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Guaifenesin and Pseudoephedrine


Pronunciation

 (gwye FEN e sin & soo doe e FED rin)


U.S. Brand Names

 Ambifed-G; Ami-Tex PSE; Aquatab® D [DSC]; Congestac® [OTC]; Dynex; Entex® PSE; Eudal®-SR; G-Phed; Guaifenex® GP; Guaifenex® PSE; Guaifenex™-Rx [DSC]; Guaimax-D®; Levall G; Maxifed®; Maxifed-G®; Miraphen PSE; Mucinex®-D [OTC]; Nasatab® LA; PanMist®-JR; PanMist®-LA; PanMist®-S; Profen Forte®; Profen II®; Pseudoevent™ 400; Pseudo GG TR; Pseudovent™; Pseudovent™-Ped; Refenesen Plus [OTC]; Respaire®-60 SR; Respaire®-120 SR; Robitussin-PE® [OTC]; Robitussin® Severe Congestion [OTC]; Sudafed® Non-Drying Sinus [OTC]; Touro LA®; Zephrex®; Zephrex LA®


Synonyms

 Pseudoephedrine and Guaifenesin


Generic Available

 Yes


Canadian Brand Names

 Novahistex® Expectorant with Decongestant


Use

 Temporary relief of nasal congestion and to help loosen phlegm and thin bronchial secretions in the treatment of cough


Pregnancy Risk Factor

 C


Pregnancy Implications

 Animal reproduction studies have not been conducted with this combination. Refer to individual monographs.


Lactation

 Enters breast milk/contraindicated (by some manufacturers)


Contraindications

 Hypersensitivity to guaifenesin, pseudoephedrine, sympathomimetic amines, or any component of the formulation; use with or within 14 days of MAO inhibitor; severe hypertension or cardiovascular disease


Warnings/Precautions

 Underlying cause of cough should be determined prior to prescribing. Use caution with persistent or chronic cough (as with smoking, asthma, chronic bronchitis, emphysema) or if cough is accompanied by excessive phlegm. Re-evaluate if cough persists >7 days. Use caution with hypertension, hyperthyroidism, diabetes mellitus, cardiovascular disease, ischemic heart disease, increased intraocular pressure, or benign prostatic hyperplasia (BPH). Elderly patients are more likely to experience adverse reactions to sympathomimetics.

When used for self medication (OTC) contact healthcare provider if needed for >7 days or if symptoms occur with a fever, rash, or persistent headache.


Adverse Reactions

 See individual agents.


Drug Interactions

 See individual agents.


Pharmacodynamics/Kinetics

 See individual agents.


Dosage

 Oral:

Children 2-6 years:

Guaifenex® PSE 60: One-half tablet every 12 hours (maximum: 1 tablet/12 hours)

Maxifed-G: One-third to 1 /2 tablet every 12 hours (maximum: 1 tablet/12 hours)

PanMist® S: 2.5 mL 4 times/day (maximum: Pseudoephedrine 4 mg/kg/day)

Robitussin® PE: 2.5 mL every 4-6 hours (maximum: 4 doses/24 hours)

Children 6-12 years:

Ambifed-G, Dynex, Eudal-SR, Guaimax-D®, Guaifenex® PSE 80, Guaifenex® PSE 120, Maxifed, Miraphen PSE, Nasatab LA, PanMist® LA, Profen II®, Profen Forte®, Zephrex® LA: One-half caplet or tablet every 12 hours (maximum: 1 tablet/24 hours)

Congestac®: One-half caplet every 4-6 hours (maximum: 2 caplets/24 hours)

Guaifenex® PSE 60, PanMist®-Jr, Pseudovent™-Ped, Respaire®-60 SR: One tablet or capsule every 12 hours (maximum: 2 tablets or capsules every 24 hours)

Levall-G: One capsule every 24 hours

Maxifed-G: One-half to 1 tablet every 12 hours (maximum: 2 tablets/24 hours)

PanMist® S: 5 mL 4 times/day (maximum: Pseudoephedrine 4 mg/kg/day)

Robitussin® PE: 5 mL every 4-6 hours (maximum: 4 doses/24 hours)

Robitussin® Severe Congestion: One capsule every 4 hours (maximum: 4 doses/24 hours)

Zephrex®: One-half tablet every 6 hours

Children >12 years and Adults:

Ambifed-G, Aquatab® D, Dynex, Entex® PSE, Eudal- SR, G-Phed, Guaifenex® GP, Guaifenex® PSE 120, Guaimax-D®, Levall-G, Miraphen PSE, Mucinex®-D 1200/120, Nasatab LA, PanMist® LA, Profen Forte®, Pseudovent™, Respaire®-120 SR, Touro LA, Zephrex® LA: One tablet or capsule every 12 hours (maximum: 2 tablets or capsules in 24 hours)

Congestac®: One caplet every 4-6 hours (maximum: 4 caplets in 24 hours)

Guaifenex® PSE 60, Maxifed-G, Mucinex®-D 600/60, PanMist®-Jr, Pseudovent™-Ped, Respaire®-60 SR: 1-2 tablets or capsules every 12 hours (maximum: 4 tablets or capsules/24 hours)

Guaifenex® PSE 80, PanMist®-LA: One tablet every twelve hours (maximum: 3 tablets/24 hours)

Guaifenex™ RX: 1-2 of the AM tablets every morning and 1-2 of the PM tablets 12 hours following morning dose

Maxifed, Profen II®: One to 1 1 /2 tablets every 12 hours (maximum: 3 tablets/24 hours)

PanMist® S: Up to 10 mL 4 times/day

Robitussin® PE: 10 mL every 4-6 hours (maximum: 4 doses/24 hours)

Robitussin® Severe Congestion, Sudafed® Non-Drying Sinus: Two capsules every 4 hours (maximum: 4 doses/24 hours)

Zephrex®: One tablet every 6 hours


Administration

 Oral: Do not open variable release capsules. Long acting formulations should not be crushed or chewed. May interfere with sleep; administering some products a few hours before bedtime may help minimize insomnia. Take with full glass of water.


Patient Education

 See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.


Dental Health: Effects on Dental Treatment

 Key adverse event(s) related to dental treatment:

Guaifenesin: No significant effects or complications reported

Pseudoephedrine: Xerostomia (normal salivary flow resumes upon discontinuation).


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response


Mental Health: Effects on Mental Status

 Guaifenesin may cause drowsiness; pseudoephedrine may cause anxiety or restlessness


Mental Health: Effects on Psychiatric Treatment

 Concurrent use with psychotropics may produce additive sedation or lessen the effects of anxiolytics depending on whether the effects of guaifenesin or pseudoephedrine predominate; concurrent use with MAO inhibitors may result in hypertensive crisis; avoid combination


Dosage Forms

 [DSC] = Discontinued product

Caplet (Congestac®, Refenesen Plus): Guaifenesin 400 mg and pseudoephedrine hydrochloride 60 mg

Caplet, long acting (Touro LA®): Guaifenesin 500 mg and pseudoephedrine hydrochloride 120 mg

Caplet, prolonged release (Ambifed-G): Guaifenesin 1000 mg and pseudoephedrine hydrochloride 60 mg

Capsule, extended release:

Respaire®-60 SR: Guaifenesin 200 mg and pseudoephedrine hydrochloride 60 mg

Respaire®-120 SR: Guaifenesin 250 mg and pseudoephedrine hydrochloride 120 mg

Capsule, liquicap (Sudafed® Non-Drying Sinus): Guaifenesin 200 mg and pseudoephedrine hydrochloride 30 mg

Capsule, softgel (Robitussin® Severe Congestion): Guaifenesin 200 mg and pseudoephedrine hydrochloride 30 mg

Capsule, variable release:

Entex® PSE: Guaifenesin 400 mg [immediate release] and pseudoephedrine hydrochloride 120 mg [extended release]

G-Phed: Guaifenesin 250 mg [immediate release] and pseudoephedrine hydrochloride 120 mg [prolonged release]

Levall G: Guaifenesin 400 mg [immediate release] and pseudoephedrine hydrochloride 90 mg [extended release]

Pseudovent™: Guaifenesin 250 mg [immediate release] and pseudoephedrine hydrochloride 120 mg [prolonged release]

Pseudovent™-Ped: Guaifenesin 300 mg [immediate release] and pseudoephedrine hydrochloride 60 mg [prolonged release]

Pseudovent™ 400: Guaifenesin 400 mg [immediate release] and pseudoephedrine hydrochloride 1200 mg [extended release]

Combination package (Guaifenex™-Rx) [14-day treatment package; each package contains] [DSC]:

Tablet, extended release: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg (28s) [for AM dose]

Tablet, extended release: Guaifenesin 600 mg (28s) [for PM dose]

Syrup: Guaifenesin 200 mg and pseudoephedrine hydrochloride 40 mg per 5 mL (480 mL)

PanMist®-S: Guaifenesin 200 mg and pseudoephedrine hydrochloride 40 mg per 5 mL (480 mL) [alcohol free; grape flavor]

Robitussin-PE®: Guaifenesin 100 mg and pseudoephedrine hydrochloride 30 mg per 5 mL (120 mL, 240 mL) [alcohol free; contains sodium benzoate]

Tablet: Zephrex®: Guaifenesin 400 mg and pseudoephedrine hydrochloride 60 mg

Tablet, extended release: Guaifenesin 550 mg and pseudoephedrine hydrochloride 60 mg; guaifenesin 595 mg and pseudoephedrine hydrochloride 48 mg; guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg; guaifenesin 600 mg and pseudoephedrine hydrochloride 120 mg; guaifenesin 795 mg and pseudoephedrine hydrochloride 85 mg; guaifenesin 800 mg and pseudoephedrine hydrochloride 45 mg; guaifenesin 800 mg and pseudoephedrine hydrochloride 60 mg; guaifenesin 800 mg and pseudoephedrine hydrochloride 90 mg; guaifenesin 1200 mg and pseudoephedrine hydrochloride 50 mg; guaifenesin 1200 mg and pseudoephedrine hydrochloride 60 mg; guaifenesin 1200 mg and pseudoephedrine hydrochloride 75 mg; guaifenesin 1200 mg and pseudoephedrine hydrochloride 90 mg; guaifenesin 1200 mg and pseudoephedrine hydrochloride 120 mg

Amitex PSE, Guaimax-D®, Zephrex LA®: Guaifenesin 600 mg and pseudoephedrine hydrochloride 120 mg

Aquatab® D: Guaifenesin 1200 mg and pseudoephedrine hydrochloride 75 mg [DSC]

Guaifenex® GP: Guaifenesin 1200 mg and pseudoephedrine hydrochloride 120 mg [dye free]

Guaifenex PSE® 60: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg

Guaifenex PSE® 80: Guaifenesin 800 mg and pseudoephedrine hydrochloride 80 mg

Maxifed®: Guaifenesin 700 mg and pseudoephedrine hydrochloride 80 mg

Maxifed-G®: Guaifenesin 550 mg and pseudoephedrine hydrochloride 60 mg

Mucinex®-D 600/60: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg

Mucinex®-D 1200/120: Guaifenesin 1200 mg and pseudoephedrine hydrochloride 120 mg

PanMist®-JR, Pseudo GG TR: Guaifenesin 595 mg and pseudoephedrine hydrochloride 48 mg

PanMist®-LA: Guaifenesin 795 mg and pseudoephedrine hydrochloride 85 mg

Profen II®: Guaifenesin 800 mg and pseudoephedrine hydrochloride 45 mg

Profen Forte®: Guaifenesin 800 mg and pseudoephedrine hydrochloride 90 mg

Tablet, long acting:

Dynex: Guaifenesin 1200 mg and pseudoephedrine hydrochloride 90 mg

Guaifenex PSE® 120: Guaifenesin 600 mg and pseudoephedrine hydrochloride 120 mg [dye free]

Miraphen PSE: Guaifenesin 600 mg and pseudoephedrine hydrochloride 120 mg

Tablet, sustained release (Nasatab® LA): Guaifenesin 500 mg and pseudoephedrine hydrochloride 120 mg


International Brand Names

 Novahistex® Expectorant with Decongestant (CA)


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