Nasobek

Nasobek – a glucocorticosteroid (GKS) with an antiinflammatory, antiallergic and immunodepressive effect for intranasal use.

Form of release and structure

Dosage form – spray nasal dosed: opaque suspension without visible foreign inclusions, white color (on 200 doses in the plastic bottles equipped with the mechanical dosing applicator on 1 bottle in cardboard packs).

Active agent: beclomethasone Dipropionas, in 1 dose of spray – 50 mkg.

Additional components: cellulose microcrystallic + a karmelloza of sodium (dispersive cellulose), фенилэтанол, Acidum hydrochloricum of 35%, polysorbate 80, a dextrose anhydrous, a benzalkoniya chloride (50% solution), the water purified.

Indications to use

• Allergic rhinitis (seasonal and year-round);
• Vasculomotor rhinitis.

Contraindications

Absolute:

• Frequent nasal bleedings;
• Viral infectious diseases;
• Fungal infections;
• Tuberculosis of a respiratory organs;
• Hemorrhagic diathesis;
• I trimester of pregnancy;
• Children's age up to 6 years;
• Hypersensitivity to drug components.

Relative:

• Ulcerations of a nasal partition;
• Recently postponed surgical intervention in a nasal cavity, nose injuries;
• Glaucoma;
• Amebiasis;
• Heavy liver failure;
• Hypothyroidism;
• Recently postponed myocardial infarction;
• II and III trimesters of pregnancy;
• Lactation.

Route of administration and dosage

Nasobek is intended for intranasal use.

The recommended doses:

• Adults and teenagers are more senior than 12 years: on 1-2 doses (50-100 mkg of beclomethasone) in each nasal course 2 times a day;
• Children of 6-12 years: on 1 dose in each nostril 2 times a day. If necessary use on 2 doses 2 times a day is possible.

The maximum daily dose – 400 mkg, it is possible to divide it into 2-4 uses.

After achievement of therapeutic effect the dose should be reduced gradually, up to full drug withdrawal.

Rules of use of Nasobek:

• Before the first use to remove the protective plastic half ring located between the dosing applicator and the screw-on part;
• To clear the nasal courses;
• To stir up a bottle, then to remove a cap;
• To arrange a bottle in a palm so that its bottom leaned on a thumb, and average and index fingers leaned on both opposite sides of the lower part of the nasal applicator;
• To press several times the doser, there will be no aerosol cloudlet yet (this procedure needs to be made surely before the first use and to repeat in cases of a long break in drug use);
• To make an easy exhalation through a nose;
• To clamp a finger the nasal course in which drug injection will not be made;
• To insert the applicator into a free nostril;
• To slightly incline the head that the bottle is in perpendicular situation;
• To enter an aerosol dose, having pressed the applicator and at the same time having slightly inhaled the open nasal course;
• To exhale through a mouth;
• If necessary to enter the second dose in the described way;
• To repeat the similar procedure with the second nostril;
• To clear an upper (trailer) part of the applicator a pure napkin and to close a cap.

At least 1 time a week it is necessary to clean the nasal applicator to prevent its contamination: to press accurately the lower part of the applicator and to disconnect it, to wash out the applicator and a cap warm water, to allow them to dry out, then to put on back a bottle.

Side effects

Nasobek is had preferential well. Seldom (including isolated cases) there are following side effects:

• Allergic reactions: urticaria, skin rash, Quincke's disease;
• From an organ of sight: decrease in sight, conjunctiva hyperemia; at prolonged use – increase in intraocular pressure, including a cataract, glaucoma;
• From a nervous system: disturbance of flavoring and olfactory feelings, headache, drowsiness, dizziness;
• From respiratory system: sneezing, a nose congestion, burning, irritation and dryness of a nasopharynx, a rhinorrhea, a nose mucosal atrophy, bleeding from a nose, an ulceration of a mucous membrane of a nose, cough, perforation of a nasal partition (is more often at the patients who transferred earlier surgical intervention to nasal cavities);
• Others: mialgiya; at long and/or use in high doses (more than 400 mkg/days) – candidiasis of an oral cavity and upper respiratory tracts, adrenal insufficiency, decrease in mineral density of bones, decrease in growth rate at children.

Special instructions

It is necessary to be careful at use of drug and not to allow its hit in eyes.

Unlike local vasoconstrictors, the therapeutic effect of Nasobek is shown not at once. Improvement of a state is usually noted 5-7 days later from an initiation of treatment. After achievement of effect the dose of drug needs to be lowered to minimum effective which will allow to control the course of a disease.

Under constant control during treatment there have to be patients belonging to risk group of development of insufficiency of bark of adrenal glands.

Infectious diseases of a nasal cavity and okolonosovy bosoms are not a contraindication to Nasobek's use, however demand performing the corresponding therapy.

Drug slows down healing of wounds therefore the patient with an ulceration of a nasal partition, to patients after injuries of a nose or surgical interventions in a nasal cavity it is not necessary to apply Nasobek until wounds do not heal completely.

The chloride which is a part of drug as preservative a benzalkoniya at prolonged use increases probability of edematization of a mucous membrane of a nose. In case of such reaction it is necessary to correct Nasobek's dose or to appoint other medicine which is not containing a benzalkoniya chloride.

At prolonged use of this drug in pediatrics it is necessary to control dynamics of growth of children.

In certain cases Nasobek causes drowsiness and dizziness therefore it is recommended to be careful when driving the car and performing the tasks requiring special attention and high speed of reactions.

Medicinal interaction

Nasobek strengthens effect of beta-adrenergic agonists.

At simultaneous use inductors of enzymes of a microsomal oxidation (rifampicin, Phenytoinum, phenobarbital) reduce efficiency of beclomethasone.

Peroral glucocorticosteroids, _{beta2-adrenomimetik}, estrogen and methandrostenolone at combined use strengthen effect of beclomethasone.

Terms and storage conditions

To store at a temperature up to 25 ºС in the place unavailable to children protected from light.

Period of validity – 4 years, after the first opening of a bottle – 6 months.