acetaminophen/dextromethorphan/pseudoephedrine/guaifenesin (OTC)

Brand and Other Names:Tylenol Cold Severe Congestion
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/dextromethorphan/pseudoephedrine/guaifenesin

tablet

  • 325mg/15mg/30mg/200mg
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Symptomatic Relief of Cough & Congestion

2 tablets PO q6hr; not to exceed 8 tablets/day

Dosage Forms & Strengths

acetaminophen/dextromethorphan/pseudoephedrine/guaifenesin

tablet

  • 325mg/15mg/30mg/200mg
more...

Symptomatic Relief of Cough & Congestion

<12 Years Old

  • Not recommended

>12 Years Old

  • 2 tablets PO q6hr; not to exceed 8 tablets/day
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Interactions

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            Adverse Effects

            Frequency Not Defined

            Arrhythmia

            Palpitations

            Convulsion

            Dizziness

            Drowsiness

            Excitability

            Headache

            Tremor

            Weakness

            Dermatologic rash

            GI disturbances

            Nausea

            Vomiting

            Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

            Bilirubin and alkaline phosphatase may increase

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            Warnings

            Contraindications

            Documented hypersensitivity to the drugs or within 14 days of MAO inhibitor therapy; known G-6-PD deficiency

            Cautions

            Caution in cardiovascular disease, diabetes mellitus, prostatic hypertrophy and increased intraocular pressure when taking 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

            Do not take dextromethorphan for persistent or chronic cough associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm unless directed by a healthcare provider; dextromethorphan may slow the breathing

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

            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

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            Pregnancy & Lactation

            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.

            Dextromethorphan is a cough suppressant that acts centrally on the cough center in the medulla.

            Pseudoephedrine stimulates the alpha-adrenergic receptors causing bronchodilation and 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

            Dextromethorphan

            • Onset: 15-30 min
            • Duration: 3-6 hr
            • Metabolism: Hepatic P450 enzyme CYP2D6
            • Excretion: Urine
            • Half-life: 2-4 hr (extensive metabolizers); 24 hr (poor metabolizers)
            • Peak plasma time: 2-3 hr

            Pseudoephedrine

            • Half-Life: 3 hr (children); 9-16 hr (adults)
            • Onset: 30 min (decongestant)
            • Duration: 3-8 hr  
            • Peak PlasmaTime: 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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