Guaifenesin: Difference between revisions

Guaifenesin
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Latest revision as of 18:39, 9 March 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Guaifenesin is an expectorant that is FDA approved for the treatment of loosening phlegm (mucus) and thinning of bronchial secretions to make coughs more productive.. Common adverse reactions include nausea, vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage

Follow dosage below or use as directed by a physician.

Do not take more than 6 doses in any 24-hour period.

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Guaifenesin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Guaifenesin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indication

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage

Follow dosage below or use as directed by a physician.

Do not take more than 6 doses in any 24-hour period.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Guaifenesin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Guaifenesin in pediatric patients.

Contraindications

There is limited information regarding Guaifenesin Contraindications in the drug label.

Warnings

Ask a doctor before use if you have

Cough that occurs with too much phlegm (mucus)
Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

You are hypersensitive to any of the ingredients.

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Guaifenesin in the drug label.

Postmarketing Experience

Common Gastrointestinal: nausea, vomiting

Drug Interactions

There is limited information regarding Guaifenesin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Guaifenesin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of guaifenesin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of guaifenesin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of guaifenesin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of guaifenesin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of guaifenesin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of guaifenesin with respect to specific gender populations.

Race

There is no FDA guidance on the use of guaifenesin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of guaifenesin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of guaifenesin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of guaifenesin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of guaifenesin in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Monitoring

There is limited information regarding Monitoring of guaifenesin in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of guaifenesin in the drug label.

Overdosage

There is limited information regarding Guaifenesin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Guaifenesin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Guaifenesin Mechanism of Action in the drug label.

Structure

There is limited information regarding Guaifenesin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of guaifenesin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of guaifenesin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of guaifenesin in the drug label.

Clinical Studies

There is limited information regarding Guaifenesin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Guaifenesin How Supplied in the drug label.

Storage

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

Images

Drug Images

{{#ask: Page Name::Guaifenesin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Guaifenesin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of guaifenesin in the drug label.

Precautions with Alcohol

Alcohol-guaifenesin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

GUAIFENESIN

Look-Alike Drug Names

There is limited information regarding Guaifenesin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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@@ Line 1: / Line 1: @@
-{{drugbox
+{{DrugProjectFormSinglePage
-| IUPAC_name = 3-(2-methoxyphenoxy)propane-1,2-diol
+|authorTag={{KS}}
-| image = Guaifenesin.svg
+|OTC=Yes
-| CAS_number = 93-14-1
+|genericName=guaifenesin
-| ATC_prefix = R05
+|aOrAn=an
-| ATC_suffix = CA03
+|drugClass=expectorant
-| ATC_supplemental =
+|indicationType=treatment
-| PubChem = 3516
+|indication=loosening phlegm (mucus) and thinning of bronchial secretions to make coughs more productive.
-| DrugBank = APRD01005
+|adverseReactions=[[nausea]], [[vomiting]]
-| C = 10 | H = 14 | O = 4
+|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
-| molecular_weight = 198.216 g/mol
+|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
-| bioavailability =
+|fdaLIADAdult===Indications==
-| protein_bound =
+* Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
-| metabolism =
-| elimination_half-life = 1 hour
+==Dosage==
-| pregnancy_category = C <small>([[US]])</small>
+* Follow dosage below or use as directed by a physician.
-| legal_status = OTC <small>([[US]], [[CA]])</small>
-| routes_of_administration = Oral
+* Do not take more than 6 doses in any 24-hour period.
-| licence_EU =
-| licence_US = Guaifenesin
+[[File:guaifenesin table.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
-}}
+|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Guaifenesin in adult patients.
-'''Guaifenesin''' ({{IPA2|gwaɪˈfɛnəsɪn}}) ([[International Nonproprietary Name|INN]]) or '''guaiphenesin''' (former [[British Approved Name|BAN]]) is an [[expectorant]] [[medication|drug]] usually taken [[Wiktionary:oral|oral]]ly to assist the expectoration ("bringing up") of [[phlegm]] from the [[airway]]s in acute respiratory tract infections.  Similar medicines derived from the [[guaiac|guaiac tree]] were in use as a generic remedy by Native Americans when explorers reached [[North America]] in the 1500s, but guaifenesin was first approved by the [[Food and Drug Administration]] (FDA) in 1952.  It is sold as pills or syrups under several [[brand name]]s such as '''Guai-Aid''', '''GuaiLife''', '''Ethex 208''', '''Humibid''', '''Mucinex''', and '''[[Robitussin]]'''.  It is also included in many over-the-counter cough and cold remedies.
+|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Guaifenesin in adult patients.
+|fdaLIADPed===Indication==
+* Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
+==Dosage==
+* Follow dosage below or use as directed by a physician.
+* Do not take more than 6 doses in any 24-hour period.
+[[File:guaifenesin table01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
+|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Guaifenesin in pediatric patients.
+|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Guaifenesin in pediatric patients.
+|warnings='''Ask a doctor before use if you have'''
+* Cough that occurs with too much phlegm (mucus)
+* Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
+'''Stop use and ask a doctor if'''
+Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
+* You are hypersensitive to any of the ingredients.
-==Uses==
+'''If pregnant or breast-feeding'''
-===Treatment of asthma===
-Guaifenesin is effective in the treatment of the thickened bronchial mucosa characteristic of [[asthma]].  It works by drawing water into the [[bronchus|bronchi]].  The water both thins [[mucus]] and lubricates the airway, facilitating the removal of mucus by [[cough|coughing]].  One may notice a sense of [[dry mouth]] when taking this medication. Water consumption is important, not only to help with dry mouth, but also to improve the effectiveness of the drug.
-===Treatment of coughing===
+* Ask a health professional before use.
-Guaifenesin is frequently combined with [[dextromethorphan]], an [[antitussive]].  Under normal circumstances this combination leads to fewer, but more productive coughs.  However, in the quantities consumed by [[Dextromethorphan#Recreational use|recreational users]] of dextromethorphan, it may cause nausea and vomiting, as well as the formation of stones in the urinary tract ([[urolithiasis]]).  Moreover, because of concerns about illegal recreational drugs, the American [[Food and Drug Administration|FDA]] has forced manufacturers of [[ephedrine]] to add guaifenesin to over the counter weight loss medications. <ref>{{cite paper | last = Riddle | first = David | year = 2005 | month = December | title = RE: Docket No. 1’976N-0052G RIN 09 lo-AFT33 Cold, Cough,, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph for Combination Drug Products | url = http://www.google.co.uk/url?sa=t&ct=res&cd=1&url=http%3A%2F%2Fwww.fda.gov%2FOHRMS%2FDOCKETS%2Fdockets%2F76n0052g%2F76n-0052G-c000234-01-vol35.pdf&ei=mowCR8LNFKbywwGhk7QZ&usg=AFQjCNEEmAM0FiM5rx3c6zOyrAgWXWVE6w&sig2=bamlI0gtVy6EKoJsjc2h5g | accessdate=2007-10-02}}</ref>
-===Treatment of fibromyalgia===
+'''Keep out of reach of children'''
-Because of its [[uricosuric]] effect, guaifenesin was chosen for the experimental [[guaifenesin protocol]] in the 1990s as a treatment for [[fibromyalgia]], and proponents of the guaifenesin protocol believe that it cures fibromyalgia by removing excess phosphate from the body.  A lesser publicized and thus lesser known fact among fibromyalgia sufferers is that guaifenesin has a skeletal muscle relaxant property, and a form of guaifenesin known as guafenesin carbomate is used for this purpose[Citation needed].  This may explain some of the symptomatic relief experienced by fibromyalgia sufferers who take guaifenesin.
-===Muscle relaxant and inhibition of platelet aggregation===
+* In case of overdose, get medical help or contact a Poison Control Center right away.
-Guaifenesin also has other known neurological effects, including an analgesic effect that is related to its action as a skeletal [[muscle relaxant]], and it may [[Antiplatelet drug|inhibit platelet aggregation]].  Guaifenesin's neurological properties first became known in the late 1940s, and it is still used in [[veterinary]] medicine to anesthetize [[horses]] being prepared for surgery.  When contrasted with other propanediol drugs used for this purpose, guaifenesin has less hemolytic activity (i.e., less destruction of red blood cells) and is more soluble in water.
+|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of Guaifenesin in the drug label.
+|postmarketing='''Common'''
+Gastrointestinal: [[nausea]], [[vomiting]]
+|useInPregnancyAUS=There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of guaifenesin in women who are pregnant.
+|useInLaborDelivery=There is no FDA guidance on use of guaifenesin during labor and delivery.
+|useInNursing=There is no FDA guidance on the use of guaifenesin with respect to nursing mothers.
+|useInPed=There is no FDA guidance on the use of guaifenesin with respect to pediatric patients.
+|useInGeri=There is no FDA guidance on the use of guaifenesin  with respect to geriatric patients.
+|useInGender=There is no FDA guidance on the use of guaifenesin with respect to specific gender populations.
+|useInRace=There is no FDA guidance on the use of guaifenesin with respect to specific racial populations.
+|useInRenalImpair=There is no FDA guidance on the use of guaifenesin in patients with renal impairment.
+|useInHepaticImpair=There is no FDA guidance on the use of guaifenesin in patients with hepatic impairment.
+|useInReproPotential=There is no FDA guidance on the use of guaifenesin in women of reproductive potentials and males.
+|useInImmunocomp=There is no FDA guidance one the use of guaifenesin in patients who are immunocompromised.
+|administration=* Oral
+|monitoring=There is limited information regarding <i>Monitoring</i> of guaifenesin in the drug label.
+|IVCompat=There is limited information regarding <i>IV Compatibility</i> of guaifenesin in the drug label.
+|PD=There is limited information regarding <i>Pharmacodynamics</i> of guaifenesin in the drug label.
+|PK=There is limited information regarding <i>Pharmacokinetics</i> of guaifenesin in the drug label.
+|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of guaifenesin in the drug label.
+|storage=* Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.
+|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of guaifenesin in the drug label.
+|alcohol=* Alcohol-guaifenesin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
+|brandNames=* GUAIFENESIN
+|drugShortage=
+}}
+{{PillImage
+|fileName=No image.jpg
+}}
+{{LabelImage}}
+{{LabelImage
+|fileName=Guaifenesin ingredients and appearance.png
+}}
+{{LabelImage
+|fileName=Guaifenesin fig01.jpg
+}}
+<!--Pill Image-->
-===Use by singers===
-Opera singers sometimes refer to guaifenesin as the "wonder drug", for its ability to promote secondary mucosal secretion in the respiratory system.  Secondary mucous is the thinner, lubricating mucus that occurs on your vocal chords naturally when they are healthy and well hydrated.  Singers use guaifenesin to improve the state of their vocal folds in extremes of humidity (very humid or very dry), after flying long distances, and during mild allergies.
-==References==
-{{reflist}}
-==Further reading==
+<!--Label Display Image-->
-==See also==
-==External links==
-*[http://www.rxlist.com/cgi/generic2/guaifen.htm RxList site giving some properties]
-* {{MedlinePlusDrugInfo|medmaster|a682494}}
-*[http://www.medicinenet.com/guaifenesin/article.htm Information from MedicineNet.com]
-*[http://www.rxlist.com/cgi/rxlistid.cgi?drug=*ethex+208 RxList information]
-[[Category:Expectorants]]
-[[de:Guaifenesin]]
+<!--Category-->
-{{Cough and cold preparations}}
+[[Category:Uric acid]]
-{{WikiDoc Sources}}
+[[Category:Drug]]

Guaifenesin: Difference between revisions

Latest revision as of 18:39, 9 March 2015

Disclaimer

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indication

Dosage

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Drug Interactions

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatic Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Administration and Monitoring

Administration

Monitoring

IV Compatibility

Overdosage

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Clinical Studies

How Supplied

Storage

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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