phenylephrine/guaifenesin (OTC)

Brand and Other Names:Sudafed PE Non-Drying Sinus Caplets
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

phenylephrine/guaifenesin

caplet

  • 5mg/200mg
  • 10mg/400mg

tablet

  • 5mg/200mg
  • 10mg/400mg

liquid

  • (7.5mg/100mg)/5mL
  • (2.5mg/100mg)/5mL
  • (10mg/200mg)/5mL
  • (5mg/100mg)/5mL

syrup

  • (5mg/200mg)/5mL
  • (2.5mg/50mg)/5mL
more...

Congestion with Mucus

2 tabs/caps [(5mg/200mg)/tab] PO q4hr; not to exceed 12 tabs/24hr

Administration

Give with food if GI upset occurs

Dosage Forms & Strengths

phenylephrine/guaifenesin

caplet 

  • 5mg/200mg
  • 10mg/400mg

tablet

  • 5mg/200mg
  • 10mg/400mg

liquid

  • (7.5mg/100mg)/5mL
  • (2.5mg/100mg)/5mL
  • (10mg/200mg)/5mL
  • (5mg/100mg)/5mL

syrup

  • (5mg/200mg)/5mL
  • (2.5mg/50mg)/5mL
more...

Congestion with Mucus

<6 years

  • Safety and efficacy not established

6-12 years

  • 10 mL [(2.5mg/50mg)/5mL] PO q4hr PRN; not to exceed 60 mL/24hr
  • 10 mL [(2.5mg/100mg)/5mL] PO q4hr PRN; not to exceed 60 mL/24hr

>12 years

  • 2 tabs/caps [(5mg/200mg)/tab] PO q4hr; not to exceed 12 tabs/24hr
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Interactions

Interaction Checker

and phenylephrine/guaifenesin

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            Frequency Not Defined

            Headache

            Dizziness

            Anxiety

            Nervousness

            Restlessness

            Tremor

            Weakness

            Insomnia

            Hallucinations

            Convulsions

            CNS depression

            Tachycardia

            Palpitations

            Arrhythmias

            Cardiovascular collapse with hypotension

            Respiratory difficulty

            Nausea

            Dysuria

            Pallor

            Rash

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            Warnings

            Contraindications

            Hypersensitivity to either component

            Severe hypertension

            Severe cardiovascular disease

            Use within 14 days of MAO inhibitor

            Closed angle glaucoma

            Cautions

            Do not use as self-medication in chronic or persistent coughs

            Caution in cardiovascular disease, diabetes, increased intraocular pressure/glaucoma, BPH, thyroid dysfunction, or GU obstruction

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: small amounts of phenylephrine excreted in breast milk, caution advised

            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.

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            Pharmacology

            Mechanism of Action

            Phenylephrine: Strong alpha effects resulting in increased PVR and BP and decreased COand renal perfusion

            Guaifenesin: Reduces viscosity of secretions by increasing amount of respiratory tract fluid

            Half-Life

            Phenylephrine: 2-3 hr

            Guaifenesin: 1 hr

            Onset

            Phenylephrine: 10-15 min

            Guaifenesin: 30 min

            Duration

            Guaifenesin: 4-6 hr

            Phenylephrine: 15 min (IV); 1-2 hr (IM); 50 min (SC)

            Metabolism

            Phenylephrine: Extensively in intestinal wall, moderately in liver

            Guaifenesin: Liver

            Metabolites

            Penylephrine: M-hydroxymandelic acid (inactive)

            Guaifenesin: b-(2-methoxyphenoxy) lactic acid

            Excretion

            Phenylephrine: Urine (80-90%)

            Guaifenesin: Urine

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