GABAPENTIN- gabapentin capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Quality Care Products, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. - Pregnancy: based on animal data, may cause fetal harm ( 8.1) - Pediatric Use: effectiveness as adjunctive therapy in treatment of partial seizures in pediatric patients below the age of 3 years has not been established ( 8.4) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 02/16 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 pregn

Resumen del producto:

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: 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: 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: 55700-763-30 55700-763-60 55700-763-90 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].

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Quality Care Products, LLC
----------
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:
•
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 act

Ficha técnica

GABAPENTIN- GABAPENTIN CAPSULE
QUALITY CARE PRODUCTS, LLC
----------
GABAPENTIN CAPSULE, USP
HIGHLIGHTS OF PRESCRIBING INFORMATION
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 02/16
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.2 Dosage for Epilepsy with Partial Onset Seizures
2.3 Dosage Adjustment in Patients with Renal Impairment
2.4 Dosage in Elderly
2.5 Administration Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS)/Multiorgan Hypersensitivity
5.2 Anaphylaxis and Angioedema
5.3 Effects on Driving and Operating Heavy Machinery
5.4 Somnolence/Sedation and Dizziness
5.5 Withdrawal Precipitated Seizure, Status Epilepticus
5.6 Suicidal Behavior and Ideation
5.7 Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12
Years of Age)
5.8 Tumorigenic Potential
5.9 Sudden and Unexplained Death in Patients with Epilepsy
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Other Antiepileptic Drugs
7.2 Opioids
7.3 MAALOX® (aluminum hydroxide, magnesium hydroxide)
7.4 Drug/Laboratory Test Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.2 Epilepsy for Partial Onset Seizures (Adjunctive Therapy)
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing
information are not listed.
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
Gabapentin is indicated for:
Adjunctive therapy in the treatment of partial onset seizures, with
and without sec