Ipratropium Bromide, Xylometazoline

Nasal spray "Meralis^® Intensive ”is used for the symptomatic treatment of nasal congestion and rhinorrhea in respiratory diseases.

Structure

1 ml of the drug contains (active substances):

• ipratropium bromide - 0.6 mg;
• xylometazoline hydrochloride - 0.5 mg.

Excipients: purified sea water, disodium edetate, 85% glycerin, hydrochloric acid and sodium hydroxide (for pH correction), purified water.

Contraindications

• hypersensitivity to any components of the drug;
• hypersensitivity to atropine or to similar drugs, for example, hyoscyamine, scopolamine;
• surgical operations on the dura mater of the brain, for example, transphenoid hypophysectomy or other transnasal surgery;
• acute coronary diseases, coronary asthma, hyperthyroidism;
• glaucoma;
• dry rhinitis;
• childrens age (up to 18 years).

Mode of application

Apply intranasally.

The recommended dose for adults is one injection 3 times a day in each nasal passage. The interval between the use of the drug "Meralis^® Intensive ”should be at least 6 hours.

Before the first use, it is necessary to do several injections into the air (4 times) to achieve uniformity of dose. The bottle must be kept upright. If the product is not used for several days (more than 6 days), you need to do two spray injections into the air to achieve a uniform dose.

After use, the spray device should be thoroughly wiped with a clean paper towel and the protective cap in place.

To minimize the risk of infection, the drug should not be used by more than one person.

The duration of treatment should not exceed 7 days. Long-term treatment with xylometazoline hydrochloride can cause swelling of the nasal mucosa and increased secretion, which is due to increased sensitivity of the cells - the “opposite effect”.

After the disappearance of the symptoms of the disease, it is recommended to stop treatment with the drug in order to avoid the risk of adverse reactions, even if the duration of treatment is less than 7 days.

The experience of using the drug in elderly patients (over 70 years old) is limited.

One injection (approximately 140 μl) of Meralis^® Intensive ”contains approximately 70 micrograms of xylometazoline hydrochloride and 84 micrograms of ipratropium bromide.

Application features

Pregnant women

There is insufficient data on the use of the drug during pregnancy. Preclinical data are insufficient to assess the effect of the drug on pregnancy, embryo / fetal development, childbirth and postpartum development. The potential risk to humans is unknown. The drug should not be used during pregnancy unless absolutely necessary.

There is no data on the penetration of ipratropium bromide and xylometazoline hydrochloride into breast milk. The systemic effect of ipratropium bromide and xylometazoline hydrochloride is low. Therefore, the effect on the breastfed infant is unlikely. It is necessary to assess the need for the use of the drug "Meralis^® Intensive ”for women, the benefits of breastfeeding and the potential risk to the baby. Exceeding the recommended dose is unacceptable.

Children

The drug is not used for children (under the age of 18 years) due to insufficient data.

Drivers

When using the drug, visual disturbances (including blurred vision and dilated pupils), dizziness, and increased fatigue may occur. Patients should be warned that if such reactions occur, it is necessary to avoid driving or working with machinery and not participate in activities that could lead to a threat to health or life.

Overdose

With oral overdose or with excessive local use of xylometazoline hydrochloride, the following phenomena are possible: severe dizziness, excessive sweating, a sharp decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma and convulsions. After arterial hypertension, arterial hypotension may develop. Children are more sensitive to toxicity than adults. The treatment is symptomatic.

With excessive intranasal use, an acute overdose of ipratropium bromide is unlikely due to very slight absorption of the drug in the blood with oral and intranasal use, but such symptoms may develop: dry mouth, difficulty in accommodation, tachycardia. The treatment is symptomatic.

A significant overdose can cause anticholinergic symptoms from the central nervous system, including hallucinations, for the elimination of which cholinesterase inhibitors are prescribed. Appropriate supportive measures are necessary for all individuals with suspected overdose; emergency symptomatic therapy under the supervision of a doctor is prescribed if necessary. Observe the patient for at least 6 hours. In case of severe overdose with cardiac arrest, resuscitation measures should be carried out for at least 1 hour.

Side effects

The most common side effects are nosebleeds (14.8%) and dry nose (11.3%).

Storage conditions

It does not require special storage conditions. Keep out of the reach of children.

Shelf life is 3 years.