GABAPENTIN tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Tên quốc tế):

GABAPENTIN

Thành phần:

GABAPENTIN 600 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Gabapentin tablets, 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 tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Teratogenic Effects: 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 pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest dose

Tóm tắt sản phẩm:

Gabapentin tablets, USP are supplied as follows: 600 mg — Each light green, capsule shaped, film coated tablet imprinted with  and 636 on one side and bisected on the other side contains 600 mg of gabapentin, USP. Tablets are supplied in blistercards of 30 (NDC 0615-6548-39) and blistercards of 15 (NDC 0615-6548-05). 800 mg — Each light gray, capsule shaped, film coated tablet imprinted with  and 637 on one side and bisected on the other side contains 800 mg of gabapentin, USP. Dispense in a tight, light-resistant container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Brands listed are the trademarks of their respective owners.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

NCS HealthCare of KY, Inc dba Vangard Labs
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MEDICATION GUIDE
GABAPENTIN (GAB-a-PEN-tin) TABLETS, USP
Rx Only
Read the Medication Guide before you start taking gabapentin tablets
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
tablets?
Do not stop taking gabapentin tablets without first talking to your
healthcare provider.
Stopping gabapentin tablets suddenly can cause serious problems.
Gabapentin can cause serious side effects including:
1. 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 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
medicin

Đặc tính sản phẩm

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin tablets, USP are indicated for: (1)
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; the effective
dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three
divided doses; the effective dose in patients 5 to
11 years of age is 25 to 35 mg/kg/day, given in three divided doses.
The effective 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg, and 800 mg (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to gabapentin or its ingredients (4) (4) (4)
WARNINGS AND PRECAUTIONS
_Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan
hypersensitivity): _discontinue gabapentin if an
alternative etiology cannot be established (5.1)
_Driving impairment_: warn patients not to drive until they have
gained sufficient experience with gabapentin to assess
whether it will impair their ability to drive (5.2)
_Somnolence/Seda