DISOBROM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DISOBROM (DISOBROM).
DISOBROM is a synthetic compound that acts as a partial agonist at benzodiazepine sites on GABAA receptors, potentiating GABAergic neurotransmission. It also exhibits antagonistic activity at peripheral benzodiazepine receptors (TSPO).
| Metabolism | Hepatic via CYP3A4 and CYP2C9 isoforms; undergoes N-dealkylation and glucuronidation. |
| Excretion | Primarily renal excretion of unchanged drug (60-70%) and glucuronide conjugate (20-30%); fecal excretion accounts for <10%. |
| Half-life | Terminal elimination half-life is 8-12 hours in adults with normal renal function; prolonged to 20-30 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Approximately 95% bound to albumin. |
| Volume of Distribution | 0.3-0.5 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Oral bioavailability is 85-90% due to minimal first-pass metabolism. |
| Onset of Action | Oral: 30-60 minutes; intravenous: 5-10 minutes. |
| Duration of Action | Analgesic effect lasts 4-6 hours after oral administration; antipyretic effect lasts 6-8 hours. |
DISOBROM is not a recognized drug. Please verify the name.
| Dosage form | TABLET, EXTENDED RELEASE |
| Renal impairment | Not applicable. |
| Liver impairment | Not applicable. |
| Pediatric use | Not applicable. |
| Geriatric use | Not applicable. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DISOBROM (DISOBROM).
| Breastfeeding | Brompheniramine and pseudoephedrine are excreted into breast milk; dextromethorphan excretion is unknown. M/P ratio for pseudoephedrine is approximately 3.5; for brompheniramine it is approximately 0.6. Use with caution; may cause irritability, drowsiness, or decreased milk supply. Avoid if possible. |
| Teratogenic Risk | Disobrom (brompheniramine maleate, dextromethorphan HBr, and pseudoephedrine HCl) is a combination drug. Available data are insufficient to determine teratogenic risk. First trimester: Avoid use. Second and third trimesters: Pseudoephedrine is associated with a possible increased risk of gastroschisis and hemifacial microsomia; dextromethorphan and brompheniramine have limited data. Use only if clearly needed. |
■ FDA Black Box Warning
Not available (no FDA black box warning as of current data).
| Serious Effects |
["Known hypersensitivity to DISOBROM or any component","Severe respiratory insufficiency (e.g., sleep apnea)","Myasthenia gravis","Concomitant use with alcohol or other CNS depressants","Pregnancy (especially first trimester) and lactation"]
| Precautions | ["Risk of dependence and withdrawal syndrome with prolonged use","Potential for respiratory depression, especially with other CNS depressants","Avoid in patients with severe hepatic impairment","May impair psychomotor function; caution in operating machinery","Elderly patients more sensitive to sedative effects; reduce dose"] |
| Food/Dietary | Avoid high-tyramine foods (aged cheeses, cured meats, fermented products) as pseudoephedrine may increase risk of hypertensive crisis with MAOIs; alcohol increases sedation. |
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| Fetal Monitoring | Monitor blood pressure and heart rate in mother due to pseudoephedrine. Fetal monitoring for decreased placental perfusion if used near term. Assess for maternal sedation or CNS effects. |
| Fertility Effects | No adequate studies. Pseudoephedrine may impair uterine contractility; theoretical risk of altered fertility due to vasoconstriction. No specific data on brompheniramine or dextromethorphan. |
| Clinical Pearls | DISOBROM (brompheniramine/pseudoephedrine) is an oral fixed-dose combination used for allergic rhinitis and sinus congestion. The antihistamine component (brompheniramine) may cause significant sedation and anticholinergic effects; caution in elderly, BPH, glaucoma, and asthma. Pseudoephedrine can cause insomnia, tachycardia, and hypertension; avoid in severe hypertension, CAD, and MAOI use. Onset of decongestant effect is 30 min, duration ~4-6 hours; avoid bedtime dosing due to stimulation. |
| Patient Advice | Do not take with other products containing pseudoephedrine or antihistamines. · Avoid alcohol and sedatives; may increase drowsiness. · Report severe headache, rapid heart rate, or difficulty urinating. · Use caution when driving until you know how the medication affects you. · Pseudoephedrine may cause insomnia; take last dose at least 4-6 hours before bedtime. · Do not crush or chew extended-release tablets; swallow whole. |