Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)
Dispensing Solutions, Inc.
PREGABALIN
PREGABALIN 75 mg
ORAL
PRESCRIPTION DRUG
LYRICA is indicated for: - Management of neuropathic pain associated with diabetic peripheral neuropathy - Management of postherpetic neuralgia - Adjunctive therapy for adult patients with partial onset seizures - 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. Pregnancy Category C. Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including lethality, growth retardation, and nervous and reproductive system functional impairment, were observed in the offspring of rats and rabbits given pregabalin during pregnancy, at doses that produced plasma pregabalin exposures (AUC) ≥5 times human exposure at the maximum recommended dose (MRD) of 600 mg/day. When pregnant rats were given pregabalin (500, 1250, or 2
75 mg capsules: White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in: Bottles of 90: NDC 68258-7980-09 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). See FDA-Approved Medication Guide
New Drug Application
LYRICA- PREGABALIN CAPSULE Dispensing Solutions, Inc. ---------- MEDICATION GUIDE LYRICA (LEER-i-kah) (pregabalin) Capsules and Oral Solution, CV 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: 1. 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 2. 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. • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal th Lue koko asiakirja
LYRICA- PREGABALIN CAPSULE DISPENSING SOLUTIONS, INC. ---------- 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) 6/2012 Dosage and Administration (2.5) 6/2012 Warnings and Precautions (5.6) 6/2012 Warnings and Precautions (5.8) 6/2012 INDICATIONS AND USAGE LYRICA is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for adult patients with partial onset seizures (1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury (1) DOSAGE AND ADMINISTRATION For all indications, begin dosing at 150 mg/day. (2.1, 2.2, 2.3, 2.4, 2.5) Dosing recommendations: INDICATION DOSING REGIMEN MAXIMUM DOSE DPN Pain (2.1) 3 divided doses per day 300 mg/day within 1 week PHN (2.2) 2 or 3 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day. Adjunctive Therapy for Adult Patients with Partial Onset Seizures (2.3) 2 or 3 divided doses per day Maximum dose of 600 mg/day. Fibromyalgia (2.4) 2 divided doses per day 300 mg/day within 1 we e k. Maximum dose of 450 mg/day. Neuropathic Pain Associated with Spinal Cord Injury (2.5) 2 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day. Dose should be adjusted in patients with reduced renal function. (2.6) Oral Solution Concentration and Dispensing (2.7) 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 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 LYRICA imme Lue koko asiakirja