Otrivin (Xylometazoline)

OTRIVIN®

Novartis Consumer Health

Xylometazoline HCl

Nasal Decongestant

Indications And Clinical Uses: Nasal congestion in colds, rhinitis, sinusitis; also for headache, tubal block and serous otitis media associated with nasal congestion. Xylometazoline facilitates rhinoscopy and is a useful pre- and postoperative adjunct.

Contra-Indications: Narrow-angle glaucoma. Concurrent therapy with MAO inhibitors. Hypersensitivity to any component. Sensitivity to even small doses of adrenergic substances as manifested by sleeplessness, dizziness, lightheadedness, weakness, tremulousness, or cardiac arrhythmias. Do not use for irrigation or displacement following surgical procedures in which the dura mater may have been entered; e.g. sinus and transnasal operations.

Precautions: Like other topical vasoconstrictors, xylometazoline should not be employed continuously for periods exceeding 2 weeks: prolonged or excessive use may cause rebound congestion. Do not exceed the recommended dose. Systemic effects from the use of topical decongestants can occur due to rapid absorption from the nasal mucous membrane, especially when it is inflamed, and from gastrointestinal absorption if given in excess so that the nasally applied solution is swallowed. Such reactions are most likely to occur in infants, young children and the elderly.

Caution is recommended in patients with hypertension, cardiovascular and thyroid disease.

Pregnancy and Lactation: Clinical data are inadequate to establish conditions for safe use in pregnancy and lactation.

Children: Overdosage in children may produce profound sedation.

Adverse Reactions: Rarely, rebound congestion, mild tingling, burning sensation in the nose or throat, local irritation or dryness of the nasal mucosa. Intranasal use of xylometazoline may occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitation, tachycardia and arrhythmia. In isolated cases, systemic allergic reactions or transient visual disturbances have been reported.

Overdose: Symptoms: In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure, and sometimes clouding of consciousness.

Treatment: Symptomatic treatment under medical supervision is indicated.

Dosage And Administration: May be used every 8 to 10 hours.

Adults: Sprays: With head tilted slightly forward, spray 1 or 2 times into each nostril. Breathe deeply.

Drops: With head tilted back, apply 2 or 3 drops into each nostril.

Measured Dose Pumps: Remove protective cap. Hold bottle upright with thumb under base and nozzle between first and second fingers. With head tilted slightly forward, insert nozzle into nostril, and spray once into each nostril. Breathe deeply. Replace cap after use. Before using Otrivin with M-D Pump for the first time, prime the pump by spraying several times into the air until a fine mist appears.

Children: Sprays: With head tilted slightly forward, spray 1 or 2 times into each nostril. Breathe deeply.

Drops: With head tilted back, apply 2 or 3 drops into each nostril.

Children under 6 years: Sprays: 1 spray into each nostril.

Drops: 1 drop into each nostril.

Availability And Storage: Nasal Drops (Adult): Each bottle contains: xylometazoline HCl 0.1% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate and water. Sodium:
Nasal Drops (Pediatric): Each bottle contains: xylometazoline HCl 0.05% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate and water. Sodium:
Nasal Spray (Adult): Each bottle contains: xylometazoline HCl 0.1% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate and water. Sodium:
Nasal Spray (Pediatric): Each bottle contains: xylometazoline HCl 0.05% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate and water. Sodium:
Measured Dose Pump (Adult): Each bottle contains: xylometazoline HCl 0.1% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate and water. Sodium:
With Menthol Eucalyptol Spray (Adult): Each bottle contains: xylometazoline HCl 0.1% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, eucalyptus oil, hydrogenated castor oil, menthol, sodium chloride, sodium phosphate, sorbitol and water. Bottles of 20 and 30 mL.

With Moisturizers Spray (Adult): Each bottle contains: xylometazoline HCl 0.1% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, polyethylene glycol, propylene glycol, sodium phosphate and water. Bottles of 20 mL.

With Moisturizers Measured Dose Pump (Adult): Each bottle contains: xylometazoline HCl 0.1% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, polyethylene glycol, propylene glycol, sodium phosphate and water. Bottles of 20 mL.

OTRIVIN® Novartis Consumer Health Xylometazoline HCl Nasal Decongestant

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