Nosefrine nasal spray dispensed 50mcg/dose 120 doses, 18g

Composition

Active ingredient:  mometasone furoate 50 mcg Excipients: MCC and sodium carboxymethylcellulose-2000 mcg; glycerol-2100 mcg; citric acid monohydrate-200 mcg; sodium citrate dihydrate-280 mcg; polysorbate 80-10 mcg;benzalkonium chloride (50% solution) – 40 mcg; purified water – up to 0.1 g

Pharmacological action

Pharmacodynamics  Mometasone is a synthetic topical corticosteroid. It has an anti-inflammatory and anti-allergic effect when used in doses that do not cause systemic effects. Inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which leads to a decrease in the release of arachidonic acid and, accordingly, inhibits the synthesis of arachidonic acid metabolism products — cyclic endoperoxides, PG. Prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and lymphokine production, inhibits macrophage migration, leads to a decrease in infiltration and granulation processes. Reduces inflammation by reducing the formation of the chemotaxis substance (influence on late allergic reactions), inhibits the development of an immediate allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells). In studies with provocative tests with the application of antigens to the nasal mucosa, a high anti-inflammatory activity of mometasone was demonstrated both in the early and late stages of an allergic reaction. This was confirmed by a decrease (compared to placebo) in histamine levels and eosinophil activity, as well as a decrease (compared to baseline) in the number of eosinophils, neutrophils, and epithelial cell adhesion proteins. Pharmacokinetics With intranasal use, the systemic bioavailability of mometasone is less than 1% (with a sensitivity of 0.25 pg/ml). Mometasone suspension is very poorly absorbed in the gastrointestinal tract, and the small amount of mometasone suspension that can enter the gastrointestinal tract after nasal inhalation, even before excretion by the kidneys or with bile, undergoes active primary metabolism.

Indications

• Seasonal or perennial allergic rhinitis in adults, adolescents and children 2 years of age;
• acute sinusitis or acute exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from 12 years as part of complex therapy;
• acute rhinosinusitis with mild and moderately severe symptoms with no signs of serious bacterial infection in patients aged 12 years and older;
• prophylactic treatment of seasonal allergic rhinitis moderate and severe in adults and adolescents from 12 years (recommended 2-4 weeks before the anticipated start of the season dusting);
• nasal polyposis, accompanied by a violation of nasal breathing and sense of smell in adults (18 years old).

Use during pregnancy and lactation

Studies of the effect of the drug in pregnant and breast-feeding women have not been conducted. As with other nasal corticosteroids, Nosephrine should be used during pregnancy and lactation only if the expected benefit to the mother exceeds the potential risk to the fetus or newborn. Newborns whose mothers used the drug Nosephrine during pregnancy should be carefully examined for possible adrenal hypofunction.

Contraindications

• hypersensitivity to mometasone or any of the components that make up the drug; recent surgery or nasal trauma with damage to the nasal mucosa-before the wound heals (due to the inhibitory effect of corticosteroids on the healing processes)
• children’s age (with seasonal and year-round allergic rhinitis-up to 2 years, with acute sinusitis or exacerbation of chronic sinusitis – up to 12 years, with polyposis-up to 18 years) due to the lack of relevant data.

With caution:  

• TB infection (active or latent) of the respiratory tract;
• untreated fungal, bacterial, systemic viral infection or an infection caused by Herpes simplex, with the defeat of the eye (the exception perhaps the use of the drug in these infections as directed by a physician);
• untreated local infection with involvement of the mucous membrane of the nasal cavity;
• long-term therapy of corticosteroids for systemic effects;
• pregnancy;
• breastfeeding.

Side effects

In adults and adolescents: headache, nosebleeds (i. e., obvious bleeding, as well as the release of blood-stained mucus or blood clots), pharyngitis, burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa, upper respiratory tract infections, irritation of the pharyngeal mucosa. Nosebleeds were usually moderate and stopped on their own, the frequency of their occurrence was slightly higher than with placebo (5%), but equal to or less than with the appointment of other nasal corticosteroids that were used as an active control (in some of them, the frequency of occurrence of nosebleeds was up to 15%). The incidence of all other adverse events was comparable to that of placebo. For children: nosebleeds, headache, irritated nose, sneezing. The incidence of these adverse events in children was comparable to that of placebo. Hypersensitivity reactions of immediate type (including bronchospasm, shortness of breath) were rarely observed. Very rarely — anaphylaxis, angioedema, impaired taste and smell. Also, very rarely — with intranasal use of corticosteroids, cases of perforation of the nasal septum and increased IOP were noted. With prolonged use of high-dose nasal corticosteroids, systemic side effects may develop. Potential systemic effects include Cushing’s syndrome, characteristic signs of Cushing’s disease, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and more rarely, a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (especially in children).

Interaction

When mometasone was co-administered with loratadine, good patient tolerance was observed. No effect of mometasone on the plasma concentrations of loratadine or its major metabolite was observed. Interaction studies with other drugs have not been conducted.

How to take, course of use and dosage

At the first signs of acute respiratory viral infection (within 5 days)

Children from 1 to 3 years – 2 spray doses in each nasal passage 3-4 times a day (single dose-20000 IU, daily dose: – 60000-80000 IU);

Children from 3 to 14 years – 2 spray doses 4-5 times a day (single dose-20000 IU, daily dose-80000-100000 IU);

Adults – 3 spray doses 5-6 times a day (single dose-30,000 IU, daily dose-150,000-180000 IU).

For the prevention of respiratory viral infections

In case of contact with the patient and hypothermia – in accordance with the age dosage 2 times a day for 5-7 days. If necessary, the preventive courses are repeated. For a single contact, one injection is sufficient.

With a seasonal increase in morbidity – in accordance with the age-related dosage once in the morning with an interval of 1-2 days.

Overdose

Symptoms:  suppression of the function of the hypothalamic-pituitary-adrenal system (may occur in the case of prolonged use of corticosteroids in high doses, as well as with the simultaneous use of several corticosteroids). Treatment: due to the low systemic bioavailability of the drug (less than 1% with a sensitivity of 0.25 pg/ml), it is unlikely that accidental or intentional overdose will require any measures other than monitoring, with possible subsequent resumption of the drug at the recommended dose. If necessary, treatment is symptomatic.

Special instructions

Do not use in ophthalmology. When using the drug for a long time (for several months or longer), a periodic examination by a doctor is necessary to timely identify possible changes in the nasal mucosa. If a local fungal infection of the nose or pharynx develops, it may be necessary to stop therapy with the drug and conduct special treatment. Persistent irritation of the nasal and pharyngeal mucosa for a long time is also an indication for discontinuation of drug therapy. Patients who switch to Nosephrine nasal spray treatment after long-term systemic corticosteroid therapy require special attention. Discontinuation of systemic corticosteroids in such patients may lead to adrenal insufficiency, which may take several months to recover. If signs of adrenal insufficiency appear, you should resume taking systemic corticosteroids and take other necessary measures. During the transition from systemic corticosteroid therapy to Nosefrin nasal spray treatment, some patients may experience symptoms of withdrawal from systemic corticosteroids (including joint and/or muscle pain, fatigue, and depression). These patients should be encouraged to continue treatment with Nosefrin nasal spray. Switching from systemic to local corticosteroids may also reveal pre – existing allergic diseases, such as allergic conjunctivitis and eczema, which were previously masked by systemic corticosteroid therapy.Patients using corticosteroids have potentially reduced immune reactivity and should be warned about their increased risk of infection in case of contact with patients with certain infectious diseases (including chickenpox, measles), as well as the need to consult a doctor if such contact has occurred. Regular monitoring of the condition of patients receiving the drug for a long time is necessary. With prolonged use of high-dose nasal corticosteroids, systemic side effects may develop. These effects are much less likely to occur than with systemic corticosteroids, and may vary from patient to patient, as well as between different corticosteroids. Potential systemic effects include Cushing’s syndrome, characteristic signs of Cushing’s disease, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and more rarely, a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (especially in children). It is recommended to regularly monitor the growth of children receiving long-term mometasone therapy. If growth slows down, the current therapy should be reviewed to reduce the dose of mometasone to the minimum effective dose that allows you to control the symptoms of the disease. In addition, the patient should be referred for consultation with a pediatrician. Treatment with corticosteroids at higher doses than recommended may lead to clinically significant suppression of adrenal function. If there are signs of a severe bacterial infection (including fever, persistent and sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area), you should immediately consult a doctor. When using mometasone in the dosage form of nasal spray for 12 months, there were no signs of atrophy of the nasal mucosa. The efficacy and safety of mometasone has not been studied in the treatment of unilateral polyps, polyps associated with cystic fibrosis, and polyps that completely cover the nasal cavity. Unilateral polyps of irregular shape or bleeding polyps should be additionally examined. Influence on the ability to drive vehicles and mechanisms. There are no data on the negative effect of the drug in the recommended doses on the ability to drive vehicles and mechanisms, as well as perform other activities that require concentration of attention and speed of psychomotor reactions.

Storage conditions

At a temperature not exceeding 25 °C (do not freeze).

Shelf life

3 years

Active ingredient

Mometasone

Conditions of release from pharmacies

By prescription

Dosage form

nasal spray

Purpose

For adults as prescribed by a doctor, Children over 2 years of age, Children as prescribed by a doctor

Indications

Allergic Rhinitis, Allergy, Sinusitis, Nasal Polyposis, Pollinosis