PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Marinol
    (Dronabinol) - Abbott

    THERAPEUTIC CLASS

    Cannabinoid

    DEA CLASS

    CIII

    INDICATIONS

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

    ADULT DOSAGE

    Adults: Individualize dose. Appetite Stimulation: 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. Antiemetic: 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

    Pediatrics: Antiemetic: 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.

    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 with history of seizure disorders, substance abuse, and cardiac disorders due to occasional hypotension, possible HTN, syncope, or tachycardia. Caution in patients with mania, depression, or schizophrenia; exacerbation of these illnesses may occur. Caution in elderly (particularly those with dementia), pregnancy, nursing, and pediatrics.

    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 with sedatives, hypnotics, or other psychoactive drugs. Additive HTN, tachycardia, and possible cardiotoxicity with sympathomimetics (eg, amphetamines, cocaine). Additive or super-additive tachycardia, and drowsiness with anticholinergics (eg, atropine, scopolamine, antihistamines). Additive tachycardia, HTN, and drowsiness with TCAs (eg, amitriptyline, amoxapine, desipramine). Additive drowsiness and CNS depression with CNS depressants (eg, barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants). May result in hypomanic reaction with 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

    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%), bile/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, substance abuse (including alcohol abuse/dependence), cardiac disorders, mania, depression, schizophrenia, pregnancy/nursing status, hepatic/renal impairment, and possible drug interactions.

    MONITORING

    Monitor for psychiatric illness exacerbation, abdominal pain, N/V, dizziness, euphoria, paranoid reaction, somnolence, abnormal thinking, hypotension or HTN, syncope, tachycardia, for psychological and physiological dependence, and other adverse reactions.

    PATIENT COUNSELING

    Inform about additive CNS depression effect if taken concomitantly with 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 notify if pregnant or breastfeeding.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Storage: 8-15°C (46-59°F). Protect from freezing.