guaifenesin/pseudoephedrine (Mucinex D, Guaifenex PSE, Refenesen Plus, Sinutab Non-Drying, Congestac)

Dosing and uses of Mucinex D, Guaifenex PSE (guaifenesin/pseudoephedrine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

guaifenesin/pseudoephedrine

caplet

• 400mg/60mg

tablet

• 400mg/20mg
• 400mg/30mg
• 400mg/40mg
• 400mg/60mg

tablet extended release

• 1200mg/120mg
• 600mg/60mg

 

Nasal Congestion, Loosening of Phlegm & Thin Bronchial Secretions

Musinex –D 600/60: 1-2 tab or cap PO q12hr; not to exceed 4 tab or cap/24hr

Musinex –D 1200/120: 1 tab or cap PO q12hr; not to exceed 2 tab or cap/24 hr

Congestac: 1 caplet PO q4-6hr; not to exceed 4 caplets/24hr

Maxifed G: 1-2 tap PO q12hr; not to exceed 4 tab/24hr

Maxifed: 1-1½ tab PO q12hr; not to exceed 3 tab/24hr

 

Pediatric dosage forms and strengths

guaifenesin/pseudoephedrine

caplet

• 400mg/60mg

tablet

• 400mg/20mg
• 400mg/30mg
• 400mg/40mg
• 400mg/60mg

tablet extended release

• 1200mg/120mg
• 600mg/60mg

 

Nasal Congestion, Loosening of Phlegm & Thin Bronchial Secretions

<6 years

• Ask a pediatrician

6-12 Years

• Ambifed G, Maxifed: ½ tab or cap PO q12hr; not to exceed 1 tab or cap/24hr
• Congestac: ½ caplet PO q4-6hr; not to exceed 2 caplets/24hr
• Maxifed-G: ½ - 1 tab PO q12hr; not to exceed 2 tab/24hr

>12 Years

• Musinex –D 600/60: 1-2 tab or cap PO q12hr; not to exceed 4 tab or cap/24hr
• Musinex –D 1200/120: 1 tab or cap PO q12hr; not to exceed 2 tab or cap/24 hr
• Congestac: 1 caplet PO q4-6hr; not to exceed 4 caplets/24hr
• Maxifed G: 1-2 tap PO q12hr; not to exceed 4 tab/24hr
• Maxifed: 1-1½ tab PO q12hr; not to exceed 3 tab/24hr

 

Mucinex D, Guaifenex PSE (guaifenesin/pseudoephedrine) adverse (side) effects

Frequency not defined

Arrhythmia

Palpitations

Convulsion

Dizziness

Drowsiness

Excitability

Headache

Tremor

Weakness

Nausea

Vomiting

 

Warnings

Contraindications

Contraindicated in documented hypersensitivity to either drug or components

Within 14 days of MAO inhibitor therapy

 

Cautions

Caution in cardiovascular disease, diabetes mellitus, prostatic hypertrophy and increased intraocular pressure when taking pseudoephedrine

Guaifenesin is not for administration in persistent cough associated with chronic bronchitis, smoking, asthma, or accompanied with excessive secretions

 

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 Mucinex D, Guaifenex PSE (guaifenesin/pseudoephedrine)

Mechanism of action

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

Pseudoephedrine stimulates the alpha-adrenergic receptors causing bronchodilation and vasoconstriction

 

Pharmacokinetics

Guaifenesin

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