LYRICA pregabalin capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

St Marys Medical Park Pharmacy

INN:

PREGABALIN

composition:

PREGABALIN 100 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

New Drug Application Authorized Generic

SPC

LYRICA- PREGABALIN CAPSULE
ST MARYS MEDICAL PARK PHARMACY
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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
RECENT MAJOR CHANGES
Dosage and Administration, Oral Solution Concentration and Dispensing
( 2.6)
INDICATIONS AND USAGE
INDICATIONS AND USAGE
LYRICA is indicated for:
- Neuropathic pain associated with diabetic peripheral neuropathy
(DPN) ( 1.1)
- Post herpetic neuralgia (PHN) ( 1.2)
- Adjunctive therapy for adult patients with partial onset seizures (
1.3)
- Fibromyalgia ( 1.4)
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION
DPN Pain ( 2.1):
- Administer in 3 divided doses per day
- Begin dosing at 150 mg/day
- May be increased to a maximum of 300 mg/day within 1 week.
PHN ( 2.2):
- Administer in 2 or 3 divided doses per day
- Begin dosing at 150 mg/day
- May be increased to 300 mg/day within 1 week
- Maximum dose of 600 mg/day.
Adjunctive Therapy for Adult Patients with Partial Onset Seizures (
2.3):
- Administer in 2 or 3 divided doses per day
- Begin dosing at 150 mg/day
- Maximum dose of 600 mg/day.
Fibromyalgia ( 2.4):
- Administer in 2 divided doses per day
- Begin dosing at 150 mg/day
- May be increased to 300 mg/day within 1 week
- Maximum dose of 450 mg/day.
Dose should be adjusted in patients with reduced renal function. (
2.5)
Oral Solution Concentration and Dispensing ( 2.6)
DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS AND STRENGTHS
- Capsules: 25mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and
300 mg. ( 3)
- Oral Solution: 20 mg/ mL. ( 3)
CONTRAINDICATIONS
CONTRAINDICATIONS
- Known hypersensitivity to pregabalin or any of its components. ( 4)
WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS
- Angioedema (e.g. swelling of the throat, head and neck) can occur,
and may be associated with life-threatening respiratory
compromise requirin