From the Guidelines
The recommended dose of clomipramine is 25-50 mg/day or 25 mg 4-24 hours before intercourse.
Clomipramine Dosing
- The dose of clomipramine can be administered daily or on-demand, with daily treatment being more effective in delaying ejaculation 1.
- The optimal dose of clomipramine for premature ejaculation is between 12.5-50 mg per day, with 25-50 mg being the most commonly recommended dose range 1.
- On-demand administration of clomipramine 3-6 hours before intercourse is also effective, but may result in less ejaculatory delay compared to daily treatment 1.
Important Considerations
- Clomipramine is a tricyclic antidepressant with serotonin reuptake inhibitor (SRI) effects, and its use may be associated with adverse events such as nausea, dry mouth, drowsiness, and reduced libido 1.
- The risk of serotonin syndrome, a potentially serious complication, should be considered when prescribing clomipramine, especially when used in combination with other serotonergic agents 1.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION The treatment regimens described below are based on those used in controlled clinical trials of clomipramine hydrochloride in 520 adults, and 91 children and adolescents with OCD. During initial titration, clomipramine hydrochloride 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 Because both clomipramine and its active metabolite, desmethylclomipramine, have long elimination half-lives, the prescriber should take into consideration the fact that steady-state plasma levels may not be achieved until 2 to 3 weeks after dosage change (see CLINICAL PHARMACOLOGY). Therefore, after initial titration, it may be appropriate to wait 2 to 3 weeks between further dosage adjustments Initial Treatment/Dose Adjustment (Adults) Treatment with clomipramine hydrochloride should be initiated at a dosage of 25 mg daily and gradually increased, as tolerated, to approximately 100 mg during the first 2 weeks. During initial titration, clomipramine hydrochloride should be given in divided doses with meals to reduce gastrointestinal side effects Thereafter, the dosage may be increased gradually over the next several weeks, up to a maximum of 250 mg daily. After titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation Initial Treatment/Dose Adjustment (Children and Adolescents) As with adults, the starting dose is 25 mg daily and should be gradually increased (also given in divided doses with meals to reduce gastrointestinal side effects) during the first 2 weeks, as tolerated, up to a daily maximum of 3 mg/kg or 100 mg, whichever is smaller Thereafter, the dosage may be increased gradually over the next several weeks up to a daily maximum of 3 mg/kg or 200 mg, whichever is smaller (see PRECAUTIONS, Pediatric Use).
The recommended dose of clomipramine is:
- Initial dose: 25 mg daily for both adults and children/adolescents
- Adults:
- Gradually increase to approximately 100 mg during the first 2 weeks
- May be increased up to a maximum of 250 mg daily
- Children and Adolescents:
- Gradually increase to a daily maximum of 3 mg/kg or 100 mg (whichever is smaller) during the first 2 weeks
- May be increased up to a daily maximum of 3 mg/kg or 200 mg (whichever is smaller) 2
From the Research
Recommended Dose of Clomipramine
The recommended dose of clomipramine varies depending on the study and the condition being treated. Here are some key points to consider:
- The usual initial adult dosage is 25-50 mg/day, titrated gradually to 250 mg/day if necessary 3
- Response is most often associated with doses greater than 75 mg/d, with 250 mg the maximum recommended daily dose 4
- In a dosage reduction study, patients with obsessive-compulsive disorder were able to maintain therapeutic benefit at a mean dose of 165 mg/day, which is approximately 40% lower than the initial dose 5
- The incidence of seizures is dose related, occurring in 0.48% of all patients receiving clomipramine less than or equal to 250 mg/day and 2.1% of patients receiving greater than or equal to 300 mg/day 6
- In a double-blind comparison of sertraline and clomipramine, the mean final daily dose of clomipramine was 90 mg, with a maximum dose of 200 mg daily 7
Key Considerations
Some key considerations when determining the recommended dose of clomipramine include:
- The condition being treated (e.g. obsessive-compulsive disorder, panic disorder)
- The patient's response to the medication and any adverse effects
- The potential for dose-related side effects, such as seizures
- The need for gradual titration to minimize adverse effects and maximize efficacy
Adverse Effects
Common adverse effects of clomipramine include: