clomipramine (Rx)

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Brand and Other Names:Anafranil

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule

  • 25mg
  • 50mg
  • 75mg
more...

Obsessive-Compulsive Disorder

25 mg PO qDay initially

Gradually increase to 100 mg/day (divided with meals) over 2 weeks, THEN

May increase further to 250 mg/day maximum; may give as single daily dose qHS once tolerated

Other Indications & Uses

Off-label: premature ejaculation

Dosage Forms & Strengths

capsule

  • 25mg
  • 50mg
  • 75mg
more...

Obsessive-Compulsive Disorder

<10 years: Safety and efficacy not established

≥10 years: 25 mg PO qDay initially

Gradually increase to maximum 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 as single dose qHS once tolerated

Avoid; strong anticholinergic and sedative effects; may cause orthostatic hypotension (Beers criteria)

Consider alternatives; if must use, initiate with lower initial dose

25 mg PO qDay initially

Gradually increase to 100 mg/day (divided with meals) over 2 weeks, THEN

May increase further to 250 mg/day maximum; may give as single daily dose qHS once tolerated

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Interactions

Interaction Checker

and clomipramine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Xerostomia (84%)

            Headache (50-55%)

            Constipation (47%)

            Ejaculation failure (42%)

            Fatigue (35-40%)

            Nausea (30-35%)

            Impotence (20-25%)

            Weight gain (18%)

            1-10%

            Weight loss (5%)

            Hepatotoxicity (1-3%)

            Frequency Not Defined

            Common

            • Dizziness, mainia, somnolence, tremor
            • Dyspepsia
            • Blurred vision
            • Urinary retention
            • Orgasm incapacity, libido change

            Rare

            • Myocardial infarction, orthostatic hypotension
            • Depression worsening, suicidal thoughts suicide, seizure
            • Hyperglycemia
            • Agranulocytosis, leukopenia, pancytopenia, thrombocytopenia
            • Body temperature above normal
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            Warnings

            Black Box Warnings

            In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 yr of age) taking antidepressants for major depressive disorders and other psychiatric illnesses

            This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >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 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

            Contraindications

            Hypersensitivity

            Severe cardiovascular disorder

            Narrow angle glaucoma

            Any drugs or conditions that prolong QT interval

            Acute recovery post-MI

            Coadministration with serotonergic drugs

            • Concomitant with or within 14 d of MAOIs (serotonin syndrome)
            • Starting clomipramine in a patient who is being treated with linezolid or 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 CNS toxicity; may resume clomipramine 24 hr after last linezolid or methylene blue dose or after 2 weeks of monitoring, whichever comes first

            Cautions

            BPH, urinary/GI retention, hyperthyroidism, seizure disorder, brain tumor, respiratory impairment

            Risk of 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 yr)

            Potentially life-threatening serotonin syndrome reported when coadministered with drugs that impair serotonin metabolism (in particular, MAOIs, including nonpsychiatric MAOIs, such as linezolid and IV methylene blue)

            Risk of anticholinergic side-effects

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: distributed in breast milk, do not nurse (AAP states effect on nursing infants is unknown but may be of concern)

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Parent drug may affect serotonin uptake; active metabolite may may affect norepinephrine uptake

            Pharmacokinetics

            Peak Plasma Time: 2-6 hr

            Concentration: 56-154 ng/mL

            Half-Life: 32 hr (parent drug), 69 hr (metabolite)

            Excretion: Urine (60%); feces (32%)

            Steady-state therpaeutic plasma concentration: 100-250 ng/mL (parent drug), 230-550 ng/mL (metabolite)

            Bioavailability: 50%

            Protein Bound: 97-98%

            Vd: 17 L/kg

            Metabolism: Hepatic CYP2D6

            Metabolites: Desmethylclomipramine

            Dialyzable: No

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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