Xylometazoline

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

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	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	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

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

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

There is limited information regarding Xylometazoline Brand Names in the drug label.

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.

Xylometazoline

Clinical data
ATC code	R01AA07 (WHO) S01GA03 (WHO)
Identifiers
IUPAC name 2-((4-(1,1-dimethylethyl)-2,6- dimethylphenyl)methyl)-4,5-dihydro- 1H-imidazole (9CI)
CAS Number	526-36-3
PubChem CID	5709
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C16H24N2
Molar mass	244.38

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Clinical Trials
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Guidelines / Policies / Govt
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Definitions
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List of terms related to Xylometazoline

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]

Xylometazoline (Neo-Rinoleina®; Novorin®; Olynth®; Otriven®; Otrivin®; Otrivine®; Xymelin®) is a topical decongestant that is directly dosed into the nose, either as a spray or as drops.

Xylometazoline is marketed under the brand names Otrivine or Otrivin, with the standard adult dose being 0.1% w/v xylometazoline. The dose for children under 12 is 0.05%.

The drug works by constricting the blood vessels in the nose. The vasoconstriction means that there is less pressure in the capillaries and less water can filter out, thus less discharge is made. (If the colour of the nasal passage is observed, it is visibly paler after dosage.)

Xylometazoline is designed to mimic the molecular shape of adrenaline meaning that it binds to the same cell receptors adrenaline does. For this reason, it should not be used by people with high blood pressure, or other heart problems. (It acts mainly on alpha-adrenergic receptors.)

Unfortunately the vessels become resistant to the drug after prolonged dosing. The number of receptors decreases, and when the administration of the drug is ceased, chronic congestion can occur; this is called rhinitis medicamentosa, commonly referred to as rebound congestion. Moreover long-term overdosing can cause degenerative changes in nasal mucous membranes that pose another health problem.

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