LYRICA- pregabalin capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Dispensing Solutions, Inc.

INN (Международно Name):

PREGABALIN

Композиция:

PREGABALIN 75 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

LYRICA is indicated for: - Management of neuropathic pain associated with diabetic peripheral neuropathy - Management of postherpetic neuralgia - Adjunctive therapy for adult patients with partial onset seizures - Management of fibromyalgia - Management of neuropathic pain associated with spinal cord injury LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy. Pregnancy Category C. Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including lethality, growth retardation, and nervous and reproductive system functional impairment, were observed in the offspring of rats and rabbits given pregabalin during pregnancy, at doses that produced plasma pregabalin exposures (AUC) ≥5 times human exposure at the maximum recommended dose (MRD) of 600 mg/day. When pregnant rats were given pregabalin (500, 1250, or 2

Каталог на резюме:

75 mg capsules: White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in: Bottles of 90: NDC 68258-7980-09 Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). See FDA-Approved Medication Guide

Статус Оторизация:

New Drug Application

Листовка

LYRICA- PREGABALIN CAPSULE
Dispensing Solutions, Inc.
----------
MEDICATION GUIDE
LYRICA (LEER-i-kah)
(pregabalin)
Capsules and Oral Solution, CV
Read this Medication Guide before you start taking LYRICA 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
LYRICA, ask your healthcare
provider or pharmacist.
What is the most important information I should know about LYRICA?
LYRICA may cause serious side effects including:
•
Serious, even life-threatening, allergic reactions
•
Suicidal thoughts or actions
•
Swelling of your hands, legs and feet
•
Dizziness and sleepiness
These serious side effects are described below:
1.
Serious, even life-threatening, allergic reactions.
Stop taking LYRICA 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
2.
Like other antiepileptic drugs, LYRICA 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
If you have suicidal thoughts or actions, do not stop LYRICA without
first talking to a healthcare
provider.
•
Stopping LYRICA suddenly can cause serious problems.
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have
suicidal th

Данни за продукта

LYRICA- PREGABALIN CAPSULE
DISPENSING SOLUTIONS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LYRICA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LYRICA.
LYRICA (PREGABALIN) CAPSULES, CV
LYRICA (PREGABALIN) ORAL SOLUTION, CV
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Indications and Usage (1)
6/2012
Dosage and Administration (2.5)
6/2012
Warnings and Precautions (5.6)
6/2012
Warnings and Precautions (5.8)
6/2012
INDICATIONS AND USAGE
LYRICA is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
(1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for adult patients with partial onset seizures (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury (1)
DOSAGE AND ADMINISTRATION
For all indications, begin dosing at 150 mg/day. (2.1, 2.2, 2.3, 2.4,
2.5)
Dosing recommendations:
INDICATION
DOSING REGIMEN
MAXIMUM DOSE
DPN Pain (2.1)
3 divided doses per day
300 mg/day within 1
week
PHN (2.2)
2 or 3 divided doses per
day
300 mg/day within 1
week. Maximum dose
of 600 mg/day.
Adjunctive Therapy for
Adult Patients with
Partial Onset Seizures
(2.3)
2 or 3 divided doses per
day
Maximum dose of 600
mg/day.
Fibromyalgia (2.4)
2 divided doses per day
300 mg/day within 1
we e k.
Maximum dose of 450
mg/day.
Neuropathic Pain
Associated with Spinal
Cord Injury (2.5)
2 divided doses per day
300 mg/day within 1
week. Maximum dose
of 600 mg/day.
Dose should be adjusted in patients with reduced renal function. (2.6)
Oral Solution Concentration and Dispensing (2.7)
DOSAGE FORMS AND STRENGTHS
Capsules: 25mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300
mg. (3)
Oral Solution: 20 mg/ mL. (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
LYRICA imme