Nasobek nasal spray 50mkg / dose, 200 dose

• seasonal and perennial allergic rhinitis;

• vasomotor rhinitis.

The drug is administered intranasally.

Adults and children over 12 years old: appoint 50-100 mcg (1-2 doses) in each nasal passage 2 times / day; the daily dose is 200-400 mcg. The maximum daily dose is 400 mcg. The daily dose can be divided into 2-4 doses.

Children aged 6 to 12 years : appoint an initial dose of 50 mcg (1 dose) in each nasal passage 2 times / day, if necessary - 100 mcg (2 doses) in each nasal passage 2 times / day. The maximum daily dose is 400 mcg. The daily dose can be divided into 2-4 doses.

When the therapeutic effect is achieved, the drug is canceled, gradually reducing the dose.

Elderly patients do not need dose adjustment.

Rules for using the drug:

Before using the drug, you must clean the nasal passages.

When using for the first time, unlock the spray mechanism: press the dispenser several times until a cloud of aerosol appears. If the drug has not been used for several days, the spraying mechanism should be unlocked again.

Before using the drug for the first time, remove the plastic protective half-ring located between the screw-on part and the dispensing nasal applicator.

1. Before use, shake the bottle slightly, then remove the cap of the nasal applicator.

2. Place the bottle between the thumb and forefinger so that the bottom of the bottle rests on the thumb and the index and middle fingers rest on both opposite sides of the bottom of the applicator.

3. Before the first use of the drug, or in the event of a long break in use, the first dose should be sprayed into the air.

4. Exhale slightly through the nose.

5. The nasal passage, into which the drug will not be injected, should be pinched with a finger, and the applicator should be inserted into the free nasal passage. Then tilt your head slightly so that the bottle is in a perpendicular position.

6. Inhale lightly through the open nasal passage and simultaneously press the nasal applicator and inject the aerosol dose.

7. Exhale through your mouth.

8. When re-injecting the drug into the same nasal passage, repeat the steps described in points 6 and 7.

When the drug is injected into another nasal passage, the steps described in paragraphs 5, 6, 7, 8 should be repeated.

After the end of the use of the drug, you should clean the end (upper) part of the applicator with a clean cloth and return the cap to its place.

Active ingredient: beclomethasone dipropionate 50 mcg - 1 dose.

Excipients: benzalkonium chloride (50% solution) - 0.04 ?l, phenylethanol - 250 ?g, polysorbate 80 - 5 ?g, anhydrous dextrose - 5 mg, microcrystalline cellulose + sodium carmellose (dispersive cellulose) - 1 mg, hydrochloric acid 35% - qs , purified water - up to 0.1 g.

• hemorrhagic diathesis;

• frequent nosebleeds;

• respiratory tuberculosis;

• fungal infections;

• viral infections;

• children under 6 years of age;

• I trimester of pregnancy;

• hypersensitivity to the components of the drug.

The drug is prescribed with caution for amebiasis, glaucoma, severe liver failure, hypothyroidism, recent myocardial infarction, ulceration of the nasal septum, after recent surgical interventions in the nasal cavity or nasal injuries, in the II and III trimesters of pregnancy, during breastfeeding.

Dosed nasal spray in the form of an opaque suspension of white color, without visible impurities.

Composition:

Active ingredient: beclomethasone dipropionate 50 mcg - 1 dose.

Excipients: benzalkonium chloride (50% solution) - 0.04 ?l, phenylethanol - 250 ?g, polysorbate 80 - 5 ?g, anhydrous dextrose - 5 mg, microcrystalline cellulose + sodium carmellose (dispersive cellulose) - 1 mg, hydrochloric acid 35% - qs , purified water - up to 0.1 g.

Clinical and pharmacological group:

GCS for intranasal use

Pharmachologic effect:

Synthetic corticosteroids for topical use. It has anti-inflammatory, anti-allergic and immunosuppressive effects. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, inhibits the release of arachidonic acid. Prevents marginal accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, and the formation of chemotaxis substance. Reduces swelling of the nasal mucosa, mucus production. Improves mucociliary transport.

The drug is well tolerated with long-term treatment, does not have mineralocorticoid activity, and practically does not have a resorptive effect.

Pharmacokinetics:

Absorption and distribution

When administered by inhalation in recommended doses, it does not exhibit significant systemic activity.

After intranasal administration, it is rapidly absorbed through the nasal mucosa. Part of the injected drug is swallowed. Absorption from the gastrointestinal tract is low. Plasma protein binding - 87%.

Metabolism and excretion

Most of the drug that enters the gastrointestinal tract is metabolized during the 'first pass' through the liver. T1 / 2 - 15 hours. The main part of the drug (35-76%), regardless of the route of administration, is excreted within 96 hours with feces, mainly in the form of polar metabolites; 10-15% is excreted by the kidneys.

Indications:

• seasonal and perennial allergic rhinitis;

• vasomotor rhinitis.

Contraindications:

• hemorrhagic diathesis;

• frequent nosebleeds;

• respiratory tuberculosis;

• fungal infections;

• viral infections;

• children under 6 years of age;

• I trimester of pregnancy;

• hypersensitivity to the components of the drug.

The drug is prescribed with caution for amebiasis, glaucoma, severe liver failure, hypothyroidism, recent myocardial infarction, ulceration of the nasal septum, after recent surgical interventions in the nasal cavity or nasal injuries, in the II and III trimesters of pregnancy, during breastfeeding.

Method of administration and dosage:

The drug is administered intranasally.

Adults and children over 12 years old: appoint 50-100 mcg (1-2 doses) in each nasal passage 2 times / day; the daily dose is 200-400 mcg. The maximum daily dose is 400 mcg. The daily dose can be divided into 2-4 doses.

Children aged 6 to 12 years : appoint an initial dose of 50 mcg (1 dose) in each nasal passage 2 times / day, if necessary - 100 mcg (2 doses) in each nasal passage 2 times / day. The maximum daily dose is 400 mcg. The daily dose can be divided into 2-4 doses.

When the therapeutic effect is achieved, the drug is canceled, gradually reducing the dose.

Elderly patients do not need dose adjustment.

Rules for using the drug:

Before using the drug, you must clean the nasal passages.

When using for the first time, unlock the spray mechanism: press the dispenser several times until a cloud of aerosol appears. If the drug has not been used for several days, the spraying mechanism should be unlocked again.

Before using the drug for the first time, remove the plastic protective half-ring located between the screw-on part and the dispensing nasal applicator.

1. Before use, shake the bottle slightly, then remove the cap of the nasal applicator.

2. Place the bottle between the thumb and forefinger so that the bottom of the bottle rests on the thumb and the index and middle fingers rest on both opposite sides of the bottom of the applicator.

3. Before the first use of the drug, or in the event of a long break in use, the first dose should be sprayed into the air.

4. Exhale slightly through the nose.

5. The nasal passage, into which the drug will not be injected, should be pinched with a finger, and the applicator should be inserted into the free nasal passage. Then tilt your head slightly so that the bottle is in a perpendicular position.

6. Inhale lightly through the open nasal passage and simultaneously press the nasal applicator and inject the aerosol dose.

7. Exhale through your mouth.

8. When re-injecting the drug into the same nasal passage, repeat the steps described in points 6 and 7.

When the drug is injected into another nasal passage, the steps described in paragraphs 5, 6, 7, 8 should be repeated.

After the end of the use of the drug, you should clean the end (upper) part of the applicator with a clean cloth and return the cap to its place.

Cleaning the applicator

The nasal applicator should be cleaned at least once a week to prevent clogging. To do this, lightly press the lower part of the applicator and detach the nasal applicator. Rinse the applicator and the cap with warm water and allow to dry. Then put the applicator and the cap back on the bottle.

Side effects:

Determination of the frequency of side effects (according to WHO recommendations): very often (? 10%); often (? 1%, but <10%); infrequently (? 0.1%, but <1%); rarely (? 0.01%, but <0.1%); very rarely (<0.01%), including isolated cases; unknown (insufficient data to estimate the frequency of the event in the population).

Allergic reactions: rarely - skin rash, urticaria, angioedema.

From the side of the nervous system: rarely - a violation of the olfactory and taste sensations, drowsiness, headache, dizziness.

From the side of the organ of vision: unknown - increased intraocular pressure, incl. glaucoma, cataract (with prolonged use), conjunctival hyperemia, decreased vision.

From the respiratory system: rarely - dryness and irritation of the nasopharynx, sneezing, burning, nasal congestion, nosebleeds, atrophy of the nasal mucosa, cough, rhinorrhea; very rarely - ulceration of the nasal mucosa, perforation of the nasal septum (usually in patients who have previously undergone surgery in the nasal cavity).

Others: rarely - myalgia, candidiasis of the oral cavity and upper respiratory tract (with prolonged use and / or in high doses (more than 400 mcg / day)); unknown - with prolonged use, it is possible to develop adrenal insufficiency, a decrease in the growth rate in children, a decrease in bone mineral density.

Overdose:

Symptoms: with prolonged use in high doses, as well as with the simultaneous administration of other (systemic) corticosteroids, symptoms of hypercortisolism may appear.

Treatment: the use of the drug should be discontinued, gradually reducing the dose.

Drug interactions:

When used together, phenobarbital, phenytoin, rifampicin reduce the effectiveness of beclomethasone (induction of microsomal oxidation enzymes).

When used together, methandrostenolone, estrogens, beta2-adrenomimetics, theophylline, oral corticosteroids enhance the effect of beclomethasone.

When used together, Nasobek increases the effect of beta-adrenergic agonists.

Special instructions:

Patients should be warned about the need to be careful not to allow Nasobek to come into contact with the eyes.

The therapeutic effect of the drug Nasobek, in contrast to local vasoconstrictor agents for the treatment of rhinitis, does not appear immediately with intranasal administration. Relief of rhinitis symptoms usually becomes noticeable after 5-7 days from the start of drug use. When a therapeutic effect is achieved, the dose of Nasobek should be reduced to the minimum effective dose that controls the course of the disease.

Patients with a high risk of developing adrenal insufficiency need medical supervision.

Since the drug slows down the healing of wounds, patients with ulceration of the nasal septum, after surgery in the nasal cavity, nasal trauma, should not use Nasobek until the wounds are completely healed.

In case of infectious diseases of the nasal cavity and paranasal sinuses, appropriate therapy should be carried out. These diseases are not contraindications to the use of the drug Nasobek.

Benzalkonium chloride, contained in Nasobek, increases the risk of swelling of the nasal mucosa with prolonged use. If such a reaction occurs, a dose adjustment of the Nasobek drug or the use of a drug that does not contain benzalkonium chloride is necessary.

Use in pediatrics

With prolonged use of the drug Nasobek in children, it is necessary to control the dynamics of their growth.

Influence on the ability to drive vehicles and use mechanisms

Due to the fact that drowsiness and dizziness may develop when using the drug Nasobek, patients should be careful when driving transport and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Pregnancy and lactation:

The use of the drug Nasobek is contraindicated in the first trimester of pregnancy. The use of the drug Nasobek in the II and III trimesters of pregnancy is allowed only if the expected benefit to the mother outweighs the possible risk to the fetus.

Use the drug Nasobek during breastfeeding with caution.

Childhood use:

Contraindicated: children under 6 years of age.

For violations of liver function:

The drug is prescribed with caution in severe hepatic impairment.

Elderly patients do not need dose adjustment.

Terms of dispensing from pharmacies:

The drug is available with a prescription.

Storage conditions:

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25 ? C; do not freeze.

Shelf life is 4 years.

After the first opening of the bottle, the drug should be used within 6 months.