Nasobek - instructions for use, doses, side effects, contraindications

Excipients: Benzalkonium chloride (50% solution) 0.04 mg, phenylethanol 250 μg, polysorbate 80 mg 5 μg, anhydrous 5 mg, microcrystalline cellulose + carmellose sodium (dispersive cellulose) 1000 μg, hydrochloric acid 35% pH, water - up to 0.1 g.

Description:White opaque suspension, with no visible foreign matter.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.01 Beclomethasone

Pharmacodynamics:

Beclomethasone is a synthetic glucocorticosteroid (SCS) for topical application, 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. It prevents the accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, the formation of a chemotactic substance. Reduces the swelling of the nasal mucosa, the production of mucus. Improves mucociliary transport. Well tolerated with long-term treatment, does not have mineralocorticoid activity, almost no resorptive effect.

Pharmacokinetics:

When the inhalation route of administration in the recommended doses is not has a significant systemic activity. After intranasal application, it is rapidly absorbed into the nasal mucosa. Part of the introduced beclomethasone is swallowed. Most beclomethasone, got into the gastrointestinal tract (GIT), is inactivated by the "first passage" through the liver. Absorption from the gastrointestinal tract is low. The connection with plasma proteins is 87%. The half-life is 15 hours. The bulk of beclomethasone (35-76%), regardless of the route of administration, is excreted for 96 hours mainly in the form of polar metabolites, 10-15% by kidneys.

Indications:

Seasonal and all-the-year-round allergic rhinitis, vasomotor rhinitis.

Contraindications:

Hypersensitivity to beclomethasone and other components of the drug; hemorrhagic diathesis, frequent nosebleeds, pulmonary tuberculosis, children under 6 years of age, pregnancy (I trimester), viral, fungal diseases.

Carefully:

Amoebiasis, glaucoma, severe hepatic insufficiency, hypothyroidism, recent myocardial infarction, ulceration of the nasal septum, recent surgical interventions in the nasal cavity, recent nose trauma, pregnancy (M-trimester), the period of breastfeeding.

Pregnancy and lactation:

The use of the drug Zaberok is contraindicated in the first trimester of pregnancy, the use of the drug Nasobek in the II-III trimester of pregnancy is allowed only if the expected benefit for the mother exceeds the possible risk to the fetus.

Care should be taken when treating Nasobek during breastfeeding.

Dosing and Administration:

Intranasally.

Adults and children over 12 years of age

For 1-2 doses (50-100 mcg) in each nasal passage 2 times a day (200-400 mcg / day). The maximum daily dose of 400 mcg / day. The daily dose can be divided into 2-4 admission. Children from 6 to 12 years old

The initial dose is 50 μg (1 dose) in each nasal passage 2 times a day, if necessary - 100 μg (2 doses) in each nasal passage 2 times a day. The maximum daily dose of 400 mcg / day. The daily dose can be divided into 2-4 admission.

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

To patients of advanced age correction of the dose is not required.

Recommendations for patients on the use of the drug.

Before applying the drug, it is necessary to clean the nasal passages.

At the first application it is necessary to unlock the spraying mechanism: press the dispenser several times until the aerosol cloud appears.If the drug has not been used for several days, the spraying mechanism must be unlocked again.

Before the first use of the drug, remove the plastic protective half ring between the screwed part and the dosing nasal applicator (see Fig. 1).

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

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 lower part of the applicator (see Figure 2).

3. Before the first use of the drug, or in the event of a prolonged disuse, spray the first dose into the air.

4. Lightly exhale through the nose.

5. The nasal passage, in which the drug will not be administered, should be clamped with a finger, and the applicator should be inserted into the free nasal passage. Then slightly bend the head so that the bottle is in a perpendicular position (see Figure 3).

6. Breathe in slightly through the open nasal passage and simultaneously press on the nasal applicator and enter the dose of aerosol.

7. Exhale through the mouth.

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

9. When the drug is injected into another nasal passage, repeat the operations described in points 5, 6, 7, 8.

After the end of the drug should be cleaned the end (top) of the applicator with a clean cloth and return the cap back to the place.

Cleaning the applicator:

The nasal applicator should be cleaned at least 1 time per week in order to prevent the possibility of its clogging.

To do this, lightly press the lower part of the applicator and detach the nasal applicator (see Figure 4).

Applicator and cap wash with warm water and allow to dry.

After that, the applicator and the cap should be put back on the vial.

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases); unknown - insufficient data for estimating the frequency of the phenomenon in the population - less than 0.01%.

From the immune system: rarely - skin rash, hives, angioedema.

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

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

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

Other: rarely - myalgia, candidiasis of the oral cavity and upper respiratory tract (with prolonged use and / or high doses (more than 400 mcg / day)); it is not known when long-term use may develop adrenal insufficiency, a decrease in the rate of growth in children, a decrease in bone mineral density.

Overdose:

With prolonged use of high doses, as well as with the simultaneous administration of other systemic SCS, symptoms of hypercorticism may appear.In this case, the drug should be stopped, gradually reducing the dose.

Interaction:

With simultaneous application phenobarbital, phenytoin, rifampicin reduce the effectiveness of beclomethasone due to the induction of enzymes of microsomal oxidation. With the simultaneous use of methandrostenolone, estrogens, beta2-adrenostimulants, theophylline, GCS for oral administration enhances the effect of beclomethasone.

Beclomethasone with simultaneous application increases the effect of beta-adrenostimulants.

Special instructions:

Care should be taken and do not allow the preparation of Nasobek to get into the eyes.

The therapeutic effect of Nasobek, unlike local vasoconstrictors for the treatment of rhinitis, with intranasal application is not immediately apparent. Relief of symptoms of rhinitis usually becomes noticeable after 5-7 days from the beginning of application of the drug.

When the therapeutic effect is achieved, the dose of the drug must be reduced to the minimum effective dose that controls the course of the disease. Patients with a high risk of developing adrenocortical insufficiency should be under the supervision of a doctor.

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

Since the preparation slows wound healing, patients with ulceration of the nasal septum, after surgical interventions in the nasal cavity, nose injuries, should not apply the preparation of the Nasobek until the wounds fully heal.

Infectious diseases of the nasal cavity and paranasal sinuses need appropriate therapy, but they are not contraindications to the use of the drug Nasobek.

Benzalkonium chloride, contained in the drug Zabobek, with prolonged use increases the risk of edema of the nasal mucosa. If such a reaction arises, a correction of the dose of Nasobek or a drug that does not contain benzalkonium chloride.

Effect on the ability to drive transp. cf. and fur:

Since drowsiness and dizziness may develop during the use of the drug Nasobek, caution should be exercised when managing transport and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Spray nasal dosed with 50 mcg / dose.

Packaging:

200 doses in a plastic bottle equipped with a screw-on mechanical dispensing applicator with a protective cap and a plastic protective half ring to protect against accidental depression.

1 bottle with instructions for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C, in a place protected from light. Do not freeze.

Keep out of the reach of children!

Shelf life:

4 years.

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

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N012652 / 01

Date of registration:03.02.2012 / 12.12.2012

Expiration Date:Unlimited

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Czech Industries, s.r.o. Czech Republic

Representation: & nbspTeva Teva Israel

Information update date: & nbsp26.05.2018

Illustrated instructions

Instructions

Nasobek (Nasobec)