Clomipramine

FDA label

Read the full label on DailyMed ↗

Titration After the initial 2-week titration, wait 2 to 3 weeks between further dosage adjustments — steady-state plasma levels of clomipramine and desmethylclomipramine are not reached until 2 to 3 weeks after a dose change.

Renal Undefined

Hepatic Undefined

Instructions

• During initial titration, give in divided doses with meals to reduce gastrointestinal side effects.
• After titration and during maintenance, the total daily dose may be given once daily QHS to minimize daytime sedation.
• Allow at least 14 days between stopping an MAOI intended to treat psychiatric disorders and starting clomipramine, and at least 14 days after stopping clomipramine before starting such an MAOI.
• If urgent treatment with linezolid or IV methylene blue is required in a patient already on clomipramine, stop clomipramine promptly, monitor for serotonin syndrome for two weeks or until 24 hours after the last linezolid/methylene blue dose (whichever comes first), and resume 24 hours after that last dose.
• OCD is chronic — continue in responders, but adjust to the lowest effective dosage and reassess periodically.

Contraindications

• MAOIs (concurrently or within 14 days) due to risk of serotonin syndrome
• Starting clomipramine in a patient being treated with linezolid or intravenous methylene blue
• Acute recovery period after myocardial infarction
• History of hypersensitivity to other tricyclic antidepressants (class cross-sensitivity)

Cautions

• Clinical worsening and suicide risk — monitor all patients, particularly children, adolescents and young adults, especially early in treatment and after dose changes.
• Serotonin syndrome with MAOIs, linezolid or IV methylene blue — observe the 14-day washouts in both directions.
• Risk of serotonin syndrome with non-intravenous methylene blue routes, or IV doses well below 1 mg/kg, is unclear — remain alert for emergent symptoms.
• Neonatal withdrawal (jitteriness, tremor, seizures) reported after maternal use up to delivery.

Adverse reactions

• Digestive: dry mouth 84%, constipation 47%, nausea 33%, dyspepsia 22%, diarrhea 13%, anorexia 12%, abdominal pain 11%.
• Nervous system: somnolence 54%, tremor 54%, dizziness 54%, headache 52%, insomnia 25%, nervousness 18%, myoclonus 13%, paresthesia 9%, memory impairment 9%, anxiety 9%.
• Genitourinary/sexual: libido change 21%, ejaculatory failure, impotence, micturition disorder.
• Body as a whole: fatigue 39%, increased sweating 29%, weight increase 18%, increased appetite 11%, flushing 8%.
• Visual changes; rash 8%, pruritus 6%.
• Approximately 20% of 3616 patients in US premarketing trials discontinued because of an adverse event — most often nervous system complaints (5.4%, chiefly somnolence), then digestive complaints (1.3%, chiefly vomiting/nausea).

Pregnancy No teratogenic effects in rats or mice; slight nonspecific embryo/fetotoxic effects at high animal doses. No adequate well-controlled studies in pregnant women; neonatal withdrawal (jitteriness, tremor, seizures) reported after use until delivery — use only if the potential benefit justifies the potential fetal risk.

Lactation Undefined