Dosing and uses of Sudafed, Nexafed (pseudoephedrine)
Adult dosage forms and strengths
tablet, immediate-release
- 30mg
- 60mg
tablet, extended-release
- 120mg
- 240mg
tablet, IMPEDE technology (Nexafed)
- 30mg
- IMPEDE technology utilizes an advanced polymer matrix to limit extraction of pseudoephedrine from tablets and deter methamphetamine manufacturing
tablet, TAREX technology (Zephrex-D)
- 30mg
- TAREX technology utilizes an advanced polymer matrix to limit extraction of pseudoephedrine from tablets and deter methamphetamine manufacturing
syrup
- 3mg/mL
Nasal Congestion
Immediate release: 60 mg PO q4-6hr PRn
Extended release: 120 mg PO q12hr or 240 mg PO q24hr
Priapism (Off-label)
60-120 mg PO
Pediatric dosage forms and strengths
tablet, immediate-release
- 30mg
- 60mg
- 120mg
tablet, extended-release
- 120mg
- 240mg
tablet, IMPEDE technology (Nexafed)
- 30mg
- IMPEDE technology utilizes an advanced polymer matrix to limit extraction of pseudoephedrine from tablets and deter methamphetamine manufacturing
tablet, TAREX technology (Zephrex-D)
- 30mg
- TAREX technology utilizes an advanced polymer matrix to limit extraction of pseudoephedrine from tablets and deter methamphetamine manufacturing
syrup
- 3mg/mL
Nasal Congestion
<2 years: Safety and efficacy not established
2-6 years: 5-30 mg PO q4-6hr PRn
6-12 years: 30 mg PO q4-6hr, OR 4 mg/kg/day divided q6hr; not to exceed 120 mg/day
>12 years: 60 mg PO q6hr PRN (immediate release); alternatively, 120 mg PO q12hr (extended release) or 240 mg PO q24hr (extended release)
Dosing Considerations
Potential toxic dose <6 years: 11 mg/kg
Sudafed, Nexafed (pseudoephedrine) adverse (side) effects
Frequency not defined
Tremor
Restlessness
Insomnia
Nausea
Vomiting
Nervousness
Hypertension
Atrial fibrillation
Myocardial infarction
Ventricular premature beats
Ischemic colitis
Warnings
Contraindications
Hypersensitivity
Severe hypertension, severe CAd
Within 14 days of MAO inhibitor therapy
Newborns, preemies
Administration of extended release to patients <12 years
Cautions
Use caution in mild to moderate hypertension, cardiac disease, hyperthyroidism, hyperglycemia, BPH, DM, renal impairment, seizure disorder, thyroid dysfunction, and glaucoma
Lactation
Elderly may be more sensitive to side effects
See health-care provider if symptoms do not improve within 7 days or are accompanied by fever
Many combo formulations are switching to phenylephrine due to restrictions arising from easy conversion to methamphetamine (the Combat Methamphetamine Epidemic Act of 2005 bans OTC sales of cold medicines that contain ingredients, such as pseudoephedrine, commonly used to make methamphetamine)
Pregnancy and lactation
Pregnancy category: C
Lactation: Concentrated in breast milk, Mfr contraindicates (AAP Committee states compatible with nursing)
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Sudafed, Nexafed (pseudoephedrine)
Mechanism of action
Alpha-adrenergic agonist of receptors present in respiratory mucosa, causing vasoconstriction; directly stimulates beta-adrenergic receptors and causes bronchial relaxation, as well as increased heart rate and contractility.
Duration
60 mg: 3-8 hr
120 mg: 12 hr
Absorption
Minimal systemic
Onset: 30 min (PO)
Peak plasma time: 1.97 hr
Concentration: 422 ng/mL
Metabolism
Liver, by N-demethylation
Metabolites: Inactive
Elimination
Half-life: 9-16 hr (adults; urine pH 8); 3-6 hr (adults; urine pH 5)
Clearance: 7.3-7.6 mL/min/kg
Excretion: Urine
