acetaminophen/pseudoephedrine/guaifenesin (OTC)

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Brand and Other Names:Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/pseudoephedrine/guaifenesin

tablet

  • 325mg/30mg/200mg
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Temporary Relief of Minor Aches & Pains, Headache, & Nasal Congestion

2 tablets PO q4-6hr; not to exceed 8 capsules/day; not to exceed 1 g acetaminophen/4hr and 4 g aceteminophen/day

Dosage Forms & Strengths

acetaminophen/pseudoephedrine/guaifenesin

capsule

  • 325mg/30mg/200mg
more...

Temporary Relief of Minor Aches & Pains, Headache, & Nasal Congestion

<12 years: Ask a pediatrician

≥12 years

  • 2 tablets PO q4-6hr; not to exceed 8 capsules/day; not to exceed 1 g acetaminophen/4hr and 4 g aceteminophen/day
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Interactions

Interaction Checker

and acetaminophen/pseudoephedrine/guaifenesin

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            Adverse Effects

            Frequency Not Defined

            Arrhythmia

            Palpitations

            Convulsion

            Dizziness

            Drowsiness

            Excitability

            Headache

            Tremor

            Nausea

            Vomiting

            Dermatologic rash

            Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

            Bilirubin & alkaline phosphatase may increase

            Weakness

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            Warnings

            Contraindications

            Hypersensitivity

            Within 14 days of MAO inhibitor therapy

            G-6-PD deficiency

            Severe hepatic impairment

            Cautions

            Cardiovascular disease, diabetes mellitus, prostatic hypertrophy & increased intraocular pressure may occur with pseudoephedrine

            Acetaminophen hepatotoxicity possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness; contained in many OTC products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose

            Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

            Guaifenesin is not for administration in persistent cough associated with chronic bronchitis, smoking, asthma, or accompanied with excessive secretions

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: excreted in breast milk, use caution

            Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

            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

            Acetaminophen: blocks pain impulse generation peripherally and may inhibit the generation of prostaglandin in the CNS; reduces fever by inhibiting the hypothalamic heat-regulating center

            Pseudoephedrine: stimulates the alpha-adrenergic receptors causing bronchodilation & vasoconstriction

            Guaifenesin: increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions

            Pharmacokinetics

            Acetaminophen

            • Peak plasma time: 10-60 min (PO immediate release); 60-120 min (PO extended release); 6 hr (PO 500 mg tablet); 8 hr (PO 650 mg extended release tablet)
            • Vd: 1 L/kg
            • Protein binding: 10-25%
            • Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic acid)
            • Half-life: 1.25-3hr
            • Excretion: Urine

            Pseudoephedrine

            • Half-Life: 3 hr (children); 9-16 hr (adults)
            • Onset: 30 min (decongestant)
            • Duration: 3-8 hr  
            • Peak Plasma Time: 1.97 hr
            • Concentration: 422 ng/mL
            • Metabolism: Liver, by N-demethylation
            • Metabolites: Inactive
            • Clearance: 7.3-7.6 mL/min/kg
            • Excretion: Urine (43-96%)

            Guaifenesin

            • Half-Life: 1 hr
            • Onset: 30 min
            • Duration: 4-6 hr
            • Metabolism: Liver
            • Metabolite: b-(2-methoxyphenoxy) lactic acid
            • Excretion: Urine
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            Images

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