ANAFRANIL Rx

Indications for ANAFRANIL:

Obsessive-compulsive disorder.

Adult:

Take with food. Initially 25mg/day; titrate to 100mg/day in divided doses in first 2 weeks. Adjust as needed; max 250mg/day. After titration, total daily dose may be given at bedtime.

Children:

<10yrs: not recommended. Take with food. ≥10yrs: initially 25mg/day. Increase gradually over first 2 wks to 3mg/kg per day or 100mg/day (in divided doses) whichever is smaller. Further increases as needed to max 3mg/kg per day or 200mg/day whichever is smaller. After titration, total daily dose may be given at bedtime.

Contraindications:

During or within 14 days of MAOIs. Concomitant linezolid or IV methylene blue. Acute post-MI.

Boxed Warning:

Increased risk of suicidality.

Warnings/Precautions:

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening and unusual changes. Monitor for emergence of serotonin syndrome; discontinue if occurs. Angle-closure glaucoma. History of seizures or other predisposing factors (eg, brain damage, alcoholism). Cardiovascular disease. Psychosis. Mania/hypomania. Bipolar disorder. ECT. Surgery. Hepatic or renal dysfunction; monitor. Hyperthyroidism. Increased intraocular pressure. Urinary retention. Adrenal tumors. Avoid abrupt cessation. Reevaluate periodically. Write ℞ for smallest practical amount. Pregnancy (Cat.C). Nursing mothers: not recommended.

Pharmacological Class:

Tricyclic.

Interactions:

See Contraindications. Hyperpyretic crisis, seizures, coma and death with MAOIs. Risk of serotonin syndrome with concomitant serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) and with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiates alcohol, phenobarbital, other CNS depressants, anticholinergics, sympathomimetics, other protein-bound drugs (eg, warfarin, digoxin). Potentiated by CYP2D6 and/or CYP1A2 inhibitors; monitor plasma levels with cimetidine, SSRIs, phenothiazines, type 1C antiarrhythmics (eg, quinidine). Potentiated by haloperidol. Antagonized by barbiturates, carbamazepine, phenytoin, other CYP450 inducers. Caution with drugs that lower seizure threshold. Blocks guanethidine, clonidine.

Adverse Reactions:

Seizures, tremors, male sexual dysfunction, hyperthermia, dry mouth, constipation, anticholinergic effects, nausea, dyspepsia, anorexia, somnolence, dizziness, nervousness, myoclonus, changed libido, impotence, weight gain, visual changes, blood dyscrasias; rare: DRESS (discontinue immediately if occurs).

Generic Availability:

YES

How Supplied:

Caps—30