acetaminophen/pseudoephedrine/guaifenesin (Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime)

Dosing and uses of Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime (acetaminophen/pseudoephedrine/guaifenesin)

• Adult
• Pediatric

 

Adult dosage forms and strengths

acetaminophen/pseudoephedrine/guaifenesin

tablet

• 325mg/30mg/200mg

 

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

 

Pediatric dosage forms and strengths

acetaminophen/pseudoephedrine/guaifenesin

capsule

• 325mg/30mg/200mg

 

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

 

Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime (acetaminophen/pseudoephedrine/guaifenesin) adverse (side) 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

 

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

 

Pregnancy and 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.

 

Pharmacology of Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime (acetaminophen/pseudoephedrine/guaifenesin)

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