Consumer medicine information

1. Why am I using INSTILLAGEL LIDO?

INSTILLAGEL LIDO contains the active ingredient lidocaine hydrochloride(as monohydrate). INSTILLAGEL LIDO is used for local anaesthesia.
For more information, see Section 1. Why am I using INSTILLAGEL LIDO? in the full CMI.

2. What should I know before I use INSTILLAGEL LIDO?

Do not use if you have ever had an allergic reaction to lidocaine hydrochloride or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use INSTILLAGEL LIDO? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with INSTILLAGEL LIDO and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use INSTILLAGEL LIDO?

• INSTILLAGEL LIDO is a sterile gel available in 6mL and 11mL pre filled syringes.

5. What should I know while using INSTILLAGEL LIDO?

6. Are there any side effects?

Some side effects that may occur include allergic reaction which may result in swelling of hands, feet, face, lips, mouth, tongue or throat, difficulties in breathing, skin rash or hives or a drop in blood pressure and shock. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Lidocaine hydrochloride monohydrate.

2 Qualitative and Quantitative Composition

Instillagel Lido contains the active ingredient lidocaine hydrochloride (as monohydrate) 2% w/w.
Instillagel Lido 6 mL prefilled syringe contains 120.84 mg lidocaine hydrochloride.
Instillagel Lido 11 mL gel contains 221.54 mg lidocaine hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Clear colourless sterile gel.

4 Clinical Particulars

4.9 Overdose

Lidocaine hydrochloride is absorbed from mucous membranes and serious toxicity has been reported following the use of lidocaine hydrochloride preparations for urethral anaesthesia.
Lidocaine hydrochloride intoxication affects the CNS and cardiovascular system. Overdose symptoms include: severe hypotension, asystole, bradycardia, apnoea, cardiac arrest, respiratory arrest, seizures, coma and possibly death.
Management of local anaesthetic emergencies. The first consideration is prevention, which is best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anaesthetic administration. At the first sign of change, oxygen should be administered.
Treatment. If convulsions occur, immediate attention is required for the maintenance of a patent airway and assisted or controlled ventilation with oxygen. Adequacy of the circulation should then be evaluated, bearing in mind that drugs used to treat convulsions depress the circulation when administered intravenously.
Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, appropriate anticonvulsant medication such as an ultrashort acting barbiturate (e.g. thiopentone) or a benzodiazepine (e.g. diazepam) may be administered intravenously.
Hypotension may be initially managed by the use of intravenous fluids and by vasopressors if the problem persists.
Dialysis is of negligible value in the treatment of acute overdosage with lidocaine hydrochloride.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Genotoxicity tests with lidocaine hydrochloride are inconclusive. In genotoxicity studies, a metabolite of lidocaine hydrochloride, 2,6-xylidine, showed evidence of activity in some tests but not in other tests. This metabolite has been shown to have carcinogenic potential (nasal and subcutaneous tumours) in preclinical toxicological studies evaluating chronic exposure.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLIDCAN.gif Molecular formula: C₁₄H₂₂N₂O. Molecular weight: 234.3.
Lidocaine hydrochloride is 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide. It is a white to almost white crystalline powder that is practically insoluble in water, very soluble in alcohol and in methylene chloride.
CAS number. 137-58-6.

7 Medicine Schedule (Poisons Standard)

S2 - Pharmacy Medicine.