Xylometazoline and Ipratropium Bromide Intranasal Preparation
Indications for use
- This entry relates to Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml nasal spray, solution. It is indicated for symptomatic treatment of nasal congestion and rhinorrhoea in connection with common colds
Age
- 18 years + [SmPC also states there is only limited experience of use in patients above 70 years of age]
Dose/Directions
- Adults: 1 puff in each nostril up to three times daily. At least 6 hours should elapse between doses. Max 3 applications daily into each nostril
Duration
- The maximum treatment period is 5 days (per MHRA Drug Safety Update, 30 April 2026, which reduced the maximum duration of use for xylometazoline-containing nasal decongestants from 7 to 5 days because of the risk of rebound congestion, rhinitis medicamentosa and tachyphylaxis with overuse). Patients should stop treatment as soon as symptoms have diminished, even before the 5-day maximum, to minimise the risk of side-effects. Manufacturer SmPCs and PILs are being updated to reflect the 5-day maximum. Continued use beyond 5 days may produce a cycle of overuse — patients reliant on these products should be advised on gradual withdrawal; abrupt cessation can transiently worsen symptoms but most patients recover within about 3 months
Contra-indications:
- Hypersensitivity to the active substance or to the excipients
- Hypersensitivity to atropine or similar substances (such as hyoscyamine and scopolamine)
- After surgical operations where dura mater may have been penetrated (such as a transnasal operation)
- Glaucoma
- Rhinitis sicca
- Hypertension, cardiovascular diseases. Patients with long QT syndrome may be at increased risk of serious ventricular arrhythmias
- Hyperthyroidism
- Diabetes mellitus
- Hypertrophy of the prostate, stenosis of the bladder
- Phaeochromocytoma
- Patients predisposed to: angle closure glaucoma, epistaxis, paralytic ileus, cystic fibrosis
- Pregnancy: insufficient data. Otrivine Extra Dual Relief should not be used in pregnancy unless deemed clearly necessary by the doctor
- Breast-feeding: insufficient data. The mother's need for treatment and the advantages of breast-feeding must be weighed against the potential risks to the infant (by the doctor, not in an OTC context)
Examples of drug interactions
- MAOIs: concomitant use or use within the last 2 weeks of sympathomimetic preparations may induce severely elevated blood pressure
- Tri- and tetra-cyclic antidepressants: concomitant use or use within the last 2 weeks of tricyclic antidepressants and sympathomimetic preparations may result in an increased sympathomimetic effect of xylometazoline
- Concomitant administration of other anticholinergic drugs may enhance the anticholinergic effect
- Per MHRA Drug Safety Update (30 April 2026): use of xylometazoline- or oxymetazoline-containing nasal sprays/drops is contraindicated in patients also taking other oral or nasal sympathomimetic decongestants (such as pseudoephedrine, phenylephrine or ephedrine). Avoid combining a topical xylometazoline product with an oral decongestant in the same recommendation
Side-effects
- Visual disturbances, dizziness and fatigue have been reported. Patients should be advised that if affected they should not drive, operate machinery or take part in activities where these symptoms may put themselves or others at risk
- The most commonly reported adverse reactions are epistaxis occurring in 14.8 % and nasal dryness occurring in 11.3 % of patients
Other pertinent information
- The SmPC states that before the first use, the pump should be primed by actuating 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. Should the spray not be ejected during the full actuation stroke, or if the product has not been used for longer than 6 days, the pump will need to be re-primed
- Reclassified POM→P: 2017