PREGABALIN capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Bryant Ranch Prepack

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)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of

제품 요약:

NDC: 71335-1751-1 30 Capsules in a BOTTLE NDC: 71335-1751-2 60 Capsules in a BOTTLE NDC: 71335-1751-3 90 Capsules in a BOTTLE

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

PREGABALIN- PREGABALIN CAPSULE
Bryant Ranch Prepack
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MEDICATION GUIDE
PREGABALIN (pre 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?
Pregabalin 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
• serious breathing problems
These serious side effects are described below:
· Serious, even life-threatening, allergic reactions.
Stop taking pregabalin and call your healthcare provider right away if
you have any of these signs of a
serious allergic reaction:
o swelling of your face, mouth, lips, gums, tongue, throat or neck
o trouble breathing
o 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:
o thoughts about suicide or dying
o attempts to commit suicide
o new or worse depression
o new or worse anxiety
o feeling agitated or restless
o panic attacks
o trouble sleeping (insomnia)
o new or worse irritability
o acting aggressive, being angry, or violent
o acting on dangerous impulses
o an extreme increase in activity and talking (mania)
o other unusual changes in behavior or mood
If you have suicidal thoughts or actions, do not stop pregabalin
without first talking to a healthcare
provider.
o Stopping pregabalin suddenly can cause serious problems.
o Suicidal thoughts or actions can be caused by things other than
medicines. I

제품 특성 요약

PREGABALIN- PREGABALIN CAPSULE
BRYANT RANCH PREPACK
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Respiratory Depression (5.4) 4/2020
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
DOSING REGIMEN
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 and 50 mg. (3)
CONTRAINDICATIONS
Known hypersensitivity to pregabalin or any of its components.
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) (5)
· Hypersensitivity reactions (e.g. hives, dyspnea, and wheezing) can
occur. Discontinue pregabalin immediately in t