Xylometazoline
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
| |
Xylometazoline
| |
| Systematic (IUPAC) name | |
| 3-(4,5-dihydro-1H-imidazol-2-ylmethyl)- 2,4-dimethyl-6-tert-butyl-phenol | |
| Identifiers | |
| CAS number | |
| ATC code | R01 R01AB07 (WHO) (combinations), S01GA04 (WHO) |
| PubChem | |
| DrugBank | |
| Chemical data | |
| Formula | Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox |
| Mol. mass | 260.375 g·mol−1 |
| SMILES | & |
| 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 | |
| Dependence Liability | Moderate |
| Routes | intranasal |
Mechanism of Action
Sympathomimetic drug, alpha receptor agonist, which constricts nasal vasculature.
Structure
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
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Package and Label Display Panel
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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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