BROMANYL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BROMANYL (BROMANYL).
Bromanyl is a synthetic opioid analgesic that acts as a selective agonist at mu-opioid receptors, producing analgesia, sedation, and euphoria. It also exhibits weak antagonism at NMDA receptors, which may contribute to its analgesic effects and reduced tolerance development.
| Metabolism | Primarily metabolized in the liver via CYP3A4 and CYP2D6 to active and inactive metabolites; undergoes glucuronidation. Major metabolites include norbromanyl and hydroxybromanyl. |
| Excretion | Renal excretion of unchanged drug accounts for 30-40% of elimination; hepatic metabolism to inactive glucuronide conjugates accounts for 50-60%; fecal excretion is minimal (<5%). |
| Half-life | Terminal elimination half-life is 12-15 hours in healthy adults; may be prolonged to 24-36 hours in severe hepatic impairment, requiring dose adjustment. |
| Protein binding | Approximately 85-90% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd is 1.5-2.0 L/kg, indicating extensive tissue distribution; higher Vd in obesity may necessitate dose adjustments. |
| Bioavailability | Oral: 70-80% (first-pass metabolism reduces absorption); Intramuscular: 90-100%; Rectal: 60-70%. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 2-5 minutes; Intramuscular: 10-15 minutes. |
| Duration of Action | Oral: 4-6 hours (immediate-release), 12-24 hours (extended-release); Intravenous: 2-4 hours; duration is dose-dependent and may be shorter with higher pain intensity. |
10 mg orally three times daily
| Dosage form | SYRUP |
| Renal impairment | GFR 30-50 mL/min: 10 mg twice daily; GFR <30 mL/min: 5 mg once daily; hemodialysis: 5 mg after dialysis |
| Liver impairment | Child-Pugh A: 10 mg twice daily; Child-Pugh B: 5 mg once daily; Child-Pugh C: contraindicated |
| Pediatric use | 0.2 mg/kg/dose orally twice daily, maximum 10 mg per dose |
| Geriatric use | Initial 5 mg orally twice daily, titrate to effect, maximum 10 mg twice daily |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BROMANYL (BROMANYL).
| Breastfeeding | Excreted in human milk; M/P ratio 0.8. Potential for infant renal toxicity. Not recommended during breastfeeding. Consider alternative therapy. |
| Teratogenic Risk | First trimester: Limited human data; animal studies show embryotoxicity and teratogenicity at clinically relevant doses. Second and third trimesters: Risk of fetal renal impairment, oligohydramnios, and premature closure of ductus arteriosus. Avoid in pregnancy unless no alternative. |
| Fetal Monitoring |
■ FDA Black Box Warning
Risk of addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of even one dose, especially by children, can be fatal. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death. Neonatal opioid withdrawal syndrome may occur with prolonged use during pregnancy.
| Serious Effects |
["Hypersensitivity to bromanyl or any components","Significant respiratory depression","Acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment","Known or suspected gastrointestinal obstruction, including paralytic ileus","Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of such therapy"]
| Precautions | ["Risk of respiratory depression, especially in elderly or debilitated patients","Addiction, abuse, and misuse potential","Neonatal opioid withdrawal syndrome","Adrenal insufficiency","Severe hypotension in patients with compromised ability to maintain blood pressure","Risk of seizures in patients with seizure disorders","May impair ability to drive or operate machinery"] |
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| Serial fetal ultrasound for amniotic fluid volume and renal function. Monitor maternal renal function and blood pressure. Consider fetal echocardiography. |
| Fertility Effects | Reversible impairment of spermatogenesis in animal studies; human data insufficient. No significant effect on female fertility reported. |
| Food/Dietary |
| Grapefruit and grapefruit juice may inhibit CYP3A4 metabolism of BROMANYL, leading to increased and prolonged effects. Avoid consumption of grapefruit products. High-fat meals may delay absorption but do not significantly alter overall exposure. |
| Clinical Pearls | BROMANYL is a potent synthetic cannabinoid agonist with high affinity for CB1 and CB2 receptors. Onset of psychoactive effects occurs within minutes of inhalation, peaking at 15-30 minutes, and lasts 1-3 hours. Monitor for severe adverse effects: acute psychosis, seizures, myocardial ischemia, and hyperemesis syndrome. Naloxone is ineffective for overdose. Supportive care and benzodiazepines for agitation are first-line. Do not use in pregnancy due to risk of fetal harm. |
| Patient Advice | This drug is not for medical use and is illegal in many jurisdictions; use may lead to severe health consequences. · Do not drive or operate machinery while under the influence; effects include altered perception and impaired coordination. · Seek immediate medical attention if you experience chest pain, severe anxiety, hallucinations, or seizures. · Avoid mixing with alcohol, opioids, or other central nervous system depressants; risk of respiratory depression increases. · Long-term use may lead to dependence, withdrawal symptoms (e.g., irritability, insomnia), and cognitive impairment. |