Nazonex Sine

Nazonex sinus is a dosed nasal spray for topical use in the treatment of nasal cavity diseases. It is a corticosteroid with anti-edema properties.

[1], [2]

Indications Nazonex Sine

Among the indications:

• year-round / seasonal colds of allergic nature in children 2+ years of age and adults. As a prophylaxis of a severe or moderate allergic rhinitis, you need to start spraying about 1 month before the supposed appearance of allergens;
• in acute sinusitis (children 12+ years, as well as adults) as an additional medicinal tool;
• the appearance of signs of sinusitis in an acute form, without symptoms of the development of a severe form of bacterial infection (children 12+ years, as well as adults);
• nasal polyps, and in addition, the manifestations provoked by them - such as loss of smell or nasal congestion (can only be used for people over 18 years of age).

Release form

Produced in the form of a suspension in vials of 10 g (enough for 60 doses). In addition, a cap-capped sprayer is attached. In the package - 1 bottle.

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Pharmacodynamics

Mometasone furoate is a synthetic GCS used topically. Possesses powerful anti-inflammatory properties.

The presence of anti-inflammatory drugs, as well as anti-allergic properties, is due to the ability of the active substance to inhibit the process of isolating the conductors of the allergic response. The active component significantly reduces the rate of synthesis and release of leukotrienes in the leukocytes of patients with allergic diseases.

Mometasone furoate has a much higher (10-fold) activity in inhibiting the release and synthesis of IL-1 and IL-5, as well as IL-6 with TNFα than other steroids (this group includes betamethasone with beclomethasone dipropionate, and besides this dexamethasone with hydrocortisone). In addition, this substance significantly slows down the production of Th2 type cytokines, and in addition IL-4 with IL-5, occurring in human CD4 + T lymphocytes. The active substance is 6 times faster (than betamethasone and beclomethasone dipropionate) slows the production of IL-5.

[4], [5]

Pharmacokinetics

The bioavailability of the active component in the blood plasma after intranasal administration is <1%. Suspension is poorly absorbed from the gastrointestinal tract, and then a small amount that can be swallowed, after absorption passes through the primary active metabolic process. Excretion occurs together with bile, mainly under the guise of decay products. A little substance is excreted along with the urine.

Dosing and administration

To eliminate the symptoms of a seasonal / year-long allergic rhinitis, children from 12 years and adults need the following dosage (both curative and preventive) - 2 sprays (1 spray-50 μg) per nostril 1 time per day (total day, 200 μg of the drug is obtained). After reaching the necessary therapeutic result, you should switch to maintenance treatment - reduce the dose to 1 spray on each of the nostrils 1 time per day (a total of 100 micrograms of medication per day).

In cases where the strength of manifestations of the disease does not decrease, it is permitted to increase the daily dosage to the maximum: 4 sprays per each nostril 1 time per day (400 μg of the drug are obtained per day). When the desired effect is achieved, the dose should be reduced.

Children in the period of 2-11 years should be given a dosage equal to 1-m spray (50 mcg) on each of the nostrils 1 time per day (in a day, 100 μg of the drug is obtained).

In the form of an auxiliary tool in the treatment of acute sinusitis - adults, as well as children from 12 years, you need to prescribe a drug in the dosage of 2 sprays (50 μg) on each of the nostrils twice a day (in general, the daily dosage in this case is 400 μg ).

In the case when it is not possible to reduce the strength of manifestation of the symptoms of the disease with the recommended therapeutic dosage, it is permitted to increase up to 4 sprays per each nostril twice per day (thus, 800 μg of the drug are obtained per day). When the desired result is achieved, the dosage should be reduced.

Acute form of rhinosinusitis - for children from 12 years, and in addition to adults, the dosage is equal to 2 sprays (50 μg) per each nostril twice per day (400 μg of medication per day).

Elimination of nasal polyps - patients from 18 years of age are assigned to 2 sprays (50 micrograms) per each nostril twice per day (in general, 24 hours in this case, 400 μg is obtained). When the desired result is achieved, it is necessary to reduce the dosage of the spray to 2 sprays on each of the nostrils 1 time per day (200 μg of the drug are released per day).

Use Nazonex Sine during pregnancy

Testing of the effect of the drug on pregnant women was not carried out, but since Nazonex sinus is a SCS, during this period it should be prescribed only in case of acute necessity, when the benefit for the mother is higher than the possible risk of developing negative consequences for the fetus.

In newborns, whose mothers during the period of gestation used this GCS, you need to carefully check the work of the adrenal glands in order to prevent the development of their hypofunction.

Contraindications

Among the contraindications:

• individual intolerance to the active ingredient or other substances that make up the drug;
• the patient has an untreated local infectious process, which also involves nasal mucosa;
• because the SCS has properties that allow them to suppress the process of wound regeneration, patients with a recent surgery in the nasal area (or in the presence of recent injuries), this drug is prohibited to use until the healing of the damaged site.

[6], [7],

Side effects Nazonex Sine

In the process of clinical testing of drugs in the process of eliminating the seasonal / all-year rhinitis of an allergic nature, the following adverse reactions were identified:

• in 8% of cases - headaches, or bleeding from the nose (a pronounced process of bleeding or the release of blood clots or mucus);
• in 4% of cases - the development of pharyngitis;
• in 2% of cases - irritation or severe burning in the nose;
• in 1% of cases - developed a ulcerative process on the nasal mucosa.

As a result of intranasal administration of the active drug component in some cases, a rapidly developing allergic reaction is possible (for example, the appearance of dyspnea or bronchospasm). The reactions of Quincke edema or anaphylaxis were uniquely developed, and in addition to this, the smell of olfaction and taste sensations.

Interactions with other drugs

In the case of drug combination with Loratadine, no significant effect was observed on the latter (as well as its main decay product) in the blood plasma. The active substance of Nazonex sinus (mometasone furoate) was not detected in the blood plasma even at the minimum level.

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Storage conditions

Contain the spray should be in standard for medicines conditions, with a temperature regime of maximum 25 ^o C. Drug is prohibited to be frozen.

Shelf life

Nazonex sinus is allowed to be used for 3 years from the date of manufacture of the medicine.