Composition, form of production and packaging
? Tablets for resorption of white with a yellowish tinge, round, biconcave, with the logo of the firm Zyma (two triangles located opposite each other with some displacement) on one side and the code "OR" - on the reverse side, with an orange smell.
1 tab.
benzoxonium chloride 1 mg
lidocaine hydrochloride 1 mg
[PRING] sorbitol - 1 g (corresponding to approximately 17 kJ / 4 kcal), microcrystalline cellulose - 20 mg, macrogol 6000 - 25 mg, corn starch - 55 mg, sodium saccharinate - 4 mg, sodium chloride - 10 mg, citric acid - 5 mg, magnesium stearate - 1 mg, flavoring orange - 40 mg.
8 pcs. - blisters (1) - packs of cardboard.
8 pcs. - blisters (2) - packs of cardboard.
8 pcs. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Antiseptic preparation for topical application in ENT-practice. It is a quaternary ammonium salt: N-benzyl N-dodecyl N, N-di (2-hydroxyethyl) ammonium chloride.Due to the cationic structure it possesses membrane-active activity and has a pronounced antibacterial effect on gram-positive and, to a lesser extent, gram-negative microorganisms. Benzoxonium also has antifungal and antiviral activity against membrane viruses (including influenza, parainfluenza and herpes viruses).
Lidocaine is a local anesthetic that, in inflammatory processes, reduces the pain in the throat when swallowing.
PHARMACOKINETICS
Benzoxonium chloride is practically not absorbed. At the person in a blood the active substance is not defined or determined. In the tissues of the body, the accumulation of the active substance was not detected. About 1% of the received dose of benzoxonium chloride is found in urine.
Lidocaine is absorbed when ingested and through the oral mucosa. Metabolized by the "first pass" through the liver. When administered orally, the bioavailability is about 35%. Metabolites of lidocaine are excreted together with urine, less than 10% of the active substance is excreted unchanged.
INDICATIONS
Infectious-inflammatory diseases of the oral cavity and pharynx:
pharyngitis;
- laryngitis;
- Catarrhal angina;
- stomatitis;
ulcerative gingivitis;
- chronic tonsillitis (as an auxiliary).
DOSING MODE
Adults appoint 1 tablet. for resorption every 2-3 hours or as a spray for 4 sprays (approximately 0.5 ml) 3-6 times / day. With severe symptoms of the disease, 1 tablet can be used. every 1-2 hours. The daily dose should not exceed 10 tablets.
Children aged 4 years and older are prescribed 1 tablet. for resorption every 2-3 hours or as a spray for 2-3 sprays 3-6 times / day. The daily dose should not exceed 6 tablets.
Duration of treatment - no more than 5 days. If there is no relief of symptoms within 5 days of therapy, the patient should consult a doctor.
The tablet should be slowly resorbed in the mouth until it dissolves completely. The solution in the form of a spray is sprayed into the oral cavity, holding the can upright.
SIDE EFFECT
Possible: local irritation; when applied for more than 2 weeks - a reversible brown color of the tongue and teeth.
Rarely: allergic reactions.
CONTRAINDICATIONS
- I trimester of pregnancy;
- the period of lactation (breastfeeding);
- Children's age up to 4 years;
- Hypersensitivity to lidocaine or ammonia compounds.
PREGNANCY AND LACTATION
The drug is contraindicated for use in the first trimester of pregnancy and lactation (breastfeeding).
Adequate and strictly controlled clinical studies of the safety of the drug during pregnancy have not been conducted. The use of the drug in the II and III trimesters is not recommended.
There are no clinical data on the release of active substances with breast milk. However, the drug is not recommended for use during breastfeeding.
In experimental studies , the effect of the drug on reproductive function and fetal development was not found.
APPLICATION FOR CHILDREN
Contraindicated: children under 4 years. Children aged 4 years and older are prescribed 1 tablet. for resorption every 2-3 hours or as a spray for 2-3 sprays 3-6 times / day. The daily dose should not exceed 6 tablets.
SPECIAL INSTRUCTIONS
During the use of the drug should avoid drinking alcohol.
OVERDOSE
Symptoms: with occasional ingestion in high doses, nausea and vomiting are possible. The content of lidocaine in the preparation is insignificant and can not cause serious symptoms of an overdose.
Treatment: it is recommended to drink milk or eat egg whites, whipped in water.
DRUG INTERACTION
The effectiveness of benzoxonium chloride decreases with simultaneous use of anionic-active agents, for example, toothpaste.
Ethanol increases the absorption of benzoxonium chloride.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dry place at a temperature of no higher than 30 В° C. The shelf life of the resorption tablets is 3 years, the spray for topical application is 5 years.
