acetaminophen/pseudoephedrine/guaifenesin (Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime)
Classes: Cough/Cold, Other Combos; Analgesic/Decongestant/Expectorant Combos
- Dosing and uses of Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime (acetaminophen/pseudoephedrine/guaifenesin)
- Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime (acetaminophen/pseudoephedrine/guaifenesin) adverse (side) effects
- Warnings
- Pregnancy
- Pharmacology of Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime (acetaminophen/pseudoephedrine/guaifenesin)
Dosing and uses of Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime (acetaminophen/pseudoephedrine/guaifenesin)
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