Guaifenesin

Class: Expectorants
VA Class: RE516
CAS Number: 93-14-1
Brands: Bronkaid, Children’s Mucinex, Children’s Robitussin, Congestac, Mucinex, Mucinex D, Mucinex DM, Pediacare, Primatene, Rescon-GG, Robitussin Peak Cold, Theraflu, Theraflu Max-D, Theraflu Warming Relief, Triaminic, Tylenol Cold & Flu Severe, Tylenol Cold Multi-Symptom Severe, Vick’s Dayquil, Vick’s Formula 44, Vick’sNature Fusion

Introduction

Expectorant.^a

Uses for Guaifenesin

Cough

Symptomatic management of productive cough to loosen and thin sputum and bronchial secretions and ease expectoration.^a

Improves cough symptoms associated with common cold, bronchitis, laryngitis, pharyngitis, pertussis, influenza, measles, and coughs provoked by chronic paranasal sinusitis.^a

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May be useful in the management of irritative nonproductive cough and coughs productive of scanty amounts of thick, viscous secretions.^a

May indirectly diminish the tendency to cough, but mechanism of this effect differs from that of antitussives (which inhibit or suppress cough); insufficient evidence to support efficacy as antitussive.^a

Used in fixed combination with other agents (e.g., acetaminophen, chlorpheniramine, dextromethorphan, ephedrine, phenylephrine, pseudoephedrine) for the temporary relief of productive cough and/or other symptoms (nasal congestion, fever).^{e f g h i j}

Guaifenesin Dosage and Administration

Administration

Administer orally.^a

Do not break, crush, or chew extended-release tablets.^a

Dosage

Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.

Pediatric Patients

Cough

Oral

Children <2 years of age: Individualize dosage.^a (See Pediatric Use under Cautions.)

Children 2 to <6 years of age, conventional preparations: 50–100 mg every 4 hours, up to 600 mg daily.^a (See Pediatric Use under Cautions.)

Children 2–6 years of age, extended-release preparations: 300 mg every 12 hours, up to 600 mg daily.^a (See Pediatric Use under Cautions.)

Children 6 to <12 years of age, conventional preparations: 100–200 mg every 4 hours, up to 1.2 g daily.^a

Children 6–12 years of age, extended-release preparations: 600 mg every 12 hours, up to 1.2 g daily.^a

Children ≥12 years of age, conventional preparations: 200–400 mg every 4 hours, up to 2.4 g daily.^a

Children ≥12 years of age, 600-mg extended-release tablets: 600 mg or 1.2 g every 12 hours, up to 2.4 g daily.^a

Adults

Cough

Oral

Conventional preparations: 200–400 mg every 4 hours, up to 2.4 g daily.^a

600-mg extended-release tablets: 600 mg or 1.2 g every 12 hours, up to 2.4 g daily.^a

Prescribing Limits

Pediatric Patients

Cough

Oral

Children 2 to <6 years of age, conventional preparations: Maximum 600 mg daily.^a

Children 2–6 years of age, extended-release preparations: Maximum 600 mg daily.^a

Children 6 to <12 years of age, conventional preparations: Maximum 1.2 g daily.^a

Children 6–12 years of age, extended-release preparations: Maximum 1.2 g daily.^a

Children ≥12 years of age, conventional preparations: Maximum 2.4 g daily.^a

Children ≥12 years of age, extended-release preparations: Maximum 2.4 g daily.^a

Adults

Cough

Oral

Conventional preparations: Maximum 2.4 g daily.^a

Extended-release preparations: Maximum 2.4 g daily.^a

Cautions for Guaifenesin

Contraindications

• Known hypersensitivity to guaifenesin.

Warnings/Precautions

General Precautions

Excessive Dosage

Emesis may result from doses larger than those required for expectorant action, but GI upset at ordinary dosage is rare.^a

Persistent Cough

Do not use as self-medication for persistent or chronic cough (e.g., that associated with smoking, asthma, chronic bronchitis, emphysema), or cough accompanied by excessive phlegm unless directed by a clinician.^a

Persistent cough may indicate serious condition; if it persists for >1 week, is recurrent, or is accompanied by fever, rash, or persistent headache, consult a clinician.^a

Use of Fixed Combinations

When used in fixed combination with other agents (e.g., acetaminophen, chlorpheniramine, dextromethorphan, ephedrine, phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).^{e f g h i j}

Specific Populations

Pregnancy

Category C.^b

Lactation

Not known whether guaifenesin is distributed into milk.^b

Pediatric Use

Safety and efficacy of Mucinex 600-mg extended-release tablets not established in children <12 years of age.^a

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.^{c d} Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.^c Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Stability

Storage

Tight containers.^a

Actions

• Reduces the viscosity of tenacious secretions and acts as an expectorant by increasing respiratory tract fluid.^a

• Increases expectorated sputum volume over the first 4–6 days of a productive cough, decreases sputum viscosity and difficulty in expectoration, and improves associated symptoms.^a

Advice to Patients

• Importance of contacting a clinician if cough persists for >1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.^a

• Importance of not using for self-medication for persistent or chronic cough unless directed by a clinician.^a

• Importance of keeping Mucinex 600-mg extended-release tablets out of reach of young children to avoid accidental swallowing and choking.^a

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Many prescription cough, cold, and allergy preparations commercially available in the US have not been approved by the US Food and Drug Administration (FDA). Because of the potentially serious health risks associated with unapproved preparations, FDA announced on March 3, 2011, that it would take enforcement action (e.g., seizure, injunction, other judicial or administrative proceeding) against any currently marketed and listed unapproved cough, cold, and allergy preparation manufactured on or after June 1, 2011, or shipped on or after August 30, 2011. For additional information and for a complete list of unapproved cough, cold, and allergy preparations affected by this FDA notice, see FDA website ().

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Guaifenesin also is commercially available in combination with antihistamines, antitussives, bronchodilators, decongestants, and expectorants.

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 118/$12.99 or 354/$19.97

Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 473/$15.99 or 1419/$25.97

Cheratussin DAC 30-10-100MG/5ML Solution (QUALITEST): 473/$35.99 or 946/$60.97

Donatussin 10-2-15-100MG/5ML Syrup (LASER PHARMACEUTICALS): 473/$36.25 or 1419/$108.75

Duraphen Forte 30-30-1200MG 12-hr Tablets (KOWA PHARMACEUTICALS AMERICA): 100/$135.98 or 300/$375.97

GFN 1200/DM 60 1200-60MG 12-hr Tablets (CYPRESS PHARMACEUTICAL): 30/$24.99 or 90/$65.97

GNP Mucus Relief 400MG Tablets (BERGEN BRUNSWIG): 50/$14.99 or 100/$19.97

GNP Tab Tussin DM 20-400MG Tablets (AMERISOURCE BERGEN DRUGS): 24/$12.99 or 48/$15.97

Guaifenesin-Codeine 100-10MG/5ML Solution (PHARMACEUTICAL ASSOCIATES): 473/$14.99 or 946/$18.97

Guaifenesin-DM 100-10MG/5ML Liquid (MORTON GROVE PHARMACEUTICALS): 240/$18.99 or 720/$49.97

Guiatuss 100MG/5ML Syrup (IVAX PHARMACEUTICALS): 473/$14.99 or 946/$18.97

Mucinex 600MG 12-hr Tablets (RECKITT BENCKISER): 20/$19.99 or 40/$28.97

Mytussin DAC 30-10-100MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 473/$39.66 or 1419/$118.98

Q-Tussin DM 100-10MG/5ML Syrup (QUALITEST): 120/$11.99 or 240/$13.97

Respaire-30 30-150MG Capsules (LASER PHARMACEUTICALS): 100/$58.99 or 200/$105.98

Robitussin DM 100-10MG/5ML Syrup (PFIZER CONSUMER HEALTHCARE): 237/$17.99 or 474/$25.98