Benzokain-FT
Producer: LLC Pharmtekhnologiya Republic of Belarus
Code of automatic telephone exchange: N01BA05
Release form: Soft dosage forms. Gel for external use.
General characteristics. Structure:
Active ingredient: 25 mg, 75 mg and 100 mg of benzocaine in 1 g of gel.
Excipients: a macrogoal 400, the water purified, carbomer, dinatrium эдетат, diethanol amide, propylene glycol.
Drug has anesthetic effect when drawing on a mucous membrane of an oral cavity.
Pharmacological properties:
Pharmacodynamics. Active ingredient of medicine is local anesthetic benzocaine. It reversibly blocks natrium channels in nervous membranes, thus, interfering with generation of painful impulses in the terminations of sensory nerves and to their carrying out on nerve fibrils.
Pharmacokinetics. When drawing on an oral cavity cover mucosal surface effect of medicine develops in 1 min. Duration of action makes from 0,5 to 1 hours. Benzocaine has no resorptive effect. Benzocaine is hydrolyzed by plasma and hepatic cholinesterase to metabolites of paraaminobenzoic acid and removed with urine.
Indications to use:
BENZOKAIN-FT is shown for local anesthesia of mucous membranes in dental practice: pain relief at a teething at children, a dentagra, gum pain, for reduction of pain from wounds of a mucous membrane of an oral cavity or language, at stomatitis.
Route of administration and doses:
2,5% apply gel at children from 4,5 months. A clean finger or a wadding stick, it is necessary to apply 1 drop of gel (size about a pea) on a gingiva in the place of the cutting-through tooth and it is easy to rub. The procedure is carried out after food by 3 - 4 times a day, after food and before going to bed.
7,5% appoint gel to children from 7,5 years.
The adult, and also to elderly people, appoint 7,5% and 10% gel. A small amount of gel is applied on mucous membranes of an oral cavity and slightly rubbed 3-4 times a day. At a dentagra gel is applied around the affected tooth. After putting gel on a surface, within 15 minutes it is impossible to rinse a mouth and to eat food.
Features of use:
BENZOKAIN-FT is intended only for topical administration.
It is necessary to avoid its hit in eyes because of possible development of irritation. At accidental hit in their eyes it is necessary to wash out immediately flowing water.
Use in pediatric practice. Use benzocaine - the containing medicines at children aged up to 2 years is recommended with care, only to destination and under observation of the doctor. In the course of use of benzocaine it is necessary to control a condition of the child. At emergence of skin rash, burning, a pricking, hypostases or irritations of skin medicine should be cancelled. And if the child has such symptoms as pale, gray or blue skin color of lips or nails, a headache, dizziness tachycardia, an asthma or unusual fatigue or weakness, it is necessary to see a doctor.
Use at pregnancy. Data on use of benzocaine at pregnancy are absent therefore its topical administration only after the careful analysis of a ratio risk/advantage for the pregnant woman and a fruit is admissible.
Use in the lactation period. Questions of absorption of benzocaine in blood and its excretion with milk after topical administration are not studied. It is improbable that at such route of administration benzocaine can make harmful effects on the child when breastfeeding. However processing by benzocaine of a breast and nipples is inadmissible as the child in the course of feeding can swallow drug, and it can lead to emergence of undesirable reactions.
A number of the diseases or morbid conditions which are present at the patient can promote emergence of undesirable problems in connection with use benzocaine - the containing medicines. Treat them: anemia owing to insufficiency of glyukozo-6-phosphodiesterase; inherited disorders of a metabolism (gemoglobin-M disease, insufficiency of a pyruvatekinase); deficit reductase NADN-methemoglobin; heart trouble and lungs, abuse of nicotine.
Side effects:
Data on side effect of benzocaine are based on the analysis of post-registration monitoring of safety. Frequency of side reactions is specified according to the standard classification: very frequent (> 1/10), frequent (> 1/100, 1/1000, 1/1000,
Treat rare reactions: bluish color of nails, lips, skin of palms.
A number of side reactions came to light with an unspecified frequency. The following concerns to them: burning, dryness or peeling of skin; dark color of urine; breath difficulty; dizziness, faints, headache; fever; paresthesias; irritability; tachycardia; pharyngalgia; drowsiness, slackness, fatigue; methemoglobinemia.
Nevertheless, medicines which active ingredient is benzocaine (2-10%) are usually well transferred. Side effects can be connected with exceeding of the recommended dosage or with individual intolerance of benzocaine. At emergence of an itch, hypostasis, a hyperemia in a site of application of gel it is necessary to stop medicine reception.
Interaction with other medicines:
At simultaneous use with non-steroidal anti-inflammatory drugs, inhibitors of cholinesterase effect of benzocaine amplifies. Antibacterial activity of streptocides decreases at simultaneous use with benzocaine.
Contraindications:
- infectious process in a medicine site of application;
- existence on a mucous membrane of the multiple injured sites;
- hypersensitivity to benzocaine.
Overdose:
At observance of the mode of reception the overdose is impossible. In the presence in an oral cavity of multiple injuries of a mucous membrane or at considerable exceeding of the recommended dose strengthening of adsorption of drug and increase in its concentration in blood serum is possible. In this case emergence of hypostasis, a hyperemia and an itch in a medicine site of application is possible. In rare instances perhaps stimulation or oppression of TsNS, oppression of cardiovascular system and emergence of a methemoglobinemia.
At emergence of these symptoms rinsing of an oral cavity warm soda solution and the subsequent address to the doctor is recommended.
Storage conditions:
To store in the place protected from light at a temperature not above + 25 °C. Period of validity 2 years.
Issue conditions:
According to the recipe
Packaging:
Tubas from the combined material on 15,0 g in packaging No. 1; the tuba together with a leaf insert is placed in a pack from a cardboard