Xylometazoline

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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.

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

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

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

• 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.

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

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

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

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.

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

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

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

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.

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

Consult your physician before using.

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

• Neo-Rinoleina
• Novorin
• Olynth
• Otriven
• Otrivin
• Otrivine
• Xymelin

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

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