CLOMIPRAMINE HYDROCHLORIDE (Page 5 of 8)

Pediatric Use

Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established (see BOX WARNING and WARNINGS, Clinical Worsening and Suicide Risk). Anyone considering the use of clomipramine in a child or adolescent must balance the potential risks with the clinical need.

In a controlled clinical trial in children and adolescents (10 to 17 years of age), 46 outpatients received clomipramine for up to 8 weeks. In addition, 150 adolescent patients have received clomipramine in open-label protocols for periods of several months to several years. Of the 196 adolescents studied, 50 were 13 years of age or less and 146 were 14 to 17 years of age. The adverse reaction profile in this age group (see ADVERSE REACTIONS) is similar to that observed in adults.

The risks, if any, that may be associated with clomipramine’s extended use in children and adolescents with OCD have not been systemically assessed. The evidence supporting the conclusion that clomipramine is safe for use in children and adolescents is derived from relatively short term clinical studies and from extrapolation of experience gained with adult patients. In particular, there are no studies that directly evaluate the effects of long term clomipramine use on the growth, development, and maturation of children and adolescents. Although there is no evidence to suggest that clomipramine adversely affects growth, development or maturation, the absence of such findings is not adequate to rule out a potential for such effects in chronic use.

The safety and effectiveness in pediatric patients below the age of 10 have not been established. Therefore, specific recommendations cannot be made for the use of clomipramine in pediatric patients under the age of 10.

Geriatric Use

Clinical studies of clomipramine did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects; 152 patients at least 60 years of age participating in various U.S. clinical trials received clomipramine for periods of several months to several years. No unusual age-related adverse events were identified in this population. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

Commonly Observed

The most commonly observed adverse events associated with the use of clomipramine and not seen at an equivalent incidence among placebo-treated patients were gastrointestinal complaints, including dry mouth, constipation, nausea, dyspepsia, and anorexia; nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes.

Leading to Discontinuation of Treatment

Approximately 20% of 3616 patients who received clomipramine in U.S. premarketing clinical trials discontinued treatment because of an adverse event. Approximately one-half of the patients who discontinued (9% of the total) had multiple complaints, none of which could be classified as primary. Where a primary reason for discontinuation could be identified, most patients discontinued because of nervous system complaints (5.4%), primarily somnolence. The second-most-frequent reason for discontinuation was digestive system complaints (1.3%), primarily vomiting and nausea.

There was no apparent relationship between the adverse events and elevated plasma drug concentrations.

Incidence in Controlled Clinical Trials

The following table enumerates adverse events that occurred at an incidence of 1% or greater among patients with OCD who received clomipramine in adult or pediatric placebo-controlled clinical trials. The frequencies were obtained from pooled data of clinical trials involving either adults receiving clomipramine (N=322) or placebo (N=319) or children treated with clomipramine (N=46) or placebo (N=44). The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the populations studied.

Incidence of Treatment-Emergent Adverse Experience in Placebo-Controlled Clinical Trials (Percentage of Patients Reporting Event)
Adults Children and Adolescents
Body System/
Adverse Event *
Clomipramine
(N=322)
Placebo
(N=319)
Clomipramine
(N=46)
Placebo
(N=44)
*
Events reported by at least 1% of clomipramine patients are included.
Nervous System
Somnolence 54 16 46 11
Tremor 54 2 33 2
Dizziness 54 14 41 14
Headache 52 41 28 34
Insomnia 25 15 11 7
Libido change 21 3
Nervousness 18 2 4 2
Myoclonus 13 2
Increased appetite 11 2 2
Paresthesia 9 3 2 2
Memory impairment 9 1 7 2
Anxiety 9 4 2
Twitching 7 1 4 5
Impaired concentration 5 2
Depression 5 1
Hypertonia 4 1 2
Sleep disorder 4 9 5
Psychosomatic disorder 3
Yawning 3
Confusion 3 2
Speech disorder 3
Abnormal dreaming 3 2
Agitation 3
Migraine 3
Depersonalization 2 2
Irritability 2 2 2
Emotional lability 2 2
Panic reaction 1 2
Aggressive reaction 2
Paresis 2
Skin and Appendages
Increased sweating 29 3 9
Rash 8 1 4 2
Pruritus 6 2 2
Dermatitis 2 2
Acne 2 2 5
Dry skin 2 5
Urticaria 1
Abnormal skin odor 2
Digestive System
Dry mouth 84 17 63 16
Constipation 47 11 22 9
Nausea 33 14 9 11
Dyspepsia 22 10 13 2
Diarrhea 13 9 7 5
Anorexia 12 22 2
Abdominal Pain 11 9 13 16
Vomiting 7 2 7
Flatulence 6 3 2
Tooth disorder 5
Gastrointestinal disorder 2 2
Dysphagia 2
Esophagitis 1
Eructation 2 2
Ulcerative stomatitis 2
Body as a Whole
Fatigue 39 18 35 9
Weight increase 18 1 2
Flushing 8 7
Hot flushes 5 2
Chest pain 4 4 7
Fever 4 2 7
Allergy 3 3 7 5
Pain 3 2 4 2
Local edema 2 4
Chills 2 1
Weight decrease 7
Otitis media 4 5
Asthenia 2
Halitosis 2
Cardiovascular System
Postural hypotension 6 4
Palpitation 4 2 4
Tachycardia 4 2
Syncope 2
Respiratory System
Pharyngitis 14 9 5
Rhinitis 12 10 7 9
Sinusitis 6 4 2 5
Coughing 6 6 4 5
Bronchospasm 2 7 2
Epistaxis 2 2
Dyspnea 2
Laryngitis 1 2
Urogenital System
Male and Female Patients Combined
Micturition disorder 14 2 4 2
Urinary tract infection 6 1
Micturition frequency 5 3
Urinary retention 2 7
Dysuria 2 2
Cystitis 2
Female Patients Only (N=182) (N=167) (N=10) (N=21)
Dysmenorrhea 12 14 10 10
Lactation (nonpuerperal) 4
Menstrual disorder 4 2
Vaginitis 2
Leukorrhea 2
Breast enlargement 2
Breast pain 1
Amenorrhea 1
Male Patients Only (N=140) (N=152) (N=36) (N=23)
Ejaculation failure 42 2 6
Impotence 20 3
Special Senses
Abnormal vision 18 4 7 2
Taste perversion 8 4
Tinnitus 6 4
Abnormal lacrimation 3 2
Mydriasis 2
Conjunctivitis 1
Anisocoria 2
Blepharospasm 2
Ocular allergy 2
Vestibular disorder 2 2
Musculoskeletal
Myalgia 13 9
Back pain 6 6
Arthralgia 3 5
Muscle weakness 1 2
Hemic and Lymphatic
Purpura 3
Anemia 2 2
Metabolic and Nutritional
Thirst 2 2 2

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