| Clomipramine |
Owing to the long elimination half-lives of clomipramine and its active metabolite, desmethylclomipramine, steady-state plasma levels may not be achieved until 2 to 3 weeks after a dosage adjustment. It may thus be advisable to wait 2 to 3 weeks after the initial dose titration phase, before attempting further dosage adjustments. It should be kept in mind that a lag in therapeutic response usually occurs at the onset of therapy, lasting from several days to a few weeks. Increasing the dosage does not normally shorten this latent period and may increase the incidence of side effects.
Depression:
Initial Dosage:
Adults:
Clomipramine therapy should be initiated at daily doses of 25 mg. Dosage may be
increased by 25 mg increments, as tolerated, at 3 to 4 day intervals up to a
total daily dose of 150 mg by the end of 2 weeks. Thereafter, the dose may be
gradually increased over a period of several weeks to 200 mg. Doses in excess of
200 mg daily are not recommended for outpatients. Occasionally, in more severely
depressed hospitalized patients, dosages up to 300 mg daily may be required.
Elderly and Debilitated Patients:
In general, lower dosages are recommended for these patients. Initially, 20 to
30 mg daily in divided doses is suggested, with very gradual increments,
depending on tolerance and response. Blood pressure and cardiac rhythm should be
checked frequently, particularly in patients who have unstable cardiovascular
function.
Maintenance Dosage:
Dosage during maintenance therapy should be kept at the lowest effective level.
To minimize daytime sedation during maintenance treatment, the total daily
dosage may be given as a single dose at bedtime. Medication should be continued
for the expected duration of the depressive episode in order to minimize the
possibility of relapse following clinical improvement.
Obsessive Compulsive Disorders:
Initial Dosage:
Adults:
Clomipramine therapy in adult obsessive compulsive patients should be initiated
at daily doses of 25 mg. Dosage may be increased by 25 mg increments, as
tolerated, at 3 to 4 day intervals up to a total daily dose of 100 or 150 mg by
the end of 2 weeks. Thereafter, the dose may be gradually increased over a
period of several weeks to 200 mg. Doses in excess of 200 mg/day are not
generally recommended for outpatients. However, in the treatment of severe cases
of Obsessive Compulsive Disorder, daily doses of up to 250 mg may be required.
Children and Adolescents:
In children aged 10 to 17 years, an initial dose of 25 mg/day is recommended.
Dosage may be increased by 25 mg increments, as tolerated, at 3 to 4 day
intervals. By the end of 2 weeks, patients may be titrated up to 100 to 150
mg/day or 3 mg/kg, whichever is lower. Thereafter, the dose may be gradually
increased to 200 mg or 3 mg/kg whichever is lower. A total daily dose above 200
mg should not be used in children or adolescents.
Elderly and Debilitated Patients:
In general, lower dosages are recommended for these patients. Initially, 20 to
30 mg daily in divided doses is suggested, with very gradual increments,
depending on tolerance and response. Blood pressure and cardiac rhythm should be
checked frequently, particularly in patients who have unstable cardiovascular
function.
Maintenance Dosage (Adults, Children, and Adolescents):
Double blind extension phase studies of clomipramine therapy in patients with
Obsessive Compulsive Disorder have followed patients for up to 52 weeks.
Although placebo enrolment in these studies was inadequate to permit a
controlled comparison, data do suggest that clomipramine therapy can be
continued for up to a year without loss of efficacy.
Dosage adjustments may be made during maintenance therapy with the objective of maintaining the patient at the lowest effective dose. To minimize daytime sedation during maintenance treatment, the total daily dosage may be given as a single dose at bedtime. If symptoms recur, the dosage should be increased until the symptoms are controlled. Patients should be reassessed periodically to determine the need for continued treatment. To avoid withdrawal symptoms upon discontinuation of therapy, a gradual decrease in dosage and careful patient monitoring are recommended.
25 mg:
Each sugar-coated, cream-colored, round tablet, with GEIGY printed on one side
and identification code FH on the other side, contains: Clomipramine HCl 25 mg.
Also contains lactose. Energy: 0.8 kJ (0.19 kcal).
50 mg:
Each film-coated, white, round, slightly biconvex, beveled-edge tablet, with
GEIGY printed on one side and identification code LP on the other side,
contains: Clomipramine HCl 50 mg. Also contains lactose. Energy: 0.96 kJ (0.23
kcal).
