Clinical Information
Gen. Code and Des.
46120 clomipramine HCl ORAL CAPSULE 25 MG
GCN and Des.
16602 clomipramine HCl ORAL CAPSULE 25 MG
Strength
25MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
28160428 TRICYCLICS, OTHER NOREPI-RU INHIBITORS
Active Ingredients
3456 clomipramine HCl 17321776
Inactive Ingredients
10141 red dye
10143 yellow dye
2549 gelatin 9000708
3203 paraben 99967
ANAFRANIL- clomipramine hydrochloride capsule
Mallinckrodt, Inc.
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 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 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)
DESCRIPTION
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-dihydro-5H -dibenz[b,f azepine monohydrochloride,
Clomipramine hydrochloride USP is 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. (50 mg capsules only), FD&C Yellow No. 6, gelatin, magnesium stearate, methylparaben, propylparaben, starch (corn), and titanium dioxide.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Clomipramine (CMI) is presumed to influence obsessive and compulsive behaviors through its effects on serotonergic neuronal transmission. The actual neurochemical mechanism is unknown, but CMI?s capacity to inhibit the reuptake of serotonin (5-HT) is thought to be important.
INDICATIONS AND USAGE
Anafranil? (clomipramine hydrochloride) Capsules USP 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
CONTRAINDICATIONS
Anafranil is contraindicated in patients with history of hypersensitivity to Anafranil or other tricyclic antidepressants.
Monoamine Oxidase Inhibitors (MAOIs)
The use of MAOIs intended to treat psychiatric disorders with Anafranil or within 14 days of stopping treatment with Anafranil is contraindicated because of an increased risk of serotonin syndrome. The use of Anafranil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.
info. for Patients
Clinical Worsening and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient?s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient?s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate need for very close monitoring and possibly changes in the medication.
Physicians are advised to discuss the following issues with patients for whom they prescribe Anafranil:
The risk of seizure ;
The relatively high incidence of sexual dysfunction among males ;
Since Anafranil may impair the mental and/or physical abilities required for the performance of complex tasks, and since Anafranil is associated with risk of seizures, patients should be cautioned about the performance of complex and hazardous tasks ;
Patients should be cautioned about using alcohol, barbiturates, or other CNS depressants concurrently, since Anafranil may exaggerate their response to these drugs;
Patients should notify their physician if they become pregnant or intend to become pregnant during therapy;
Patients should notify their physician if they are breast-feeding.
Patients should be advised that taking Anafranil can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have prophylactic procedure (e.g., iridectomy), if they are susceptible.
Pregnancy Category C
DOSAGE AND ADMINISTRATION
The treatment regimens described below are based on those used in controlled clinical trials of Anafranil in 520 adults, and 91 children and adolescents with OCD. During initial titration, Anafranil should be given in divided doses with meals to reduce gastrointestinal side effects. The goal of this initial titration phase is to minimize side effects by permitting tolerance to side effects to develop or allowing the patient time to adapt if tolerance does not develop.
