Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
GUANFACINE HYDROCHLORIDE (UNII: PML56A160O) (GUANFACINE - UNII:30OMY4G3MK)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)] . Guanfacine is contraindicated in patients with a history of a hypersensitivity reaction to guanfacine extended-release tablets or its inactive ingredients, or other products containing guanfacine. Rash and pruritus have been reported. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including guanfacine extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388. Risk Summary Available data with guanfacine over decades of use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, use of guanfacine in p
NDC: 63629-8161-1: 30 Tablets in a BOTTLE
Abbreviated New Drug Application
GUANFACINE- GUANFACINE TABLET, EXTENDED RELEASE BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GUANFACINE EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1986 INDICATIONS AND USAGE Guanfacine extended-release tablets are a central alpha -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications (1, 14). (1) DOSAGE AND ADMINISTRATION • • • • • • • DOSAGE FORMS AND STRENGTHS Extended-release tablets: 1 mg, 2 mg, 3 mg and 4 mg (3) (3) CONTRAINDICATIONS History of hypersensitivity to guanfacine, its inactive ingredients, or other products containing guanfacine (4). (4) WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS Most common adverse reactions (≥ 5% and at least twice placebo rate) in fixed-dose monotherapy ADHD trials in children and adolescents (6 to 17 years): hypotension, somnolence, fatigue, nausea, and lethargy (6.1). (6) Flexible dose-optimization ADHD trials in children (6 to 12 years) and adolescents (13 to 17 years): somnolence, hypotension, abdominal pain, insomnia, fatigue, dizziness, dry mouth, irritability, nausea, vomiting, and bradycardia (6.1). (6) 2A Recommended dose: 1 mg to 7 mg (0.05 to 0.12 mg/kg target weight based dose range) once daily in the morning or evening based on clinical response and tolerability (2.2). Begin at a dose of 1 mg once daily and adjust in increments of no more than 1 mg/week (2.2). Do not crush, chew or break tablets before swallowing (2.1). Do not administer with high-fat meals, because of increased exposure (2.1). Do not substitute for immediate-release guanfacine tablets on a mg-per-mg basis, because of differing pharmacokinetic profiles (2.3). If switching from immediate-release guanfacine, di Perskaitykite visą dokumentą