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acetaminophen/pseudoephedrine (Allerest Allergy and Sinus Relief, Children's Tylenol Cold Daytime, Genatap Sinus Maximum Strength, Mapap Sinus Maximum Strength, Medi-Synal, Omex, Oranyl Plus, Sinus-Relief, Tylenol Cold Daytime, Tylenol Sinus Daytime)

 

Classes: Cough/Cold, Other Combos; Analgesic/Decongestant Combos

Dosing and uses of Allerest Allergy and Sinus Relief, Children's Tylenol Cold Daytime (acetaminophen/pseudoephedrine)

 

Adult dosage forms and strengths

acetaminophen/pseudoephedrine

caplet

  • 325mg/30mg
  • 500mg/30mg

 

Relief of Cold & Flu Symptoms

2 caplets [(325mg/30mg)/caplet] PO q4-6hr; not to exceed 12 caplets/24hours

2 caplets [(500mg/30mg)/caplet] PO q6hr; not to exceed 8 caplets/24hours

 

Pediatric dosage forms and strengths

acetaminophen/pseudoephedrine

caplet

  • 325mg/30mg
  • 500mg/30mg

 

Relief of Cold & Flu Symptoms

<6 Years Old

  • Ask a pediatrician

6-12 Years Old

  • 1 caplet [(325mg/30mg)/caplet] PO q4-6hr; not to exceed 12 caplets/24hours

>12 Years Old

  • 2 caplets [(325mg/30mg)/caplet] PO q4-6hr; not to exceed 12 caplets/24hours
  • 2 caplets [(500mg/30mg)/caplet] PO q6hr; not to exceed 8 caplets/24hours

 

Allerest Allergy and Sinus Relief, Children's Tylenol Cold Daytime (acetaminophen/pseudoephedrine) adverse (side) effects

Common Adverse effects

Arrhythmia

Palpitations

Convulsion

Dizziness

Drowsiness

Excitability

Tremor

Dermatologic rash

Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

Bilirubin and alkaline phosphatase may increase

Weakness

 

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

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

 

Pregnancy and 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.

 

Pharmacology of Allerest Allergy and Sinus Relief, Children's Tylenol Cold Daytime (acetaminophen/pseudoephedrine)

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 and vasoconstriction.

 

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%)