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GuaiFENesin


General


Pronunciation

(gwye FEN e sin)


Brand Names: U.S.

  • Altarussin [OTC]
  • Bidex [OTC]
  • Buckleys Chest Congestion [OTC]
  • Cough Syrup [OTC]
  • Diabetic Siltussin DAS-Na [OTC]
  • Diabetic Tussin Mucus Relief [OTC]
  • Diabetic Tussin [OTC]
  • Fenesin IR [OTC]
  • Geri-Tussin [OTC]
  • GoodSense Mucus Relief [OTC]
  • Iophen-NR [OTC]
  • Liquibid [OTC]
  • Liquituss GG [OTC]
  • Mucinex Chest Congestion Child [OTC]
  • Mucinex For Kids [OTC]
  • Mucinex Maximum Strength [OTC]
  • Mucinex [OTC]
  • Mucosa [OTC]
  • Mucus Relief Childrens [OTC]
  • Mucus Relief [OTC]
  • Mucus-ER [OTC]
  • Organ-I NR [OTC]
  • Q-Tussin [OTC]
  • Refenesen 400 [OTC]
  • Refenesen [OTC]
  • Robafen [OTC]
  • Robitussin Chest Congestion [OTC]
  • Robitussin Mucus+Chest Congest [OTC]
  • Scot-Tussin Expectorant [OTC]
  • Siltussin DAS [OTC]
  • Siltussin SA [OTC]
  • Tussin [OTC]
  • Xpect [OTC]

Indications


Use: Labeled Indications

Cough (expectorant): Help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


Contraindications


OTC labeling: When used for self-medication, do not use extended-release tablets in children <12 years.


Dosing and Administration


Dosing: Adult

Cough (expectorant): Oral:

Granules: 200 to 400 mg every 4 hours as needed; maximum: 2,400 mg/24 hours

Extended-release tablet: 600 mg to 1,200 mg every 12 hours as needed; maximum: 2,400 mg/24 hours

Immediate-release tablet: 200 to 400 mg every 4 hours as needed; maximum: 2,400 mg/24 hours

Liquid: 200 to 400 mg every 4 hours as needed; maximum: 2,400 mg/24 hours


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Cough (expectorant): Oral:

Granules:

Children 4 years to <6 years: 100 mg every 4 hours as needed; maximum: 600 mg/24 hours

Children 6 years to <12 years: 100 to 200 mg every 4 hours as needed; maximum: 1,200 mg/24 hours

Children ≥12 years and Adolescents: 200 to 400 mg every 4 hours as needed; maximum: 2,400 mg/24 hours

Extended-release tablet: Children ≥12 years and Adolescents: 600 mg to 1,200 mg every 12 hours as needed; maximum: 2,400 mg/24 hours

Immediate-release tablet: Children ≥12 years and Adolescents: 200 to 400 mg every 4 hours as needed; maximum: 2,400 mg/24 hours

Liquid:

Children 2 years to <4 years: Limited data available: 50 to 100 mg every 4 hours as needed; maximum: 600 mg/24 hours (Kliegman, 2007)

Children 4 years to <6 years: 50 to 100 mg every 4 hours as needed; maximum: 600 mg/24 hours

Children 6 years to <12 years: 100 to 200 mg every 4 hours as needed; maximum: 1,200 mg/24 hours

Children ≥12 years and Adolescents: 200 to 400 mg every 4 hours as needed; maximum: 2,400 mg/24 hours


Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturers labeling.


Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturers labeling.


Administration

Oral: Administer with a large quantity of fluid to ensure proper action.

Extended-release tablet: Do not break, crush, or chew extended-release tablet.

Granules: Empty contents of packet onto tongue and swallow; for best taste, do not chew granules.


Dietary Considerations

Some products may contain phenylalanine and/or sodium.


Storage

Store at room temperature; do not refrigerate. Protect from light.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Liquid, Oral:

Buckleys Chest Congestion: 100 mg/5 mL (118 mL) [alcohol free, sugar free; contains butylparaben, menthol, propylene glycol, propylparaben]

Diabetic Siltussin DAS-Na: 100 mg/5 mL (118 mL) [alcohol free, color free, fructose free, sodium free, sorbitol free, sugar free; contains aspartame, benzoic acid, methylparaben, propylene glycol; strawberry flavor]

Diabetic Tussin: 100 mg/5 mL (118 mL) [alcohol free, dye free, fructose free, sodium free, sorbitol free, sugar free; contains aspartame, menthol, methylparaben]

Diabetic Tussin Mucus Relief: 200 mg/5 mL (118 mL) [alcohol free, dye free, fructose free, sodium free, sorbitol free, sugar free; contains aspartame, benzoic acid, menthol, polyethylene glycol, propylene glycol]

Iophen-NR: 100 mg/5 mL (473 mL) [contains propylene glycol, saccharin sodium, sodium benzoate; raspberry flavor]

Liquituss GG: 200 mg/5 mL (118 mL, 473 mL) [alcohol free, sugar free; contains methylparaben, propylene glycol, propylparaben, saccharin sodium]

Mucinex Chest Congestion Child: 100 mg/5 mL (118 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), edetate disodium, fd&c red #40, propylene glycol, sodium benzoate; grape flavor]

Mucinex Chest Congestion Child: 100 mg/5 mL (118 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, propylene glycol, saccharin sodium, sodium benzoate; grape flavor]

Mucus Relief Childrens: 100 mg/5 mL (118 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, propylene glycol, saccharin sodium, sodium benzoate]

Robitussin Mucus+Chest Congest: 100 mg/5 mL (118 mL) [alcohol free; contains fd&c red #40, menthol, propylene glycol, saccharin sodium, sodium benzoate]

Scot-Tussin Expectorant: 100 mg/5 mL (30 mL, 118 mL [DSC], 240 mL, 480 mL, 3780 mL) [alcohol free, dye free, saccharin free, sodium free, sorbitol free, sugar free]

Siltussin DAS: 100 mg/5 mL (118 mL) [alcohol free, dye free, sugar free; strawberry flavor]

Generic: 100 mg/5 mL (473 mL)

Packet, Oral:

Mucinex For Kids: 50 mg (12 ea [DSC]) [contains aspartame; grape flavor]

Mucinex For Kids: 100 mg (12 ea) [contains aspartame; bubble-gum flavor]

Solution, Oral:

Q-Tussin: 100 mg/5 mL (118 mL, 240 mL, 473 mL) [alcohol free; contains fd&c red #40, saccharin sodium, sodium benzoate; cherry flavor]

Generic: 100 mg/5 mL (5 mL, 10 mL, 15 mL); 200 mg/10 mL (10 mL); 300 mg/15 mL (15 mL)

Syrup, Oral:

Altarussin: 100 mg/5 mL (120 mL, 236 mL, 473 mL, 3840 mL)

Altarussin: 100 mg/5 mL (120 mL, 240 mL, 480 mL, 3840 mL) [contains alcohol, usp]

Cough Syrup: 100 mg/5 mL (118 mL) [alcohol free; contains disodium edta, fd&c red #40, propylene glycol, sodium benzoate]

Cough Syrup: 100 mg/5 mL (118 mL, 473 mL) [alcohol free; contains fd&c red #40, menthol, propylene glycol, saccharin sodium, sodium benzoate; fruit flavor]

Geri-Tussin: 100 mg/5 mL (473 mL) [alcohol free, sugar free; contains fd&c red #40, menthol, saccharin sodium, sodium benzoate]

Robafen: 100 mg/5 mL (118 mL, 240 mL [DSC], 473 mL) [contains alcohol, usp; cherry flavor]

Robitussin Chest Congestion: 100 mg/5 mL (118 mL, 237 mL) [alcohol free; contains fd&c red #40, saccharin sodium, sodium benzoate; flavored flavor]

Siltussin SA: 100 mg/5 mL (118 mL, 237 mL, 473 mL) [strawberry flavor]

Tussin: 100 mg/5 mL (118 mL, 237 mL) [alcohol free]

Generic: 100 mg/5 mL (480 mL)

Tablet, Oral:

Bidex: 400 mg [DSC] [scored]

Bidex: 400 mg [scored; contains saccharin sodium]

Diabetic Tussin Mucus Relief: 400 mg [scored; dye free, sodium free, sugar free]

Fenesin IR: 400 mg

GoodSense Mucus Relief: 400 mg [scored]

Liquibid: 400 mg

Mucosa: 400 mg [scored]

Mucus Relief: 400 mg

Mucus Relief: 400 mg [scored; dye free]

Organ-I NR: 200 mg [DSC] [scored]

Organ-I NR: 200 mg [scored; contains fd&c red #40 aluminum lake]

Refenesen: 200 mg [scored; contains fd&c red #40 aluminum lake]

Refenesen 400: 400 mg [scored; dye free]

Xpect: 400 mg [scored; contains saccharin sodium]

Generic: 200 mg, 400 mg

Tablet Extended Release 12 Hour, Oral:

Mucinex: 600 mg [contains fd&c blue #1 aluminum lake]

Mucinex Maximum Strength: 1200 mg [contains fd&c blue #1 aluminum lake]

Mucus-ER: 600 mg [gluten free]

Generic: 600 mg, 1200 mg


Drug Interactions

There are no known significant interactions.


Lab Test Interferences


Test Interactions

Possible color interference with determination of 5-HIAA and VMA; discontinue for 48 hours prior to test


Adverse Reactions


Frequency not defined.

Central nervous system: Dizziness, drowsiness, headache

Dermatologic: Skin rash

Endocrine & metabolic: Hypouricemia

Gastrointestinal: Nausea, stomach pain, vomiting

<1% (Limited to important or life-threatening): Nephrolithiasis (with consumption of large quantities)


Warnings/Precautions


Dosage form specific issues:

- Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol ( ≥99 mg/kg/day) have been associated with a potentially fatal toxicity ( "gasping syndrome " �) in neonates; the "gasping syndrome " � consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer 's labeling.

- Phenylalanine: Some products may contain phenylalanine.

Other warnings/precautions:

- Self-medication (OTC use): When used for self-medication (OTC), discontinue use and notify health care provider if symptoms do not improve within 7 days, or are accompanied by fever, rash, or persistent headache, or if you are hypersensitive to any component of the formulation. For persistent or chronic cough (as with smoking, asthma, chronic bronchitis, emphysema) or if cough is accompanied by excessive phlegm, consult a health care provider prior to use.


Pregnancy Considerations

Based on the limited available data, an increased risk of adverse birth outcomes has not been observed following maternal use of guaifenesin in pregnancy (Aselton 1985; Heinonen 1977; Jick 1981; Shaw 1998). Alcohol may be present in some liquid formulations of guaifenesin. If consumed in sufficient quantities during pregnancy, fetal alcohol syndrome may result (Chasnoff 1981). Guaifenesin has been investigated as an agent to improve cervical mucus and improve fertility (Check 1982).


Actions


Pharmacology

Thought to act as expectorant by increasing the effective hydration of the respiratory tract, maintains the sol layer needed for ciliary clearance and reduces the viscosity of respiratory mucus, thereby further facilitating its removal by natural clearance processes.

Guaifenesin inhibits cough reflex sensitivity in subjects with upper respiratory tract infections whose cough receptors are transiently hypersensitive, but not in healthy volunteers. Possible mechanisms include a central antitussive effect, or a peripheral effect by increased sputum volume serving as a barrier shielding cough receptors within the respiratory epithelium from the tussive stimulus (Dicpinigaitis 2003).


Absorption

Well absorbed


Excretion

Urine


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience nausea or vomiting (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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