PREGABALIN capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Advanced Rx Pharmacy of Tennessee, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Pregabalin is 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 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 [see WARNINGS AND PRECAUTIONS (5.2)]. 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regard

제품 요약:

100 mg capsules: Maroon, hard gelatin capsule printed with black ink “CC” on the cap, “04 100” on the body; available in: Bottles of 90 Capsules NDC: 80425-0166-03 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).

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

PREGABALIN- PREGABALIN CAPSULE
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE SECTION
MEDICATION GUIDE
MEDICATION GUIDE
Pregabalin Capsules
(pree-GAB-a-lin)
Capsules, CV
This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised: 04/2020
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?
Pregabalin may cause serious side effects including:
serious, even life-threatening, allergic reactions
suicidal thoughts or actions
serious breathing problems
swelling of your hands, legs and feet
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 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 pregabalin
capsules without first talking to a healthcare
provider.
Stoppin

제품 특성 요약

PREGABALIN- PREGABALIN CAPSULE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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PREGABALIN 100MG CAPSULES
1. INDICATIONS AND USAGE SECTION
Pregabalin is 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.
2. DOSAGE AND ADMINISTRATION SECTION
2.1 Important Administration Instructions
Pregabalin is given orally with or without food.
When discontinuing pregabalin, taper gradually over a minimum of 1
week [see
WARNINGS AND PRECAUTIONS (5.6)].
Because pregabalin is eliminated primarily by renal excretion, adjust
the dose in adult
patients with reduced renal function [see DOSAGE AND ADMINISTRATION
(2.7)].
2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in
Adults
The maximum recommended dose of pregabalin is 100 mg three times a day
(300
mg/day) in patients with creatinine clearance of at least 60 mL/min.
Begin dosing at 50
mg three times a day (150 mg/day). The dose may be increased to 300
mg/day within 1
week based on efficacy and tolerability.
Although pregabalin was also studied at 600 mg/day, there is no
evidence that this dose
confers additional significant benefit and this dose was less well
tolerated. In view of the
dose-dependent adverse reactions, treatment with doses above 300
mg/day is not
recommended [see ADVERSE REACTIONS (6.1)].
2.3 Postherpetic Neuralgia in Adults
The recommended dose of pregabalin is 75 to 150 mg two times a day, or
50 to 100 mg
three times a day (150 to 300 mg/day) in patients with creatinine
clearance of at least 60
mL/min. Begin dosing at 75 mg two times a day, or 50