Composition, form of production and packaging
? Spray for topical application in the form of a clear, colorless solution with the smell of mint.
100 ml
benzoxonium chloride 0.2%
lidocaine hydrochloride 0.15%
[PRING] ethanol 96% (v / v) - 10%, glycerol 15%, hydrochloric acid 0.1N - 0.0581%, peppermint oil 0.01%, menthol 0.0025%, purified water 100%.
30 ml - bottles of high-density polyethylene (1) complete with a spraying device - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Combined for topical use, contains antiseptic and local anesthetic.
Benzoxonium chloride - 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. It 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. The concentration of benzoxonium chloride is practically not 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 4 sprays (approximately 0.5 ml) 3-6 times / day.
Children aged 4 years and older are prescribed no more than 2-3 sprays 3-6 times / day.
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.
Spray is sprayed in the mouth, holding the can upright.
SIDE EFFECT
Determination of the frequency of adverse reactions: very often (? 10%); often (? 1%, but? 10%), infrequently (? 0.1%, but? 1%), rarely (≥0.01%, ≥ 0.1%), very rarely (≥0.01%).
Local reactions: infrequently - irritation, which is temporary. When using the drug for more than 2 weeks, a reversible brown color of the tongue or teeth can be observed.
Allergic reactions: in isolated cases - hives, swelling of the face, swelling of the larynx.
CONTRAINDICATIONS
- Pregnancy;
- the period of lactation (breastfeeding);
- Children's age up to 4 years;
- hypersensitivity to the components of the drug;
- Hypersensitivity to ammonia compounds.
PREGNANCY AND LACTATION
TeraFlu В® LAR is contraindicated in pregnancy and lactation (breastfeeding).
The clinical experience of the drug during pregnancy is very limited.
There are no clinical data on the release of active substances with breast milk.
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.
SPECIAL INSTRUCTIONS
When using TeraFlu В® LAR, alcohol should be avoided.
Impact on the ability to drive vehicles and manage mechanisms
Does not affect.
OVERDOSE
Symptoms: when you accidentally take the drug (as well as other ammonium compounds) 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 at a temperature of no higher than 30 В° C. Shelf life - 5 years.
