Star ENT, 0.3% spray 15 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 effect 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 found in blood plasma in amounts insufficient to produce systemic effects. The drug is excreted mainly by the kidneys, as inactive metabolites or conjugation products

Indications

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

– 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 surgical interventions and injuries (tonsillectomy, jaw fractures) – after treatment and tooth extraction;

– periodontal disease.

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

Pharmacological effect

Pharmacodynamics:

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

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

Causes structural modifications of the cell wall of fungi and their metabolic chains, thus preventing their reproduction, which was the basis for the use of benzydamine for inflammatory processes in the oral cavity, including infectious etiology.

Pharmacokinetics:

When applied topically, the drug is well absorbed through the mucous membranes and penetrates into inflamed tissues; it is found in the blood plasma in quantities insufficient to obtain systemic effects. Excretion of the drug occurs mainly by the kidneys, in the form of inactive metabolites or conjugation products

Special instructions

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

Ulcerative lesions of the mucous membrane of the oropharynx may indicate the presence of 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 a history of bronchial asthma due to the possibility of developing bronchospasm in them while using the drug.

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

Active ingredient

Benzydamine

Composition

Active ingredient:

benzydamine hydrochloride – 45 mg;

Auxiliary components:

glycerol – 1.5 g,

ethanol – 3.0 g,

sodium saccharinate – 15 mg,

mint flavor – 15 mg,

water – up to 15 ml.

Contraindications

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

Side Effects

Classification of the frequency of side effects of the World Health Organization (WHO): very often – ≥ 1/10; often – from ≥ 1/100 to < 1/10; uncommon - from ≥ 1/1000 to < 1/100; rarely - from ≥ 1/10000 to < 1/1000; very rarely - <1/10000; frequency unknown - cannot be estimated from available data.Local reactions: rarely – dryness, burning in the mouth; frequency unknown – feeling of numbness in the mouth.Allergic reactions: infrequently – photosensitivity; rarely – hypersensitivity reactions, skin rash, itching; very rarely – angioedema, laryngospasm; frequency unknown – anaphylactic reactions.If any of the side effects indicated in the instructions are aggravated, or other side effects not listed in the instructions are noted, you should immediately inform your doctor.

Interaction

No interaction studies have been conducted with other drugs.

Overdose

Currently, no cases of benzydamine overdose have been reported.

When using the drug in accordance with the instructions for use, an overdose is unlikely.

If the drug is accidentally ingested, the following symptoms may occur: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.

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

Storage conditions

In a place protected from light, at a temperature not exceeding 30 °C.
Keep out of the reach of children.

Shelf life

3 years

Manufacturer

Danafa Pharmaceutical Joint, Vietnam