Clomipramine

Clomipramine is used to treat obsessive-compulsive disorder (OCD). It helps decrease persistent/unwanted thoughts (obsessions), and it helps reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living.

• Clomipramine belongs to a class of medications called tricyclic antidepressants. It works by restoring the balance of certain natural substances (serotonin, among others) in the brain.
• Clomipramine has also been used to treat depression, panic attacks, and ongoing pain.
• Clomipramine is available under the following different brand names: Anafranil.

Adult and Pediatric Dosage Forms and Strengths

Capsule

• 25 mg
• 50 mg
• 75 mg

Dosing Considerations

Obsessive-Compulsive Disorder

Adult:

• 25 mg orally once/day initially
• Gradually increase to 100 mg/day (divided with meals) over 2 weeks, THEN
• May increase further to 250 mg/day maximum; may give a single daily dose at bedtime once tolerated

Pediatric:

• Children under 10 years: Safety and efficacy not established
• Children 10 years and older: 25 mg orally once/day initially
• Gradually increase to a maximum of 3 mg/kg/day or 100 mg/day, whichever is less
• May further increase to maximum 3 mg/kg/day or 200 mg/day, whichever is less; may give a single dose at bedtime once tolerated

Geriatric:

• Avoid; strong anticholinergic and sedative effects; may cause orthostatic hypotension (Beers criteria)
• Consider alternatives; if must use, initiate with a lower initial dose
• 25 mg orally once/day initially
• Gradually increase to 100 mg/day (divided with meals) over 2 weeks, THEN
• May increase further to 250 mg/day maximum; may give a single daily dose at bedtime once tolerated

Other Indications and Uses

• Off-label: premature ejaculation

Common side effects of clomipramine include:

• Dry mouth
• Headache
• Constipation
• Ejaculation failure
• Fatigue
• Nausea
• Impotence
• Weight gain
• Weight loss
• Liver damage
• Dizziness
• Mania
• Drowsiness
• Tremor
• Indigestion/heartburn
• Blurred vision or vision changes
• Urinary retention
• Difficulty having an orgasm
• Changes in sex drive (libido)
• Stomach upset
• Vomiting
• Changes in appetite
• Flushing
• Increased sweating
• Tiredness
• Anxiety
• Restlessness
• Sleep problems (insomnia)
• Memory problems
• Trouble concentrating
• Numbness or tingling

Rare side effects of clomipramine include:

• Heart attack
• Dizziness upon standing
• Worsening depression
• Suicidal thoughts/suicide
• Seizure
• High blood sugar (hyperglycemia)
• Agranulocytosis, leukopenia, pancytopenia, thrombocytopenia
• Body temperature above normal

Serious side effects of clomipramine include:

• Mental/mood changes (e.g., confusion, depression)
• Enlarged or painful breasts
• Unwanted breast milk production
• Irregular or painful menstrual periods
• Muscle stiffness
• Ringing in the ears
• Shakiness (tremors)
• Trouble urinating

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Clomipramine has severe interactions with at least 23 different drugs.
• Clomipramine has serious interactions with at least 127 different drugs.
• Clomipramine has moderate interactions with at least 409 different drugs.
• Clomipramine has mild interactions with at least 118 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (under 24 years of age) taking antidepressants for major depressive disorders and other psychiatric illnesses.
• This increase was not seen in patients aged over 24 years; a slight decrease in suicidal thinking was seen in adults over 65 years.
• In children and young adults, risks must be weighed against the benefits of taking antidepressants.
• Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during the initial 1-2 months of therapy and dosage adjustments.
• The patient's family should communicate any abrupt changes in behavior to the healthcare provider.
• Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy.
• This drug is not approved for use in pediatric patients.
• This medication contains clomipramine. Do not take Anafranil if you are allergic to clomipramine or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Severe cardiovascular disorder
• Narrow-angle glaucoma
• Any drugs or conditions that prolong QT interval
• Acute recovery post-heart attack (myocardial infarction [MI])
• Coadministration with serotonergic drugs:
  • Concomitant with or within 14 days of monoamine oxidase inhibitors (MAOIs) (serotonin syndrome)
  • Starting clomipramine in a patient who is being treated with linezolid or intravenous (IV) methylene blue is contraindicated because of an increased risk of serotonin syndrome
  • If linezolid or IV methylene blue must be administered, discontinue clomipramine immediately and monitor for central nervous system (CNS) toxicity; may resume clomipramine 24 hours after last linezolid or methylene blue dose or after 2 weeks of monitoring, whichever comes first

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Clomipramine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Clomipramine?"

Cautions

• Benign prostatic hyperplasia (BPH), urinary/GI retention, hyperthyroidism, seizure disorder, brain tumor, respiratory impairment.
• The risk of dilated pupils (mydriasis); may trigger angle closure attack in patients with angle-closure glaucoma with anatomically narrow angles without a patent iridectomy.
• Clinical worsening and suicide ideation may occur despite medication in adolescents and young adults (18-24 years).
• Potentially life-threatening serotonin syndrome is reported when coadministered with drugs that impair serotonin metabolism (in particular, monoamine oxidase inhibitors (MAOIs), including non-psychiatric MAOIs, such as linezolid and intravenous [IV] methylene blue).
• Risk of anticholinergic side effects.

Pregnancy and Lactation

• Use clomipramine with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• Clomipramine is distributed in breast milk. Do not nurse. The American Academy of Pediatrics (AAP) states the effect of clomipramine on nursing infants is unknown but may be of concern.