Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
SUPRENZA vs BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Partial agonist at mu-opioid receptors; also a weak antagonist at kappa-opioid receptors. Provides analgesic effects with reduced respiratory depression compared to full agonists.
Brompheniramine is a first-generation antihistamine that competitively inhibits histamine at H1 receptors, reducing allergic symptoms. Pseudoephedrine is a sympathomimetic amine that directly stimulates alpha-adrenergic receptors, causing vasoconstriction and nasal decongestion. Dextromethorphan is an NMDA receptor antagonist and sigma-1 receptor agonist that suppresses the cough reflex in the medulla oblongata.
Management of moderate to severe chronic pain,Off-label: Treatment of opioid use disorder (as a maintenance therapy similar to buprenorphine)
Symptomatic relief of upper respiratory symptoms associated with allergic rhinitis, common cold, or sinusitis including nasal congestion, rhinorrhea, sneezing, and cough.
Adults: 200 mg orally twice daily with meals.
Adults and children ≥12 years: 1 tablet (brompheniramine maleate 4 mg, pseudoephedrine HCl 60 mg, dextromethorphan HBr 15 mg) orally every 4 hours, not to exceed 4 tablets in 24 hours, or 2 tablets (extended-release) every 12 hours, not to exceed 4 tablets in 24 hours.
Terminal elimination half-life is approximately 12-15 hours in patients with normal renal function, allowing for twice-daily dosing.
Brompheniramine: 12-34 hours (mean ~24 h), prolonged in hepatic impairment. Pseudoephedrine: 5-8 hours (p H-dependent urinary excretion; alkaline urine prolongs half-life). Dextromethorphan: 3-4 hours (extensive metabolizers) or 18-24 hours (poor metabolizers of CYP2D6).
Primarily hepatic via CYP3A4 and CYP3A5 to norbuprenorphine (active metabolite); also undergoes glucuronidation.
Brompheniramine: extensively metabolized via hepatic CYP450 (CYP2D6, CYP3A4) to desmethylbrompheniramine and other metabolites. Pseudoephedrine: partially metabolized via N-demethylation (CYP450) to norgseudoephedrine; 43-96% excreted unchanged. Dextromethorphan: primarily metabolized via CYP2D6 to dextrorphan (active), also via CYP3A4/5 to 3-methoxymorphinan.
Approximately 60-80% of a dose is excreted renally as unchanged drug, with 20-40% eliminated via biliary/fecal routes.
Brompheniramine: Renal (approx. 80% as metabolites, <1% unchanged). Pseudoephedrine: Renal (70-90% unchanged, rest as metabolites). Dextromethorphan: Renal (primarily as metabolites, <1% unchanged). Biliary/fecal: Minor for all three.
Approximately 95-98% bound to plasma proteins, primarily albumin.
Brompheniramine: 60-80% (primarily albumin, alpha-1-acid glycoprotein). Pseudoephedrine: <10% (negligible). Dextromethorphan: 50-60% (possibly to albumin).
Volume of distribution is approximately 2-3 L/kg, indicating extensive tissue distribution beyond plasma volume.
Brompheniramine: 7-10 L/kg (large, due to extensive tissue distribution). Pseudoephedrine: 2.5-3.5 L/kg (moderate, distributes into body water). Dextromethorphan: 3-5 L/kg (moderate, distributed to tissues including brain).
Oral bioavailability is approximately 70-80%.
Brompheniramine: ~70% (oral). Pseudoephedrine: 90-100% (oral). Dextromethorphan: ~10-30% (oral, due to extensive first-pass metabolism; in poor metabolizers, bioavailability higher).
e GFR <45 m L/min/1.73m²: contraindicated. e GFR ≥45: no adjustment.
GFR ≥30 m L/min: No adjustment. GFR 10-29 m L/min: Administer every 6 hours; monitor for CNS effects. GFR <10 m L/min: Avoid use (risk of toxicity from pseudoephedrine and dextromethorphan accumulation).
Child-Pugh Class A: no adjustment; Class B: reduce to 200 mg once daily; Class C: contraindicated.
Child-Pugh A: No adjustment. Child-Pugh B: Reduce frequency (e.g., every 6 hours) and monitor for CNS depression. Child-Pugh C: Avoid use (dextromethorphan metabolism reduced; brompheniramine may accumulate).
Not recommended for patients under 18 years; safety and efficacy not established.
Children 6-11 years: 1/2 tablet (brompheniramine maleate 2 mg, pseudoephedrine HCl 30 mg, dextromethorphan HBr 7.5 mg) orally every 4 hours, not to exceed 4 doses in 24 hours. Children 2-5 years: Not recommended (safety and efficacy not established). Children <2 years: Contraindicated (risk of respiratory depression).
No specific dose adjustment; monitor renal function and use caution due to increased risk of adverse effects.
Elderly >65 years: Initiate at lowest effective dose (e.g., 1/2 tablet) every 6-8 hours due to increased anticholinergic effects, hypotension, and CNS excitation. Maximum: 2 tablets in 24 hours. Monitor for confusion, urinary retention, and elevated blood pressure.
Risk of respiratory depression, especially in non-opioid-tolerant patients. Risk of neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Risk of serious injury or death due to accidental exposure in children.
None.
Respiratory depression, particularly in the first 24-72 hours of treatment; caution in patients with pulmonary disease. Risk of QT prolongation. Adrenal insufficiency. Severe hypotension. Risk of misuse, abuse, and addiction. Tolerance and physical dependence.
Cardiovascular effects: hypertension, palpitations, tachycardia, arrhythmias, especially in patients with pre-existing heart disease or hyperthyroidism.,CNS depression: avoid concurrent use with alcohol or other sedatives; may impair mental/physical abilities.,Serotonin syndrome: risk with concomitant serotonergic drugs including MAOIs, SSRIs, SNRIs, triptans, linezolid, methylene blue.,QT prolongation: caution with drugs that prolong QT interval or predisposing conditions (e.g., electrolyte abnormalities, bradycardia).,Anticholinergic effects: caution in patients with glaucoma, prostatic hypertrophy, urinary retention, or asthma.,Inhibition of CYP2D6: dextromethorphan may increase levels of CYP2D6 substrates (e.g., TCAs, antipsychotics).
Hypersensitivity to buprenorphine or any component of the formulation. Severe respiratory insufficiency. Acute or severe bronchial asthma. Gastrointestinal obstruction, including paralytic ileus.
Hypersensitivity to any component,Concurrent use or within 14 days of MAO inhibitors (hypertensive crisis),Severe hypertension or coronary artery disease,Narrow-angle glaucoma,Urinary retention,During or immediately after treatment with serotonergic drugs (risk of serotonin syndrome)
No significant food interactions. Grapefruit juice may increase buprenorphine levels; avoid large quantities.
Avoid alcohol, which may potentiate CNS depression. Limit caffeine intake (coffee, tea, cola) as pseudoephedrine may increase stimulant effects. High-tyramine foods (e.g., aged cheese, cured meats, fermented products) may cause hypertensive crisis if combined with MAOIs, but this combination is contraindicated. No other significant food interactions.
Supr ENza (testosterone) is contraindicated in pregnancy due to virilization of female fetus. First trimester: high risk of clitoromegaly, labial fusion, and urogenital sinus abnormalities. Second and third trimesters: risk of continued virilization, including phallic enlargement and ambiguous genitalia. Fetal growth restriction may occur.
Brompheniramine: Limited human data; animal studies show no teratogenicity at clinically relevant doses. Pseudoephedrine: Case-control studies suggest small increased risk of gastroschisis and hemifacial microsomia with first-trimester use; vasoconstriction may reduce uteroplacental blood flow in third trimester. Dextromethorphan: No human teratogenicity data; animal studies show no fetal harm at therapeutic doses. Overall, combination is not recommended in first trimester; avoid in third trimester due to pseudoephedrine effects.
Testosterone is present in breast milk; M/P ratio not reported. Avoid breastfeeding due to potential for androgenization of the infant. Use only if clearly needed and no safer alternative.
Brompheniramine: excreted in breast milk in small amounts; may cause infant irritability or drowsiness. Pseudoephedrine: concentrated in breast milk (M/P ratio ~3.0); may reduce milk production. Dextromethorphan: likely excreted in breast milk but no data on infant levels. Avoid during breastfeeding due to potential infant CNS effects and reduced milk supply.
Not applicable; Supr ENza is contraindicated in pregnancy. No dose adjustments are recommended as use is avoided entirely.
No specific dose adjustments studied for combination in pregnancy. Due to increased plasma volume and clearance, standard adult doses may be less effective; however, avoid use in pregnancy due to risks. No PK studies available.
SUPRENZA (buprenorphine/naloxone) sublingual film is used for opioid dependence. Monitor for respiratory depression especially when combined with benzodiazepines or alcohol. The naloxone component is poorly absorbed sublingually but precipitates withdrawal if injected. Administer only after clear signs of withdrawal to avoid precipitated withdrawal. Adjust dose in hepatic impairment as buprenorphine is hepatically metabolized.
Do not use in children under 6 years due to risk of respiratory depression from dextromethorphan. Avoid in patients with hypertension or coronary artery disease due to pseudoephedrine. Brompheniramine has pronounced anticholinergic effects; use cautiously in elderly or those with glaucoma, urinary retention, or BPH. For severe cough, dextromethorphan efficacy is limited; consider if nonproductive cough is disruptive. Maximum duration of treatment is 7 days; prolonged use may lead to rebound congestion and dependence.
Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,Place film under the tongue until fully dissolved; do not chew or swallow.,Avoid alcohol and benzodiazepines as they can cause severe respiratory depression.,Keep out of reach of children; accidental exposure can be fatal.,Do not abruptly stop; withdrawal symptoms may occur.,Store at room temperature away from moisture and heat.
Do not take more than 6 doses in 24 hours. Do not exceed 7 days of use without consulting a doctor.,Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) as they may increase drowsiness.,Do not use if you have taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.,Stop use and ask a doctor if symptoms do not improve within 7 days, are accompanied by fever, or if cough persists with headache, rash, or persistent headache.,Take with a full glass of water. May cause drowsiness; avoid driving or operating heavy machinery until you know how this medication affects you.,For the decongestant effect, take the last dose of the day several hours before bedtime to minimize insomnia.,Shake suspension well before use. Use only the dosing device provided.
No interactions on record
"Brompheniramine, a first-generation antihistamine, may inhibit the hepatic metabolism of sulfamethoxazole, a sulfonamide antibiotic, via competitive inhibition of cytochrome P450 enzymes, particularly CYP2C9. This results in elevated plasma concentrations of sulfamethoxazole, potentially increasing the risk of dose-dependent adverse effects such as hypersensitivity reactions, crystalluria, and hematologic toxicity (e.g., agranulocytosis). Clinically, patients may present with prolonged or intensified drug effects, including increased bone marrow suppression and renal impairment, especially in those with pre-existing hepatic or renal dysfunction."
"Dextropropoxyphene, an opioid analgesic, and brompheniramine, a first-generation antihistamine with anticholinergic properties, can synergistically depress the central nervous system (CNS) and respiratory centers. This interaction increases the risk of profound sedation, respiratory depression, coma, and death, particularly in elderly patients or those with pre-existing respiratory or hepatic impairment. Concurrent use also amplifies anticholinergic adverse effects such as urinary retention, constipation, and cognitive dysfunction."
"Brompheniramine, a first-generation antihistamine with significant central nervous system (CNS) depressant properties, can potentiate the CNS depressant effects of brimonidine, an alpha-2 adrenergic agonist used for ocular hypertension and glaucoma. This interaction leads to additive sedation, drowsiness, and dizziness, which may impair cognitive and motor function, increasing the risk of falls and accidents. Severe cases could result in excessive CNS depression, including somnolence and respiratory depression, particularly in elderly patients or those with compromised hepatic function."
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about SUPRENZA vs BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, answered by our medical review team.
SUPRENZA is a Sympathomimetic Anorectic that works by Partial agonist at mu-opioid receptors; also a weak antagonist at kappa-opioid receptors. Provides analgesic effects with reduced respiratory depression compared to full agonists.. BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is a Sympathomimetic that works by Brompheniramine is a first-generation antihistamine that competitively inhibits histamine at H1 receptors, reducing allergic symptoms. Pseudoephedrine is a sympathomimetic amine that directly stimulates alpha-adrenergic receptors, causing vasoconstriction and nasal decongestion. Dextromethorphan is an NMDA receptor antagonist and sigma-1 receptor agonist that suppresses the cough reflex in the medulla oblongata.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between SUPRENZA and BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of SUPRENZA is: Adults: 200 mg orally twice daily with meals.. The standard adult dose of BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is: Adults and children ≥12 years: 1 tablet (brompheniramine maleate 4 mg, pseudoephedrine HCl 60 mg, dextromethorphan HBr 15 mg) orally every 4 hours, not to exceed 4 tablets in 24 hours, or 2 tablets (extended-release) every 12 hours, not to exceed 4 tablets in 24 hours.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between SUPRENZA and BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. SUPRENZA is classified as Category C. SuprENza (testosterone) is contraindicated in pregnancy due to virilization of female fetus. First trimester: high risk of clitoromegaly, labial fusion, and urogenital sinus abnorm. BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is classified as Category A/B. Brompheniramine: Limited human data; animal studies show no teratogenicity at clinically relevant doses. Pseudoephedrine: Case-control studies suggest small increased risk of gastr. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.