Expiration date: 01/2025

The composition and form of issue:

Spray nasal dose (100, 180, or 200 doses). 1 dose contains:

beclomethasone dipropionate 50 mcg

excipients: benzalkonium chloride phenylethanol Polysorbate 80 dextrose unhedged MCC, sodium carboxymethyl cellulose hydrochloric acid purified water 

polymer in vial of 15 ml with a dosing device in the paper cartons 1 a bottle.

Description pharmaceutical form:

The white suspension free of any visible foreign inclusions.

Pharmacokinetics:

The inhalation method of administration recommended doses has no significant systemic activity. After intranasal application is rapidly absorbed from the nasal mucosa. Part of the drug is swallowed. A large part of trapped in the digestive tract of a dose is inactivated by the "first pass" through the liver. Absorption from the gastrointestinal tract is low. T1/2 15 hours Relationship to plasma proteins is 87%. The bulk of the drug (35-76%), regardless of the route of administration, excreted within 96 h from the stool, mainly in the form of polar metabolites, 10-15% — in the urine by the kidneys.

Description pharmacological action:

It increases production of lipomodulin, which is an inhibitor of phospholipase A, inhibits the release of arachidonic acid. Warns boundary accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of the processes of infiltration and granulation, the formation of substances of chemotaxis. Reduces swelling of the nasal mucosa, production of mucus. Improves mucociliary transport. Well tolerated in long-term care, has no mineralocorticoid activity.

Clinical pharmacology:

Therapeutic effect when administered intranasally, in contrast to the local vasoconstrictor for the treatment of rhinitis that develops after a few days of use.

Indications:

Seasonal and year-round allergic rhinitis, vasomotor rhinitis.

Contraindications:

Hypersensitivity to drug, bleeding diathesis, frequent nosebleeds, children up to age 6 years, systemic infection (fungal, e.g. candidiasis of the upper respiratory tract, bacterial including tuberculosis), herpetic eye disease, acute respiratory infections.

Caution: amoebiasis, glaucoma, severe liver failure, hypothyroidism, recent myocardial infarction, ulceration of the nasal septum, a recent surgical intervention in the nose, recent nose injury, the period of breastfeeding.

Application of pregnancy and breast-feeding:

Allowed only in the case when expected benefit for mother exceeds the possible risk to the fetus. In drug treatment during breast-feeding, caution is advised.

Side effects:

When applied at therapeutic doses are rare.

Respiratory system: sneezing, irritation, burning and dryness of the mucous membrane of the nasal cavity and infection of the nasopharynx caused by the fungal flora, rhinorrhea and rarely epistaxis, atrophy of the nasal mucosa, cough is extremely rare — perforation of the nasal septum.

Allergic reactions: rash, urticaria, angioneurotic edema, hyperemia of the conjunctiva.

Other: headache, increased intraocular pressure, myalgia, drowsiness, decrease in taste sensations.

Long-term use at doses over 1500 mcg/day systemic effects (including adrenal insufficiency).

Drug interactions:

Phenobarbital, phenytoin, rifampicin reduces the efficacy (induction of enzymes of microsomal oxidation). Methandrostenolone, estrogens, beta2-agonists, theophylline, corticosteroids, taken by mouth, increase the effect of beclomethasone. Enhances the effect of beta-agonists.

Method of application and dose:

Intranasal, in the application to release the nasal passages. Adults and children over 6 years: 1 dose (50 mcg) in each nostril 2-4 times a day (200-400 mcg). Then reduce the dose depending on the patient's response.

Overdose:

With prolonged use of high doses, as well as the simultaneous use of other systemic glucocorticoids can appear symptoms of hypercortisolism. In this case, the drug should be discontinued, gradually reducing the dose.

Precautions:

Avoid contact with eyes.

Special instructions:

Be sure to protect the eyes from getting the drug.

Cleaning the nasal applicator:

The nasal applicator should be cleaned at least 1 time a week to prevent clogging. To do this, lightly push the bottom of the bottle and remove it from the nasal applicator. The applicator and cap are washed with warm water and allowed to dry. After that, the applicator and put the cap back on the bottle.

Expiration date:

After opening — 3 months.