Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)
Teva Pharmaceuticals USA, Inc.
ORAL
PRESCRIPTION DRUG
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
Pregabalin capsules are available as follows: 25 mg – Hard gelatin capsules with a white opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7622” on the body and cap, in bottles of 90 (NDC 0093-7622-98). 50 mg – Hard gelatin capsules with a buff opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with “TEVA” and “7623” on the body and cap, in bottles of 90 (NDC 0093-7623-98). Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
Teva Pharmaceuticals USA, Inc. ---------- 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 • swelling of your hands, legs and feet • suicidal thoughts or actions • 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. 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 • trouble sleeping (insomnia) • attempts to commit suicide • new or worse irritability • new or worse depression • acting aggressive, being angry, or violent • new or worse anxiety • acting on dangerous impulses • feeling agitated or restless • an extreme increase in activity and talking (mania) • panic attacks • 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 capsules suddenly can cause serious problems. • Suicidal thoughts or actions can be ca Aqra d-dokument sħiħ
PREGABALIN- PREGABALIN CAPSULE TEVA PHARMACEUTICALS USA, INC. ---------- 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 DO SING REG IMEN 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, (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) Increased seizure frequency or other adverse reactions ma Aqra d-dokument sħiħ