PREGABALIN capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Actavis Pharma, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Pregabalin capsules are available as follows: 25 mg -  Each capsule with buff opaque cap and body, printed with and 2856 on both cap and body in black ink contains 25 mg of pregabalin, USP. Capsules are supplied in bottles of 90 (NDC 0228-2856-09). 50 mg -  Each capsule with ivory opaque cap and body, printed with  and 2857 on both cap and body in black ink contains 50 mg of pregabalin, USP. Capsules are supplied in bottles of 90 (NDC 0228-2857-09). 75 mg -   Each capsule with orange opaque cap and ivory opaque body, printed with  and 2858 on both cap and body in black ink contains 75 mg of pregabalin, USP. Capsules are supplied in bottles of 90 (NDC 0228-2858-09). 100 mg -  Each capsule with rich yellow opaque cap and ivory opaque body, printed with  and 2859 on both cap and body in black ink contains 100 mg of pregabalin, USP. Capsules are supplied in bottles of 90 (NDC 0228-2859-09). 150 mg - Each capsule with buff opaque cap and body, printed with  and 2860 on both cap and body in black ink contains 150 mg of pregabalin, USP. Capsules are supplied in bottles of 90 (NDC 0228-2860-09). 200 mg - Each capsule with rich yellow opaque cap and ivory opaque body, printed with   and 2861 on both cap and body in black ink contains 200 mg of pregabalin, USP. Capsules are supplied in bottles of 90 (NDC 0228-2861-09). 225 mg - Each capsule with orange opaque cap and ivory opaque body, printed with  and 2862 on both cap and body in black ink contains 225 mg of pregabalin, USP. Capsules are supplied in bottles of 90 (NDC 0228-2862-09). 300 mg - Each capsule with rich yellow opaque cap and buff opaque body, printed with  and 2863 on both cap and body in black ink contains 300 mg of pregabalin, USP. Capsules are supplied in bottles of 90 (NDC 0228-2863-09). Storage and Handling Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Actavis Pharma, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
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
•
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 capsules may cause suicidal
thoughts or actions in a very small number of people, about 1 in 500.
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.
•
Stopping pregabalin cap

Scheda tecnica

PREGABALIN- PREGABALIN CAPSULE
ACTAVIS PHARMA, INC.
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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
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, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300
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)
Antiepileptic dr