LYRICA- pregabalin capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

REMEDYREPACK INC.

INN (Tarptautinis Pavadinimas):

PREGABALIN

Sudėtis:

PREGABALIN 75 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

LYRICA is indicated for:LYRICA 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 4 years of age and older - 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 [see Warnings and Precautions (5.2)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYRICA during pregnancy. To provide information regarding the effects of in utero exposure to LYRICA, physicians are advised to recommend that pregnant patients taking LYRICA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll fr

Produkto santrauka:

25 mg capsules: White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in: 50 mg capsules: White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in: 75 mg capsules: White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in: 100 mg capsules: Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in: 150 mg capsules: White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in: 200 mg capsules: Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in: 225 mg capsules: White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in: 300 mg capsules: White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in: 20 mg/mL oral solution: 16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure: 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).

Autorizacija statusas:

New Drug Application

Pakuotės lapelis

REMEDYREPACK INC.
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MEDICATION GUIDE
LYRICA (LEER-I-KAH)
(PREGABALIN)
CAPSULES, CV
LYRICA (LEER-I-KAH)
(PREGABALIN)
ORAL SOLUTION, CV
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 5/2018
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:
•
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
•
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.
•
S

Prekės savybės

LYRICA- PREGABALIN CAPSULE
REMEDYREPACK INC.
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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)
5/2018
Dosage and Administration, Adjunctive Therapy for Partial Onset
Seizures in Patients 4 Years of Age
and Older ( 2.4)
5/2018
Dosage and Administration, Dosing for Adult Patients with Renal
Impairment ( 2.7)
5/2018
INDICATIONS AND USAGE
LYRICA 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 4 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. For partial onset
seizure dosing in pediatric patients 4 years of age
and older, refer to section 2.4. ( 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
Patients 4 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)
Oral Solution: 20 mg/mL. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to pregabalin or any of its components. (