GUANFACINE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUANFACINE HYDROCHLORIDE (UNII: PML56A160O) (GUANFACINE - UNII:30OMY4G3MK)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

NDC: 63629-8161-1: 30 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GUANFACINE- GUANFACINE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
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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
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
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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
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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). (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