Vertum Lor, spray 0.255 mg/dose 40 ml

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug.

ATC code

A01AD02

Pharmacological properties

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.

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 use of benzidamine in inflammatory processes in the oral cavity, including infectious etiology.

Pharmacokinetics

When used topically, benzidamine is well absorbed through mucous membranes and penetrates inflamed tissues, being detected in blood plasma in amounts insufficient to produce systemic effects.

The excretion of benzidamine 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 (various etiologies):

• pharyngitis, laryngitis, tonsillitis;
• gingivitis, glossitis, stomatitis (including after radiation and chemotherapy);
• parodontosis;
• calculous inflammation of the salivary glands;
• after dental treatment or extraction;
• after surgical interventions and traumas (tonsillectomy, jaw fractures);
• candidosis of the oral mucosa (as a part of combined therapy).

Infectious inflammatory diseases requiring systemic treatment VERTUM ENT is used in combination therapy.

Active ingredient

Benzidamine

Composition

1 dose of the spray contains:

The active ingredient: benzidamine hydrochloride – 0.255 mg.

Auxiliary substances: ethanol (95% ethyl alcohol) – 13.6 mg, glycerol (glycerin)

– 8.5 mg; methyl parahydroxybenzoate (methylparaben) – 0.17 mg; natural food flavoring Mint* – 0.051 mg; sodium saccharinate – 0.0408 mg; polysorbate 20 – 0.0085 mg; purified water – up to 0.17 ml.

*composition: natural food flavoring, propylene glycol. Propylene glycol content in 1 ml of solution – less than 0.3 mg.

How to take, the dosage

Topical spray 0.255 mg/dose:

Topically. After meals. One dose (one injection) corresponds to 0.255 mg of benzidamine. Adults (including elderly patients) and children over 12 years of age 4-8 injections 2-6 times daily.

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

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

Instructions for use

• Turn the cannula (the tube that is part of the spray nozzle) to either side 90 degrees to the bottle.
• Place the cannula in your mouth and point at the inflamed areas in your mouth or throat.

Push the dosing pump on top of the bottle as many times as your prescribed doses. One press corresponds to one dose. Hold your breath while injecting.

Do not exceed the recommended dose.

The duration of treatment should not exceed 7 days. If after 7 days of treatment, there is no improvement or new symptoms develop, you should consult a physician.

The drug should only be used according to the route of administration and in the dosages described in the instructions. If necessary, please talk to your doctor before using this medicine.

Interaction

Studies of interaction with other drugs have not been conducted.

Special Instructions

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

In a limited number of patients, the presence of ulcers in the throat and mouth may indicate a more serious pathology. If symptoms persist for more than 3 days, you should consult a physician.

The use of benzidamine 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 that they may develop bronchospasm with benzidamine.

The drug contains parahydroxybenzoates, which may cause allergic reactions.

Influence on driving and operating ability

The drug does not affect the ability to drive vehicles and engage in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Transparent colorless solution with a characteristic odor.

Contraindications

• Hypersensitivity to benzidamine or any other component of the drug;
• children under 3 years of age.

With caution

• Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• bronchial asthma (including anamnesis).

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Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO):
very often ≥ 1/10;
often from ≥ 1/100 to < 1/10; infrequent from ≥ 1/1000 to < 1/100; rare from ≥ 1/10000 to < 1/1000;
very rare < 1/10000, including individual reports;
frequency is unknown – based on available data it is impossible to determine the incidence.

Immune system disorders:
infrequent – photosensitization;
rare – hypersensitivity reactions, skin rash, itching; very rare – angioedema, laryngospasm;
frequency unknown – anaphylactic reactions.

General disorders and reactions at the site of administration:
rarely – dry mouth, burning in the mouth; frequency unknown – feeling of numbness in the mouth.
If any of the side effects specified in the instructions worsen, or any other side effects not specified in the instructions are noted, you should immediately inform your doctor.

Overdose

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

Symptoms
The following symptoms may occur if the drug is accidentally swallowed: vomiting, abdominal cramps, restlessness, fear, hallucinations, seizures, ataxia, fever, tachycardia, respiratory depression.

Treatment
Treatment is 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.

Pregnancy use

It is not recommended to use benzidamine during pregnancy and during breastfeeding.

Similarities

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