Zipelor (benzidamine hydrochloride) spray for the oral cavity 1.5 mg/ml. 30 ml. vial №1

Description

Zipelor (benzidamine hydrochloride) spray for the oral cavity 1.5 mg/ml. 30 ml. vial №1

Composition

active substance: benzydamine;

1 ml of spray contains benzydamine hydrochloride 1.5 mg;

Excipients: ethanol 96%, glycerin, methylparaben (E 218), saccharin sodium, sodium bicarbonate, polysorbate 20, peppermint flavor, purified water.

Dosage form

Oral spray.

Basic physical and chemical properties: clear colorless liquid with a characteristic mint odor.

Pharmacotherapeutic group

Means for use 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 irritant pathological processes in the mouth and pharynx. In addition, benzydamine has anti-inflammatory and local analgesic effects on the oral mucosa.

Indications

Zipelor spray is applied:

•  with gingivitis (inflammation of the gums);
•  with glossitis (inflammation of the tongue);
•  with stomatitis (inflammatory processes in the oral cavity), including after radiation, chemotherapy;
•  with laryngitis (inflammation of the larynx);
•  with tonsillitis (inflammation of the tonsils);
•  with pharyngitis (inflammation of the pharynx);
•  with calculous (with the formation of stones) inflammation of the salivary glands;
•  with candidiasis (fungal infection) of the oral cavity;
•  after surgery, injuries (fractures of the jaw, tonsillectomy);
•  after tooth extraction, other dental treatment;
• with periodontitis (inflammation of the periodontal tissue).

Contraindications

Contraindicated Zipelor spray: at intolerance of components of drug;children under 4 years.

Use during pregnancy and breastfeeding

There have been no adequate human studies on the use of benzydamine in the treatment of pregnant women and nursing mothers. There are insufficient data from animal studies. The ability of this drug to pass into breast milk has not been studied. As the potential risk for humans is unknown, the use of Zipelor during these periods is not recommended.

Method of application and dose

Zipelor spray is applied topically – by irrigating the oropharynx.
The nebulizer must be installed before use.
When the pump is pressed, an aerosol is formed, which contains one dose of spray (0.17 ml, which corresponds to 0.255 mg of active substance).

• adults are recommended 4-8 sprays 2-6 times a day;
• children 6-12 years old are recommended 4 sprays 2-6 times a day;
• children 4-6 years old calculate the dose depending on body weight – one spray for every 4 kg (maximum 4 sprays 2-6 times a day).

Overdose

There have been no reports of overdose with this drug when applied topically. However, it is known that the active ingredient when ingested in large doses (hundreds of times higher than therapeutic doses of this dosage form) can cause intoxication.
Symptoms: palpitations, abdominal cramps, hallucinations, vomiting, anxiety, fear, fever, convulsions, ataxia (incoordination), respiratory depression.
Treatment of overdose: gastric lavage, use of enterosorbents (eg, activated charcoal), medical supervision, symptomatic, supportive therapy.

Side effects:

• neurological disorders: cephalgia (headache), vertigo (dizziness);
• local reactions: dryness, burning in the mouth, numbness, swelling, discoloration of the tongue;
• allergic reactions: skin rash, photosensitization (sensitivity to the sun), angioneurotic edema, pruritus, laryngospasm, anaphylaxis, up to shock.