Medique Apap Extra Strength Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this 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)].
There is currently no drug history available for this drug.
Guanfacine extended-release tablets are a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) in a matrix tablet formulation for oral administration only. The chemical designation is N-Amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C9H9Cl2N3O●HCl corresponding to a molecular weight of 282.55. The chemical structure is:
Guanfacine hydrochloride, USP is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (> 30 mg/mL). Each tablet contains guanfacine hydrochloride equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain ammonium hydroxide, colloidal silicon dioxide, crospovidone, ethylcellulose, glyceryl behenate, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol and povidone. The 2 mg tablets also contain D&C Yellow No. 10 Aluminum Lake. The 3 mg and 4 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake.