PSEUDO-12
Clinical safety rating
cautionComprehensive clinical and safety monograph for PSEUDO-12 (PSEUDO-12).
Decongestant; acts on alpha-adrenergic receptors in the nasal mucosa to produce vasoconstriction, reducing edema and nasal congestion.
| Metabolism | Hepatic metabolism via N-demethylation (CYP3A4) and glucuronidation; minor renal excretion as unchanged drug. |
| Excretion | Renal: 70-90% as unchanged drug; biliary/fecal: <10% |
| Half-life | Terminal elimination half-life: 4-6 hours (adults); 6-8 hours (children); prolonged in renal impairment (up to 20 hours in severe disease). |
| Protein binding | Binding: 30-40%; primarily to albumin. |
| Volume of Distribution | Vd: 2.6-3.5 L/kg; indicates extensive tissue distribution (e.g., lungs, liver, kidney). |
| Bioavailability | Oral: 90-100% (immediate-release); 80-90% (extended-release). |
| Onset of Action | Oral: 30 minutes (immediate-release); 1-2 hours (extended-release). |
| Duration of Action | Oral: 4-6 hours (immediate-release); 12 hours (extended-release). Tolerance may develop with prolonged use. |
| Molecular Weight | 165.23 |
60 mg orally every 4 to 6 hours as needed; maximum 240 mg per day.
| Dosage form | SUSPENSION, EXTENDED RELEASE |
| Renal impairment | eGFR 30-50 mL/min: 30 mg every 6 hours as needed; maximum 120 mg/day. eGFR <30 mL/min: 30 mg every 12 hours as needed; maximum 60 mg/day. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: 30 mg every 6 hours as needed; maximum 120 mg/day. Child-Pugh C: use is not recommended. |
| Pediatric use | Children 6-12 years: 30 mg orally every 4-6 hours; maximum 120 mg/day. Children 12-17 years: same as adult dosing. |
| Geriatric use | Initiate at 30 mg every 6 hours as needed; maximum 120 mg/day due to increased sensitivity and higher risk of adverse effects. |
| 1st trimester | Avoid due to potential association with infant gastroschisis. |
| 2nd trimester | Avoid unless benefit outweighs risk; monitor for hypertension. |
| 3rd trimester | Avoid near term due to risk of neonatal hemorrhage. |
Clinical note
Comprehensive clinical and safety monograph for PSEUDO-12 (PSEUDO-12).
| Placental transfer | Crosses placenta; fetal concentrations similar to maternal. |
| Breastfeeding | Pseudoephedrine is excreted into breast milk in small amounts; may reduce milk production. Use with caution. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: no evidence of structural teratogenicity in human studies but avoid due to potential vasoconstriction. Second/third trimester: risk of fetal tachycardia, decreased placental perfusion, and potential for maternal hypertension; prolonged use may cause fetal hypoxia. |
| Fetal Monitoring | Monitor maternal blood pressure and heart rate; fetal heart rate monitoring if prolonged use or high doses; assess for signs of placental insufficiency. |
| Fertility Effects | No known adverse effects on human fertility; animal studies show no impairment. |
■ FDA Black Box Warning
None.
| Serious Effects |
Malignant hypertensionSevere coronary artery diseaseConcurrent MAOI therapyAngle-closure glaucoma
| Precautions | Cardiovascular effects: hypertension, palpitations, arrhythmias; CNS stimulation: insomnia, anxiety, tremor; exacerbation of glaucoma, hyperthyroidism, diabetes; urinary retention in prostatic hypertrophy; rebound congestion with prolonged use. |
| Food/Dietary | Avoid high-tyramine foods (e.g., aged cheeses, cured meats, fermented products) if taking MAOIs concurrently. Limit caffeine-containing beverages as they may increase CNS stimulation. |
| Clinical Pearls | Pseudoephedrine is a sympathomimetic amine used as a decongestant. It is contraindicated in severe hypertension, coronary artery disease, and concurrent MAOI use. Monitor for CNS stimulation, insomnia, and elevated blood pressure. Extended-release formulations should not be crushed or chewed. |
| Patient Advice | Do not use if you have high blood pressure or heart disease unless directed by a doctor. · Avoid taking within 4 hours of bedtime to prevent insomnia. · Do not crush or chew extended-release tablets. · Limit caffeine intake while taking this medication. · Stop use and consult a doctor if symptoms persist after 7 days. |
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