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(clomipramine hydrochloride) Capsules USP (25 mg, 50 mg, and 75 mg)
Suicidality and Antidepressant Drugs
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 clomipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Clomipramine hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) (see WARNINGS, Clinical Worsening and Suicide Risk; PATIENT INFORMATION; and PRECAUTIONS, Pediatric Use).
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.
Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is:
Clomipramine hydrochloride USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane.
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.
What are the possible side effects of clomipramine (Anafranil)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these serious side effects:
What are the precautions when taking clomipramine hcl (Anafranil)?
Before taking clomipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., imipramine, nortriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., purpura, thrombocytopenia), breathing problems (e.g., asthma, chronic bronchitis), certain eye problems (e.g., glaucoma, increased intraocular pressure), eating disorders (e.g., bulimia), heart problems (e.g., arrhythmias, coronary artery disease, recent heart attack), intestinal problems (e.g., chronic constipation, ileus), liver...
Last reviewed on RxList: 11/5/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Anafranil Information
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