PREGABALIN- pregabalin capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)

Предлага се от:

Teva Pharmaceuticals USA, Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Pregabalin capsules are indicated for: - Management of neuropathic pain associated with diabetic peripheral neuropathy - Management of postherpetic neuralgia - Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older - Management of fibromyalgia - Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer’s LYRICA ® (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information r

Каталог на резюме:

Pregabalin capsules are available as follows: 25 mg – Hard gelatin capsules with a white opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7622” on the body and cap, in bottles of 90 (NDC 0093-7622-98). 50 mg – Hard gelatin capsules with a buff opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7623” on the body and cap, in bottles of 90 (NDC 0093-7623-98). Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Pregabalin (pree gab' a lin)
Capsules CV
Read this Medication Guide before you start taking pregabalin 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. If you have any questions
about pregabalin capsules, ask your
healthcare provider or pharmacist.
What is the most important information I should know about pregabalin
capsules?
Pregabalin capsules may cause serious side effects including:
•
serious, even life-threatening,
allergic reactions
•
swelling of your hands, legs and
feet
•
suicidal thoughts or actions
•
dizziness and sleepiness
These serious side effects are described below:
•
Serious, even life-threatening, allergic reactions.
Stop taking pregabalin capsules and call your healthcare provider
right away if you have any of these
signs of a serious allergic reaction:
•
swelling of your face, mouth, lips, gums, tongue, throat or neck
•
trouble breathing
•
rash, hives (raised bumps) or blisters
•
Like other antiepileptic drugs, pregabalin 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
•
trouble sleeping (insomnia)
•
attempts to commit suicide
•
new or worse irritability
•
new or worse depression
•
acting aggressive, being angry, or
violent
•
new or worse anxiety
•
acting on dangerous impulses
•
feeling agitated or restless
•
an extreme increase in activity and
talking (mania)
•
panic attacks
•
other unusual changes in behavior or
mood
If you have suicidal thoughts or actions, do not stop pregabalin
capsules without first talking to a healthcare
provider.
•
Stopping pregabalin capsules suddenly can cause serious problems.
•
Suicidal thoughts or actions can be ca

Данни за продукта

PREGABALIN- PREGABALIN CAPSULE
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREGABALIN CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PREGABALIN CAPSULES.
PREGABALIN CAPSULES, FOR ORAL USE CV
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Pregabalin is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
(1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial-onset seizures in
patients 17 years of age and older (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury (1)
DOSAGE AND ADMINISTRATION
For adult indications, begin dosing at 150 mg/day. (2.2, 2.3, 2.4,
2.5, 2.6)
Dosing recommendations:
INDICATION
DO SING
REG IMEN
MAXIMUM DOSE
DPN Pain (2.2)
3 divided doses per
day
300 mg/day within
1 week
PHN (2.3)
2 or 3 divided
doses per day
300 mg/day within
1 week. Maximum dose of
600 mg/day.
Adjunctive Therapy for Partial-Onset Seizures in Adult Patients 17
Years of Age and Older (2.4)
2 or 3 divided
doses per day
Maximum dose of 600
mg/day.
Fibromyalgia (2.5)
2 divided doses per
day
300 mg/day within
1 week. Maximum dose of
450 mg/day.
Neuropathic Pain Associated with Spinal Cord Injury (2.6)
2 divided doses per
day
300 mg/day within
1 week. Maximum dose of
600 mg/day.
Dose should be adjusted in adult patients with reduced renal function.
(2.7)
DOSAGE FORMS AND STRENGTHS
Capsules: 25 mg, 50 mg, (3)
CONTRAINDICATIONS
Known hypersensitivity to pregabalin or any of its components. (4)
WARNINGS AND PRECAUTIONS
Angioedema (e.g., swelling of the throat, head and neck) can occur,
and may be associated with life-threatening
respiratory compromise requiring emergency treatment. Discontinue
pregabalin immediately in these cases. (5.1)
Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can
occur. Discontinue pregabalin immediately in these
patients. (5.2)
Increased seizure frequency or other adverse reactions ma