Xylometazoline

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Xylometazoline
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: Alberto Plate [2]

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Overview

Xylometazoline is a sympathomimetic, descongestant that is FDA approved for the treatment of nasal congestion due to cold, hay fever or other respiratory allergies. Common adverse reactions include rhinitis medicamentosa, atrophic rhinitis, sinusitis and otitis media.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Cold, Hay Fever or Allergies
  • Dosage: 2 or 3 sprays in each nostril not more often than every 8 to 10 hours.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Cold, Hay Fever or Allergies
  • Dosage: Only for pediatric patients > 12 years old. Use 2 or 3 sprays in each nostril not more often than every 8 to 10 hours.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

When using this product:

  • Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
  • This product may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge.
  • The use of this container by more than one person may spread infection.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Xylometazoline Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Consult your physician before using.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Xylometazoline in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

Consult your physician before using.

Pediatric Use

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Geriatic Use

There is no FDA guidance on the use of Xylometazoline in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Xylometazoline Administration in the drug label.

Monitoring

There is limited information regarding Xylometazoline Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Xylometazoline and IV administrations.

Overdosage

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

Pharmacology

Oxymetazoline structure.png
Xylometazoline
Systematic (IUPAC) name
3-(4,5-dihydro-1H-imidazol-2-ylmethyl)- 2,4-dimethyl-6-tert-butyl-phenol
Identifiers
CAS number 1491-59-4
ATC code R01AA05
R01AB07 (WHO) (combinations), S01GA04 (WHO)
PubChem 4636
DrugBank DB00935
Chemical data
Formula C16H24N2O 
Mol. mass 260.375 g·mol−1
SMILES eMolecules & PubChem
Physical data
Melt. point 301.5 °C (575 °F)
Pharmacokinetic data
Bioavailability ?
Metabolism Kidney (30%), Fecal (10%)
Half life 5-6 hours
Excretion ?
Therapeutic considerations
Pregnancy cat.

C

Legal status

GSL(UK) OTC(US)

Dependence Liability Moderate
Routes intranasal

Mechanism of Action

Sympathomimetic drug, alpha receptor agonist, which constricts nasal vasculature.

Structure

Oxymetazoline structure.png

Pharmacodynamics

There is limited information regarding Xylometazoline Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Xylometazoline Pharmacokinetics in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

Store at 20-25 degrees C (68-77 degrees F)

Images

Drug Images

Package and Label Display Panel

Oxymetazoline Appearance.png
Oxymetazoline Package.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

There is limited information regarding Xylometazoline 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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