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dextromethorphan/phenylephrine/guaifenesin (Children's Mucinex Multi-Symptom Cold, Robitussin Peak Cold Multi-Symptom Cold, Robitussin Peak Cold Maximum Strength Multi-Symptom Cold, Children's Robitussin Cough and Cold CF, Robafen CF Liquid, Broncotron-D Suspension, Deconex DMX Tablets, Mucinex Fast-Max Severe Congestion and Cough, Q-Tussin CF Liquid)

 

Classes: Cough/Cold, Non-narcotic Combos; Antitussive/Decongestant/Expectorant Combos

Dosing and uses of Children's Mucinex Multi-Symptom Cold, Robitussin Peak Cold Multi-Symptom Cold (dextromethorphan/phenylephrine/guaifenesin)

 

Adult dosage forms and strengths

dextromethorphan/phenylephrine/guaifenesin

liquid

  • (5mg/2.5mg/100mg)/5mL
  • (5mg/2.5mg/50mg)/5mL
  • (10mg/5mg/200mg)/5mL
  • (20mg/10mg/200mg)/5mL
  • (10mg/5mg/100mg)/5mL

tablet

  • 20mg/10mg/400mg

syrup

  • (10mg/5mg/100mg)/5mL

 

Temporary Relief of Nasal Congestion, Cough & Bronchial Irritation

1 tab PO q4-6hr; not to exceed 4 tabs/day

10 mL [(10mg/5mg/200mg)/5mL] PO q4hr; not to exceed 60 mg/day

 

Pediatric dosage forms and strengths

dextromethorphan/phenylephrine/guaifenesin

liquid

  • (5mg/2.5mg/100mg)/5mL
  • (5mg/2.5mg/50mg)/5mL
  • (10mg/5mg/200mg)/5mL
  • (20mg/10mg/200mg)/5mL
  • (10mg/5mg/100mg)/5mL

tablet

  • 20mg/10mg/400mg

syrup

  • (10mg/5mg/100mg)/5mL

 

Temporary Relief of Nasal Congestion, Cough & Bronchial Irritation

4-6 years

  • 5 mL [(5mg/2.5mg/100mg)/5mL] PO q4hr; not to exceed 30 mL/day
  • 5 mL [(5mg/2.5mg/50mg)/5mL] PO q4hr; not to exceed 30 mL/day

6-12 years

  • ½ tablet PO q4-6hr; not to exceed 2 tablets/day
  • 10 mL [(5mg/2.5mg/100mg)/5mL] PO q4hr; not to exceed 30 mL/day
  • 10 mL [(5mg/2.5mg/50mg)/5mL] PO q4hr; not to exceed 30 mL/day

>12 years

  • 1 tab PO q4-6hr; not to exceed 4 tabs/day
  • 10 mL [(10mg/5mg/200mg)/5mL] PO q4hr; not to exceed 60 mg/day

 

Children's Mucinex Multi-Symptom Cold, Robitussin Peak Cold Multi-Symptom Cold (dextromethorphan/phenylephrine/guaifenesin) adverse (side) effects

Frequency not defined

Hypertension

Severe peripheral and visceral vasoconstriction

Tachycardia

Dizziness

Drowsiness

Excitability

Headache

Restlessness

Tremor

Nausea

Vomiting

 

Warnings

Contraindications

Documented hypersensitivity to any of the drugs or component of the formulations

Severe hypertension; coronary artery disease; use within 14 days of a MAO inhibitor; prostatic hypertrophy

 

Cautions

Guaifenesin may increase renal clearance of urate and lower serum uric acid levels; may interfere with urine laboratory tests for 5-hydroxyindoleacetic acid and urine testing for catecholamines

Guanethidine may increase pressor response of direct-acting vasopressors, like phenylephrine, possibly resulting in severe hypertension

Quinidine may inhibit the metabolism of dextromethorphan increasing its toxicity (adjust dose); concurrent use of dextromethorphan with MAO inhibitors may cause hyperpyrexia, abnormal muscle movement, hypotension, coma, and death (avoid use for 2 weeks after stopping the MAO inhibitor; coadministration of dextromethorphan with sibutramine may cause serotonin syndrome (concomitant use not recommended)

Caution in diabetes, cardiovascular disease, increased intraocular pressure, thyroid dysfunction

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Excretion in milk unknown; use with 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 Children's Mucinex Multi-Symptom Cold, Robitussin Peak Cold Multi-Symptom Cold (dextromethorphan/phenylephrine/guaifenesin)

Mechanism of action

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

Guaifenesin increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions.

Phenylephrine is a vasoconstrictor and a decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue. It shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia.

 

Pharmacokinetics

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

Guaifenesin

  • Half-Life: 1 hr
  • Onset: 30 min
  • Duration: 4-6 hr
  • Metabolism: Liver
  • Metabolite: b-(2-methoxyphenoxy) lactic acid
  • Excretion: Urine

Phenylephrine

  • Half-life: 2-3 hr
  • Onset: 10-15 min
  • Duration: 15 min
  • Bioavailability: < 38%
  • Excretion: Urine (80-90%)
  • Peak plasma time: 0.75-2 hr
  • Vd: 26-61 L
  • Vdss: 340 L