Oxymetazoline: Difference between revisions

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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = 3-(4,5-dihydro-1H-imidazol-2-ylmethyl)- 2,4-dimethyl-6-tert-butyl-phenol
|authorTag={{DB}}
| image = Oxymetazoline structure.png
|genericName=Oxymetazoline
| CAS_number = 1491-59-4
|aOrAn=a
| ATC_prefix = R01
|drugClass=nasal decongestant, opthalmologic agent
| ATC_suffix = AA05
|indicationType=treatment
| ATC_supplemental = {{ATC|R01|AB07}}, {{ATC|S01|GA04}}
|indication=nasal congestion, ocular irritation in [[conjunctivitis]]
| PubChem = 4636
|adverseReactions=[[headache]], [[insomnia]], feeling nervous, rebound nasal congestion, dry nasal mucosa , [[nasal stinging]]/burning, [[sneezing]]
| DrugBank = APRD01158
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| C=16 | H=24 | N=2 | O=1
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
| molecular_weight = 260.375&thinsp;g·mol<sup>&minus;1</sup>
 
| melting_point = 301.5
* Content
| bioavailability =  
 
| protein_bound =  
<!--Adult Indications and Dosage-->
| metabolism =  
 
| elimination_half-life =  
<!--FDA-Labeled Indications and Dosage (Adult)-->
| pregnancy_category =  
|fdaLIADAdult=*temporarily relieves nasal congestion due to:
| legal_status =  
:*common cold
| routes_of_administration =  
:*[[hay fever]]
:*[[upper respiratory allergies]]
:*temporarily relieves [[sinus congestion]] and pressure
:*shrinks swollen nasal membranes so you can breathe more freely
 
=====Conjunctivitis, Ocular irritation=====
 
* Dosing Information
 
:*For [[CONJUNCTIVITIS]], the usual adult dose of oxymetazoline for adults and children 6 years old or greater is 1 to 2 drops of 0.025% ophthalmic solution instilled into the affected eye(s) every 6 hours.
:* Contact lens wear during ophthalmic use is not recommended
 
=====Nasal congestion=====
 
* Dosing Information
 
:* For [[RHINITIS]], the usual intranasal dose of oxymetazoline in adults and children 6 years old or greater is 2 to 3 drops or sprays of 0.05% solution in each nostril twice a day for up to 3 days
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
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<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Conjunctivitis, Ocular irritation=====
 
=====Nasal congestion=====
 
* Dosing Information
 
:*For RHINITIS, the usual dose of oxymetazoline in children 2 to 5 years old is 2 to 3 drops of a 0.025% solution in each nostril twice a day for up to 3 days. Drops are preferred to spray dosage forms since dosage can be more easily controlled with the former.
:*Use should be limited to less than 5 days to minimize occurrence of rebound congestion.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=
 
<!--Warnings-->
|warnings=*Ask a doctor before use if you have
 
:*heart disease
:*high blood pressure
:*diabetes
:*thyroid disease
:*trouble urinating due to an enlarged prostate gland
 
*When using this product
 
:*do not use more than directed
:*do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
:*temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
:*use of this container by more than one person may spread infection
 
*Stop use and ask a doctor if
 
:*symptoms persist
 
*If pregnant or breast-feeding,
 
:*ask a health professional before use.
 
*Keep out of reach of children.
 
:*If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
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There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
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|useInGeri=* There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=* There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=* There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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|useInHepaticImpair=* There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
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|useInImmunocomp=* There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=*
 
* Intravenous
|monitoring=* There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
<!--IV Compatibility-->
|IVCompat=* There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
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: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
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<!--Pharmacokinetics-->
|PK=* There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
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<!--Clinical Studies-->
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<!--How Supplied-->
|howSupplied=*
|storage=* store at 20°-25°C (68°-77°F)
*retain carton for future reference on full labeling
|packLabel=[[File:Oxymetazoline pdp.png|600px|thumbnail|left]]
{{clear}}
 
[[File:Oxymetazoline label.png|600px|thumbnail|left]]
{{clear}}
|fdaPatientInfo=*adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
*children under 6 years of age: ask a doctor
 
*To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.
|alcohol=Alcohol-Oxymetazoline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=Afrin,
4-Way Long Lasting,
Neo-Synephrine 12 Hour,
Vicks Sinex 12 Hour,
Visine L.R.,
Nasacon,
Sinarest Nasal,
Duramist Plus.
 
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date = }}</ref>
 
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{{LabelImage
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{{EH}}
{{SI}}


==Overview==
<!--Label Display Image-->
'''Oxymetazoline''' is a [[topical decongestant]] used, in the form of Oxymetazoline [[hydrochloride]], in products such as Nasivion,  [[Vicks Sinex]] and [[Afrin (nasal spray)|Afrin]]. Oxymetazoline is generally available as a [[nasal spray]]. If overused it can cause a "rebound congestion" ([[rhinitis medicamentosa]]) where the tissues of the [[sinuses]] are damaged, become swollen, and therefore become congested after the drug wears off.  As a result, a user can develop physiological tolerance to the drug, manifested by prolonged nasal congestion without continued use of the medication. (See the discussion of the effect of [[benzalkonium chloride]], a common additive to oxymetazoline nasal sprays, in the article [[Rhinitis medicamentosa]].)


The medication has [[sympathomimetic amine|sympathomimetic]] properties, and thus constricts the blood vessels of the nose and sinuses via activation of alpha1 adrenergic receptors, in turn causing less production of mucous.  It is frequently used by anaesthesiologists to reduce nasal bleeding during nasal endotracheal [[intubation]]s. This drug, not unlike most [[sympathomimetic amine]]s, has adrenaline-releasing properties due to its mode of action. However, since the application is topical, it has practically no CNS stimulation as of the systemic application of decongestants such as [[pseudoephedrine]].


Since no clinical data on exposed pregnancies are available with oxymetazoline, the safe use of oxymetazoline during pregnancy has not been established. 


If accidentally ingested, standard methods to remove unabsorbed drugs should be considered.  There is no specific antidote for oxymetazoline.  In children, oxymetazoline may produce profound central nervous system depression.


Oxymetazoline HCl 0.025% is also the active ingredient in [[Visine]] L.R. Long-Lasting Redness Relief eye drops.


{{Nasal preparations}}
<!--Category-->


[[Category:Topical decongestants]]
[[Category:Drug]]
[[Category:Imidazolines]]
<br>
[[he:אוקסימטזולין]]
[[hu:Oxymetazolin]]
[[nl:Oxymetazoline]]
[[pl:Oksymetazolina]]
[[ru:Оксиметазолин]]
{{WH}}
{{WikiDoc Sources}}

Latest revision as of 19:28, 23 December 2014

Oxymetazoline
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

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

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Oxymetazoline is a nasal decongestant, opthalmologic agent that is FDA approved for the treatment of nasal congestion, ocular irritation in conjunctivitis. Common adverse reactions include headache, insomnia, feeling nervous, rebound nasal congestion, dry nasal mucosa , nasal stinging/burning, sneezing.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • temporarily relieves nasal congestion due to:
Conjunctivitis, Ocular irritation
  • Dosing Information
  • For CONJUNCTIVITIS, the usual adult dose of oxymetazoline for adults and children 6 years old or greater is 1 to 2 drops of 0.025% ophthalmic solution instilled into the affected eye(s) every 6 hours.
  • Contact lens wear during ophthalmic use is not recommended
Nasal congestion
  • Dosing Information
  • For RHINITIS, the usual intranasal dose of oxymetazoline in adults and children 6 years old or greater is 2 to 3 drops or sprays of 0.05% solution in each nostril twice a day for up to 3 days

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Conjunctivitis, Ocular irritation
Nasal congestion
  • Dosing Information
  • For RHINITIS, the usual dose of oxymetazoline in children 2 to 5 years old is 2 to 3 drops of a 0.025% solution in each nostril twice a day for up to 3 days. Drops are preferred to spray dosage forms since dosage can be more easily controlled with the former.
  • Use should be limited to less than 5 days to minimize occurrence of rebound congestion.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

  • Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • When using this product
  • do not use more than directed
  • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection
  • Stop use and ask a doctor if
  • symptoms persist
  • If pregnant or breast-feeding,
  • ask a health professional before use.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Oxymetazoline in the drug label.

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oxymetazoline in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Intravenous

Monitoring

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

IV Compatibility

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

Overdosage

  • There is limited information regarding Chronic Overdose of Oxymetazoline in the drug label.

Pharmacology

Mechanism of Action

Structure

File:Oxymetazoline01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

  • There is limited information regarding Clinical Studies of Oxymetazoline in the drug label.

How Supplied

Storage

  • store at 20°-25°C (68°-77°F)
  • retain carton for future reference on full labeling

Images

Drug Images

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

Patient Counseling Information

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor
  • To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.

Precautions with Alcohol

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

Brand Names

Afrin, 4-Way Long Lasting, Neo-Synephrine 12 Hour, Vicks Sinex 12 Hour, Visine L.R., Nasacon, Sinarest Nasal, Duramist Plus.

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. "http://www.ismp.org". External link in |title= (help)

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