Star ENT, 0.15% spray 30 ml

Pharmacodynamics:

Benzidamine is a non-steroidal anti-inflammatory drug, belongs to the group of indazoles. It has anti-inflammatory and local analgesic effect, has antiseptic action against a wide range of microorganisms. Mechanism of action of the drug is related to cell membranes stabilization and inhibition of prostaglandins synthesis.

Benzidamine has antibacterial and specific antimicrobial action due to rapid penetration through the membranes of microorganisms with subsequent damage of cellular structures, disrupting metabolic processes and cell lysosomes. It has antifungal effect against Candida albicans.

Causes structural modifications of cell wall of fungi and their metabolic chains thus preventing their reproduction which is the reason for benzidamine application in inflammatory processes of oral cavity including infectious etiology.

Pharmacokinetics:

When applied topically the drug is well absorbed through mucous membranes and penetrates into inflamed tissues and is detected in blood plasma in amount insufficient for systemic effects. The drug is excreted 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 (various etiologies):

– gingivitis, glossitis, stomatitis (including after radiation therapy). After radiation and chemotherapy)

– pharyngitis, laryngitis, tonsillitis;

– oral mucous membrane candidiasis (as a part of combined therapy);

– calculous inflammation of salivary glands;

– After surgical interventions and injuries (tonsillectomy, jaw fractures);

– After teeth treatment and extractions;

– periodontitis;

– Infectious and inflammatory diseases that require systemic treatment that must be used in combination therapy.

Active ingredient

Benzidamine

Composition

Spray for topical use 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 flavoring – 30 mg,

Water – up to 30 ml.

How to take, the dosage

The drug should be used topically, after meals. One injection, when the nebulizer is pressed briefly (1-2 seconds) corresponds to 0.255 mg of benzidamine for 0.15% dosage or 0.51 mg of benzidamine for 0.3% dosage.

Topical spray 0.15%: Adults (including elderly patients) and children over 12 – 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 old – 1 injection for each 4 kg of body weight, but not more than 4 injections (maximum single dose) 2-6 times a day.

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 to stop the treatment and consult a physician for prescribing an appropriate therapy. Ulcerative lesions of the oropharyngeal mucosa may indicate the presence of more serious pathology. If the symptoms persist for more than 3 days, it is necessary to consult a physician.

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

The drug should be used with caution in patients with a history of bronchial asthma due to the possibility of development of bronchospasm in them against the background of the drug.

The drug Zvezdochka ENT contains low levels of ethanol. Containing less than 100 mg of ethanol in a single dose.

Contraindications

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

Side effects

The World Health Organization (WHO) side effect frequency classification: very frequently – ≥ 1/10; frequently – ≥ 1/100 to < 1/10; infrequently – ≥ 1/1000 to < 1/100; rarely – ≥ 1/10000 to < 1/1000; very rarely – < 1/10000; frequency unknown – cannot be estimated based on available data.

Local reactions: rare – dryness, burning in the oral cavity; frequency unknown – feeling of numbness in the oral cavity.

Allergic reactions: infrequent – photosensitization, rarely – hypersensitivity reactions, skin rash, itching, very rare – angioedema, laryngospasm, frequency unknown – anaphylactic reactions.

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

Overdose

No cases of benzidamine overdose have been reported at present. If the drug is used in accordance with the instructions for use, overdose is unlikely.

In case of accidental ingestion the following symptoms are possible: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.

Antidote is unknown. In case of overdose gastric lavage and symptomatic treatment are recommended.

Similarities

Tantum verde, Tantum rose, Oralsept, Angidak, Asterisk ENT spray, Tantum, Asterisk for colds, Vertum Lor, Farbentum, No time to be sick