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Instillagel

instillagel

(Lidocaine and Chlorhexidine Gel BP)

Therapeutic Class:

Topical Anaesthetic/Antiseptic

Form:

Gel

Formats:

Instillagel® is available as sterile, pre-filled syringes containing 6 mL or 11 mL of gel. The syringes are made of polypropylene with a butyl rubber stopper piston, and are packed in boxes of 10 syringes.

Ingredients:

Medicinal Ingredients: Lidocaine Hydrochloride 2% w/w and Chlorhexidine Gluconate 0.05% w/w; Non-medicinal Ingredients: Methylparaben, propylparaben, hydroxyethylcellulose, sodium hydroxide, propylene glycol, purified water.

Indications:

Surface anaesthesia, lubrication and antisepsis for:

  • The male and female urethra during cystoscopy
  • Catheterization
  • Exploration by sound and other endourethral operations
Dosage and Directions for Use:

Refer to the Instillagel Prescribing Information for full dosing instructions.

Adults:

  • Males: Instil 11 mL of gel and possibly an additional 6 mL or 11 mL. After the normal cleaning of the glans and the external urethral orifice, instil Instillagel slowly into the urethra, keeping the glans compressed, until the local anaesthetic and antiseptic action has set in.
  • Females: Instil 6 mL of gel in small portions to fill the whole urethra. If desired, some gel may be deposited on the orifice and covered with a cotton swab.
  • Maximum Dosage: Adults: No more than 4 doses should be given during a 24-hour period.

Children:

  • Under 12 years of age: The maximum amount of lidocaine per dose should not exceed 6 mg/kg of body weight or 3 mL per 10 kg weight. No more than 4 doses should be given during a 24-hour period.
  • Over 12 years of age: Doses should be commensurate with weight and physical condition.

In order to obtain adequate anaesthesia and antiseptic action, 5-10 minutes should be allowed prior to performing urological procedures.

Contraindications:

Instillagel is contraindicated in patients with known or suspected hypersensitivity to local anaesthetics of the amide type, to chlorhexidine or to any ingredient in the formulation (e.g., methylparaben, propylparaben, etc.).

Warnings and Precautions:
  • Instillagel is for topical use only. Do not use parentally.
  • Immediate systemic hypersensitivity reactions, including hypotension, tachycardia, shortness of breath, skin erythema and anaphylaxis have been reported in individuals who received chlorhexidine gluconate preparations applied topically to the skin or given intraurethrally, intranasally, or on central venous catheters impregnated with the drug. If adverse reactions or hypersensitivity occur in patients using Instillagel, treatment should be discontinued immediately.
Storage:

Store below 25˚C.

lnstillagel® is the registered trademark of Farco-Pharma, Cologne, Germany, used under license by Pharmascience Inc.