Source: Health Products and Food Branch (CA) Revision Year: 2021
Cathejell (lidocaine hydrochloride) is indicated as a surface anesthesia and lubrication for:
Elderly patients should be given reduced doses commensurate with their age and physical condition (see DOSAGE AND ADMINISTRATION, Special Populations).
Children should be given reduced doses commensurate with their age, weight and physical condition (see DOSAGE AND ADMINISTRATION, Special Populations).
Lidocaine should be used with caution in children younger than two years of age as there are insufficient data to support the safety and efficacy of this product in this patient population at this time (see WARNINGS AND PRECAUTIONS, Special Populations).
When Cathejell (lidocaine hydrochloride) is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.
Cathejell in the pre-filled syringe is preservative-free, latex free, and intended for single use only.
The absorption of lidocaine jelly from the nasopharynx is usually lower than with other lidocaine products. Blood concentrations of lidocaine after instillation of the jelly in the intact urethra and bladder in doses up to 800 mg are fairly low and below toxic levels.
Lidocaine should also be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic, or renal function and in severe shock (see WARNINGS AND PRECAUTIONS).
Debilitated patients, elderly patients, acutely ill patients, patients with sepsis, and children should be given reduced doses commensurate with their age, weight and physical condition (see WARNINGS AND PRECAUTIONS).
Cathejell should be used with caution in children under the age of 2 as there is insufficient data to support the safety and efficacy of this product in this patient population at this time (see WARNINGS AND PRECAUTIONS).
When fully compressed, each 13.3 g syringe will express approximately 10 g (9.4 mL) of Cathejell (200 mg of lidocaine hydrochloride). The amount expressed may vary with the technique used.
Surface Anesthesia of the Male Adult Urethra:
For adequate analgesia in males, 20 g (400 mg lidocaine hydrochloride) of jelly (2 syringes) is usually required. The jelly is instilled slowly until the patient has a feeling of tension, approximately 10 g (200 mg lidocaine hydrochloride) of jelly (1 syringe). A penile clamp is then applied for several minutes at the corona, after which another 10 g (200 mg lidocaine hydrochloride) of jelly (1 syringe) is instilled.
When anesthesia is especially important (e.g., during sounding or cystoscopy), a larger quantity of jelly (e.g., 30–40 g, i.e., 600-800 mg lidocaine hydrochloride) (3–4 syringes) may be instilled in 3–4 portions and allowed to act for 10–12 minutes before insertion of the instrument. The jelly instilled into the bladder is also effective for procedures in this region.
To anesthetize only the anterior male urethra (e.g., for catheterization), small volumes (e.g. 5–10 g, i.e., 100–200 mg lidocaine hydrochloride) (½ to 1 syringe) are usually adequate for lubrication.
For Surface Anesthesia of the Female Adult Urethra:
Instill 5-10 g (100-200 mg lidocaine hydrochloride) of jelly (½ to 1 syringe) in small portions to fill the whole urethra. If desired, some jelly may be deposited on the orifice and covered with a cotton swab. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.
The instillation of 10–20 g (200–400 mg lidocaine hydrochloride) of jelly (1–2 syringes) is recommended for adequate analgesia and a small amount may be applied to the lubricating instrument. When combined with other lidocaine products (e.g., for bronchoscopy), the total dose of lidocaine hydrochloride should not exceed 400 mg (20 g of jelly) (2 syringes).
Up to 20 g (400 mg lidocaine hydrochloride) of jelly (2 syringes) can be used for anal and rectal procedures. The total dose of lidocaine hydrochloride should not exceed 400 mg (20 g of jelly) (2 syringes).
Apply approximately 2 g of jelly to the external surface of the endotracheal tube just prior to insertion. Care should be taken to avoid introducing the product into the lumen of the tube (see WARNINGS AND PRECAUTIONS). Do not use the jelly to lubricate endotracheal stylettes. It is also recommended that the use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.
The dose of Cathejell depends on the application site. A safe dose for oral use is 400 mg lidocaine hydrochloride (20 g of jelly) (2 syringes). A safe dose for use in the urethra and bladder is 800 mg lidocaine hydrochloride (40 g of jelly) (4 syringes). A maximum single dosage for Cathejell is not established. No more than four doses should be given during a 24-hour period.
It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. The maximum amount per dose should not exceed 6 mg lidocaine hydrochloride per kg of body weight or 3 g Cathejell per 10 kg body weight. No more than four doses should be given during a 24-hour period.
For children over 12 years of age doses should be commensurate with weight and physical condition.
Children should be closely observed during and after use of topical anesthetics, as they are at greater risk than adults for serious adverse events (e.g., methemoglobinemia).
For management of suspected drug overdose, contact your regional Poison Control Centre.
Acute systemic toxicity from local anesthetics is generally related to high plasma levels encountered during therapeutic use of local anesthetics and originates mainly in the central nervous and the cardiovascular systems (see ADVERSE REACTIONS and WARNINGS AND PRECAUTIONS). It should be kept in mind that clinically relevant pharmacodynamic drug interactions (i.e., toxic effects) may occur with lidocaine and other local anesthetics or structurally related drugs, and Class I and Class III antiarrhythmic drugs due to additive effects (see DRUG INTERACTIONS).
This is a graded response, with symptoms and signs of escalating severity. The first symptoms are circumoral paresthesia, numbness of the tongue, light-headedness, hyperacusis, and tinnitus. Visual disturbance and muscular tremors are more serious and precede the onset of generalized convulsions. Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with normal respiration. In severe cases apnea may occur. Acidosis, hyperkalemia, hypocalcemia, and hypoxia increase and extend the toxic effects of local anesthetics.
Recovery is due to redistribution and metabolism of the local anesthetic drug. Recovery may be rapid unless large amounts of the drug have been administered.
The effects may be seen in cases with high systemic concentrations. Severe hypotension, bradycardia, arrhythmia, and cardiovascular collapse may be the result in such cases. Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system unless the patient is receiving a general anesthetic or is heavily sedated with drugs such as a benzodiazepine or barbiturate.
Rare cases of methemoglobinemia have been reported.
Mild methemoglobinemia is characterized by tissue cyanosis, a bluish-grey or brownish discoloration of the skin, especially around the lips and nail beds, which is not reversed by breathing 100% oxygen. Clinical signs may also include pallor and marbleization.
Severe methemoglobinemia (MetHb concentrations above approximately 25%) is associated with signs of hypoxemia, ie. dyspnea, tachycardia and depression of consciousness.
Drug-induced methemoglobinemia may occur with the use of drugs including but not limited to amino-amide, sulfonamides, acetanilid, aniline dyes, benzocaine, lidocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine and quinine.
Acetaminophen has been shown to induce methemoglobin formation in vitro and in animals. In humans, methemoglobin formation is very rare at therapeutic doses and overdoses of acetaminophen.
The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic administration. At the first sign of change, oxygen should be administered.
The first step in the management of systemic toxic reactions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. This may prevent convulsions if they have not already occurred.
If convulsions occur, the objective of the treatment is to maintain ventilation and oxygenation and support circulation. Oxygen must be given, and ventilation assisted if necessary (mask and bag or tracheal intubation). Should convulsions not stop spontaneously after 15–20 seconds, an anticonvulsant should be given intravenous (i.v.) to facilitate adequate ventilation and oxygenation. Thiopental sodium 1–3 mg/kg body weight (bw) i.v. is the first choice. Alternatively, diazepam 0.1 mg/kg bw i.v. may be used, although its action will be slow. Prolonged convulsions may jeopardise the patient’s ventilation and oxygenation. If so, injection of a muscle relaxant (e.g., succinylcholine 1 mg/kg bw) will facilitate ventilation and oxygenation can be controlled. Early endotracheal intubation is required when succinylcholine is used to control motor seizure activity.
If cardiovascular depression is evident (hypotension, bradycardia), ephedrine 5–10 mg i.v. should be given and may be repeated, if necessary, after 2–3 minutes.
Should circulatory arrest occur, immediate cardiopulmonary resuscitation should be instituted. Continual oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance since hypoxia and acidosis will increase the systemic toxicity of local anesthetics. Epinephrine (0.1–0.2 mg as intravenous or intracardial injections) should be given as soon as possible and repeated, if necessary.
Children should be given doses of epinephrine commensurate with their age and weight.
In neonates, methemoglobin concentrations of up to 5 – 6% are not considered to be of clinical significance, with treatment of symptomatic methemoglobinemia not typically necessary unless methemoglobin concentrations are above 25 – 30%. However, the severity of clinical symptoms should be the primary consideration in the decision to initiate treatment, rather than the level of methemoglobin. Most patients recovered spontaneously after removal of the jelly. Methemoglobinemia may be treated with a slow intravenous injection of methylene blue. It has been reported in published literature that methylene blue should be used cautiously as a treatment for methemoglobinemia in patients with glucose-6-phosphate dehydrogenase deficiency because it may not be effective for these patients and may cause hemolytic anemia.
Store between 15°C–30°C.
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