EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE
Clinical safety rating: safe
MAOIs can cause hypertensive crisis Can cause insomnia and tachycardia.
Pseudoephedrine is a sympathomimetic amine that acts as a decongestant by stimulating alpha-adrenergic receptors in the respiratory tract mucosa, causing vasoconstriction and reducing nasal congestion. Brompheniramine is a first-generation antihistamine that competitively antagonizes histamine at H1 receptors, alleviating symptoms of allergic rhinitis.
| Metabolism | Pseudoephedrine is partially metabolized in the liver by N-demethylation via CYP450 enzymes; about 70-90% is excreted unchanged in urine. Brompheniramine is extensively metabolized in the liver via CYP450 enzymes (CYP2D6, CYP3A4) and other pathways, with renal excretion of metabolites. |
| Excretion | Pseudoephedrine: ~70-90% excreted unchanged in urine, with the remainder as inactive metabolites; renal elimination depends on urine pH (acidic urine increases excretion). Brompheniramine: ~75% metabolized in liver; renal excretion of metabolites and <5% unchanged; biliary/fecal elimination is minor. |
| Half-life | Pseudoephedrine: 4-6 hours (range 3-16 hours); prolonged in alkaline urine or renal impairment. Brompheniramine: 11-27 hours (mean ~24 hours); prolonged in elderly or hepatic impairment. |
| Protein binding | Pseudoephedrine: Low, ~20-30% bound to plasma proteins (primarily albumin). Brompheniramine: 70-80% bound to plasma proteins (albumin). |
| Volume of Distribution | Pseudoephedrine: 2.6-3.3 L/kg; distributes widely including CSF. Brompheniramine: 4.5-12 L/kg; extensive tissue distribution. |
| Bioavailability | Pseudoephedrine: Oral, ~100% (well absorbed). Brompheniramine: Oral, 50-70% due to first-pass metabolism. |
| Onset of Action | Pseudoephedrine: Oral, 15-30 minutes. Brompheniramine: Oral, 1-2 hours. |
| Duration of Action | Pseudoephedrine: Immediate release, 4-6 hours; extended release, up to 24 hours (as per EFIDAC 24). Brompheniramine: 4-6 hours for immediate release; extended release up to 12-24 hours (as per EFIDAC 24). |
1 tablet orally every 12 hours. Each tablet contains pseudoephedrine HCl 120 mg and brompheniramine maleate 4 mg.
| Dosage form | TABLET, EXTENDED RELEASE |
| Renal impairment | For eGFR 15-30 mL/min: avoid or reduce to 1 tablet every 24 hours. For eGFR <15 mL/min: contraindicated. |
| Liver impairment | Child-Pugh class A: no adjustment. Child-Pugh class B: reduce to 1 tablet every 24 hours. Child-Pugh class C: avoid or contraindicated. |
| Pediatric use | Not recommended for children under 12 years. For ages 12 and above, same as adult dosing. |
| Geriatric use | Avoid in patients >65 years due to increased risk of anticholinergic effects; if necessary, use 1 tablet every 24 hours. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
MAOIs can cause hypertensive crisis Can cause insomnia and tachycardia.
| FDA category | Animal |
| Breastfeeding | Pseudoephedrine: Excreted into breast milk; M/P ratio approximately 3.4. May reduce milk production due to vasoconstriction and decreased prolactin; avoid in breastfeeding. Brompheniramine: Excreted in small amounts; M/P ratio not well established. May cause irritability or drowsiness in infant; use with caution. Combination: Contraindicated due to pseudoephedrine's effect on milk supply. |
| Teratogenic Risk |
■ FDA Black Box Warning
None
| Common Effects | Insomnia |
| Serious Effects |
["Hypersensitivity to pseudoephedrine, brompheniramine, or any component","Severe hypertension or coronary artery disease","Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation","Glaucoma","Urinary retention due to prostatic hypertrophy or other obstructive uropathy","Breastfeeding (may reduce milk production due to pseudoephedrine)","Children under 6 years of age (due to risk of serious adverse effects)"]
| Precautions | ["May cause drowsiness; avoid driving or operating machinery","Use with caution in patients with hypertension, cardiovascular disease, diabetes, hyperthyroidism, increased intraocular pressure, prostatic hypertrophy, or urinary retention","Avoid concurrent use with MAO inhibitors or within 14 days of stopping them","Do not exceed recommended dosage due to risk of serious cardiovascular effects","Not recommended for patients with severe hepatic or renal impairment","May cause excitability in children, especially with overdose"] |
Loading safety data…
| Pseudoephedrine: First trimester use associated with gastroschisis (OR 1.8, 95% CI 1.0-3.2); avoid in first trimester. Second/third trimester: Risk of fetal tachycardia and reduced uterine blood flow; use only if benefit outweighs risk. Brompheniramine: Generally considered low risk; no consistent teratogenic signals. FDA Category for combination: Not assigned; pseudoephedrine is C, brompheniramine is B. |
| Fetal Monitoring | Monitor maternal blood pressure and heart rate due to pseudoephedrine's sympathomimetic effects. In third trimester, assess fetal heart rate and uterine activity if prolonged use. Watch for signs of fetal tachycardia or maternal hypertension. No specific fetal monitoring required for brompheniramine. |
| Fertility Effects | No direct evidence of adverse effects on fertility. Pseudoephedrine may cause transient vasoconstriction of reproductive organs; theoretical concern but no human data. Brompheniramine has no known impact on fertility. Combination not studied for fertility endpoints. |