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Oxy-Nase

Oxy-Nase

oxymetazoline

Manufacturer:

Hoe Pharma

Distributor:

Zuellig Pharma

Marketer:

Taisho Pharmaceutical
Full Prescribing Info
Contents
Oxymetazoline hydrochloride.
Description
Each mL of OXY-NASE Nasal Spray/Drops 0.05% contains oxymetazoline HCl 0.05% w/v and benzalkonium chloride 50% Solution 0.04% w/v as preservative.
Excipients/Inactive Ingredients: Amino acetic acid, sorbitol solution, hydrochloric acid and purified water.
Each mL of OXY-NASE Nasal Spray/Drops 0.025% contains oxymetazoline HCl 0.025% w/v and benzalkonium chloride 50% solution 0.04% w/v as preservative.
Excipients/Inactive Ingredients: Amino acetic acid, sorbitol solution, hydrochloric acid and purified water.
Action
Pharmacology: Pharmacodynamics: 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.
Pharmacokinetics: Oxymetazoline hydrochloride is a sympathomimetic amine with L-receptor action. It caused marked vasoconstriction and blanching when applied to nasal and pharyngeal muscosal 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
Nasal Spray 0.05%: For adults and children 6 years of age and older: 2 or 3 sprays into 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 sprays in each nostril. Wipe nozzle clean after use.
Nasal Drops 0.05%: Adults and children over 6 years: 2 to 3 drops in each nostril twice daily; in the morning & evening.
Nasal Spray 0.025%: 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.
Nasal Drops 0.025%: Children above 1 year: 1 to 2 drops. Doses to be given twice to three times daily.
Apply up to four times daily until condition improves, then reduce frequency.
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.
Use in children: The dosage of OXY-NASE Nasal Spray/Drops 0.05% for children below 6 years of age has not been established.
For children 2 to 6 years of age, OXY-NASE Nasal Spray/Drops 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 not to be used during pregnancy and lactation unless the potential benefits outweigh the risks.
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.
MIMS Class
Nasal Decongestants & Other Nasal Preparations
ATC Classification
R01AA05 - oxymetazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
Presentation/Packing
Form
Oxy-Nase nasal drops 0.025%
Packing/Price
10 mL x 1's
Form
Oxy-Nase nasal drops 0.05%
Packing/Price
10 mL x 1's
Form
Oxy-Nase nasal spray 0.025%
Packing/Price
15 mL x 1's
Form
Oxy-Nase nasal spray 0.05%
Packing/Price
15 mL x 1's
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