GABAPENTIN capsule

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:

MedVantx, Inc.

INN (Tên quốc tế):

GABAPENTIN

Thành phần:

GABAPENTIN 300 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Gabapentin capsules are indicated for the management of postherpetic neuralgia in adults. Gabapentin capsules are 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 are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of gabapentin has not been evaluated in human studies.

Tóm tắt sản phẩm:

Gabapentin Capsules USP, 100 mg are white/white size ‘3’ hard gelatin capsules imprinted with ‘D’ on white cap and ‘02’ on white body with black edible ink filled with white to off-white crystalline powder.           Bottles of 100                          NDC 16714-661-01         Bottles of 500                          NDC 16714-661-02         Bottles of 1000                        NDC 16714-661-03 Gabapentin Capsules USP, 300 mg are yellow/yellow size ‘1’ hard gelatin capsules imprinted with ‘D’ on yellow cap and ‘03’ on yellow body with black edible ink filled with white to off-white crystalline powder.           Bottles of 100                          NDC 16714-662-01         Bottles of 500                          NDC 16714-662-02         Bottles of 1000                        NDC 16714-662-03 Gabapentin Capsules USP, 400 mg are orange/orange size ‘0’ hard gelatin capsules imprinted with ‘D’ on orange cap and ‘04’ on orange body with black edible ink filled with white to off-white crystalline powder.           Bottles of 100                          NDC 16714-663-01         Bottles of 500                          NDC 16714-663-02 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].   Maalox ® is a registered trademark of Novartis Consumer Health, Inc.   Manufactured for:  Northstar Rx LLC                              Memphis, TN 38141                              Toll Free: 1-800-206-7821   Manufactured by:  Aurobindo Pharma Limited                             Unit-VII (SEZ)                             Mahaboob Nagar (Dt)                             AP-509302, INDIA   M.L.No.: 22/MN/AP/2009/F/G   Issued:  10/2010

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

GABAPENTIN- GABAPENTIN CAPSULE
MedVantx, Inc.
----------
MEDICATION GUIDE
Gabapentin Capsules, USP
Rx only
Read the Medication Guide before you start taking gabapentin capsules
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
capsules?
Do not stop taking gabapentin capsules without first talking to your
healthcare provider.
Stopping gabapentin capsules suddenly can cause serious problems.
Gabapentin capsules
can cause serious side effects including:
1. Like other antiepileptic drugs, gabapentin capsules 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 capsules without first talking to a healthcare provider.
•
Stopping gabapentin capsules 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.

Đặc tính sản phẩm

GABAPENTIN- GABAPENTIN CAPSULE
MEDVANTX, INC.
----------
GABAPENTIN CAPSULES, USP
DESCRIPTION
Gabapentin capsules, USP are supplied as imprinted hard shell capsules
containing 100 mg, 300 mg, and
400 mg of gabapentin. Each capsule contains the following inactive
ingredients: corn starch and talc.
The empty hard gelatin capsule shell consists of gelatin, titanium
dioxide, and sodium lauryl sulfate. In
addition 300 mg also contains yellow iron oxide and 400 mg also
contains yellow iron oxide and red
iron oxide. The capsules are printed with edible ink containing black
iron oxide and shellac.
Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with
a molecular formula of C
H
NO
and a molecular weight of 171.24. The structural formula of gabapentin
is:
Gabapentin is a white to off-white crystalline solid with a pK
of 3.7 and a pK
of 10.7. It is freely soluble in water and both basic and acidic
aqueous solutions. The log of the
partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is
–1.25.
CLINICAL PHARMACOLOGY
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
9
17
2
a1
a2
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). The relevance of these models to human pain is not
known.
The mechanism by which gabapentin exerts its anticonvulsant action is