Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)
Alvogen Inc.
ORAL
PRESCRIPTION DRUG
Pregabalin extended-release tablets are indicated for the management of: - Neuropathic pain associated with diabetic peripheral neuropathy - Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. Pregabalin extended-release tablets 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 (5.1, 5.2), Adverse Reactions (6)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of in utero exposure to pregabalin extended-release tablets, physicians are advised to recommend that pregnant patients taking pregabalin extended-release tablets enroll in the North
Pregabalin extended-release tablets are supplied in the following strengths and package configurations: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) in the original container. (See USP Controlled Room Temperature)
Abbreviated New Drug Application
Alvogen Inc. ---------- MEDICATION GUIDE PREGABALIN (PREE GAB’ A LIN) EXTENDED-RELEASE TABLETS, CV This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 12/2020 PL379-00 Read this Medication Guide before you start taking pregabalin extended-release tablets 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 extended-release tablets, ask your healthcare provider or pharmacist. What is the most important information I should know about pregabalin extended-release tablets? Pregabalin extended-release tablets 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 • Serious breathing problems These serious side effects are described below: • Serious, even life-threatening, allergic reactions. Stop taking pregabalin extended-release tablets 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 • skin redness • Pregabalin extended-release tablets 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 • trouble sleeping (insomnia) • new or worse irritability • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • 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 MEDICATION G Lees het volledige document
PREGABALIN EXTENDED RELEASE- PREGABALIN TABLET, FILM COATED, EXTENDED RELEASE ALVOGEN INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PREGABALIN EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PREGABALIN EXTENDED-RELEASE TABLETS. PREGABALIN EXTENDED-RELEASE TABLETS, FOR ORAL USE, CV INITIAL U.S. APPROVAL: 2004 RECENT MAJOR CHANGES Warnings and Precautions, Respiratory Depression (5.4) 04/2020 INDICATIONS AND USAGE Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) Postherpetic neuralgia (PHN) (1) Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. DOSAGE AND ADMINISTRATION Pregabalin extended-release tablets should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. (2.1) Dosing recommendations for pregabalin extended-release tablets: INDICATION DOSING REGIMEN INITIAL DOSE MAXIMUM DOSE DPN Pain (2.2) Single dose per day 165 mg/day 330 mg/day within 1 week. PHN (2.3) Single dose per day 165 mg/day 330 mg/day within 1 week. Maximum dose of 660 mg/day. Conversion from pregabalin capsules or oral solution to pregabalin extended-release tablets: See full prescribing information. (2.4) Dose modification recommended in patients with renal impairment. (2.5) DOSAGE FORMS AND STRENGTHS Extended-release tablets: 82.5 mg, 165 mg, and 330 mg. (3) CONTRAINDICATIONS Known hypersensitivity to pregabalin or any of its components. (4) WARNINGS AND PRECAUTIONS Angioedema: Angioedema [e.g., swelling of the face, mouth (tongue, lips, and gums) and neck (throat and larynx)] can occur and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue pregabalin extended-release tablets immedia Lees het volledige document