Asterisk of the ENT (Zvezdochka LOR)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBenzidamineBenzidamine
Dosage form: & nbspspray for topical application
Composition:

Spray for topical application 0.15% (30 ml):

Active ingredient: benzidamine hydrochloride 45 mg;

Auxiliary components: glycerol 3.0 g, ethanol 6.0 g, sodium saccharinate 30 mg, mint flavor 30 mg, water up to 30 ml.

Spray for topical application 0.30% (15 ml):

Active component: benzidamine hydrochloride 45 mg;

Auxiliary components: glycerol - 1,5 g, ethanol - 3,0 g, sodium saccharinate - 15 mg, flavoring mint - 15 mg, water - up to 15 ml.

Description:Transparent, colorless liquid with a characteristic smell of mint.
Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug
ATX: & nbsp

A.01.A.D.02   Benzidamine

G.02.C.C.03   Benzidamine

Pharmacodynamics:

Benzydamine is a non-steroidal anti-inflammatory drug, belongs to the group of indazoles. It has anti-inflammatory and local anesthetic effect, antiseptic action against a wide range of microorganisms. The mechanism of action of the drug is associated with the stabilization of cell membranes and the inhibition of the synthesis of prostaglandins.

Benzydamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through membranes, followed by damage to cellular structures, metabolic disturbances and cell lysosomes.

Has antifungal effect against Candida albicans. It causes structural modifications of the cell wall of fungi and their metabolic chains, thus inhibiting their reproduction, which was the basis for the use of benzidamine in inflammatory processes in the oral cavity, including infectious etiology.

Pharmacokinetics:With topical application, the preparation is well absorbed through the mucous membranes and penetrates into inflamed tissues, is found in blood plasma in an amount insufficient to obtain systemic effects.
Excretion of the drug occurs mainly by the kidneys, in the form of inactive metabolites or conjugation products.

Indications:

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

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

- pharyngitis, laryngitis, tonsillitis;

- Candidiasis of the oral mucosa (as part of combination therapy);

- calculous inflammation of the salivary glands;

- after surgery and trauma (tonsillectomy, jaw fractures)

- after treatment and removal of teeth;

- Parodontosis;

With infectious and inflammatory diseases requiring systemic treatment, it is necessary to use as part of a combination therapy.

Contraindications:

Hypersensitivity to benzidamine or other components of the drug, children under 3 years of age (for a spray for topical use, 0.15%), or children under 18 years of age (for a topical spray of 0.30%).

Carefully:

Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including in the anamnesis).

Pregnancy and lactation:

It is not recommended to use the drug during pregnancy and lactation (breastfeeding) because of the lack of clinical data.

Dosing and Administration:

The drug should be applied topically after eating.

One injection, with a brief (1-2 sec.) Depression of the nebulizer, corresponds to 0.255 mg of benzidamine for a dosage of 0.15% or 0.51 mg of benzidamine for a dosage of 0.3%.

Spray for topical application 0,15%:

Adults (including elderly patients) and children over 12 years of age for 4-8 injections 2-6 times a day.

Children from 6 to 12 years old - 4 injections 2-6 times a day.

Children from 3 to 6 years 1 injection for every 4 kg of body weight, but not more than 4 injections (maximum single dose) 2-6 times a day.

Spray for topical application 0.3%:

Adults 2-4 injections 2-6 times a day.

The duration of treatment should not exceed 7 days. If after the expiration of the recommended term of treatment no improvement occurs or new symptoms appear, you should consult a doctor.

Use the drug only according to the method of administration and the doses specified in the instructions.

If necessary, please consult with your doctor before using the medication.

Side effects:

Classification of the frequency of development of side effects of the World Organization Health (WHO):

Often - ≥ 1/10;

often from ≥ 1/100 to <1/10;

infrequently - from ≥ 1/1000 to <1/100;

rarely from ≥ 1/10000 to <1/1000;

very rarely - <1/10000;

frequency is unknown - can not be estimated from the available data.

Local reactions: rarely dryness, burning in the mouth; frequency unknown - feeling of numbness in the oral cavity.

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

If any of the side effects indicated in the manual are aggravated, or other side effects not indicated in the instructions are noted, you should inform the doctor immediately.

Overdose:

At present, cases of benzydamine overdose have not been reported. When using the drug in accordance with the instructions for use, an overdose is unlikely. If the product is accidentally swallowed, the following are possible symptoms: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.

The antidote is unknown. When an overdose is recommended, gastric lavage, symptomatic treatment.

Interaction:Studies of interaction with other drugs have not been conducted.
Special instructions:

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

Ulcerative lesions of the mucous membrane of the oropharynx may indicate a more serious pathology.

If symptoms persist for more than 3 days, you should consult your doctor.

The use of the drug is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

The drug should be used with caution in patients with bronchial asthma in the anamnesis because of the possibility of developing their bronchospasm on the background of the drug.

The asterisk of the ENT contains a low level of ethanol. Containing ethanol less than 100 mg in a single dose.

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

Admission of the drug does not affect the management of vehicles and maintenance of machines and mechanisms that require concentration of attention.

Form release / dosage:

Spray for topical application, 0.15% and 0,3%.

Packaging:

Spray for topical application 0,15%:

To 30 ml in a plastic bottle, equipped with a protective cover with a spray device made of plastic. One bottle together with instructions for use in a cardboard tutu.

Spray for topical application 0,3%:

For 15 ml in a plastic bottle, equipped with a protective cover with a spray device made of plastic. One bottle together with instructions for use in a cardboard tutu.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe
Registration number:LP-004157
Date of registration:28.02.2017
Expiration Date:28.02.2022
The owner of the registration certificate:Danson Trading Pharmaceutical Company LimitedDanson Trading Pharmaceutical Company Limited Vietnam
Manufacturer: & nbsp
Representation: & nbspDominanta-Service CJSCDominanta-Service CJSC
Information update date: & nbsp29.03.2017
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