Zvezdochka Sprocket ENT spray for external application 0.15%, 30ml

Composition

Topically applied spray 0.15% (30 ml): Active ingredient: benzydamine 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

Pharmacological action

Pharmacodynamics : Benzydamine is a nonsteroidal anti-inflammatory drug that belongs to the indazole group. It has an anti-inflammatory and local analgesic effect, 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. Benzydamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, disruption of metabolic processes and cell lysosomes. It has an antifungal effect against Candida albicans. It 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 in 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 an amount insufficient to produce 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 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 that require systemic treatment, it is necessary to use as part of a combination therapy.

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

World Health Organization (WHO) classification of side effects: very common – ≥ 1/10; common – ≥ 1/100 to < 1/10; uncommon – ≥ 1/1000 to < 1/100; rare – ≥ 1/10000 to < 1/1000; very rare – Local reactions: rarely-dryness, burning sensation in the oral cavity; frequency unknown-feeling of numbness in the oral cavity. Allergic reactions: infrequently-photosensitization; rarely-hypersensitivity reactions, skin rash, pruritus; very rarely-angioedema, laryngospasm; frequency unknown – anaphylactic reactions. If any of the side effects indicated in the instructions are aggravated, or other side effects are noted that are not specified in the instructions, you should immediately inform your doctor.

Interaction

Interaction studies with other drugs have not been conducted.

How to take, course of use and dosage

The drug should be applied topically, after meals. One injection, with a short (1-2 s) pressure on the nebulizer, corresponds to 0.255 mg of benzydamine for a dosage of 0.15% or 0.51 mg of benzydamine for a dosage of 0.3%. Spray for topical application 0.15%: Adults (including elderly patients) and children over 12 years of age 4-8 injections 2-6 times a day. Children from 6 to 12 years – 4 injections 2-6 times a day. Children from 3 to 6 years of age: 1 injection for every 4 kg of body weight, but no more than 4 injections (maximum single dose) 2-6 times a day.

Overdose

Currently, no cases of benzydamine overdose have been reported. When using the drug in accordance with the instructions for use, overdose is unlikely. If the drug is accidentally swallowed, the following symptoms may occur: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression. The antidote is unknown. In case of overdose, gastric lavage and symptomatic treatment are recommended.

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 oropharyngeal mucosa 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 nonsteroidal 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 during the use of the drug. The drug Sprocket ENT contains a low level of ethanol. Containing less than 100 mg of ethanol in a single dose.

Storage conditions

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

Shelf life

3 years

Active ingredient

Benzydamine

Dosage form

spray for external use