Оралсепт®

General characteristics. Structure:

Active ingredient: 0,255 mg of benzydamine of a hydrochloride.

Excipients: methylparahydroxybenzoate, ethanol of 96%, glycerin (глицерол), fragrance of a peppermint 27198/14, sodium saccharinate, polysorbate-60, Natrii hydrocarbonas, dye quinolinic yellow 70 (Е 104), dye indigotin of 85% (Е 132), the purified water.

Pharmacological properties:

Pharmacodynamics. Benzydamine a hydrochloride – the non-steroidal anti-inflammatory drug derivative of an indazol, without carboxyl group. Absence of carboxyl group gives the following features: Benzydamine is the weak basis (whereas the majority of NPVP weak acids), has high lipophilicity, on pH gradient well gets into the inflammation center (where рН below) and collects in therapeutic concentration.

Has the antiinflammatory and local anesthetizing effect, possesses antiseptic (against a wide range of microorganisms), and also antifungal action.

Antiinflammatory effect of drug is caused by reduction of permeability of capillaries, stabilization of cellular membranes owing to braking of synthesis and an inactivation of prostaglandins, a histamine, bradikinin, cytokines, factors of a complement and others the nonspecific internal "damaging" causes.

Benzydamine suppresses products of pro-inflammatory cytokines, especially the tumor necrosis factor (TNF), to a lesser extent interleykina-1 (IL-1). The main feature of benzydamine is that being weak inhibitor of synthesis of prostaglandins, it shows powerful inhibition of pro-inflammatory cytokines. Benzydamine can be classified by this reason as cytokine - overwhelming antiinflammatory drug.

Mestnoanesteziruyushchy effect of benzydamine is connected with structural features of its molecule, similar to local anesthetics. Analgeziruyushchy action is caused by indirect decrease in concentration of the biogenic amines having algogenny properties, and increase in a threshold of painful sensitivity of the receptor device; benzydamine also blocks interaction of bradikinin with fabric receptors, recovers microcirculation and reduces painful sensitivity in the inflammation center.

Benzydamine has antibacterial effect due to bystry penetration through membranes of microorganisms with the subsequent damage of cellular structures, disturbance of metabolic processes and lysosomes of a cell.

Possesses antifungal action concerning 20 strains of Candida albicans and non-albicans of strains, causing structural modifications of a cell wall of mushrooms and their metabolic chains, thus, interfering with their reproduction.

Pharmacokinetics. At topical administration it is well soaked up through mucous membranes and quickly gets into the inflamed fabrics, it is found in a blood plasma in quantity insufficient for obtaining system effects. It is removed, generally by kidneys and through intestines in the form of metabolites or products of conjugation.

Indications to use:

Symptomatic therapy of a pain syndrome of inflammatory diseases of an oral cavity and ENT organs (various etiology):

- pharyngitis, laryngitis, tonsillitis;

- an ulitis, a glossitis, periodontosis, stomatitis (including after beam and chemotherapy);

- calculous inflammation of sialadens;

- after treatment or an exodontia;

- after operative measures and injuries (a tonsilectomy, jaw fractures);

- candidiasis of a mucous membrane of an oral cavity (as a part of a combination therapy);

At the infectious and inflammatory diseases demanding system treatment, the drug ORALSEPT® is used as a part of a combination therapy.

Route of administration and doses:

It is applied locally. One dose of spray corresponds to 1 pressing. One dose corresponds to one breath and is equivalent to 0,17 ml of solution.

To adults and children 12 years are more senior appoint 4-8 doses of 2-6 times a day.

To children at the age of 3-6 years: on 1 dose on 4 kg of body weight (as much as possible – 4 doses) 2-6 times a day.

To children at the age of 6-12 years: on 4 doses of 2-6 times a day.

Course of treatment:

- at inflammatory diseases of an oral cavity and throat: from 4 to 15 days;

- at odonto-dental pathology: from 6 to 25 days;

- after operative measures and injuries (a tonsilectomy, jaw fractures): from 4 to 7 days.

At use of drug during long terms, consultation of the doctor is necessary.

Instructions on use:

1. Holding a bottle vertically, lift a cap nozzle at an angle 90 ° to a bottle (fig. 1).

2. Enter a nozzle into an oral cavity and press a cap (in fig. 2 it is noted by an arrow) several times, according to the recommended dose. The period between two pressing has to be not less than 5 seconds.

3. Return a nozzle to initial situation (fig. 3).

Attention: before the first use press several times the sprayer in air.

Do not exceed the recommended dosage. Before use, consult with the doctor.

Features of use:

Use during pregnancy and during breastfeeding. Data on a research on animals in the attitude towards effects during pregnancy and during breastfeeding are not enough whether and adequate and strictly controlled researches at pregnant women it is not conducted, besides, it is unknown benzydamine gets into breast milk, therefore, the potential risk for the person can be defined.

At pregnancy and during breastfeeding the drug ORALSEPT® is used only after consultation with the attending physician if the estimated advantage for mother exceeds potential risk for a fruit and the child.

At use of the drug ORALSEPT® development of reactions of hypersensitivity is possible. In this case it is recommended to stop treatment and to consult with the doctor, for purpose of the corresponding therapy. In the presence of a canker of a mucous membrane of a stomatopharynx, the patient has to see a doctor if symptoms remain within more than three days. Use of the drug ORALSEPT® is not recommended at patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. The drug ORALSEPT® should be used with care at patients with bronchial asthma as in this case development of a bronchospasm is possible.

It is necessary to avoid hit of spray in eyes. At hit of spray in eyes wash out their large number waters.

Influence on ability to manage vehicles and mechanisms. Drug does not exert impact on ability to drive the car, performance of potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions or to other type of activity requiring special attention.

Side effects:

Local reactions: dryness in a mouth, feeling of numbness, burning in an oral cavity.

Allergic reactions: hypersensitivity reactions, including skin rash, a skin itch, a small tortoiseshell, a photosensitization, a Quincke's disease, anaphylactic reactions.

Others: laryngospasm.

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

It was not studied. It is not established to pharmaceutical incompatibility of the drug ORALSEPT® with other medicines.

Contraindications:

Hypersensitivity to benzydamine or other components of drug.

Children's age up to 3 years.

With care. Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Bronchial asthma (including in the anamnesis).

Overdose:

So far about overdose cases by the drug ORALSEPT® it was not reported. However it is known that benzydamine at accidental hit inside in a high dose (in hundreds of times exceeding therapeutic), especially at children, can cause excitement, spasms, a tremor, the increased sweating, an ataxy and vomiting. Such acute overdose demands an immediate gastric lavage, recovery of water and electrolytic balance, a symptomatic treatment, adequate hydration.

If you accepted a dose more than recommended, rinse a mouth enough water, at emergence of side reactions see the attending physician.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 4 years. Not to apply after a period of validity.

Issue conditions:

Without recipe

Packaging:

Spray for topical administration dosed 0,255 mg / a dose. On 30 ml (176 doses) in a plastic, white, opaque container with the doser and the developing tip. Each container together with the application instruction is located in a cardboard pack.