tablets debossed with “G” and “31” on one side. They are available as: NDC: 70518-1807-00 NDC: 70518-1807-01 PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

REMEDYREPACK INC.
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MEDICATION GUIDE
Gabapentin Tablets, USP
(gab´´ a pen´ tin)
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 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 in children 3 to
12 years of age can cause
emotional changes, aggressive behavio

Preparatomtale

GABAPENTIN- GABAPENTIN TABLET
REMEDYREPACK INC.
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions, Respiratory Depression ( 5.7) 04/2020
INDICATIONS AND USAGE
Gabapentin tablets are indicated for:
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)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to gabapentin or its ingredients ( 4)
WARNINGS AND PRECAUTIONS
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
immediately ( 5.2)
Driving Impairment; Somnolence/Sedation and Dizziness: Warn patients
not to drive until they have gain