Sanomen (mometasone) nasal spray, suspension 50 mcg/dose 60 doses vial

Description

Sanomen (mometasone) nasal spray, suspension 50 mcg/dose 60 doses vial

Composition

active substance: 1 dose of spray contains mometasone furoate 50 mcg (in the form of mometasone furoate monohydrate);

excipients: microcrystalline cellulose and carmellose sodium (Avicel RC-591), glycerin, citric acid monohydrate, sodium citrate dihydrate, polysorbate 80, benzalkonium chloride, water for injections.

Medicinal form

Nasal spray, dosed, suspension.

Main physicochemical properties: white homogeneous suspension.

Pharmacotherapeutic group

Anti-edematous and other drugs for local use in diseases of the nasal cavity. Corticosteroids. Mometasone.
ATX code R01A D09.

Pharmacological properties

This drug belongs to the group of corticosteroid drugs used in otolaryngology to treat diseases of the nasal cavity.
Mometasone furoate – the main active ingredient of the drug, is a synthetic corticosteroid used topically. Has a pronounced anti-inflammatory and anti-allergic effect.
An important factor is that the therapeutic effect is achieved with minimal doses of the drug. As a result, side effects of a systemic nature do not occur when using it.
The mechanisms that make it possible to achieve such a medicinal effect when using mometasone are based on the ability of this drug to cause a decrease in the amount of released mediators of an allergic reaction.
Even in patients with seasonal allergic rhinitis, there was a decrease in the number of secreted leukocytes and leukotrienes.

Indications

This drug Sanomen is used to treat:

• perennial allergic rhinitis – both perennial and seasonal, in patients from 3 years of age;
• sinusitis (as an adjunct to antibiotic treatment);
• acute rhinosinusitis (without signs of severe bacterial infection);
• nasal polyps and nasal congestion and loss of smell with them (in patients over 18 years of age).

It is also used as a prophylactic agent in patients with a tendency to allergic rhinitis in patients aged 12 and older (with seasonal rhinitis, it is recommended to start prophylaxis 4 weeks before the expected peak of allergy).

Contraindications

You should not use the specified drug if the patient has had a previous hypersensitivity (allergy) with respect to one of the components that are part of the drug – both basic and auxiliary.
Also contraindicated for:

• pulmonary tuberculosis;
• the presence of a local infection of the nasal mucosa;
• condition after recent nose surgery;
• condition after facial injuries, until the wound is completely healed.

This drug should be used with caution in patients with fungal, bacterial, systemic viral infection or herpes infection with eye damage.
Used in pediatrics:

• treatment – from 3 years of age;
• prevention – from 12 years of age.

Application during pregnancy and lactation

Treatment of pregnant women is carried out with every possible care, only for serious indications.
Breastfeeding should be suspended during treatment.

Method of administration and dosage

Sanomen is intended for nasal use only.

Before starting to use the drug, it should be calibrated. Calibration is carried out by approximately 10 presses of the dosing device, while establishing a stereotypical delivery of the medicinal substance, in which with each press, approximately 100 mg of suspension containing 50 μg of mometasone (1 dose) is released.

If the nasal spray is not used for 14 days or longer, it is necessary to “spray” again by 2 pressures before the next use until a full supply is observed.

Treatment of seasonal or year-round allergic rhinitis
For adults (including the elderly) and children over 12 years of age, the recommended prophylactic and therapeutic dose of the drug is 2 injections (50 mcg each) into each nostril once a day (total daily dose – 200 mcg). After achieving a therapeutic effect for maintenance therapy, it is advisable to reduce the dose to 1 injection into each nostril once a day (total daily dose – 100 mcg).

If alleviation of the symptoms of the disease cannot be achieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to the maximum: 4 injections into each nostril once a day (total daily dose – 400 mcg). After the symptoms of the disease subside, it is recommended to reduce the dose.

The drug demonstrated a clinically significant onset of action within 12 hours after the first application in some patients with seasonal allergic rhinitis. However, the full benefit of the treatment cannot be obtained in the first 48 hours, so the patient must continue regular use to achieve the full therapeutic effect.

It is recommended to start treatment with Sanomen nasal spray a few days before the expected start of the pollination (flowering) season in patients who have a history of symptoms of moderate to severe seasonal allergic rhinitis.

For children aged 3-11 years, the recommended therapeutic dose is 1 injection (50 mcg) in each nostril 1 time a day (total daily dose – 100 mcg).

Auxiliary treatment of acute episodes of sinusitis. For adults (including the elderly) and children over 12 years of age, the recommended therapeutic dose is 2 injections (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg).

If alleviation of the symptoms of the disease cannot be achieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 injections in each nostril 2 times a day (total daily dose – 800 mcg). After the symptoms of the disease subside, it is recommended to reduce the dose.

Acute rhinosinusitis
For adults and children over 12 years of age, the recommended therapeutic dose is 2 injections (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg).

Nasal polyps
For patients over 18 years of age (including the elderly), the recommended starting dose is 2 injections (50 mcg) in each nostril once a day (total daily dose – 200 mcg). If, after using the drug for 5-6 weeks, it is not possible to reduce the symptoms of the disease, the daily dose can be increased to 2 injections in each nostril 2 times a day (total daily dose – 400 mcg). The dose should be titrated to the lowest dose that maintains effective symptom control. If after 5-6 weeks of taking the drug 2 times a day, there is no relief of symptoms, alternative methods of treatment should be considered.

The study of the effectiveness and safety of the use of mometasone furoate nasal spray for the treatment of nasal polyposis lasted 4 months.

Children

• Seasonal or year-round allergic rhinitis
  The safety and efficacy of Sanomen in children under 3 years of age have not been studied.
• Nasal polyps
  The safety and efficacy of Sanomen in children and adolescents under the age of 18 have not been studied.

Overdose

An overdose of this drug does not cause any particular adverse effects due to too low a dosage.
In the case of long-term use, theoretically, depression of the hypothalamic-pituitary-adrenal system can develop.
In this case, it is recommended to apply symptomatic therapy.

Side effects

The drug is usually well tolerated. Side effects can occur only in rare cases. In particular, there may be observed:

• headache;
• bleeding from the nose;
• pharyngitis;
• burning sensation in the nose;
• irritation of the mucous membrane in the nose.

Discomfort in the nose usually goes away on its own, bleeding is not prolonged.
In isolated cases, patients had an immediate allergic reaction in the form of bronchospasm, dyspnea.