Otrivin 0.1% and 0.05% contains 1 mg/ml and 0.05 mg/ml of Xylometazoline hydrochloride, respectively.
Each metered-dose spray of Otrivin 0.1% delivers 0.14 ml per actuation (0.14 mg of xylometazoline hydrochloride).
Each metered-dose spray of Otrivin 0.05% delivers 0.07 ml per actuation (0.035 mg of xylometazoline hydrochloride).
Excipients/Inactive Ingredients: Benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate, disodium phosphate, sodium chloride, sorbitol, methylhydroxypropylcellulose and purified water.
Pharmacotherapeutic group: Decongestants for topical use, sympathomimetics, plain. ATC code: R01A A07.
Pharmacology: Pharmacodynamics: Mechanism of action and pharmacodynamic effects: Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors in the nasal mucosa. Administered in the nose, it constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. It also reduces associated symptoms of mucus hypersecretion and facilitates drainage of blocked secretions. This decongests nasal passages and enables patients suffering from a blocked nose to breathe more easily through the nose. The effect of Otrivin begins within a few minutes and lasts for up to 12 hours. (e.g. all night).
In a double-blinded, saline solution controlled study in patients with common cold, the decongestant effect of Otrivin was significantly superior (p < 0.0001) to saline solution based on rhinomanometry measurement. Relief of blocked nose developed twice as fast in the Otrivin group compared to saline solution as of 5 minutes post treatment (p = 0.047).
Otrivin is well tolerated, even by patients with a sensitive mucosa, and does not impair the mucociliary function.
In vitro assays have shown that xylometazoline reduces the infectious activity of some human rhinoviruses (HRV-14, HRV-16, HRV-39) associated with the common cold.
Otrivin has a balanced pH within the range found in the nasal cavity. The moisturising formula contains soothing ingredients that help prevent dryness and irritation of the nasal mucosa.
Otrivin may also be used in case of ear infections, by helping to decongest the nasopharyngeal mucosa.
Pharmacokinetics: Plasma concentrations of Xylometazoline in man after local nasal application of the product are below the limit of detection.
Toxicology: Preclinical Safety Data: Xylometazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylometazoline was given subcutaneously in mice and rats.
For the relief of nasal congestion due to colds, hay fever or other allergic rhinitis, sinusitis.
To aid drainage of secretions in affections of the paranasalsinuses.
As an adjuvant in otitis media, to decongest the nasopharyngeal mucosa.
To facilitate rhinoscopy.
Otrivin should not be used for more than seven consecutive days. (See Precautions).
The recommended dose should not be exceeded, especially in children and older people.
0.1%: Adults and adolescents over 12 years of age: 1 spray into each nostril, up to 3 times daily as needed. Do not exceed 3 applications daily into each nostril.
Paediatric population: Otrivin 0.1% should not be used in children aged less than 12 years old.
0.05%: Children 1 to 5 years of age: With adult supervision.
1 spray into each nostril once or twice daily (every 8 to 10 hours) are generally sufficient. Do not exceed 3 applications daily into each nostril.
Children 6 to 11 years of age: With adult supervision.
1 to 2 sprays into each nostril, 2 to 3 times daily as needed. Do not exceed 3 applications daily into each nostril.
It is recommended to make the last application shortly before retiring to bed.
The metered-dose spray permits accuracy of dosage and ensures that the solution is well distributed over the surface of the nasal mucosa. It precludes the possibility of unintentional overdose.
Before the first application, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be reprimed with 4 actuations.
Instructions for use/handling: Do not cut the nozzle. The metered dose spray is ready to prime before use.
Gently clear nose.
Remove protective cap.
Before using for the first time, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be reprimed with 4 actuations (for 0.1% nasal spray), 2 actuations (for 0.5% nasal spray). Be very careful not to spray in the eyes or mouth.
Hold the bottle upright with thumb under base and nozzle between two fingers.
Lean the head forward slightly and insert the nozzle into a nostril. Spray and breathe in gently through the nose at the same time.
Repeat with the other nostril.
Clean and dry the nozzle before replacing back the cap right after use.
To avoid possible spread of infection, the spray should only be used by one person.
Excessive administration of topical xylometazoline hydrochloride or accidental ingestion may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.
Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This would include observation of the individual for several hours. In the event of a severe overdose with cardiac arrest, resuscitation should be continued for at least 1 hour.
Hypersensitivity to xylometazoline or to any of the excipients.
Like other vasoconstrictors, Otrivin should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
Patients with narrow angle glaucoma.
Patients with Rhinitis sicca or atrophic rhinitis.
Otrivin, like other sympathomimetic agents, should be used with caution in patients showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Otrivin should be used with caution in: patients with hypertension, cardiovascular disease; patients with hyperthyroidism, diabetes mellitus, phaeochromocytoma; patients with prostatic hypertrophy; patients treated with monoamine oxidase inhibitors (MAOI) or who have received them in the last two weeks (see Interactions).
Like other topical vasoconstrictors, Otrivin should not be used for more than seven consecutive days: prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.
Do not exceed the recommended dose, especially in children and in the elderly.
Effects on ability to drive and use machines: Otrivin has no or negligible influence on the ability to drive and use machines.
Pregnancy: In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivin during pregnancy.
Lactation: There is no evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivin should be used only on prescription while breast-feeding.
Fertility: There are no adequate data for the effects of Otrivin on fertility and no animal studies are available. As the systemic exposure to xylometazoline hydrochloride is very low, effects on fertility are therefore very unlikely.
Adverse reactions are listed below, by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. See Table.
Click on icon to see table/diagram/image
Monoamine oxidase inhibitors (MAO inhibitors): Xylometazoline may potentiate the action of monoamine oxidase inhibitors and may induce hypertensive crisis. Xylometazoline is not recommended in patients who are taking or have taken MAOIs within the past two weeks (see Precautions).
Tri- and tetra-cyclic antidepressants: concomitant use of tri- or tetra cyclic antidepressants and sympathomimetic preparations may result in an increased sympathomimetic effect of xylometazoline and is therefore not recommended.
Incompatibilities: Not applicable.
Protect from heat.
Do not store above 30°C.
R01AA07 - xylometazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
Nasal spray (moisturizing formula, clear colourless and practically odourless solution) 0.05% x 10 mL x 1's. 0.1% x 10 mL x 1's.