Oralsept spray, 30ml (176 doses)

Symptomatic therapy of pain syndrome in inflammatory diseases of the oral cavity and ENT organs of various etiologies:

-pharyngitis, laryngitis, tonsillitis;

- gingivitis, glossitis, periodontal disease, stomatitis (including after radiation and chemotherapy);

-calculous inflammation of the salivary glands;

-after treatment or tooth extraction;

-after surgical interventions and injuries (tonsillectomy, jaw fractures);

- candidiasis of the oral mucosa (as part of combination therapy).

For infectious and inflammatory diseases requiring systemic treatment, the drug OralseptЃ is used as part of a combination therapy.

Locally.

One spray dose corresponds to 1 press. One dose corresponds to one inhalation and is equivalent to 0.17 ml of solution.

Adults and children over 12 years of age are prescribed 4Ц8 doses 2Ц6 times a day; children 3Ц6 years old: 1 dose / 4 kg (maximum 4 doses) 2Ц6 times a day; 6Ц12 years old - 4 doses 2Ц6 times a day.

A course of treatment:

- for inflammatory diseases of the oral cavity and pharynx - 4-15 days;

- for odonto-dental pathology - 6Ц25 days;

- after surgical interventions and injuries (tonsillectomy, jaw fractures) - 4-7 days.

When using the drug for a long time, a doctor's consultation is necessary.

Directions for use

1. Holding the vial upright, lift the cap tip at a 90 ? C angle to the vial.

2. Insert the nozzle into the oral cavity and press the cap several times, according to the recommended dose. The period between two presses must be at least 5 s.

3. Return the nozzle to its original position.

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

Do not exceed the recommended dosage. Consult your doctor before use.

Dosed topical spray

1 dose

active substance: benzydamine hydrochloride 0.255 mg

excipients: methyl parahydroxybenzoate - 0.17 mg; ethanol 96% - 17 mg; glycerin (glycerol) - 8.5 mg; peppermint flavor 27198/14 - 0.17 mg; sodium saccharinate - 0.0408 mg; polysorbate60 - 0.0085 mg; sodium bicarbonate - 0.0034 mg; dye quinoline yellow 70 (E104) - 0.0034 mg; dye indigotine 85% (E132) - 0.00017 mg; purified water - up to 170 ?l

- Hypersensitivity to benzydamine or other components of the drug;

-Children under 3 years old.

Precautions: hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including history).

pharmachologic effect

Benzydamine hydrochloride is an NSAID, a derivative of indazole, without a carboxyl group. The absence of a carboxyl group gives the following features: benzydamine is a weak base (whereas most NSAIDs are weak acids), has a high lipophilicity, along the pH gradient it penetrates well into the inflammation focus (where the pH is lower) and accumulates in therapeutic concentrations.

It has anti-inflammatory and local analgesic effects, antiseptic (against a wide range of microorganisms) and antifungal effects.

The anti-inflammatory effect of the drug is due to a decrease in capillary permeability, stabilization of cell membranes due to inhibition of the synthesis and inactivation of prostaglandins, histamine, bradykinin, cytokines, complement factors and other nonspecific endogenous damaging factors.

Benzydamine inhibits the production of proinflammatory cytokines, especially tumor necrosis factor-alpha (TNF?), to a lesser extent interleukin-1?? (IL-1?). The main feature of benzydamine is that, as a weak inhibitor of prostaglandin synthesis, it demonstrates potent inhibition of pro-inflammatory cytokines. For this reason, benzydamine can be classified as a cytokine-suppressing anti-inflammatory drug.

The local anesthetic effect of benzydamine is associated with the structural features of its molecule, similar to local anesthetics. The analgesic effect is due to an indirect decrease in the concentration of biogenic amines with algogenic properties, and an increase in the pain sensitivity threshold of the receptor apparatus; benzydamine also blocks the interaction of bradykinin with tissue receptors, restores microcirculation and reduces pain sensitivity at the site of inflammation.

Benzydamine has an antibacterial effect due to the rapid penetration of microorganisms through the membranes with subsequent damage to cellular structures, disruption of metabolic processes and the function of cell lysosomes.

Has antifungal effect against 20 strains of Candida albicans and Candida non-albicans, causing structural modifications of the cell wall of fungi and their metabolic chains, thus preventing their reproduction.

Pharmacokinetics

When applied topically, it is well absorbed through the mucous membranes and quickly penetrates into inflamed tissues. It is found in blood plasma in an amount insufficient to obtain systemic effects. It is excreted mainly by the kidneys and through the intestines in the form of metabolites or conjugation products.

Side effect

In each group, side effects are presented in order of decreasing severity.

Local reactions: rarely - dry mouth, burning sensation in the mouth; frequency unknown - feeling of numbness in the mouth.

Allergic reactions: infrequently - photosensitivity; rarely - sensitivity reactions, skin rash, pruritus, very rarely - angioedema, laryngospasm; frequency unknown - anaphylactic reactions.

Application during pregnancy and lactation

There are insufficient data from animal studies on the effects during pregnancy and during breastfeeding, adequate and well-controlled studies in pregnant women have not been conducted, and it is not known whether benzydamine passes into breast milk, therefore, the potential risk to humans cannot be determined ...

During pregnancy and during breastfeeding, OralseptЃ is used only after consultation with the attending physician, if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Application in children

The use of the drug in children under 3 years of age is contraindicated.

special instructions

When using the drug OralseptЃ, hypersensitivity reactions may develop. In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy.

In the presence of ulcerative lesions of the mucous membrane of the oropharynx, the patient should see a doctor if symptoms persist for more than 3 days.

The use of OralseptЃ is not recommended in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

The drug OralseptЃ should be used with caution in patients with bronchial asthma, because development of bronchospasm is possible.

Avoid getting the spray in the eyes. If the spray gets into your eyes, rinse with plenty of water.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive a car and perform potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, or other activities that require increased attention.

Overdose

To date, no cases of overdose of OralseptЃ have been reported. However, it is known that, if accidentally ingested in a high dose (hundreds of times higher than the therapeutic dose), especially in children, benzydamine can cause agitation, convulsions, tremors, increased sweating, ataxia and vomiting.

Treatment: acute overdose requires immediate gastric lavage, restoration of water and electrolyte balance, symptomatic therapy, adequate rehydration. If the patient has taken a dose higher than the recommended dose, rinse the mouth with sufficient water. If any adverse reactions occur, you should consult your doctor.

Drug interactions

Drug interactions have not been studied.

Pharmaceutical incompatibility of the drug OralseptЃ with other drugs has not been established.