Universal reference book for medicines
Name of the drug: NASOBEC (NASOBEC)

Active substance: beclometasone

Type: GCS for intranasal administration

Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured by TEVA Czech Industries (Czech Republic)
Composition, form of production and packaging
Spray nasal dosed
in the form of an opaque white suspension, with no visible foreign inclusions.

1 dose

beclomethasone dipropionate 50 μg

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

200 doses - plastic bottles (1) with a mechanical dosing applicator - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

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

PHARMACOKINETICS

Suction and distribution

When inhaled, the method of administration in the recommended doses does not have a significant systemic activity.

After intranasal use, it is rapidly absorbed through the nasal mucosa.
Part of the injected drug is swallowed. Absorption from the gastrointestinal tract is low. Binding to plasma proteins - 87%.
Metabolism and excretion

Most of the drug, got into the digestive tract, is metabolized by the "first pass" through the liver.
Т 1/2 - 15 hours. The main part of the preparation (35-76%), regardless of the mode of administration, is excreted for 96 hours with feces, mainly in the form of polar metabolites; 10-15% is excreted by the kidneys.
INDICATIONS

- seasonal and year-round allergic rhinitis;

vasomotor rhinitis.

DOSING MODE

The drug is administered intranasally.

Adults and children over 12 years of age are prescribed 50-100 mcg (1-2 doses) in each nasal passage 2 times / day;
The daily dose is 200-400 μg. The maximum daily dose is 400 mcg. The daily dose can be divided into 2-4 admission.
Children aged 6 to 12 years are prescribed in the initial dose 50 μg (1 dose) in each nasal passage 2 times / day, if necessary - 100 μg (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 admission.
When the therapeutic effect is achieved, the drug is canceled, gradually reducing the dose.

Older patients do not need a dose adjustment.

Terms of use

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 should be removed plastic protective semicircle, located between the screwed part and the dosing nasal applicator.

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

2. Arrange 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.

3. Before the first use of the drug, or in the event of a prolonged interruption in use, 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 your head so that the bottle is in a perpendicular position.

6. Lightly inhale 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 actions described in paragraphs 6 and 7.

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

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 once a 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. 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 EFFECT

Determination of the frequency of adverse 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 phenomenon in the population).
Allergic reactions: 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, incl.
glaucoma, cataract (with prolonged use), conjunctival hyperemia, decreased vision.
On the part of the respiratory system: 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 μg / day));
it is not known - with prolonged use, it is possible to develop adrenal insufficiency, a decrease in the rate of growth in children, a decrease in bone mineral density.
CONTRAINDICATIONS

- hemorrhagic diathesis;

- frequent nasal bleeding;

- tuberculosis of the respiratory system;

- fungal infections;

- viral infections;

- children's age till 6 years;

- I trimester of pregnancy;

- Hypersensitivity to the components of the drug.

With caution appoint a drug for amoebiasis, glaucoma, severe hepatic insufficiency, hypothyroidism, recently transferred myocardial infarction, ulceration of the nasal septum, after recent surgery in the nasal cavity or nose trauma, in the II and III trimesters of pregnancy, during breastfeeding.

PREGNANCY AND LACTATION

The use of the drug Zaberok is contraindicated in the first trimester of pregnancy.
Use of the drug Zaberok in the II and III trimesters of pregnancy is allowed only if the expected benefit for the mother exceeds the possible risk to the fetus.
Use Nasobek during breastfeeding should be done with caution.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution appoint a drug for severe hepatic insufficiency.

APPLICATION FOR CHILDREN

Contraindicated: children under 6 years.

APPLICATION IN ELDERLY PATIENTS

Older patients do not need a dose adjustment.

SPECIAL INSTRUCTIONS

Patients should be warned about the need to be careful and not to get into the eyes of the drug Nasobek.

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 lowest effective dose that controls the course of the disease.
Patients with a high risk of developing adrenocortical insufficiency need control of the doctor.

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.

With infectious diseases of the nasal cavity and paranasal sinuses, appropriate therapy should be carried out.
These diseases are not contraindications to 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, correction of the dose of Nasobek or the use of a preparation containing no benzalkonium chloride is necessary.
Use in Pediatrics

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

Impact on the ability to drive vehicles and manage mechanisms

Since drowsiness and dizziness may develop during use of the Nasobek preparation, patients should be careful in managing transportation and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

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

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

DRUG INTERACTION

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

When combined, methandrostenolone, estrogens, beta 2 -adrenomimetics, theophylline, GCS for oral administration enhance the effect of beclomethasone.

With the joint application of Nasobek increases the effect of beta-adrenomimetics.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from light, at a temperature of no higher than 25 ° C;
Do not freeze. Shelf life - 4 years.
After the first opening of the vial, the drug should be used within 6 months.

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