Pharmacological properties
Pharmacodynamics. Cathegel with lidocaine is a sterile antiseptic gel with a local anesthetic effect. By means of local, superficial anesthesia, Cathegel with lidocaine provides anesthesia of the mucous membrane, which leads to a rapid symptomatic reduction of pain. Anesthesia occurs 5-10 minutes after application of the drug and lasts 20-30 minutes. In addition to the analgesic effect, Cathegel with lidocaine significantly prevents urinary tract infections after catheterization.
Lidocaine is a clinically proven local anesthetic of the amide group. Lidocaine can be stopped and locally inhibits the conduction of sensitive nerve fibers. Sensitivity is sequentially reduced: cold / heat, touch and pressure. With local anesthesia, the effect of the drug occurs after 3-5 minutes. In inflammatory tissues, its effect is reduced due to the acidic pH value that dominates. In addition to the anesthetic effect, lidocaine also has an antiarrhythmic effect. Unlike most other local anesthetics, lidocaine does not have a vasodilating effect.
Chlorhexidine is an antimicrobial agent active against most gram-positive and gram-negative bacteria, as well as against a number of fungi and viruses. Chlorhexidine is used as a prophylactic agent to prevent iatrogenic infections when used topically.
Indication
For local anesthesia of the mucous membrane and as a lubricant during urethral catheterization, probing, endoscopic examinations, intubation.
Application
Use of the drug when inserting a catheter, endoscope or other medical instruments into the urethra.
The corrugated syringe tube contains 12.5 g of gel, of which approximately 10 g enters the urethra during instillation.
Recommended doses for adult men: 12.5 g of the drug is used to sufficiently fill the urethra. The contents of one corrugated syringe tube are sufficient to fill the urethra. It is not recommended to use more than one tube for one manipulation. The drug begins to act after 5-10 minutes.
Women, children (2-12 years of age) and adolescents (12 years of age and older): There are no specific dosage recommendations for this patient group. Do not use more than 4 doses in 24 hours.
Method of application:
1. Clean and disinfect the external urethral opening.
2. Remove the paper covering the transparent blister to the tapered end.
3. Break off the tip of the tube; if possible, leaving the tube in the blister.
4. Remove the tip of the tube completely to avoid accidentally inserting it into the urethra.
5. Squeeze out a drop of gel to facilitate insertion of the tip.
6. Gently press on the tube and slowly insert the gel into the urethra.
Any remaining medication should be discarded along with the syringe-tube.
Anesthesia during general and tracheal intubation
Adults and children over 15 years of age: evenly distribute approximately 5 ml of gel over the lower third of the tube. To avoid drying, apply the gel to the instrument immediately before use. The gel should not enter the lumen of the tube. For adults of average body weight, the maximum dose of Cathegel with lidocaine is 16 g.
Doses for children aged 2-15 years: For children under 15 years of age, the dose of the drug should not exceed 6 mg of lidocaine (= 0.3 ml of gel/kg body weight). Do not use more than 4 doses within 24 hours.
Dosage recommendations for patients at risk
For the elderly, debilitated and seriously ill patients, as well as for those with impaired liver function or severe renal failure, the dose of the drug should be selected individually.
The maximum single dose is calculated in mg of lidocaine hydrochloride per 1 kg of body weight (2.9 mg of lidocaine hydrochloride / kg of body weight).
Contraindication
Hypersensitivity to one of the components of the drug, as well as hypersensitivity to other local anesthetics of the amide type; bulbocavernosus (urethrocavernous) reflux; severe heart failure (IV functional class according to the NYHA classification); severe bradycardia (33 beats / min); severe AV block (III degree); cardiogenic shock; hypovolemic shock.
Side effects
Adverse reactions after using the drug Cathegel with lidocaine appear rarely (1/10,000) if the drug is used in accordance with the dosage recommendations and method of administration.
Rarely, cases of local and/or systemic hypersensitivity reactions to lidocaine and/or chlorhexidine may occur.
Special instructions
It is necessary to avoid getting the drug Kategel with lidocaine in the eyes. The drug should be used with caution in patients with severe liver dysfunction (stages III and IV), renal dysfunction (creatinine clearance 30 ml/min), with severe cardiac or respiratory dysfunction (stages III-IV).
Use during pregnancy and breastfeeding. During pregnancy, Cathegel with lidocaine can be used only after a careful analysis of the benefit/risk ratio by the doctor and after establishing an individual dose. Repeated use of the drug during pregnancy is not recommended. During breastfeeding, Cathegel with lidocaine should be used only if necessary; doses should be selected individually. The interval between instillation of Cathegel with lidocaine and subsequent breastfeeding should be 12 hours. Repeated use of the drug during breastfeeding is not recommended.
Ability to influence the reaction rate when driving vehicles or working with other mechanisms. Cathegel with lidocaine practically does not affect the ability to drive vehicles or work with other mechanisms, but its effect cannot be completely excluded in cases of increased individual sensitivity.
Interactions
Cathegel with lidocaine should not be used together with preparations containing lidocaine hydrochloride or with other amide-type local anesthetics, as this may lead to unpredictable drug interactions.
Due to possible additive effects on the heart muscle, lidocaine should be used with caution in patients who are concomitantly receiving antiarrhythmic drugs such as mexiletine and tocainide, β-adrenergic blockers (e.g. propranolol) or calcium channel antagonists (e.g. diltiazem, verapamil).
Propranolol, diltiazem and verapamil lead to a significant increase in T ½ due to a decrease in lidocaine clearance. Drugs that reduce lidocaine clearance can lead to potentially toxic plasma concentrations if lidocaine is used repeatedly in high doses over a long period of time. Therefore, with short-term use of Cathegel with lidocaine in recommended doses, such interactions are not clinically significant.
Specific studies of the interaction of lidocaine and class III antiarrhythmic drugs (e.g. amiodarone) have not been conducted, but caution is recommended when using them together.
Caution should be exercised when using Cathegel with lidocaine and cimetidine, an H2 receptor antagonist. Plasma concentrations of lidocaine may increase due to decreased hepatic perfusion and inhibition of microsomal enzymes.
Overdose
When used correctly, Cathegel with lidocaine does not reach a toxic concentration of the drug in the blood plasma (5 μg/ml). However, simultaneous administration with other local anesthetics may cause an additive effect, which, in turn, may lead to an overdose of the drug with the subsequent development of systemic toxic reactions.
Storage conditions
In a place protected from light.
