מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
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
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).
New Drug Application
REMEDYREPACK INC. ---------- 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 קרא את המסמך השלם
LYRICA- PREGABALIN CAPSULE REMEDYREPACK 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) 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. ( קרא את המסמך השלם