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Lidocaine and chlorhexidine (United States: Not available): Drug information

Lidocaine and chlorhexidine (United States: Not available): Drug information
(For additional information see "Lidocaine and chlorhexidine (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Instillagel
Pharmacologic Category
  • Analgesic, Topical;
  • Antibiotic, Topical;
  • Local Anesthetic
Dosing: Adult
Anesthetic, lubricant, and antiseptic prior to urologic procedure

Anesthetic, lubricant, and antiseptic prior to urologic procedure: Note: Total lidocaine dose should be considered with concomitant use of other lidocaine-containing agents.

Females: Intraurethral: Instill 6 mL in small portions to fill whole urethra 5 to 10 minutes prior to procedure; may deposit some gel on the orifice and cover with cotton swab if desired. Maximum: 4 doses per 24-hour period.

Males:

Introduction of instruments into the urethra: Intraurethral: Instill 11 mL and some patients may require an additional 6 to 11 mL; when greater anesthetic effects are desired (eg, for ultrasound or cystoscopy), may instill up to 39 mL in 3 to 4 portions 10 to 12 minutes prior to procedure; maximum: 4 doses per 24-hour period.

Anterior urethra: Intraurethral: Instill 6 to 11 mL prior to procedure.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Lidocaine undergoes hepatic metabolism; use with caution.

Dosing: Older Adult

Refer to adult dosing; use with caution. Repeated doses may lead to increased systemic exposure and dose reductions may be necessary.

Dosing: Pediatric
Anesthetic, lubricant, and antiseptic prior to urologic procedure

Anesthetic, lubricant, and antiseptic prior to urologic procedure: Note: Total lidocaine dose should be considered with concomitant use of other lidocaine-containing agents.

Intraurethral:

Children <12 years: Maximum lidocaine dose: 6 mg/kg or 3 mL per 10 kg. Do not administer more than 4 doses per 24-hour period.

Children ≥12 years and Adolescents: The manufacturer labeling recommends that the dose should correspond with the patient's weight and physical condition; maximum: 4 doses per 24-hour period

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Lidocaine undergoes hepatic metabolism; use with caution.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.

<1%, postmarketing, and/or case reports: Anaphylaxis, hypersensitivity reaction, local discomfort

Contraindications

Hypersensitivity to local anesthetics of the amide type, chlorhexidine, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: [Canadian Boxed Warning]: Serious hypersensitivity reactions including anaphylaxis, hypotension, tachycardia, shortness of breath, and erythema have been reported with use of chlorhexidine gluconate, including topical and/or intraurethral use. Discontinue use immediately in patients who develop hypersensitivity reactions.

• Malignant hyperthermia: Use may trigger familial malignant hyperthermia; a protocol for managing malignant hyperthermia should be available during use.

• Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (eg, cyanosis, headache, rapid pulse, shortness of breath, lightheadedness, fatigue).

• Systemic adverse effects: Application to broken or inflamed skin, excessive dosing, or short dosing intervals may lead to increased absorption and systemic toxicity; lowest effective dose should be administered. Children, individuals who are acutely ill, debilitated, and/or elderly patients may be at increased risk of systemic toxicity; dose reductions may be necessary.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease due to the propensity of amide anesthetics to prolong A-V conduction.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment.

• Seizures: Use with caution in patients with a history of seizures.

• Sepsis: Use with caution in septic patients due to potential for rapid systemic absorption; dose reduction may be necessary.

• Shock: Use with caution in patients with severe shock.

Other warnings/precautions:

• Appropriate use: [Canadian Boxed Warning]: For topical use only. Do not use parenterally. Avoid contact with eyes.

Product Availability

Not available in the US

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, topical:

Instillagel: Lidocaine hydrochloride 2% and chlorhexidine gluconate 0.05% (6 mL, 11 mL)

Administration: Adult

Instill small portions of gel slowly into the urethra 5 to 10 minutes prior to less invasive procedure (eg, catheterization) and 10 to 12 minutes prior to more invasive procedures (eg, cystoscopy). In males, the entire urethral area including the external sphincter should be covered with gel and the glans compressed until a local anesthetic effect is achieved. In females, some gel may be deposited onto the orifice and covered with a cotton swab. Discard unused portion of gel. Do not administer parenterally. Avoid contact with eyes.

Administration: Pediatric

Intraurethral: Instill small portions of gel slowly into the urethra 5 to 10 minutes prior to less invasive procedure (eg, catheterization) and 10 to 12 minutes prior to more invasive procedures (eg, cystoscopy). In males, the entire urethral area including the external sphincter should be covered with gel and the glans compressed until a local anesthetic effect is achieved. In females, some gel may be deposited onto the orifice and covered with a cotton swab. Discard unused portion of gel. Do not administer parenterally. Avoid contact with eyes.

Use: Labeled Indications

Note: Not approved in the US

Local anesthetic/lubricant/antiseptic: To provide local anesthesia, lubrication, and antisepsis during urologic procedures including catheterization, cystoscopy, ultrasound, or other intraurethral procedures.

Medication Safety Issues
Safety concerns:

ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Antiarrhythmic Agents (Class IB): Lidocaine (Topical) may enhance the adverse/toxic effect of Antiarrhythmic Agents (Class IB). Risk C: Monitor therapy

Cimetidine: May increase the serum concentration of Lidocaine (Topical). Risk C: Monitor therapy

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Pregnancy Considerations

See individual agents.

Breastfeeding Considerations

See individual agents.

Mechanism of Action

Lidocaine: Lidocaine blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction.

Chlorhexidine: The bactericidal effect of chlorhexidine is a result of the binding of this cationic molecule to negatively charged bacterial cell walls and extramicrobial complexes. At low concentrations, this causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorous resulting in a bacteriostatic effect. At high concentrations of chlorhexidine, the cytoplasmic contents of the bacterial cell precipitate and result in cell death.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Cathejell;
  • (BE) Belgium: Cathejell;
  • (BG) Bulgaria: Cathejell lidocain;
  • (CH) Switzerland: Instillagel;
  • (CL) Chile: Endogel Esteril;
  • (CO) Colombia: Cathejell;
  • (CZ) Czech Republic: Instillagel;
  • (EE) Estonia: Cathejell lidocain;
  • (GB) United Kingdom: Hydro caine | Lignoca/chlorh;
  • (KR) Korea, Republic of: Cathejell with Lidocaine | Inkain | Wantila;
  • (LV) Latvia: Cathejell lidocain;
  • (MY) Malaysia: Cathejell with lidocain;
  • (NL) Netherlands: Cathejell | Instillagel;
  • (NZ) New Zealand: Lignocaine/Chlorhexidine;
  • (RU) Russian Federation: Kategel with lidocaine;
  • (SK) Slovakia: Instillagel;
  • (TH) Thailand: Cathejell with Lidocaine;
  • (TR) Turkey: Cathejell
  1. Instillagel (lidocaine and chlorhexidine) [product monograph]. Montreal, Quebec, Canada; PENDOPHARM, Division of Pharmascience Inc; January 2012.
Topic 17138 Version 95.0

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