NASOBEK

Active material: Beklometazon
When ATH: R01AD01
CCF: GCS for intranasal use
ICD-10 codes (testimony): J30.0, J30.1, J30.3
When CSF: 04.04.01
Manufacturer: IVAX Pharmaceuticals s.r.o. (Czech Republic)

Pharmaceutical form, composition and packaging

Spray nazalynыy dozirovannыy as an opaque white slurry, without visible inclusions.

Excipients: benzalkonium chloride, phenylethanol, polysorbate 80, dextrose anhydride, microcrystalline cellulose, sodium carboxymethylcellulose, hydrochloric acid, Purified water.

200 doses – plastic bottles with screw cap (1) with applicator – packs cardboard.

Pharmacological action

Synthetic corticosteroids for local application. Anti-inflammatory, anti-allergic and immunosuppressive effect. Increases production lipomodulina, an inhibitor of phospholipase A, inhibits the release of arachidonic acid. It prevents the accumulation of neutrophils boundary, reduces the inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, It reduces the intensity of infiltration and granulation, formation Substance chemotaxis. It reduces swelling of the nasal mucosa, mucus production. It improves mucociliary transport.

The drug was well tolerated during long-term treatment, It has no mineralocorticoid activity, almost no resorptive action.

The therapeutic effect of the drug is not immediately (Unlike vasoconstrictors topical). Relief of symptoms of rhinitis usually becomes evident in a few days from the start of therapy.

Pharmacokinetics

Absorption and distribution

When inhaled route of administration at recommended doses has no significant systemic activity.

After intranasal administration is rapidly absorbed through the nasal mucosa. Frequent administration swallowed. Absorption from the gastrointestinal tract is low. Plasma protein binding – 87%.

Metabolism and excretion

Most of the drug, caught in the digestive tract, when metabolised “first pass” through the liver. T_1/2 – 15 no. The main part of the drug (35-76%), regardless of the route of administration, is displayed during 96 h with feces, predominantly in the form of polar metabolites; 10-15% excreted by the kidneys.

Testimony

- Seasonal and perennial allergic rhinitis;

- Vasomotor rhinitis.

Dosage regimen

The drug is used intranasally. Before applying Nasobeka nasal passages should be free.

Adults and children over 6 years appoint 1 doze spray (50 g) in each nostril 2-4 times / day (200-400 g). Then reduce the dose depending on the effectiveness and tolerability. The maximum daily dose – 400 g.

Side effect

Maybe: chikhaniye, irritation, burning, dry nose; rash, hives, angioedema, infections of the nasopharynx, caused by a fungal flora, rhinorrhea, headache.

In rare cases,: nose bleed, conjunctival hyperemia, increased intraocular pressure, myalgia, drowsiness, cough, decrease in sense of taste, atrophy of the nasal mucosa.

Rarely: perforation of the nasal septum, ulceration of the nasal mucosa.

At prolonged administration in more doses 1500 mg / day may develop systemic side effects (incl. adrenal insufficiency).

When used in therapeutic doses side effects are rare.

Contraindications

- Gyemorragichyeskii diatyez;

- Frequent nosebleeds;

- Pulmonary tuberculosis;

- Fungal Infections;

- Viral infections;

- Children up to age 6 years;

- Pregnancy (I trimester);

- Hypersensitivity to the drug.

FROM caution prescribe the drug for amebiasis, glaucoma, severe hepatic insufficiency, gipotireoze, recent myocardial infarction, ulceration of the nasal septum, after recently undergone surgery in the nose or nose injury, Pregnancy (II-III trimesters), lactation.

Pregnancy and lactation

During pregnancy, the drug should be used Nasobek only, where the intended benefits of its application to the mother outweighs the potential risk to the fetus.

Nasobek use the drug during lactation (breast-feeding) with caution.

Cautions

Protect the eyes from getting the drug.

Notes on the correct use of a spray

Before the first use, remove the strip from the spray plastic, existing between the cap of the bubble and the nasal applicator.

1. Before use, gently shake the vial and then remove the cap of the nasal applicator.

2. Take the vial between your thumb and forefinger so, to the bottom of the bubble was based on the thumb, and the index and middle fingers rested on both opposite sides of the bottom of the applicator.

3. Before the first use of the drug, or in the case of using a week break in the first dose should be released into the headspace.

4. Gently exhale through the nose.

5. Nostrils, to which no drug is administered, should hold a finger, nostril and the free end portion of the insert applicator. Then bow your head slightly so, to bubble into a perpendicular position.

6. Then inhale gently through the open nostril and press simultaneously on the nasal applicator and enter the dose.

7. Exhale through your mouth.

8. Repeated administration of the drug to the same nostril, repeat, described in paragraphs. 7 and 8.

9. With the introduction of the drug in the other nostril, repeat, described in paragraphs. 6, 7, 8 and 9.

After the end of the drug should be cleaned end of the applicator with a clean cloth and back cover in place.

Cleaning the nasal applicator

The nasal applicator must be cleaned at least 1 times a week, to prevent its obstruction.

To do this, gently press the bottom of the vial and remove the nasal applicator from the bottle. Applicator cap and washed with warm water and allowed to dry. After that, the applicator and the cap back on the bubble dress.

Overdose

Prolonged use of high doses, and while receiving other (system) GKS can appear symptoms of Cushing.

In this case, the use of the preparation should be discontinued, gradually reducing the dose.

Drug Interactions

When combined phenobarbital, phenytoin, rifampicin reduces the effectiveness of beclomethasone (enzyme induction of microsomal oxidation).

In a joint application methandrostenolone, Estrogens, beta₂ -adrenostimulyatorov, theophylline, Oral corticosteroids enhance the effect of beclomethasone.

In a joint application Nasobek enhances the effect of beta-agonists.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in the dark, inaccessible to children at temperature from 10 ° to 25 ° C. Shelf life – 4 year.

After opening the bottle the drug should be used within 3 Months.