Oralcept - instructions for use, doses, side effects, contraindications

Methylparahydroxybenzoate 0.17 mg, ethanol 96% 17.00 mg, glycerol (glycerol) 8.50 mg,flavor of peppermint 27198/14 0.17 mg, sodium saccharinate 0.0408 mg, polysorbate 60 0.0085 mg, sodium hydrogen carbonate 0.0034 mg, dye quinoline yellow 70 (E 104) 0.0034 mg , dye indigotine 85% (E 132) 0.00017 mg, purified water up to 170 μl.

Description:Transparent solution of yellow-green color with the aroma of peppermint.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug

ATX: & nbsp

A.01.A.D.02 Benzidamine

G.02.C.C.03 Benzidamine

Pharmacodynamics:

Benzidamine hydrochloride is a non-steroidal anti-inflammatory drug, an indazole derivative, without a carboxyl group. The absence of a carboxyl group imparts the following features: Benzidamine is a weak base (whereas most NSAIDs are weak acids), has a high lipophilicity, a pH gradient well penetrates the inflammation site (where the pH is lower) and accumulates in therapeutic concentrations.

Has anti-inflammatory and local anesthetic effect, antiseptic (against a wide range of microorganisms), as well as antifungal action.

Anti-inflammatory effect of the drug is due to a decrease in the permeability of capillaries, the stabilization of cell membranes due to inhibition of synthesis and inactivation of prostaglandins, histamine,bradykinin, cytokines, complement factors and other nonspecific endogenous "damaging" factors. Benzidamine suppresses the production of proinflammatory cytokines, especially tumor necrosis factor-α (TNF-α), to a lesser extent interleukin-1β (IL-1β). The main feature of benzidamine is that, being a weak inhibitor of the synthesis of prostaglandins, it demonstrates a powerful inhibition of pro-inflammatory cytokines. For this reason benzydamine can be classified as a cytokine-suppressing anti-inflammatory drug.

The local anesthetic effect of benzidine is related to 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 possessing 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 in the focus of inflammation.

Benzydamine has an antibacterial effect due to rapid penetration through the membranes of microorganisms followed bydamage to cellular structures, metabolic disorders and cell lysosomes.

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

Pharmacokinetics:

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

Indications:

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

- pharyngitis, laryngitis, tonsillitis;

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

- calculous inflammation of the salivary glands;

- after treatment or removal of teeth;

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

- Candidiasis of the oral mucosa (as part of combination therapy); For infectious-inflammatory diseases requiring systemic treatment, Oralsept® is used as a combination therapy.

Contraindications:

Hypersensitivity to benzydamine or other components of the drug. Children under 3 years.

Carefully:

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

Bronchial asthma (including in the anamnesis).

Pregnancy and lactation:

Data on animal studies with respect to effects during pregnancy and during breastfeeding are not sufficient, and adequate and strictly controlled studies in pregnant women are not carried out, in addition, it is not known whether benzydamine in breast milk, therefore, the potential risk to humans can not be determined.

During pregnancy and during breastfeeding, Oralsept® is used only after consultation with the treating doctor, if the intended benefit to the mother exceeds the potential risk to the fetus and the baby.

Dosing and Administration:

It is applied locally.

One dose of spray corresponds to 1 push. One dose corresponds to one breath and is equivalent to 0.17 ml of the solution.

Adults and children over 12 years of age are prescribed 4-8 doses 2-6 times a day.

Children aged 3-6 years: 1 dose per 4 kg of body weight (maximum - 4 doses) 2-6 times a day.

Children aged 6-12 years: 4 doses 2-6 times a day.

A course of treatment:

- with inflammatory diseases of the oral cavity and pharynx: 4 to 15 days;

- with odonto-stomatologic pathology: from 6 to 25 days;

- after surgical interventions and traumas (tonsillectomy, jaw fractures): from 4 to 7 days.

When using the drug for long periods, it is necessary to consult a doctor.

Directions for use:

1. While holding the bottle vertically, lift the cap cap at an angle of 90 ° to the bottle (Fig. 1).

2. Insert the nozzle into the oral cavity and press the cap (in Figure 2 marked with an arrow) several times, according to the recommended dose. The period between two presses must be at least 5 seconds.

3. Return the nozzle to its original position (Fig. 3).

Attention: before the first use, press the spray gun several times in the air.

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

Side effects:

Local Reactions: dry mouth, numbness, burning in the mouth.

Allergic reactions: reactions of hypersensitivity, including skin rash, itching, hives, photosensitivity, angioedema, anaphylactic reactions.

Other: laryngospasm.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

To date, no cases of overdose with Oralsept® have been reported. However, it is known that benzydamine when accidentally ingested in a high dose (hundreds of times higher than the therapeutic dose), especially in children, can cause excitation, convulsions, tremor, increased sweating, ataxia and vomiting. Such an acute overdose requires immediate washing of the stomach, restoration of water electrolyte balance, symptomatic treatment, adequate hydration.

If you took a dose higher than recommended, rinse the mouth with sufficient water, if any adverse reactions occur, consult your doctor.

Interaction:

Not studied. The pharmaceutical incompatibility of Oralcept® with other drugs has not been established.

Special instructions:

When using Oralsept® possibly the development of hypersensitivity reactions. In this case, it is recommended that you stop treatment and consult with your doctor to prescribe appropriate therapy.If there is a ulcerative lesion of the mucous membrane of the oropharynx, the patient should consult a doctor if the symptoms persist for more than three days. The use of Oralsept® is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Oralsept® should be used with caution in patients with bronchial asthma, since in this case it is possible to develop bronchospasm.

Avoid contact with the eyes. In case of contact with eyes, rinse with plenty of water.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive a car, the performance of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions or to another type of activity, requiring increased attention.

Form release / dosage:

Spray for topical use dosed with 0.255 mg / dose.

Packaging:

For 30 ml (176 doses) in a plastic, white, opaque container with a dispenser and a folding tip.

Each container, along with instructions for use, is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002669

Date of registration:22.10.2014 / 30.03.2017

Expiration Date:22.10.2019

The owner of the registration certificate:SELVIM, LLC SELVIM, LLC Russia

Manufacturer: & nbsp

REPLEK PHARM, Ltd. Macedonia

Representation: & nbspSELVIM LLC SELVIM LLC Russia

Information update date: & nbsp10.06.2017

Illustrated instructions

Instructions

Oralcept® (Oralsept®)