DROLBAN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DROLBAN (DROLBAN).
Cannabinoid receptor type 1 (CB1) agonist; inhibits adenylate cyclase and modulates calcium and potassium channels in presynaptic neurons, reducing neurotransmitter release.
| Metabolism | Hepatic via CYP2C9 and CYP3A4; also undergoes glucuronidation. |
| Excretion | ~70% renal (primarily as glucuronide conjugates, minor unchanged), ~30% biliary/fecal |
| Half-life | Terminal elimination half-life: 18-24 hours; clinical context: supports once-daily dosing, requires dose adjustment in renal impairment (CrCl <30 mL/min increase half-life by ~2-fold) |
| Protein binding | ~95% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 0.5-1.0 L/kg; clinical meaning: indicates moderate tissue distribution, primarily into highly perfused organs; Vd increased in obesity (up to 1.5 L/kg) due to lipophilicity |
| Bioavailability | Oral: 60-80% (first-pass metabolism reduces absorption); rectal: 70-85%; intravenous: 100% |
| Onset of Action | Oral: 30-60 minutes; parenteral (IM/IV): 5-15 minutes; clinical effect: measurable reduction in intraocular pressure within 1 hour of oral administration |
| Duration of Action | Oral: up to 12-24 hours; parenteral: 4-8 hours; clinical notes: prolonged effect in elderly and hepatic impairment due to reduced clearance; duration may extend to 36-48 hours in severe hepatic dysfunction |
50 mg orally twice daily or 50 mg intramuscularly/intravenously every 8 hours.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 10-50 mL/min: 25 mg twice daily; CrCl <10 mL/min: 25 mg daily or avoid use. |
| Liver impairment | Child-Pugh A: 25 mg twice daily; Child-Pugh B: 12.5 mg twice daily; Child-Pugh C: avoid use. |
| Pediatric use | No established pediatric dosing; use not recommended in children <18 years. |
| Geriatric use | Initiate at 25 mg twice daily; increase cautiously to 50 mg twice daily based on tolerance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DROLBAN (DROLBAN).
| Breastfeeding | It is unknown whether DROLBAN is excreted in human breast milk. Due to potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during therapy and for at least 2 weeks after the last dose. |
| Teratogenic Risk | DROLBAN is contraindicated in pregnancy. It is classified as Pregnancy Category X. Teratogenic effects have been demonstrated in animal studies, including skeletal and visceral malformations. There is no indication for use during any trimester due to risk of fetal harm. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to dronabinol or cannabinoids; concurrent use with disulfiram (contains alcohol in sesame oil vehicle); severe hepatic impairment.
| Precautions | Risk of CNS depression (drowsiness, dizziness, euphoria, dysphoria); may impair cognitive and motor function; potential for abuse and dependence; increase in heart rate and blood pressure; not recommended in patients with cardiac disease or seizure disorders; may cause psychiatric reactions. |
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| Fetal Monitoring |
| If accidental exposure occurs during pregnancy, monitor fetal development with serial ultrasounds and assess for congenital anomalies. Maternal monitoring includes liver function tests, renal function, and complete blood counts due to potential hematologic toxicity. |
| Fertility Effects | DROLBAN may impair fertility in both males and females. In animal studies, reduced spermatogenesis and ovarian follicular development were observed. Clinically, reversible infertility may occur; patients should be counseled on potential reproductive impact. |