PREGABALIN - pregabalin capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

A-S Medication Solutions

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Pregabalin capsule 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 rega

leaflet_short:

Product: 50090-4465 NDC: 50090-4465-0 90 CAPSULE in a BOTTLE

מצב אישור:

Abbreviated New Drug Application

עלון מידע

PREGABALIN - PREGABALIN CAPSULE
A-S Medication Solutions
----------
MEDICATION GUIDE
Pregabalin (pree-GAH-ba-lin)
Capsules, CV
Read this Medication Guide before you start taking pregabalin 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, 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
• 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 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 trouble sleeping (insomnia)
o attempts to commit suicide
o new or worse irritability
o new or worse depression
o acting aggressive, being angry, or violent
o new or worse anxiety
o acting on dangerous impulses
o feeling agitated or restless
o an extreme increase in activity and talking
(mania)
o panic attacks
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.
•
Stopping pregabalin suddenly can cause serious problems.
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions

מאפייני מוצר

PREGABALIN - PREGABALIN CAPSULE
A-S MEDICATION SOLUTIONS
----------
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 capsule 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) (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: (2)
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 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) (2)
DOSAGE FORMS AND STRENGTHS
•Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and
300 mg. (3) (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 pregaba