Categel with Lidocaine 12.5g (external application) syringe
The instruction for medical use
Katedzhel with lidocaine
A trade name
Katedzhel with lidocaine
the International unlicensed name
Is not present
the Dosage form
Gel sterile on 12.5 g,
active agents in the corrugated polypropylene syringe Structure of 100 G of Gel – lidocaine a hydrochloride of 2.00 g
– a chlorhexidin dihydrochloride of 0.05 g,
excipients: a giyeteloza (hydroxyethylcellulose), glitserol, sodium hydroxide or hydrochloric acid, water for injections.
Colourless transparent gel.
Drugs for treatment of urological diseases. Other uroantiseptik.
The code of automatic telephone exchange G 04AG
Lidokain is quickly absorbed through a mucous membrane of an urethra. Peak concentration in blood plasma in 0,06 0,2 mkg/ml of lidocaine are reached in 45 60 minutes after intra urethral introduction of 10 – 40 ml of lidocaine of gel of 2% (200 – 800 mg of lidocaine). Lidocaine is quickly distributed on all fabrics. Lidocaine approximately for 65% is attached with proteins of blood plasma and acid alpha 1 – to glycoproteins (AAG). About 90% of a dose of lidocaine are metabolized in less active metabolites. Elimination half-life – 1.8 hours, it can be prolonged at elderly people till 2.3 o’clock. The half-life period of active metabolites is 0.9 hours. Less than 5% of lidocaine are allocated invariable with urine. It is necessary to consider that at the significant inflammation of a mucous membrane of an urethra the absorption of lidocaine increases
Chlorhexidin. Only very small quantities of a chlorhexidin are absorbed after topical administration.
Katedzhel with lidocaine is the sterile and antiseptic gel with local anesthetic effect intended for instillation in an urethra. It reduces the pain connected with transurethral procedures and substantially prevents infections of urinary tract after catheterization.
Lidocaine is local anesthetic. Its action begins in 5 10 minutes, and the effect lasts 20 30 minutes.
Chlorhexidin has antimicrobic effect against many gram-positive (Staphylococcus aureus Streptococcus salivarius Staphylococcus epidermidis) and gram-negative bacteria (Micrococcus pyogenes, E. coli, Pseudomonas pyocyanea and Salmonella typhi, E. coli, Pseudomonas aeruginosa) and also against a number of mushrooms (Candida utilis) and viruses. In this concentration he is applied to prevention of the ascending infection of an upper urethra and a bladder.
– Local anesthesia and prevention of infectious complications at catheterization of an urethra.
A route of administration and doses
in an urethra before introduction of tools (the doctor or according to trained by personnel) it is necessary For slow instillation:
– to clean and disinfect an external opening of an urethra
– to open the blister, removing paper from the transparent body (whenever possible only to a banner)
– to break off a tip of a protective cap without considerable effort (whenever possible even in packing). At the same time it is necessary to track that the tip was removed completely, in order to avoid damage mucous an urethra. For simplification of input of an application cone it is recommended to squeeze out previously Katedzhel’s drop
– introduction of the tool is recommended in 10 minutes after gel instillation.
The recommended dose for one procedure at men – 10 g (the corrugated syringe on 12, 5 g of gel) vnutriuretralno.
– are possible reactions of supersensitivity
– seldom: bradycardia at repeated use of Katedzhel with lidocaine or at the significant inflammation mucous an urethra.
– hypersensitivity to local anesthetics of amide type
– children’s age up to 2 years
– a bulbokavernozny reflex
– heavy heart failure, bradycardia, AV blockade, cardiogenic or hypovolemic shock
Katedzhel with lidocaine should not be applied to active agents or one of fillers along with the drugs containing lidocaine a hydrochloride or other local anesthetics of amide type as it can lead to unpredictable mutual strengthening of effects.
Because of potential additional impacts on heart lidocaine has to be applied with care at the patients who are at the same time accepting antiarrhytmic means, beta blockers or antagonists of a calcium channel.
Katedzhel with lidocaine has to be applied with care at patients with a heavy liver or renal failure and cardiac or respiratory dysfunction.
Use Katedzhel with lidocaine is not recommended to patients with the inflamed, injured or ulcerated mucous membrane of an urethra.
If contents more than one syringe are entered or a significant amount of gel gets into a bladder or the urethra is inflamed or ulcerated, absorption of lidocaine can be increased in general that can lead to overdose with collateral impacts on the central nervous and cardiovascular system. Children and elderly patients are especially subject to risk.
The extra care should be shown for the elderly, weakened and seriously ill patients and also at having tendency to spasms.
The patients having asthenic bulbar paralysis are especially sensitive to local anesthetics.
Katedzhel with lidocaine anesthetizing gel should not contact to eyes, ulcerated fabric or wounds.
Pregnancy, a lactation
is not available any controlled clinical trials of Katedzhel with lidocaine for pregnant women. The potential risk for a fruit is unknown.
Concerning a chlorhexidin in Katedzhel with lidocaine there is practically no risk as only very small quantities of a chlorhexidin get to system blood circulation of mother.
Katedzhel with lidocaine has to be applied during pregnancy only after careful weighing of a ratio risk/advantage to mother and a fruit. Reuse during pregnancy is not recommended.
Use in the period of a lactation
Katedzhel with lidocaine has to be applied in the period of a lactation only after careful weighing of a ratio risk/advantage to mother and
child Vliyaniye on ability to driving and potentially dangerous mechanisms.
Considering a possibility of the individual increased absorption of lidocaine at inflammation of a mucous urethra at patients to whom procedures using Katedzhel with lidocaine, perhaps insignificant decrease in reaction within 2 hours after instillation of drug in an urethra are carried out.
Symptoms: (at systemic action of lidocaine in cases of heavy injuries of an urethra) bradycardia, spasms, collapse.
Treatment: in bradycardia – beta adrenostimulyatory, in spasms barbiturates or muscle relaxants of short action, at collapse epinephrine or a dopamine in / century.
A form of release and packing
Gel for external use on 12.5 g, in the corrugated polypropylene syringe with the nozzle applicator and the breaking-off tip, on 1 or 5 syringes with the instruction for use in a cardboard box.
To Store storage conditions at a temperature not over 250C, in external packing for protection against light. To store out of children’s reach!
Not to apply a period of storage of 5 years after expiry date!
According to the prescription
the Producer Montawit Hess. m b. X, Abzam, Austria
Sabipharm LLP, 050008, Almaty, ave of Abay 66/1. Ph. / fax: (3277) 242-00-37.
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