Afrin

Afrin

oxymetazoline

Manufacturer:

Bayer

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Oxymetazoline HCl.
Description
Each ml of AFRIN Nasal Spray contains 0.5 mg (0.05%) oxymetazoline hydrochloride.
Benzalkonium chloride is used as a preservative.
Excipients/Inactive Ingredients: Benzalkonium chloride, sodium biphosphate, disodium edetate, propylene glycol, hydrochloric acid and purified water.
Action
The sympathomimetic action of oxymetazoline hydrochloride constricts the arteriolar network within the nasal mucosa producing a prolonged decongestant effect.
Indications/Uses
AFRIN Nasal Spray is indicated for symptomatic relief of nasal and nasal pharyngeal congestion due to the common cold, sinusitis, hay fever or other upper respiratory allergies.
Dosage/Direction for Use
For Adults and Children 6 year of age and older: Two of 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 spray the dose into each nostril by squeezing the bottle rapidly and strongly.
Overdosage
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.
Contraindications
Oxymetazoline-containing nasal sprays should not be used: In patients with known hypersensitivity to oxymetazoline or other adrenergic agents, or to any component of the medicinal product; in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs in the previous two weeks; in patients with narrow-angle glaucoma; in patients after trans-sphenoidal hypophysectomy; where there is inflammation of the skin and mucosa of the nasal vestibule and encrustation (rhinitis sicca); in patients with acute cardiovascular disease or cardiac asthma; in patients with severe high blood pressure.
Special Precautions
Do not exceed the recommended dosage. The product may cause rebound congestion if used for >3 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: Afrin is not recommended for use in children under 6 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 and lactation unless the potential benefits outweigh the risks.
Adverse Reactions
Afrin is generally well tolerated and side effects, should they occur, are usually mild and transient. They include burning, stinging, sneezing or increased nasal discharge.
Drug Interactions
Concomitant use of tricyclic antidepressants, maprotiline, other vasoconstrictive drugs or monoamine oxidase inhibitors (MAOI), may potentiate the pressor effects of oxymetazoline.
Storage
Store below 30°C.
ATC Classification
R01AA05 - oxymetazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
Presentation/Packing
Nasal spray 0.05% x 15 mL x 1's.
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