What is Otrivin Nasal Spray 10ml (Xylometazoline Hydrochloride 1.0 mg/ml)?
Otrivin Nasal Spray contains xylometazoline hydrochloride 1.0 mg/ml — a nasal decongestant — and is used for the relief of nasal congestion due to rhinitis and sinusitis. Each metered-dose spray delivers 0.14 ml (0.14 mg xylometazoline hydrochloride) per actuation.
Otrivin Nasal Spray Indications
- Rhinitis and nasal congestion (blocked nose), including from colds
- Perennial and allergic rhinitis (including hay fever)
- Sinusitis
- Facilitating rhinoscopy (nasal decongestion)
Dosage and Administration
For adults and children above 12 years: one application in each nostril as required, 2–3 times daily for a maximum of ten days. It is recommended to make the last application shortly before retiring to bed.
Before first use, prime the pump by actuating it four times. Re-prime with four actuations if the spray does not eject during a full stroke, or if unused for longer than six days.
Otrivin Menthol is not recommended for use in children below 12 years of age due to insufficient safety data.
Contraindications
- Hypersensitivity to xylometazoline hydrochloride, menthol, or any other excipient
- Narrow angle glaucoma
- After transsphenoidal hypophysectomy or surgery exposing the dura mater
- Rhinitis sicca or atrophic rhinitis
Warnings and Precautions
Use with caution in patients sensitive to adrenergic substances — symptoms such as sleep disturbances, dizziness, tremors, cardiac arrhythmias, or elevated blood pressure may result. Also use with caution in:
- Patients with hypertension or cardiovascular disease; patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias
- Patients with hyperthyroidism, diabetes mellitus, or phaeochromocytoma
- Patients with prostatic hypertrophy
- Patients treated with monoamine oxidase inhibitors (MAOIs) or who have received them in the last two weeks
Do not use for more than ten successive days to avoid rebound nasal congestion and drug-induced rhinitis. Instillation of decongestant preparations containing menthol directly into the nostrils of infants and young children must be avoided, as it has resulted in acute respiratory distress with cyanosis and respiration arrest. Do not exceed the recommended dose, especially in children and the elderly.
Pregnancy and Breast-feeding
In view of its potential systemic vasoconstrictor effect, it is advisable not to use Otrivin Menthol during pregnancy. As it is not known whether xylometazoline is excreted in breast milk, use only under medical advice while breastfeeding.
Undesirable Effects
Common: headache, nasal dryness or discomfort, burning sensation, nausea. Very rare: rebound congestion. Not known: hypersensitivity reactions (angiooedema, rash, pruritus), visual impairment, irregular or increased heart rate, elevated blood pressure.
Ingredients and Storage
Contains: menthol, cineole, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, sorbitol, macrogol glycerol hydroxystearate, purified water. Free from preservatives. Store below 25°C. Shelf life: 30 months.
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