Composition:
Each 1ml Nasal solution (Drops) contains 0.5 or 1mg Xylometazoline HCl.
Each 1ml Nasal solution (spray) contains 1mg Xylometazoline HCl.
Pharmacodynamic properties:
Xylometazoline is a sympathomimetic agent with marked alpha- adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighboring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. Its effect begins within a few minutes and lasts for up to 10 hours. It's generally well tolerated and does not impair the function of ciliated epithelium.
Pharmacokinetics:
Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions.
Indications:
For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.
Contraindications:
• Known hypersensitivity to Xylometazoline or any of the excipients.
• Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
• Concomitant use of other sympathomimetic decongestants.
• Cardiovascular disease including hypertension.
• Diabetes mellitus, Phaeochromocytoma, Hyperthyroidism, Closed angle glaucoma
• Concomitant Use of Monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment.
• Concomitant Use of Beta-blockers.
• Inflammation of the skin and/or mucosa of the nasal vestibule.
• Children under the age of 6 years(Child Nasal Drops).
Warnings and precautions:
1- Patients are advised not to take decongestants for more than seven consecutive days.
2- Xylometazoline, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.
3- Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, narrow angle glaucoma or diabetes mellitus.
4- Do not exceed the stated dose
5- Do not use continuously for more than seven consecutive days, If symptoms persist, consult your doctor
6- If you are pregnant or taking other medicines or are under a doctor's care, consult your doctor before using Xylometazoline.
7- Adult Nasal drops and Adult Nasal Spray are not to be used for infants or children under 12 years.
8- For reasons of hygiene do not use this bottle for more than 28 days after first opening it, and each Xylometazoline pack should be used by one person only to prevent any cross infection
9- Keep medicines out of the reach of children
Additional leaflet warnings and precautions
• Do not take with any other cough and cold medicine.
• Do not use if you have had recent neurosurgery.
• Consult your doctor before using Xylometazoline if you have heart or circulatory disease.
• Some patients who have sensitive nasal passages may feel some local discomfort when applying the product.
Pregnancy, breast feeding:
- In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using xylometazoline during pregnancy.
- 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 xylometazoline should be used only on the advice of a doctor whilst breastfeeding.
Undesirable effects:
- The following side effects have occasionally been encountered: A burning sensation in the nose and throat, local irritation, nausea, headache and dryness of the nasal mucosa.
- Systemic cardiovascular effects have occurred, and this should be kept in mind when giving xylometazoline to people with cardiovascular disease. In isolated cases, systemic allergic reactions and transient visual disturbances.
- Topical agents:
• Rebound congestion (rhinitis medicaments) – especially with prolonged and/or heavy use
• Tolerance with diminished effect – especially with prolonged and/or heavy use.
- Cardiovascular effects (as with oral agents) particularly with prolonged and/or excessive use.
- CNS effects (as with oral agents) particularly with prolonged and/or excessive use.
- Other side effects such as palpitations, nausea and headache are very rare
- Occasionally small children may show restlessness or sleep disturbance when Xylometazoline is used. If this occurs Xylometazoline should be stopped
Drug Interactions:
As for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.
Posology and method of administration:
- Child Nasal Drops:
Child Nasal Drops are contra-indicated in children under 6 years of age.
Children between 6 and 12 years:
1 or 2 drops, in each nostril 1 or 2 times daily.
Not to be used for more than 5 days without the advice of a doctor.
Not more than 2 doses should be given in any 24 hours. Do not exceed the stated dose.
- Adults Nasal Drops:
Adults and elderly: 2 or 3 drops in each nostril 2 or 3 times daily.
This drops are suitable for children over 12 years of age.
- Adult Nasal spray:
Adults, children over 12 years old and elderly: One application in each nostril 2 to 3 times daily.
Not suitable for children under 12 years.
Overdose:
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 consciousness clouding.
There is no specific treatment. Appropriate supportive measures should be initiated.