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pseudoephedrine (OTC)Brand and Other Names:Sudafed, Nexafed, more...Zephrex-D

 
 
 

Dosing & Uses

AdultPediatric

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
more...

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
more...

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 

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Interactions

Interaction Checker

pseudoephedrine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Tremor

            Restlessness

            Insomnia

            Nausea

            Vomiting

            Nervousness

            Hypertension

            Atrial fibrillation

            Myocardial infarction

            Ventricular premature beats

            Ischemic colitis

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            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)

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            Pregnancy & 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.

            more...
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            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

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