Zipelor (benzidamine hydrochloride) solution for the oral cavity 1.5 mg/ml. 100 ml. vial №1

Description

Zipelor (benzidamine hydrochloride) solution for the oral cavity 1.5 mg/ml. 100 ml. vial №1

Composition

active substance: benzydamine;

1 ml of solution contains 1.5 mg of benzydamine hydrochloride;

Excipients: ethanol 96%, glycerin, methylparaben (E 218), saccharin sodium, sodium bicarbonate, polysorbate 20, mint flavor, quinoline yellow 70% (E 104), blue patented V (E 131), purified water.

Dosage form

Oral solution.

Main physical and chemical properties: transparent green liquid with a characteristic odor of mint.

Pharmacotherapeutic group

Means for application in dentistry. Other means for topical use in the oral cavity.

ATX code A01A D02.

Pharmacological properties

Benzidamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

In clinical trials, benzydamine has been shown to be effective in relieving the symptoms that accompany localized irritating pathological processes in the mouth and pharynx. In addition, benzydamine has anti-inflammatory and local analgesic effects on the oral mucosa.

Indications

Symptomatic treatment of irritation and inflammation of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry used after tooth extraction or for prophylactic purposes.

Contraindications:

• hypersensitivity to the active substance or other components of the drug;
• interaction with other drugs and other types of interactions;
• interaction studies have not been performed;
• features of application;
• if you develop sensitivity with prolonged use, you should stop treatment and consult a doctor to prescribe appropriate treatment.

In some patients, ulcers of the mucous membranes of the cheeks / pharynx can be caused by serious pathological processes. Therefore, patients whose symptoms have worsened or not decreased within 3 days or who have a fever or other symptoms should consult a physician or dentist as appropriate.

Benzidamine is not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

The drug can cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned.

For athletes: the use of drugs containing ethyl alcohol may give a positive anti-doping test result.

Use during pregnancy or breastfeeding

There are no adequate data from the use of benzydamine in pregnant or breast-feeding women. The ability of this drug to penetrate into breast milk has not been studied. There are insufficient data from animal studies to draw any conclusions about the effects of this product during pregnancy and breastfeeding. The potential risk for humans is unknown.

Zipelor should not be used during pregnancy or breastfeeding.

Ability to influence the speed of reaction when driving a car or other mechanisms.

When used in the recommended doses, the drug has no effect on the ability to drive and use machines.

Method of application and dose

Measure 15 ml of Zipelor solution from the vial using a measuring cup and rinse the mouth with undiluted or diluted (15 ml of solution can be diluted with 15 ml of water) preparation. Rinses should be performed 2-3 times a day. Do not exceed the recommended dose.

The drug should not be used in children under 12 years due to the possibility of swallowing the solution while rinsing the mouth.

Overdose

There have been no reports of topical benzidamine overdose.

However, it is known that benzydamine when ingested in large doses (which is hundreds of times higher than possible doses of this dosage form), especially in children, can cause agitation, convulsions, tremor, nausea, sweating, ataxia, vomiting. Such an acute overdose requires immediate gastric lavage, treatment of water-electrolyte imbalance and symptomatic treatment, adequate hydration.

Adverse reactions:

• in each frequency grouping, adverse reactions are presented in order of decreasing seriousness;
• from the gastrointestinal tract: rarely – burning sensation in the mouth, dry mouth; frequency unknown – hypoesthesia of the oral cavity, nausea, vomiting, edema and discoloration of the tongue, discoloration;
• from the immune system: rarely – hypersensitivity reaction; frequency unknown – anaphylactic reaction;
• from the respiratory system, chest and mediastinum: very rarely – laryngospasm; frequency unknown – bronchospasm;
• from the skin and subcutaneous tissue: infrequently – photosensitivity; very rarely – angioneurotic edema; frequency unknown – rash, itching, hives;
• from the nervous system: frequency unknown – dizziness, headache.