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  • Marinol
    (dronabinol)

    THERAPEUTIC CLASS

    Cannabinoid

    DEA CLASS

    CIII

    INDICATIONS

    Treatment of anorexia associated w/ weight loss in AIDS patients and N/V associated w/ cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

    ADULT DOSAGE

    Anorexia

    Associated w/ Weight Loss in AIDS Patients:

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

    Chemotherapy-Associated Nausea/Vomiting

    Use in patients who have failed to respond to conventional antiemetics

    Initial: 5mg/m2 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

    Chemotherapy-Associated Nausea/Vomiting

    Use in patients who have failed to respond to conventional antiemetics

    Initial: 5mg/m2 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

    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 pregnancy and nursing.

    ADVERSE REACTIONS

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

    DRUG INTERACTIONS

    May displace highly protein-bound drugs; dose requirement changes may be needed. 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 smoked marijuana. May decrease clearance of antipyrine and barbiturates. May increase theophylline metabolism in patients who smoked marijuana/tobacco.

    PREGNANCY AND LACTATION

    Category C, not for use in nursing.

    MECHANISM OF ACTION

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

    PHARMACOKINETICS

    Absorption: Administration of variable doses resulted in different pharmacokinetic parameters. Distribution: Vd=10L/kg; plasma protein binding (97%); found in breast milk. Metabolism: Liver via 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, abdominal pain, N/V, dizziness, euphoria, paranoid reaction, somnolence, abnormal thinking, hypotension or HTN, syncope, tachycardia, psychological and physiological 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). Advise to use caution while performing hazardous tasks (eg, operating machinery/driving) until effect is well tolerated. Inform of 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). Protect from freezing.