Dosing & Uses
Dosage Forms & 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
Dosage Forms & 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)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse 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
Cautions
Use caution in mild to moderate hypertension, cardiac disease, hyperthyroidism, hyperglycemia, BPH, DM, renal impairment, seizure disorder, thyroid dysfunction, glaucoma, lactation
Elderly may be more sensitive to side effects
When used for self-medication, see health-care provider if symptoms do not improve within 7 days or are accompanied by fever
Some products may contain sodium
Some dosage forms may contain sodium benzoate/benzoic acid; large amounts have been associated with a potentially fatal toxicity (gasping syndrome) in neonates
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 & Lactation
Pregnancy
Avoid, during first trimester; may be associated with possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to pseudoephedrine’s vasoconstrictive effects; magnitude of risk unknown
Fetal tachycardia reported following maternal use of extended release formulation for multiple days
Lactation
Excreted in breast milk; irritability reported in nursing infants (limited data); milk production may be decreased in some women
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
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
