Instillagel®

Active substance: Lidocaine hydrochloride 1H2O, Chlorhexidine digluconate, Methyl-4-hydroxybenzoate, Propyl-4-hydroxybenzoate.

Composition:

Other ingredients: Hyetellose, propylene glycol, sodium hydroxide, purified water

Areas of application: As a gel for mucous membrane disinfection and for local anesthesia, e.g., during catheterization, probe insertion, including intra-operatively, all forms of endoscopy, fistula catheter replacement, intubation, including for ventilation, for the prevention of iatrogenic damage to the rectum and colon.

Instillagel^® 6 ml/11 ml is suitable for use in adults and children aged 2 years and above.

Contraindications: Do not use Instillagel^® 6 ml/11 ml

• in the presence of known hypersensitivity to lidocaine and other local anesthetics of the amide type,
• in patients with significant disorders of the cardiac conduction system,
• if the patient has a hypersensitivity (allergy) to lidocaine hydrochloride 1 H2O, chlorhexidine digluconate, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate, or one of the other ingredients of this medicinal product,
• in children under 2 years.

Use in pregnancy and lactation: Lidocaine should not be used during the first three months of pregnancy unless absolutely necessary. It is unknown whether lidocaine is excreted in breast milk, for which reason breastfeeding should not take place for up to about 12 hours after administration.

Side effects: Not known: in spite of the proven wide safety range of Instillagel® 6 ml/11 ml, systemic adverse effects of the local anesthetic lidocaine, such as anaphylactic shock, a fall in blood pressure, bradycardia or seizures, are possible in the case of severe urethral damage. In very rare cases, allergic reactions (in the most serious cases, anaphylactic shock) to a local anesthetic of the amide type and/or to chlorhexidine may occur. Very rare: allergic reactions, including late reactions, due to chlorhexidine and/or methyl- or propyl-4-hydroxybenzoate.

Use in children
The systemic absorption of lidocaine may be increased in children and caution is therefore required. In general, the maximum dose should not exceed 2.9 mg of lidocaine hydrochloride per kg of body weight in children between 2 and 12 years of age. This is equivalent to 1.5 ml of Instillagel 6 ml/11 ml per 10 kg of body weight.

Warning: Methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate may trigger hypersensitivity reactions, including late reactions. Propylene glycol may cause skin irritation.

FARCO-PHARMA GmbH, 50670 Cologne, Germany