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Full Prescribing Info
Oxymetazoline hydrochloride.
Each ml of AFRIN Nasal Spray contains 0.5 mg (0.05 %) oxymetazoline hydrochloride. Benzalkonium chloride is used as preservative.
Excipients/Inactive Ingredients: Other inactive ingredients include benzalkonium chloride, sodium phosphate monobasic monohydrate, edetate disodium, propylene glycol, hydrochloric acid, sodium hydroxide and purified water.
The sympathomimetic action of oxymetazoline hydrochloride constricts the arteriolar network within the nasal mucosa producing a prolonged decongestant effect.
AFRIN Nasal Spray is indicated for the symptomatic relief of nasal and nasopharyngeal congestion due to the common cold, sinusitis, hay fever or other upper respiratory allergies. It is also recommended for orifice use on a nasal tampon to facilitate intranasal examination or before nasal surgery.
Dosage/Direction for Use
For adults and children six years of age and older: AFRIN Nasal Spray 0.05% - Two or three sprays into each nostril twice daily, morning and evening. With the head upright, place the sprays nozzle into the nostril without completely occluding the nostril. During each administration, the patient should bend his head slightly forward and squeeze bottle quickly and firmly to spray the recommended number of sprays in each nostril.
If accidentally ingested, standard methods to remove unabsorbed drug should be considered. There is no specific antidote for oxymetazoline. In children, oxymetazoline may produce profound central nervous system depression. Consultation with a Poison Control Center should be considered and treatment will be supportive.
Hypersensitivity to any of the ingredients in AFRIN Nasal Spray is a contraindication to its use.
Special Precautions
Do not exceed the recommended dosage. This product may cause rebound congestion if used for longer than three days. This product should not be used by patients who have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland without careful clinical consideration. Use of the product by more than one person may spread infection.
Use in Children: This product is not recommended for use in children under six years of age.
Use In Pregnancy & Lactation
Since no clinical data on exposed pregnancies are available with oxymetazoline, the safe use of oxymetazoline during pregnancy has not been established. Oxymetazoline is not to be used during pregnancy unless the potential benefits outweigh the risks.
Adverse Reactions
AFRIN Nasal Spray is generally well tolerated; side effects are usually mild and transient and include burning, stinging, sneezing or increased nasal discharge.
Drug Interactions
If significant systemic absorption of oxymetazoline occurs, concomitant use of tricyclic antidepressants, maprotiline, or monoamine oxidase inhibitors (MAOI), may potentiate the pressor effects of oxymetazoline.
Caution For Usage
How To Use Afrin Nasal Spray: 1. To Spray, squeeze bottle quickly and firmly.
2. Spray 2 or 3 times in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
3. Do not tilt head backward while spraying.
4. Wipe nozzle clean after use.
ATC Classification
R01AA05 - oxymetazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
Nasal spray 0.05% x 15 mL.
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