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  • Marinol
    (dronabinol)

    THERAPEUTIC CLASS

    Cannabinoid

    DEA CLASS

    CIII

    ADULT DOSAGE & INDICATIONS

    Anorexia

    Associated w/ Weight Loss in AIDS Patients:

    Initial: 2.5mg bid before lunch and supper
    Titrate: Reduce dose to 2.5mg/day, administered as qpm or qhs, if 5mg/day dose is intolerable
    Max: 20mg/day in divided doses

    Chemotherapy-Induced Nausea/Vomiting

    Use in patients who have failed to respond to conventional antiemetics

    Initial: 5mg/m2 given 1-3 hrs before chemotherapy, then q2-4h after
    chemotherapy, for a total of 4-6 doses/day
    Titrate: May increase dose by 2.5mg/m2 increments
    Max: 15mg/m2/dose

    PEDIATRIC DOSAGE & INDICATIONS

    Chemotherapy-Induced Nausea/Vomiting

    Use in patients who have failed to respond to conventional antiemetics

    Initial: 5mg/m2 given 1-3 hrs before chemotherapy, then q2-4h after
    chemotherapy, for a total of 4-6 doses/day
    Titrate: May increase dose by 2.5mg/m2 increments
    Max: 15mg/m2/dose

    DOSING CONSIDERATIONS

    Elderly
    Start at lower end of dosing range

    ADMINISTRATION

    Oral route

    HOW SUPPLIED

    Cap: 2.5mg, 5mg, 10mg

    CONTRAINDICATIONS

    Known sensitivity to this medication or any of its ingredients, sesame oil hypersensitivity.

    WARNINGS/PRECAUTIONS

    May impair mental/physical abilities. Seizure and seizure-like activity reported; d/c immediately if seizures develop. Caution in patients w/ history of seizure disorders, and history of substance abuse, including alcohol abuse or dependence. Caution in patients w/ cardiac disorders due to occasional hypotension, possible HTN, syncope, or tachycardia. Caution in patients w/ mania, depression, or schizophrenia; exacerbation of these illnesses may occur. Caution in elderly patients w/ dementia.

    ADVERSE REACTIONS

    Abdominal pain, N/V, dizziness, euphoria, paranoid reaction, somnolence, abnormal thinking.

    DRUG INTERACTIONS

    May displace highly protein-bound drugs; monitor for dose requirement changes. Additive or synergistic CNS effects w/ sedatives, hypnotics, or other psychoactive drugs. Additive HTN, tachycardia, and possible cardiotoxicity w/ sympathomimetics (eg, amphetamines, cocaine). Additive or super-additive tachycardia, and drowsiness w/ anticholinergics (eg, atropine, scopolamine, antihistamines). Additive tachycardia, HTN, and drowsiness w/ TCAs (eg, amitriptyline, amoxapine, desipramine). Additive drowsiness and CNS depression w/ CNS depressants (eg, barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants). May result in hypomanic reaction w/ disulfiram and fluoxetine in patients who smoke marijuana. May decrease clearance of antipyrine and barbiturates. May increase theophylline metabolism in patients who smoke marijuana/tobacco.

    PREGNANCY AND LACTATION

    Pregnancy: Category C.
    Lactation: Not for use in nursing.

    MECHANISM OF ACTION

    Cannabinoid; has complex effects on the CNS, including central sympathomimetic activity.

    PHARMACOKINETICS

    Absorption: Cmax= 1.32ng/mL (2.5mg bid), 2.96ng/mL (5mg bid), 7.88ng/mL (10mg bid); (median) Tmax=1 hr (2.5mg bid), 2.5 hr (5mg bid), 1.5 hr (10mg bid); AUC0-12= 2.88ng•hr/mL (2.5mg bid), 6.16ng•hr/mL (5mg bid), 15.2ng•hr/mL (10mg bid). Distribution: Vd=10L/kg; plasma protein binding (97%); found in breast milk. Metabolism: Extensive 1st-pass hepatic metabolism primarily by microsomal hydroxylation; 11-OH-delta-9-THC (active metabolite). Elimination: Urine (10-15%), feces (50%, <5% unchanged); T1/2=25-36 hrs.

    ASSESSMENT

    Assess for history of hypersensitivity to the drug and sesame oil, history of seizure disorders, history of substance abuse (including alcohol abuse/dependence), cardiac disorders, mania, depression, schizophrenia, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for psychiatric illness exacerbation, seizure and seizure-like activity, hypotension or HTN, syncope, tachycardia, dependence, and other adverse reactions.

    PATIENT COUNSELING

    Inform about additive CNS depression effect if taken concomitantly w/ alcohol or other CNS depressants (eg, benzodiazepines, barbiturates). Warn not to drive, operate machinery, or engage in any hazardous activity while receiving treatment until effect is well tolerated. Advise of possible mood changes and other behavioral effects that may occur during therapy. Advise that patients must be under constant supervision of a responsible adult during initial use and following dosage adjustments. Instruct to immediately report to physician any adverse effects and to notify if pregnant or breastfeeding.

    STORAGE

    8-15°C (46-59°F) and alternatively could be stored in a refrigerator. Protect from freezing.