Oxy-Nase Paediatric Nasal Spray

Oxy-Nase Paediatric Nasal Spray

oxymetazoline

Manufacturer:

Taisho

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Contents
Oxymetazoline HCl.
Description
A colourless solution containing Oxymetazoline HCI 0.025% w/v and Benzalkonium Chloride 50% Solution 0.04% w/v as preservative.
Action
Oxymetazoline hydrochloride is a sympathomimetic drug which acts as a topical decongestant by stimulating the L-adrenergic receptors of the vascular smooth muscle, constricting the dilated arteriolar network within the nasal mucosa and reducing blood flow in the engorged edematous nasal area. The constriction results in shrinkage of the engorged mucous membranes, which promotes drainage, improves nasal ventilation and relieves the feeling of stuffiness.
Pharmacology: Oxymetazoline hydrochloride is a sympathomimetic amine with L-receptor action. It caused marked vasoconstriction and blanching when applied to nasal and pharyngeal mucosal surfaces. Sufficient absorption may cause central nervous system depression, leading to coma and marked reduction in body temperature especially in infants. Oxymetazoline hydrochloride is a long acting topical nasal decongestant. It acts within a few minutes and the effect up to 12 hours.
Indications/Uses
It is indicated for the relief of nasal congestion.
Dosage/Direction for Use
For children 2 to 6 years of age: Administer 2 to 3 spray in each nostril twice daily - morning and evening. With the head upright, place the spray nozzle into the nostril without completely occluding the nostril. During each administration, the patient should bend his head slightly forward and press the pump spray quickly and firmly to spray the recommended number of spray in each nostril. Wipe nozzle clean after use.
Overdosage
Oxymetazoline may produce profound central nervous system depression, leading to coma and marked reduction in body temperature, especially in infants.
Consult a physician for more information on the management of overdose.
Contraindications
Hypersensitivity to any of the ingredients.
Warnings
The recommended dosage should not be exceeded because symptoms may occur such as burning, stinging, sneezing or an increase of nasal discharge. It should not be used for more than 3 days. Use of the product dispenser by more than one person may spread infection.
Special Precautions
Caution should be observed in patients with hypertension, coronary artery disease, hyperthyroidism or diabetes mellitus or difficulty in urination due to enlargement of the prostate gland. Use with extreme caution in patients who are receiving monoamine oxidase inhibitor therapy.
For children 2 to 6 years of age, OXY-NASE Paediatric Nasal Spray/Solution 0.025% is available. Do not exceed the recommended dosage and do not use for longer than 3 days.
Use In Pregnancy & Lactation
Safety in pregnancy and lactation has not been established. It is used during pregnancy and lactation only when instructed by a clinician.
Adverse Reactions
It may occasionally cause local stinging or burning, sneezing and dryness of the mouth and throat. Prolonged use may cause rebound congestion and drug-induced rhinitis.
Drug Interactions
Combinations containing antidepressants, Tricyclic or Maprotiline or Monoamine oxidase inhibitors, depending on the amount present, may also interact with this medication.
Storage
Keep container well closed. Protect from strong light. Store below 30°C.
Recommended shelf-life: 3 years.
ATC Classification
R01AA05 - oxymetazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
Presentation/Packing
Nasal spray 0.025% (colourless solution) x 15 mL.
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