Cathejell With Lidocaine

The active substances are: Lidocaine hydrochloride, chlorhexidine dihydrochloride. 1 g gel contains 20 mg lidocaine hydrochloride and 0.5 mg chlorhexidine dihydrochloride.
Excipients/Inactive Ingredients: Hydroxyethylcellulose, glycerol, sodium lactate solution, water for injections, sodium hydroxide and hydrochloric acid for pH adjustment.

Cathejell is a sterile gel used as a lubricant for catheters, endoscopes or other medical instruments.
It is intended for use on mucous membranes. Due to its lubricant effect, local anaesthetic and antibacterial action, it is designed to relieve pain during such procedures and prevent most infections. The effect sets in as early as 5-10 minutes after application and lasts for 20-30 minutes.
Cathejell is indicated in adults, adolescents and children from 2 to 11 years.
As a local anaesthetic, it contains lidocaine. In surface anaesthesia, it generally takes effect in about 3-5 minutes. In inflamed tissue, the effect is reduced.
To avoid infections at the application site, Cathejell contains chlorhexidine. This agent disinfects and acts against many bacteria, some fungi and viruses.

HOW TO USE CATHEJELL: This medicine should only be used by a doctor or medically trained nursing staff. The dose is individually adjusted.
The following dosing information is a guideline; the doctor's experience and knowledge about the patient's physical condition are important when calculating the appropriate dose.
The degree of absorption is particularly high in the bronchial tree.
Use in the urethra before inserting a catheter, endoscope or other medical instruments: The accordion syringes (hereinafter called 'syringes') contain 12.5 g or 8.5 g gel, of which approximately 10 g and 6 g respectively is inserted into the urethra during instillation.
The amount of gel instilled is adapted to the individual anatomical conditions of the urethra.
Dosage recommendations: Adult men: The 12.5 g syringes are generally needed. The contents of one syringe are sufficient for sufficient filling of the male urethra; no more than one syringe should be instilled. The effect sets in as early as 5-10 minutes after application and lasts for 20-30 minutes.
In women, adolescents (under 18 years) and children (2-11 years) the effect of Cathejell is not so well demonstrated and therefore the need to use it should be assessed by the doctor. Specific dosage recommendations cannot be given for these groups of patients.
The systemic absorption of lidocaine can be increased in children and caution is accordingly required. In general, the maximum dose in children aged 2 to 11 years of 2.9 mg/kg lidocaine hydrochloride should not be exceeded.
Cathejell must not be used in children under 2 years (see Contraindications).
Dosage recommendations for risk patients: The dosage must be adjusted accordingly in elderly, debilitated and acutely ill patients, as well as in cases of impaired hepatic function or severe renal dysfunction (see Precautions). The maximum dose must be calculated in mg lidocaine hydrochloride/kg body weight (2.9 mg lidocaine hydrochloride/kg BW).
Method of administration: 1. Clean and disinfect the external urethral orifice.
2. Peel off the paper from the transparent blister cover up until the tapered end of the blister.
3. Snap off the tip; if possible, while it is still in the blister.
4. Remove the tip completely, thereby ruling out any inadvertent insertion into the urethra.
5. Squeeze out a drop of gel for easier insertion of the application nozzle.
6. Instill slowly by applying gentle and even pressure on the syringe.
Cathejell syringes are intended for single use. Discard any remaining gel.
Use for anaesthesia in general and tracheal intubation: Dosage recommendations: Adults and adolescents aged 12 years and older: Evenly distribute approximately 5 ml over the bottom third of the tube. To avoid desiccation, the gel is not applied to the instrument until immediately prior to use. The gel should not get inside the tube lumen. For adults of normal body weight, the maximum dose is 16 g Cathejell.
Dosage for children up to 11 years of age: The systemic absorption of Lidocaine can be increased in children and caution is accordingly required. In general, the maximum dose of 2.9 mg/kg BW Lidocaine hydrochloride should not be exceeded in children aged 2 to 11 years.
Cathejell must not be used in children under 2 years (see Contraindications).
Dosage recommendations for risk patients: The dosage must be adjusted accordingly in elderly, debilitated and acutely ill patients, as well as in cases of impaired hepatic function or severe renal dysfunction (see Precautions). The maximum dose must be calculated in mg lidocaine hydrochloride/kg body weight (2.9 mg lidocaine hydrochloride/kg BW).
Method of administration: For distribution over probes, endoscopes and tubes.
Cathejell syringes are intended for single use. Discard any remaining gel.

As this medicine is administered by a doctor or medically trained nursing staff, no overdose is likely. However, should an overdose occur, e.g. if the amount of gel used has not been optimally adjusted to suit the patient's needs, if a large amount of gel gets into the bladder, or if the patient's mucous membranes are inflamed, ulcerous or injured, this can lead to increased absorption of lidocaine, resulting in disturbances of the central nervous system or cardiovascular system. In particular, this also applies if the patient has been using other local anaesthetics at the same time.
Excitation/depression of the central nervous system may occur in the event of an overdose, which may manifest as symptoms such as nervousness, dizziness, drowsiness and trembling. First signs of an overdose may be numbness of the tongue, eye twitching, dizziness or tiredness.
Side effects of the cardiovascular system, such as slowed pulse, poor heart function or a drop in blood pressure, normally occur only at very high blood concentrations of lidocaine.
Respiratory paralysis and cardiovascular failure may occur in the event of a massive overdose with lidocaine.
If signs of an overdose occur, consult a doctor immediately.
If the patient has any further questions on the use of this product, ask the doctor or pharmacist.
Emergency procedures in the event of an overdose: Treatment of intoxication in the CNS region (convulsions, CNS depression) or the cardiovascular system symptomatic, e.g. with administration of anticonvulsants and/or emergency cardiopulmonary support: immediate suspension of lidocaine administration; maintenance of airway patency; oxygen administration until all vital functions have normalised; monitoring of blood pressure, pulse and pupil width.
Other possible countermeasures: For acutely serious hypotension: elevation of the legs and slow IV injection of a beta-sympathomimetic (e.g. 10-20 drops per minute of a 1 mg isoprenaline solution in 200 ml glucose solution 5%) and additional volume substitution.
For increased vagal tone (bradycardia), 0.5-1.0 mg atropine is administered IV.
Convulsions lasting for more than 30 seconds are treated by administering an anticonvulsant (thiopental sodium 1-3 mg/kg IV or diazepam 0.1 mg/kg BW IV).
Persistent seizures can be controlled by injecting a muscle relaxant (e.g. succinylcholine (suxamethonium) 1 mg/kg BW).

Do not use Cathejell: if the patient is allergic (hypersensitive) to the active substances or any of the other ingredients of Cathejell; if the patient is allergic (hypersensitive) to certain other local anaesthetics (of the amide type); in children below 2 years of age; in bulbocavernosus reflux (an injury to the thin urethral lining, which may cause the lubricant to infiltrate into erectile tissue, where absorption may occur); in patients with a severely weak heart, extremely slow heartbeat, heart conduction disturbances (AV block), shock due to heart failure or reduced blood volume.
Talk to the doctor if one or more of these statements apply or have ever applied to the patient in the past.

Take special care with Cathejell if: used frequently and at high doses, as this may lead to severe side effects. Increased absorption of lidocaine is likely when used in the bronchial area, which is associated with a particularly high risk of overdose; if the patient has any wounds, injury to the mucous membranes or an ulcer/inflammation in or around the proposed application site; if the patient's liver or kidney function is severely impaired; if the patient has heart or respiratory tract dysfunction; in elderly, debilitated or acutely ill patients; if the patient is prone to seizures; if the patient is suffering from a certain muscle disease (myasthenia gravis); if the patient is on treatment with certain medications to treat heart rhythm disorders, known as class III antiarrhythmics (e.g. amiodarone), as the effects on the heart may be enhanced; if the patient suffers from porphyria (a blood formation disorder).
Swallowing difficulties may occur when using Cathejell in the mouth and throat region. There is a risk of inhaling the gel (aspiration). Numbness of the tongue or mouth area can lead to a bite injury.
If the contents of more than one syringe are inserted into the urethra, if a large amount of gel gets into the bladder or if the urethra is ulcerous/inflamed, this may generally lead to increased absorption of lidocaine through the mucous membranes, particularly in children and elderly patients, resulting in severe side effects (see also Overdosage).
Cathejell must not come into contact with the eyes.
In general anaesthesia, a lubricant without lidocaine should be preferred.
Driving and using machines: Effects on the ability to drive and use machines are unlikely, but cannot be completely ruled out in cases of increased individual sensitivity.

Pregnancy and breast-feeding: Ask the doctor or pharmacist for advice before taking any medicine.
During pregnancy and breast-feeding, Cathejell should only be used after the doctor has carefully considered the benefits and risks and has decided on the patient's individual dose.
Repeated use during pregnancy and breast-feeding is not recommended.
Note that there should be a 12-hour interval between using Cathejell and subsequent breastfeeding.
Women planning a pregnancy or who think they are pregnant should tell their doctor.

Like all medicines, Cathejell can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if the patient notices any side effects not listed in this monograph, tell the doctor or pharmacist.
The side effects can be: Very rare: affecting less than 1 in 10,000 patients treated.
Frequency not known: cannot be estimated from the available data.
Side effects rarely occur after the use of Cathejell, provided that the product is used as directed in the dosage recommendations/recommendations for use and the necessary precautions are taken (see Precautions).
Immune system disorders: Local hypersensitivity reactions occur in rare cases, such as redness, stinging or itching and/or systemic reactions to lidocaine and/or chlorhexidine, although severe reactions too (often accompanied by a drop in blood pressure, dizziness, nausea and possibly shortness of breath), including anaphylactic shock, cannot be ruled out.
Effects on the central nervous system and cardiovascular system: These are mainly due to rapid absorption, overdose or hypersensitivity.
The following symptoms may occur: Nervousness, dizziness, blurred vision or trembling, drowsiness, unconsciousness and respiratory arrest, drop in blood pressure, slow heart rate, cardiac arrest. For the treatment of side effects, see Overdosage.
As a local reaction, hoarseness can occur when used as a lubricant for the endotracheal (airway) tube.
As only low lidocaine blood levels are likely during use in urology, no other systemic side effects are expected to occur after instilling Cathejell into the urethra.

Using other medicines: Tell the doctor or pharmacist if the patient is taking/using or has recently taken/used any other medicines, including medicines obtained without a prescription.
Cathejell should not be used at the same time as other medicines containing lidocaine or certain other local anaesthetics (of the amide type), as this may enhance their respective effects in a unpredictable manner.
As there may be an enhanced effect on the heart, lidocaine should be used with caution in patients also receiving medication used to treat heart rhythm disorders (antiarrhythmics, e.g. mexiletine, tocainide), high blood pressure (beta-blockers, such as propranolol) or calcium channel blockers (e.g. diltiazem, verapamil).
No specific interaction studies have been performed with lidocaine and class III antiarrhythmics; however, caution is advised (see also Precautions), as the effects on the heart may be enhanced.
If the patient is taking cimetidine (which blocks stomach acid production), discuss this with the doctor before treatment with Cathejell. Using such medicines at the same time can increase the risk of side effects.

Keep the blister in the outer carton, in order to protect from light.
Cathejell syringes are intended for single use. Any gel remaining in partially emptied syringes must no longer be used.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Anaesthetics - Local & General

N01BB52 - lidocaine, combinations ; Belongs to the class of amides. Used as local anesthetics.

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