Marinol

— THERAPEUTIC CATEGORIES —
  • Anorexia/cachexia
  • Nausea

Marinol Generic Name & Formulations

General Description

Dronabinol 2.5mg, 5mg, 10mg; caps; contains sesame oil.

Pharmacological Class

Cannabinoid.

How Supplied

Caps—60

Manufacturer

Generic Availability

YES

Marinol Indications

Indications

Anorexia with weight loss in AIDS patients.

Marinol Dosage and Administration

Adult

Initially 2.5mg twice daily 1hr before lunch and dinner. If intolerable, may reduce to 2.5mg daily in the evening or at bedtime. May increase gradually to max 10mg twice daily. Elderly: initially 2.5mg once daily.

Children

Not established.

Marinol Contraindications

Not Applicable

Marinol Boxed Warnings

Not Applicable

Marinol Warnings/Precautions

Warnings/Precautions

Avoid in history of psychiatric disorders (eg, mania, depression, schizophrenia); if unavoidable, monitor for new or worsening symptoms. Reduce dose or discontinue therapy if cognitive impairment develops, or if nausea, vomiting, or abdominal pain worsens. Cardiac disorders. Seizures. Substance abuse. Monitor BP, HR. Write ℞ for smallest practical amount. Keep patient under responsible adult supervision (esp. when dose is adjusted). CYP2C9 polymorphism; monitor. Elderly (monitor: esp. with dementia). Pregnancy: avoid. Nursing mothers: not recommended.

Marinol Pharmacokinetics

Absorption

Dronabinol (delta-9-THC) is almost completely absorbed (90–95%) after single oral doses. Due to the combined effects of first pass hepatic metabolism and high lipid solubility, only 10–20% of the administered dose reaches the systemic circulation.

Distribution

Dronabinol has an apparent volume of distribution of ~10 L/kg, because of its lipid solubility. The plasma protein binding is ~97%.

Metabolism

Hepatic (primarily by hydroxylation). 

Elimination

Fecal (major), renal (10–15%). Half-life: ~4 hours (initial), ~25–36 hours (terminal).

Marinol Interactions

Interactions

Avoid concomitant amphetamines, sympathomimetics, atropine, scopolamine, antihistamines, anticholinergics, TCAs. CNS depression potentiated with concomitant benzodiazepines, barbiturates, alcohol, other CNS depressants and other psychoactive substances (avoid). May potentiate concomitant highly protein-bound drugs with narrow therapeutic index (eg, warfarin, cyclosporine, amphotericin B); monitor. May be potentiated by inhibitors of CYP2C9 (eg, amiodarone, fluconazole) and CYP3A4 (eg, ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir, grapefruit juice).

Marinol Adverse Reactions

Adverse Reactions

Abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, abnormal thinking, vomiting; neuropsychiatric effects, hypotension, hypertension, syncope, tachycardia, seizures (discontinue if occurs).

Marinol Clinical Trials

See Literature

Marinol Note

Not Applicable

Marinol Patient Counseling

See Literature

Marinol Generic Name & Formulations

General Description

Dronabinol 2.5mg, 5mg, 10mg; caps; contains sesame oil.

Pharmacological Class

Cannabinoid.

How Supplied

Caps—60

Manufacturer

Generic Availability

YES

Marinol Indications

Indications

Refractory nausea and vomiting associated with cancer chemotherapy.

Marinol Dosage and Administration

Adult

Give first dose on an empty stomach. Initially 5mg/m2 1–3 hrs before chemotherapy, then every 2–4 hrs after chemo; max 4–6 doses per day. May increase if needed by increments of 2.5mg/m2; max 15mg/m2 per dose. May decrease to 2.5mg once daily before chemo to reduce adverse events. Elderly: initially 2.5mg/m2 once daily.

Children

Not established.

Marinol Contraindications

Not Applicable

Marinol Boxed Warnings

Not Applicable

Marinol Warnings/Precautions

Warnings/Precautions

Avoid in history of psychiatric disorders (eg, mania, depression, schizophrenia); if unavoidable, monitor for new or worsening symptoms. Reduce dose or discontinue therapy if cognitive impairment develops, or if nausea, vomiting, or abdominal pain worsens. Cardiac disorders. Seizures. Substance abuse. Monitor BP, HR. Write ℞ for smallest practical amount. Keep patient under responsible adult supervision (esp. when dose is adjusted). CYP2C9 polymorphism; monitor. Elderly (monitor: esp. with dementia). Pregnancy: avoid. Nursing mothers: monitor infants.

Marinol Pharmacokinetics

Absorption

Dronabinol (delta-9-THC) is almost completely absorbed (90–95%) after single oral doses. Due to the combined effects of first pass hepatic metabolism and high lipid solubility, only 10–20% of the administered dose reaches the systemic circulation.

Distribution

Dronabinol has an apparent volume of distribution of ~10 L/kg, because of its lipid solubility. The plasma protein binding is ~97%.

Metabolism

Hepatic (primarily by hydroxylation). 

Elimination

Fecal (major), renal (10–15%). Half-life: ~4 hours (initial), ~25–36 hours (terminal).

Marinol Interactions

Interactions

Avoid concomitant amphetamines, sympathomimetics, atropine, scopolamine, antihistamines, anticholinergics, TCAs. CNS depression potentiated with concomitant benzodiazepines, barbiturates, alcohol, other CNS depressants and other psychoactive substances (avoid). May potentiate concomitant highly protein-bound drugs with narrow therapeutic index (eg, warfarin, cyclosporine, amphotericin B); monitor. May be potentiated by inhibitors of CYP2C9 (eg, amiodarone, fluconazole) and CYP3A4 (eg, ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir, grapefruit juice).

Marinol Adverse Reactions

Adverse Reactions

Abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, abnormal thinking, vomiting; neuropsychiatric effects, hypotension, hypertension, syncope, tachycardia, seizures (discontinue if occurs).

Marinol Clinical Trials

See Literature

Marinol Note

Not Applicable

Marinol Patient Counseling

See Literature