Clomipramine Indications and Dosage
- autism †
- depression †
- obsessive-compulsive disorder (OCD)
- premature ejaculation †
† non-FDA-approved indication
Clomipramine Indications and Dosage
For treatment of obsessive-compulsive disorder (OCD) or major depression † :
Oral dosage:
Adults: Initially, 25 mg PO once daily, may gradually increase in the first two weeks to 100 mg/day PO, given in divided doses. During initial titration, daily dose should be given in divided doses with meals to reduce gastrointestinal side effects. Maximum dosage 250 mg/day. After titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation.
Adolescents and children >= 10 years: Initially, 25 mg PO once daily, gradually increasing up to a total of 100 mg/day PO given in divided doses; or 3 mg/kg/day given in divided doses, whichever is the smaller, over the first 2 weeks. These initial doses should be divided and taken with meals to reduce gastrointestinal side effects. After the initial titration, the dosage may be increased further gradually over the next several weeks up to a daily maximum of 3 mg/kg/day or 200 mg/day, whichever is smaller. After titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation. In clinical trials of children for OCD, the average effective dose range was 100 - 200 mg/day.
Children < 10 years: Safe and effective use has not been established.
For the treatment of autism † :
Oral dosage:
Adults: Initially, 25 mg PO once daily. Increase if needed to 75 - 100 mg/day PO. Further titrate gradually if necessary. Maximum dosage 250 mg/day.
Children: Initially, 25 mg PO once daily. May increase gradually to 200 mg/day PO or to 3 mg/kg/day PO, whichever is smaller.
For the treatment of premature ejaculation † :
Oral dosage:
Adult males: In one study doses of 25 mg/day and 50 mg/day PO produced marked improvement.
Maximum Dosage Limits:
- Adults: 250 mg/day PO.
- Elderly: 250 mg/day PO.
- Adolescents: 3 mg/kg/day PO or 200 mg/day PO, whichever is smaller.
- Children >= 10 years: 3 mg/kg/day PO or 200 mg/day PO, whichever is smaller.
- Children < 10 years: Safe and effective use has not been established.
Patients with hepatic impairment:
Specific guidelines for dosage adjustments in hepatic impairment are not available; but dosage adjustments may be necessary. In dosing clomipramine in patients with liver disease, use caution by using the lower initial doses and titrating slowly to patient clinical response and tolerance.
Patients with renal impairment:
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
† non-FDA-approved indication
[ Last revised: 7/18/2005 2:41:00 PM ]
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