INSTRUCTIONS FOR USE

MOMETOP

MOMETOP

Trade name of the drug: Mometop

Active ingredients (INN): mometasone furoate

Dosage form: nasal spray

Compound:

active ingredients: mometasone furoate BF 0.5 mg;

excipients: microcrystalline cellulose and sodium carboxymethylcellulose (Neocel — C91), sodium citrate, citric acid monohydrate, polysorbate 80, glycerin, phenylethyl alcohol, benzalkonium chloride, water for injection.

Pharmacotherapeutic group : glucocorticosteroids for intranasal use.

ATX code: R01AD09

Pharmacological properties

GCS for local use. It has anti-inflammatory and antiallergic effects when used in doses at which systemic effects do not occur.

Inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, accordingly, inhibition of the synthesis of arachidonic acid metabolic products — cyclic endoperoxides, prostaglandins. Prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, and leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of a chemotaxis substance (impact on late allergy 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, the high anti-inflammatory activity of mometasone was demonstrated, both in the early and late stages of the allergic reaction.

This was confirmed by a decrease (compared with placebo) in histamine concentrations and eosinophil activity, as well as a decrease (compared with baseline) in the number of eosinophils, neutrophils and epithelial cell adhesion proteins.

Pharmacokinetics

Suction

When administered intranasally, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of the detection method of 0.25 pg/ml).

Mometasone is very poorly absorbed from the gastrointestinal tract.

Metabolism and excretion

A small amount of the active substance that can enter the gastrointestinal tract after intranasal administration undergoes active metabolism during the “first pass” through the liver. Excreted in urine and bile.

Indications for use

— seasonal and year-round allergic rhinitis in adults, adolescents and children over 2 years of age;

— acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents over 12 years of age — as an auxiliary therapeutic agent in treatment with antibiotics;

— acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years and older;

— prevention of moderate and severe seasonal allergic rhinitis in adults and adolescents from 12 years of age (recommended 2-4 weeks before the expected start of the dusting season);

— nasal polyposis, accompanied by impaired nasal breathing and sense of smell in adults (over 18 years of age).

Directions for use and doses

The drug is used intranasally.

Treatment of seasonal or year-round allergic rhinitis

Adults (including elderly patients) and adolescents from 12 years of age

The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) into each nostril 1 time / day (total daily dose — 200 mcg). Upon achieving a therapeutic effect for maintenance therapy, it is possible to reduce the dose to 1 inhalation in each nostril 1 time / day (total daily dose — 100 mcg).

If a reduction in the symptoms of the disease cannot be achieved by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations into each nostril 1 time per day (total daily dose — 400 mcg). After the symptoms of the disease decrease, a dose reduction is recommended.

The onset of action of the drug is usually observed clinically within 12 hours after the first use of the drug.

Children aged 2 to 11 years

The recommended therapeutic dose is 1 inhalation (50 mcg) into each nostril 1 time / day (total daily dose — 100 mcg).

To use the drug in young children, adult assistance is required.

Adjuvant treatment of acute sinusitis or exacerbation of chronic sinusitis

Adults (including elderly patients) and adolescents from 12 years of age

The recommended therapeutic dose is 2 inhalations (50 mcg each) into each nostril 2 times a day (total daily dose — 400 mcg).

If a reduction in the symptoms of the disease cannot be achieved by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations into each nostril 2 times a day (total daily dose — 800 mcg). After the symptoms of the disease decrease, a dose reduction is recommended.

Treatment of acute rhinosinusitis without signs of severe bacterial infection

The recommended dose for adults and adolescents is 2 inhalations of 50 mcg in each nasal passage 2 times a day (total daily dose 400 mcg). If symptoms worsen during treatment, consultation with a specialist is necessary.

Treatment of nasal polyposis

For adults (including elderly patients) over 18 years of age, the recommended therapeutic dose is 2 inhalations (50 mcg each) into each nostril 2 times a day (total daily dose — 400 mcg).

After the symptoms of the disease have reduced, it is recommended to reduce the dose to 2 inhalations (50 mcg each) into each nostril 1 time / day (total daily dose — 200 mcg).

Rules for using the drug Mometop ^®

Inhalation of the suspension contained in the spray bottle is carried out using a special dispensing nozzle on the bottle.

Before using Mometop ^® nasal spray for the first time , it is necessary to calibrate by pressing the dispensing device 10 times until splashes appear, indicating that the drug is ready for use.

You should tilt your head and inject the medicine into each nostril as recommended by your doctor.

If the nasal spray has not been used for 14 days or longer, press the dispenser nozzle 2 times until it sprays.

Before each use, shake the bottle vigorously.

Cleaning the dispensing nozzle

It is important to clean the dispensing nozzle regularly to prevent it from malfunctioning. Remove the cap that protects the nozzle from dust, then carefully remove the spray tip. It is necessary to thoroughly rinse the spray tip and dust cap in warm water and rinse under the tap.

Do not attempt to open the nasal applicator with a needle or other sharp object, as This will damage the applicator, which may result in the wrong dose being given.

Dry the cap and tip in a warm place. After this, you need to attach the spray tip to the bottle and screw the dust cap back onto the bottle. When using the nasal spray for the first time after cleaning, you must recalibrate by pressing the dispensing nozzle 2 times.

Side effects

In adults and adolescents: headache, nosebleeds (i.e., obvious bleeding, as well as discharge of blood-stained mucus or blood clots), pharyngitis, burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa. Nosebleeds, as a rule, stopped on their own and were not severe; they occurred with a frequency slightly higher than with placebo (5%), but equal to or less than with the administration of other intranasal corticosteroids studied, which were used as active controls (in some of them the frequency of nosebleeds was up to 15%) . The incidence of other side effects was comparable to that observed with placebo.

In children: nosebleeds, headache, irritation in the nose, sneezing. The incidence of these adverse events is comparable to the incidence of side effects in children when using placebo.

Rarely, immediate hypersensitivity reactions (eg, bronchospasm, shortness of breath) have been reported.

Very rare: anaphylaxis, angioedema, disturbances of taste and smell.

Very rarely, with intranasal use of GCS, cases of perforation of the nasal septum or increased intraocular pressure have been reported.

Contraindications

— recent surgery or trauma to the nose with damage to the mucous membrane of the nasal cavity — before the wound heals (due to the inhibitory effect of GCS on the healing processes);

— childhood and adolescence (for seasonal and year-round allergic rhinitis — up to 2 years, for acute sinusitis or exacerbation of chronic sinusitis — up to 12 years, for polyposis — up to 18 years) — due to the lack of relevant data;

— hypersensitivity to the components of the drug.

The drug should be used with caution in case of tuberculosis infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye damage (as an exception, the drug can be prescribed for these infections as directed by a doctor), the presence of untreated local infection involving the nasal mucosa.

Use during pregnancy and breastfeeding

There have been no special, well-controlled studies of the safety of Mometop ^® during pregnancy.

Like other corticosteroids for intranasal use, Mometop ^® should be prescribed during pregnancy and breastfeeding only if the expected benefit from its use justifies the potential risk to the fetus or infant.

Infants whose mothers received corticosteroids during pregnancy should be carefully examined to identify possible adrenal hypofunction.

Use for liver dysfunction

A small amount of the active substance, which can enter the gastrointestinal tract during intranasal use, is absorbed to a small extent and is actively biotransformed during the “first pass” through the liver.

Use in children

Contraindicated for seasonal and year-round allergic rhinitis — in children under 2 years of age, for acute sinusitis or exacerbation of chronic sinusitis — up to 12 years, for polyposis — up to 18 years of age (due to the lack of relevant data).

In placebo-controlled clinical studies in children, when Mometop ^® was used at a dose of 100 mcg/day for a year, no growth retardation was observed.

Drug interactions

Combination therapy with loratadine was well tolerated by patients. However, no effect of the drug on the concentration of loratadine or its main metabolite in the blood plasma was noted. In these studies, mometasone furoate was not detected in blood plasma (with a sensitivity of the detection method of 50 pg/ml).

special instructions

^{When using Mometop ®} nasal spray for a long time (as with any long-term treatment), periodic examination of the nasal mucosa by an ENT doctor is necessary. If a local fungal infection of the nose or throat develops, it is recommended to stop treatment with the drug and begin special treatment. Irritation of the mucous membrane of the nasal cavity and pharynx that persists for a long time is grounds for discontinuation of the drug.

With long-term use of the drug, no signs of suppression of the function of the hypothalamic-pituitary-adrenal system were observed.

Patients who switch to treatment with Mometop ^® nasal spray after long-term treatment with systemic GCS require special attention. Withdrawal of systemic corticosteroids in such patients can lead to adrenal insufficiency, the subsequent recovery of which may take up to several months. If symptoms of adrenal insufficiency appear, you should resume taking systemic corticosteroids and take other necessary measures.

During the transition from treatment with systemic corticosteroids to treatment with Mometop ^® nasal spray , some patients may experience withdrawal symptoms of systemic corticosteroids (for example, joint and/or muscle pain, fatigue, depression), despite a decrease in the severity of symptoms associated with damage to the nasal mucosa; such patients must be specifically convinced of the advisability of continuing treatment with Mometop ^® nasal spray . A change in therapy may also reveal previously developed allergic diseases, such as allergic conjunctivitis and eczema, which were previously masked by systemic corticosteroid therapy.

Patients who have undergone GCS therapy have a potentially reduced immune reactivity and should be warned about the increased risk of infection when contacting patients with infectious diseases (including chickenpox, measles), as well as the need to consult a doctor if such contact occurs.

If signs of a severe bacterial infection appear (for example, fever, persistent and sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area), immediate consultation with a doctor is required.

After using Mometop ^® for 12 months, there were no signs of atrophy of the nasal mucosa. When studying biopsy samples of the nasal mucosa, it was revealed that mometasone furoate tended to contribute to the normalization of the histological picture.

Use in pediatrics

In placebo-controlled clinical studies in children, when Mometop ^® was used at a dose of 100 mcg/day for a year, no growth retardation was observed.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of Mometop ^® on the ability to drive a car or drive machinery.

The drug should be stored out of the reach of children and not used after the expiration date.

Overdose

With long-term use of GCS in high doses or with the simultaneous use of several GCS, suppression of the hypothalamic-pituitary-adrenal system is possible.

The drug has low systemic bioavailability (<1%, with a sensitivity of the detection method of 0.25 pg/ml), so it is unlikely that in case of accidental or intentional overdose, any special measures will be required, other than observation with the possible subsequent resumption of the drug at the recommended dose.

Release form

10 ml in a polypropylene bottle with a nasal adapter and cap. One bottle in a cardboard box along with instructions — insert

Storage conditions

Store at a temperature not exceeding 30 ⁰ C in a place protected from light. Do not freeze.

Keep out of the reach of children.

Best before date

2 years.

Conditions for dispensing from pharmacies

According to a doctor’s prescription.

Made in India:

Coral Laboratories Ltd.

At: 5,6, Khokhani Ind. complex no. 2,

Near Sai Temple, Sativali, Vasai (E),

Dist. Thane — 401208, INDIA.

E-mail: exports@corallab.com

Website: www.corallab.com

MOMETOP

Price on Request

MOMETOP

Price on Request