Axcel Oxymetazoline

Axcel Oxymetazoline

oxymetazoline

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Full Prescribing Info
Contents
Oxymetazoline hydrochloride.
Description
Nasal drops: Contains Oxymetazoline HCl 0.025% w/v.
Nasal spray: Oxymetazoline HCl 0.05% w/v in buffered aqueous solution.
Excipient/Inactive Ingredient: Benzalkonium Cl 0.01% w/v as preservative.
Action
Pharmacology: Mechanism of Action: Oxymetazoline is a direct-acting sympathomimetic agent which has a vasoconstrictor effect on mucosal blood vessels. Sympathomimetic agent mimic the actions produced by stimulation of postganglionic sympathetic or adrenergic nerves, including vasoconstriction of blood vessels supplying skin and mucous membranes. Topical use of Oxymetazoline has the advantage of selective of site of action and more rapid action than do oral agents. It acts within a few minutes and the effects last for up to 12 hours. Nasal congestion is frequently a symptom of conditions such as rhinitis. They act by vasoconstriction and redistributing local blood flow to reduce oedema of the nasal mucosa thus improving ventilation, drainage and nasal stuffiness.
Nasal drops: Sympathomimetic agents are widely employed as nasal decongestants to provide symptomatic relief.
Pharmacokinetics: Most sympathomimetic agents undergo enzymatic degradation in the gut and first-pass metabolism of the liver. They are inactivated by the enzymes catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO). The metabolites are excreted in the urine mainly as their glucuronide and ethereal sulphate conjugates. Oxymetazoline, however, is an imidazoline derivative and is more resistant to the inactivating enzymes of liver and other tissues. It is thus longer action and metabolised at a slower rate than the catecholamines such as ephedrine or phenylephrine. When used in the form of nasal drops or spray it acts with a few minutes and the effects lasts for several hours.
Indications/Uses
Nasal drops: Relief of nasal congestion in acute colds, paranasal sinusitis and otitis media.
Nasal spray: Symptomatic relief of nasal & nasopharyngeal congestion.
Dosage/Direction for Use
Nasal drops: Children above 1 year old: Unless otherwise prescribed, instill 1-2 drops of Oxymetazoline 0.025% Nasal Drops from the dropper into each nostril 2-3 times daily.
Application: Do not swallow.
Oxymetazoline 0.025% Nasal Drops should not be used more frequently than recommended. Unless specifically prescribed by the doctor, should not be used for up to 4 weeks.
Nasal spray: Adult & children above 6 years: 2-3 sprays into each nostril twice a day, 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.
Overdosage
Overdosage may cause CNS depression, leading to coma and marked reduction in body temperature, especially in infants. In case of overdosages, the appropriate symptomatic and supportive treatment should be given.
Nasal drops: Systemic effects such as tachycardia, somnolence and shock-like states have been reported in infants and children after administration of a large number of drops.
Nasal spray: Consult a physician for more information on the management of overdose.
Contraindications
Contraindicated in patients with known hypersensitivity to Oxymetazoline & Benzalkonium Chloride.
Nasal drops: Should not be used where there is inflammation of the skin and mucosal of the nasal vestibule with incrustation (rhinitis sicca).
Special Precautions
May cause hypertensive crisis if used during treatment with monoamine-oxidase inhibitors (MAOI's) and it should not be given to patients receiving such treatment or within 14 days of its termination. Prolonged use of nasal decongestant drops and spray may cause rebound congestion and drug-induced rhinitis. Avoid excessive use. 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.
Nasal drops: Use is therefore restricted to periods of not more than 7 consecutive days (nasal drops) or if necessary not longer than 4 weeks. In cases of chronic rhinitis, observing a 3 week treatment is recommended.
Prolonged use of nasal decongestant drops and spray may cause rebound congestion and drug-induced rhinitis. Avoid excessive use. 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.
Nasal drops: May cause hypertensive crisis if used during treatment with monoamine-oxidase inhibitors (MAOI's) and it should not be given to patients receiving such treatment or within 14 days of its termination. Use is therefore restricted to periods of not more than 7 consecutive days; or if necessary not longer than 4 weeks. In cases of chronic rhinitis, observing a 3 week treatment is recommended.
Nasal spray: Do not exceed the recommended dosage. Use is therefore restricted to periods of not more than 3 consecutive days.
Use in Pregnancy & Lactation: Nasal drops: Safe use of Oxymetazoline hydrochloride has not been established with respect to adverse effects upon fetal development. Therefore it is not recommended for use in pregnancy.
Nasal spray: Safe use of Oxymetazoline hydrochloride in pregnancy and lactation has not been established. Hence, it is not to be used during pregnancy and lactation unless the potential benefits outweigh the risk.
Use in Children: Nasal drops: Should not be used in children younger than 1 year of age.
Nasal spray: The dosage of Axcel Oxymetazoline 0.05% Nasal Spray for children below 6 years of age has not been established. For children 2 to 6 years of age, Axcel Oxymetazoline Spray 0.025% is available. Use of product dispenser by more than one person may spread infection.</br.>
Use In Pregnancy & Lactation
Nasal drops: Safe use of Oxymetazoline hydrochloride has not been established with respect to adverse effects upon fetal development. Therefore it is not recommended for use in pregnancy.
Nasal spray: Safe use of Oxymetazoline hydrochloride in pregnancy and lactation has not been established. Hence, it is not to be used during pregnancy and lactation unless the potential benefits outweigh the risk.
Side Effects
Oxymetazoline may occasionally cause local stinging or burning, sneezing and dryness of the mouth and throat. Prolonged or excessive use may cause rebound congestion and drug induced rhinitis.
Drug Interactions
Nasal drops: Sympathomimetic may increase blood pressure and therefore special care advisable in patient receiving anti-hypertensive therapy. May cause hypertensive crisis if used during treatment with monoamine-oxidase inhibitor.
Nasal spray: Concomitant use of tricyclic antidepressants, maprotiline or monoamine oxidase inhibitors (MAOI), depending on the amount present, may also interact with this medication.
Storage
Keep container well closed. Store below 30°C. Protect from light.
ATC Classification
R01AA05 - oxymetazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
Presentation/Packing
Nasal drops 0.025% (clear, colourless liquid) x 10 mL. Nasal spray 0.05% (colourless liquid) x 10 mL.
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