GUANFACINE EXTENDED-RELEASE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

GUANFACINE (UNII: 30OMY4G3MK) (GUANFACINE - UNII:30OMY4G3MK)

Mevcut itibaren:

Par Pharmaceutical Inc.

INN (International Adı):

GUANFACINE

Kompozisyon:

GUANFACINE 1 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

GUANFACINE EXTENDED-RELEASE- GUANFACINE TABLET, EXTENDED RELEASE
PAR PHARMACEUTICAL INC.
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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
RECENT MAJOR CHANGES
Dosage and Administration (2.7)
7/2016
INDICATIONS AND USAGE
Guanfacine extended-release tablets are central alpha
-adrenergic receptor agonist indicated for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD) as monotherapyand as
adjunctive therapy to stimulant medications (1,
14 ).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 1 mg, 2 mg, 3 mg and 4 mg (3)
CONTRAINDICATIONS
History of hypersensitivity to guanfacine extended-release tablets,
its inactive ingredients, or other products containing
guanfacine (4) .
WARNINGS AND PRECAUTIONS
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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).
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).
Adjunctive treatment to psychostimulant ADHD trial in children and
adolescents (6 to 17 years): somnolence, fatigue,
insomnia, dizziness, and abdominal pain (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PAR PHARMACEUTICAL
1-800-828-9393 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
2A
Recommended dose: 1 mg to 7 mg (0.05-0.12 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 adju