Dronabinol

Indications

Dronabinol is used for: Chemotherapy-Induced Nausea & Vomiting

Adult Dose

Chemotherapy-Induced Nausea & Vomiting Indicated for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments Oral capsules: 5 mg/m² PO 1-3 hr before and q2-4hr after chemotherapy; may be increased in 2.5 mg/m² increments to 15 mg/m²; not to exceed 4-6 doses/day Oral solution Starting dose: 4.2 mg/m² PO 1-3 hr before chemotherapy, THEN q2-4 hr after chemotherapy for a total of 4-6 doses/day Give first dose on an empty stomach at least 30 minutes before a meal; subsequent doses can be given without regard to meals Calculate starting dose Starting dose (mg) = Patient body surface area (BSA) in m² multiplied by 4.2 mg/m² Round dose to the nearest 0.1 mg increment To correspond with the calibrated oral dosing syringe, the dose may need to be rounded to the nearest 0.1 mL increment Anorexia Indicated for anorexia associated with weight loss in patients with AIDS Oral capsules: 2.5 mg PO q12hr initially, taken right before meals; may be increased to no more than 20 mg/day or decreased to 2.5 mg at bedtime PRN Oral solution Starting dose 2.1 mg PO BID, 1 hr before lunch and 1 hr before dinner Dosing later in the day may reduce the frequency of CNS adverse reactions If CNS adverse reactions of feeling high, dizziness, confusion, and somnolence occur, they usually resolve in 1-3 days and usually do not require dosage reduction If CNS adverse reactions are severe or persistent, reduce the dose to 2.1 mg qDay 1 hr before dinner or in the evening at bedtime

Child Dose

Chemotherapy-Induced Nausea & Vomiting Indicated for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments NOTE: Has not been studied in pediatric patients with AIDS-related anorexia Oral capsule: 5 mg/m² PO 1-3 hr before and q2-4hr after chemotherapy; may be increased in 2.5 mg/m² increments to 15 mg/m²; not to exceed 4-6 doses/day

Renal Dose

Administration

Oral solution Always use the enclosed calibrated oral dosing syringe when administering to ensure the dose is measured and administered accurately The calibrated oral syringe measures a maximum dronabinol dose of 5 mg; if the prescribed dose exceeds 5 mg, the total dose will need to be divided and drawn up in 2 or more portions using the oral syringe Take each dose with a full glass of water (6-8 oz) Meals CINV: Take first dose on an empty stomach at least 30 minutes before eating; subsequent doses can be taken without regard to meals Anorexia: Take BID 1 hr before lunch and dinner

Contra Indications

Hypersensitivity to dronabinol

Precautions

Neurologic effects May cause psychiatric and cognitive effects and impair mental and/or physical abilities Monitor patients with mania, depression, or schizophrenia; dronabinol may exacerbate these illnesses Avoid in patients with a psychiatric history Monitor for symptoms and avoid concomitant use of drugs with similar effects; reduce the dose or discontinue use if signs or symptoms of cognitive impairment develop Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol does not affect them adversely Abrupt discontinuation may cause withdrawal symptoms Hemodynamic instability Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia Avoid concomitant use of drugs with similar effects and monitor for hemodynamic changes; monitor patients for changes in blood pressure, heart rate, and syncope after initiating or increasing the dosage Caution when initiating or increasing the dosage Caution in elderly patients; may be more sensitive to neurological, psychoactive, and postural hypotensive effects of drug Seizures Seizures and seizure-like activity reported Weigh potential risk before prescribing to patients with a history of seizures, including those with factors that can lower seizure threshold If a seizure occurs, discontinue dronabinol immediately Multiple substance abuse Patients with a history of substance abuse or dependence, including marijuana or alcohol, may be more likely to abuse dronabinol Assess risk for abuse or misuse before prescribing

Pregnancy-Lactation

Pregnancy May cause fetal harm; avoid use during pregnancy Published studies suggest that during pregnancy, the use of cannabis, which includes THC, whether for recreational or medicinal purposes, may increase the risk of adverse fetal/neonatal outcomes including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, admission to the NICU, and stillbirth Contains alcohol; alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development Delta-9-THC has been measured in the cord blood of some infants whose mothers reported prenatal use of cannabis, suggesting that dronabinol may cross the placenta to the fetus during pregnancy Effects of delta-9-THC on the fetus are not known Lactation Women with HIF: Advise HIV infected women not to breastfeed Women with CINV: Do not breastfeed during treatment with dronabinol and for 9 days after the last dose

Interactions

Adverse Effects

Side effects of Dronabinol : 1-10% Dizziness Euphoria Paranoid reaction Somnolence Abnormal thinking Abdominal pain Nausea Vomiting <1% Depression Nightmares Speech difficulties Emotional lability Hypotension Tremors Flushing Sweating Anorexia Hepatic enzyme elevation Tinnitus

Mechanism of Action

Dronabinol is an orally active cannabinoid which has complex effects on the CNS, including central sympathomimetic activity Cannabinoid receptors have been discovered in neural tissues; these receptors may play a role in mediating the effects of dronabinol Has appetite stimulant effect Antiemetic mechanism unknown but probably involves inhibition of vomiting center in medulla oblongata