Product Description.:
ANAFRANIL 25 mg
capsule , off-white yellow , oblong oblong
M within a squareBlack ink
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of imipramine pamoate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ANAFRANIL is not approved for use in pediatric patients.
Description: Ivory Body/Melon Yellow Capsule
Identification Code: Ivory body imprinted in black with M in a box and melon-yellow cap imprinted in black with ANFRANIL 25 mg
Anafranil?, (clomipramine hydrochloride capsules USP), is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Anafranil is available as capsules of 25, 50, and 75 mg for oral administration.
Inactive Ingredients. D&C Red No. 33 (25-mg capsules only), D&C Yellow No. 10, FD&C Blue No. 1 (50-mg capsules only), FD&C Yellow No. 6, gelatin, magnesium stearate, methylparaben, propylparaben, starch (corn), and titanium dioxide.
INDICATIONS AND USAGE
Anafranil is indicated for the treatment of obsessions and compulsions in patients with
Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked
distress, be time-consuming, or significantly interfere with social or occupational functioning, in
order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic.
Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an
obsession or in a stereotyped fashion, and are recognized by the person as excessive or
unreasonable.