Properties
What is it?
International Nonproprietary Name - Oxymetazoline Dosage Form Nasal spray Description Clear, colorless liquid with a faint smell of menthol, eucalyptus, and camphor. Composition Active substance: Oxymetazoline hydrochloride 0.5mg/ml. Excipients: Camphor (racemic camphor), Menthol (levomenthol), Eucalyptol (cineole), Benzalkonium chloride, Polysorbate 80, Propylene glycol, Sodium dihydrogen phosphate dihydrate, Disodium phosphate dihydrate, Disodium edetate dihydrate, Concentrated hydrochloric acid, Purified water. Pharmacotherapeutic Group Medication for nasal diseases. Decongestants and other agents for local use in rhinology. Indications for Use Acute, allergic, and vasomotor rhinitis; restoration of drainage during Eustachian tube and nasal sinus inflammation, otitis media; prevention of swelling before diagnostic procedures in the upper respiratory tract. Method of Administration and Dosage Spray into both nostrils, do not tilt head back while spraying. For adults and children over 6 years of age: 1 spray in each nostril. Spraying is repeated at intervals of at least 12 hours. Do not exceed the recommended dose and do not use the preparation for more than 7 days. Side Effects Oxymetazoline is generally well tolerated; side effects, if they occur, are mild and temporary. Frequent: Burning and dryness of the nasal mucosa, sneezing. Occasional: After the effect of the preparation wears off, a strong feeling of nasal congestion (reactive hyperemia), nosebleeds, allergic reactions (angioedema, urticaria, itching). Rare: Palpitations, tachycardia, arterial hypertension. Very Rare: Apnea in newborns, insomnia, fatigue (drowsiness, sedative effect), headache, restlessness, hallucinations (mainly in children), arrhythmia, seizures (especially in children). Not known: Dizziness, pre-syncope, chills, nervousness, excitability, fear, blurred vision, excessive nasal discharge, increased nasal congestion, dry mouth, nasal and throat irritation, nausea, rash, weakness. If any of the listed side reactions, as well as those indicated in the package insert, occur, consult a doctor. Pregnancy and Lactation Pregnancy: Due to limited data on the use of oxymetazoline in the first trimester of pregnancy, there is no information on its effect on the course of pregnancy or the health of the fetus/newborn. Other epidemiological data are not yet available. During pregnancy, the use of the spray is recommended only after assessing the benefit/risk ratio. Since overdose can disrupt blood supply to the unborn child, strict adherence to the recommended dose is necessary during pregnancy. Breastfeeding: The use of the spray during lactation is possible only after assessing the benefit/risk ratio. Since overdose of oxymetazoline reduces milk production, the recommended dose should not be exceeded during breastfeeding, as there is no data on the penetration of oxymetazoline into breast milk.