Angidac, spray 0.255 mg/dose 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, restores microcirculation. The mechanism of action of the drug is associated with stabilization of cell membranes and inhibition of prostaglandin synthesis.

Benzidamine has antibacterial and specific antimicrobial action due to rapid penetration through the membranes of microorganisms with subsequent damage of cell structures, disruption of metabolic processes and cell lysosomes.

It has antifungal action 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 benzidamine in inflammatory processes in the oral cavity, including infectious etiology.

Pharmacokinetics

When used topically, the drug is well absorbed through mucous membranes and penetrates 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 therapy of pain syndrome of inflammatory diseases of the mouth and ENT organs (different etiology):

Active ingredient

Composition

Excipients:

ethanol 95% – 13.89 mg,

glycerol (glycerin) – 8.52 mg,

methyl parahydroxybenzoate – 0.17 mg,

menthol flavoring – 0.051 mg,

sodium saccharinate – 0.041 mg,

sodium bicarbonate – 0.019 mg,

polysorbate 20 – 0.009 mg,

Sodium hydroxide solution – 1 M or 0.5 M hydrochloric acid solution – up to pH 5.0-7.0,

d/i water – up to 170 µl.

How to take, the dosage

Topically, after meals. One dose (one injection) corresponds to 0.255 mg of benzidamine.

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

In children from 6 to 12 years of age, 4 injections 2-6 times a day.

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

The course of treatment

The course of treatment is 7 days; if after 7 days of treatment there is no improvement, a physician should be consulted.

Interaction

Special Instructions

Hypersensitivity reactions may occur when using the drug. In this case, it is recommended to discontinue treatment and consult a physician for prescribing appropriate therapy.

In a limited number of patients, the presence of ulcers in the throat and mouth may indicate the presence of more serious pathology. If symptoms persist for more than 3 days, you should 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 bronchial asthma in anamnesis due to possible development of bronchospasm in them with the drug. The drug contains parahydroxybenzoates that may cause allergic reactions. The drug contains 13.2 mg of ethanol in a single dose (one injection). The content of ethanol in a single dose:

– for adults (including Older patients) and children over 12 years – 52.8 – 105.6 mg;

– For children from 6 to 12 years – 52.8 mg;

– For children from 3 to 6 years – 13.2 mg of ethanol for every 4 kg of body weight, but not more than 52.8 mg (maximum single dose).

Impact on driving and operating machinery

There is no effect on the ability to drive and operate machinery.

Contraindications

Cautions

High sensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including history).

Side effects

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

Very common- > 1/10.
Frequent-from > 1/100 to < 1/10.
Infrequent-from > 1/1000 to < 1/100.
Rare- From > 1/10000 to < 1/1000.
Very rare-< 1/10000.
Frequency unknown- cannot be estimated based on available data.

In each group, adverse effects are presented in decreasing order of severity.

Local reactions:

Rarely, dry mouth, burning sensation in the oral cavity; frequency unknown, feeling of numbness in the oral cavity.

Allergic reactions:

Infrequent – photosensitization; rare – hypersensitivity reactions, skin rash, skin itching; very rare – angioedema, laryngospasm; frequency unknown – anaphylactic reactions.

If any of the side effects listed in the instructions worsen, or any other side effects not listed in the instructions are noted, the physician should be informed immediately.

Overdose

There are currently no reported cases of overdose of the drug.

Symptoms: 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.

Treatment: symptomatic; clear the stomach by inducing vomiting or gastric lavage using a gastric tube (under medical supervision); provide medical supervision, supportive therapy, and adequate hydration. An antidote is not known.

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