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Composition:


active ingredient: benzydamine hydrochloride;


1 ml of oral spray contains 1.5 mg of benzydamine hydrochloride;


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


Dosage form. Spray for the oral cavity.


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


Pharmacotherapeutic group. Products for use in dentistry. Other products for topical use in the oral cavity.


ATX code A01A D02.


Pharmacological properties.


Pharmacodynamics.


Benzydamine Hydrochloride is a nonsteroidal anti-inflammatory drug that has analgesic and anti-inflammatory effects by stabilizing cell membranes and reducing prostaglandin synthesis.


In clinical studies of the original benzydamine, it has been shown to relieve symptoms in localized irritating pathological processes in the oral cavity and pharynx.


The drug has an anti-inflammatory and local analgesic effect, has a local anesthetic effect on the oral mucosa.


Pharmacokinetics.


Benzydamine Hydrochloride is absorbed through the oral and pharyngeal mucosa. However, when using the drug in the form of an oral spray, the amount of benzydamine that enters the systemic circulation is insufficient to detect any systemic pharmacological effect. About half of the absorbed benzydamine is excreted by the kidneys, the rest is metabolized in the liver, mainly to N-oxide.


Clinical characteristics.


Indications.


Symptomatic treatment:


- irritation and inflammation of the oropharynx;


- pain caused by gingivitis, stomatitis, pharyngitis;


- in dentistry after tooth extraction or for preventive purposes.


Contraindications.


Hypersensitivity to the active substance or other components of the drug.


Interactions with other drugs and other types of interactions.


No data available.


Application features.


In cases of hypersensitivity with prolonged use of the drug, you should stop using it and seek medical advice regarding the appointment of appropriate treatment.


In some patients, ulcers of the cheek/pharyngeal mucosa can be caused by serious systemic pathological processes. In this regard, patients whose symptoms have increased or not decreased within 3 days, or who have increased body temperature or other symptoms, should consult a doctor.


It is not recommended to use benzydamine in patients with hypersensitivity to acetylsalicylic acid or to other nonsteroidal anti-inflammatory drugs.


The use of the drug may cause bronchospasm in patients suffering from bronchial asthma, or in patients with a history of bronchial asthma. Such patients should definitely be warned about this.


For athletes: the use of drugs containing ethyl alcohol can give a positive result of an anti-doping test, given the limits set by some sports federations.


The drug contains up to 10 vol. % ethanol (alcohol).


The drug contains methyl parahydroxybenzoate (methylparaben), which can cause allergic reactions (possibly delayed), and in some cases – bronchospasm.


Use during pregnancy or lactation.


Do not use the drug during pregnancy or lactation.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


When used in the recommended doses, the drug does not have any effect on the ability to drive vehicles and work with mechanisms.


Dosage and administration.


Adults should apply 4-8 sprays 2-6 times a day.


Children aged 6 to 12 years - 4 sprays 2-6 times a day.


Children aged 4 to 6 years - 1 spray for every 4 kg of body weight, but no more than 4 sprays, 2-6 times a day.


Do not exceed the recommended dosage.


Children.


The drug can be used in children aged from 4 years.


Overdose.


There are no data on cases of benzydamine overdose when applied topically. But it is known that benzydamine, when taken orally in a large dose (hundreds of times higher than that of this dosage form), especially in children, can cause agitation, convulsions, tremors, nausea, increased sweating, ataxia, vomiting. Such an acute overdose requires immediate gastric lavage, treatment of water-electrolyte balance disorders and symptomatic treatment, adequate hydration.


Adverse reactions.


From the gastrointestinal tract: burning sensation in the mouth, dry mouth, hypesthesia of the oral cavity, nausea, vomiting, swelling and discoloration of the tongue, taste changes.


Immune system disorders: hypersensitivity reactions, anaphylactic reactions.


From the respiratory system: laryngospasm, bronchospasm.


From the skin and subcutaneous tissue: photosensitivity, angioedema, rash, pruritus, urticaria.


Nervous system disorders: dizziness, headache.


Expiration date.


2 years.


Do not use after the expiration date indicated on the package.


Storage conditions.


Store at a temperature not exceeding 25 °C. keep out of reach of children. 

Tags: Benzidamine