acetaminophen/dextromethorphan (Children's Triaminic Cough and Sore Throat Daytime, Children's Tylenol Plus Cough and Sore Throat, Tylenol Cough and Sore Throat Daytime)

Dosing and uses of Children's Triaminic Cough and Sore Throat Daytime, Children's Tylenol Plus Cough and Sore Throat (acetaminophen/dextromethorphan)

• Adult
• Pediatric

 

Adult dosage forms and strengths

acetaminophen/dextromethorphan

liquid

• (1000mg/30mg)/30mL
• (160mg/5mg)/5mL

 

Relief of Cold & Flu Symptoms

30mL [(1000mg/30mg)/30mL] PO q6hr; not to exceed 120 mL/day

 

Pediatric dosage forms and strengths

acetaminophen/dextromethorphan

liquid

• (1000mg/30mg)/30mL
• (160mg/5mg)/5mL

 

Relief of Cold & Flu Symptoms

4 Years Old

• Not recommended

4-6 Years Old

• 5mL [(160mg/5mg)/5mL] PO q4hr; not to exceed 5 doses/day

6-12 Years Old

• 10mL [(160mg/5mg)/5mL] PO q4hr; not to exceed 5 doses/day

>12 Years Old

• 30mL [(1000mg/30mg)/30mL] PO q6hr; not to exceed 120mL/day

 

Interactions

Frequency not defined

Dizziness

Drowsiness

Dermatologic rash

GI disturbances

Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

Bilirubin and alkaline phosphatase may increase

 

Warnings

Contraindications

Contraindicated in documented hypersensitivity; asthma attacks, narrow-angle glaucoma, symptomatic prostate hypertrophy, bladder-neck obstruction, and stenosing peptic ulcer; known G-6-PD deficiency

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

 

Cautions

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 Children's Triaminic Cough and Sore Throat Daytime, Children's Tylenol Plus Cough and Sore Throat (acetaminophen/dextromethorphan)

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.

 

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