LIDOFAST GEL 1% 100G

LIDOFAST

active ingredients

LIDOFAST 25 mg/g urethral gel 100 g of product contain: Active ingredient: lidocaine hydrochloride 2,5 g; excipients with known effects: methyl parahydroxybenzoate, propile parahydroxybenzoate, sodium benzoate. LIDOFAST 10 mg/g gel 100 g of product contain: Active ingredient: lidocaine hydrochloride 1 g; Excipients with known effects: methyl parahydroxybenzoate, propile parahydroxybenzoate, sodium benzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium carboxylcellulose; glycerol; methyl parahydroxybenzoate; propile parahydroxybenzoate; benzoate sodium; purified water.

Therapeutic indications

LIDOFAST 25 mg/g urethral gel Endouretral maneuvers (introduction of catheters, dilations, cystoscopies, etc.) combining with the lubricating action that anesthetic. LIDOFAST 10 mg/g gel Hexophagoscopic intubations and for curative anesthesia, tracheobroncoscopies, pharyngoscopes, gastroscopies, rectoscopes and all endoscopic investigations with an exploratory and curative character. The product combining the lubricant action with the anesthetic action allows to avoid in endoscopic manoeuvres spastic reactions and reflections that start from the mucosa with which the instruments come in contact.

Contraindications

Hypersensitivity known to the active ingredient, to other local amidic anaesthetics or to any of the excipients listed in the paragraph 6.1. Pregnancy and nursing (see paragraph 4.6).

Population

Population LIDOFAST 25 mg/g urethral gel Push the gel directly into the urethra by crushing the tube and massaging at the same time the back urethra, applying a urethra caliper for 10 minutes, after which you can practice the desired endouretra maneuvers. The content of the tube is sufficient to fill the urethra completely. The introduction of gel in the urethra is facilitated by the use of plastic applicator annex LIDOFAST 10 mg/g gel Carefully spread a product layer on the tool before introduction. The neutrality of the vehicle of both formulations of the product, its complete solubility in water and the absence of fatty substances make sure that, even with a continued use of LIDOFAST, the lenses of the tools used for the various types of maneuvers do not deteriore their rubber parts.

Conservation

LIDOFAST does not require any special conservation conditions.

Warnings

The effectiveness and safety of lidocaine depend on a correct dosage and application technique. It is therefore necessary to use the minimum quantity of the preparation sufficient to obtain the desired effect, applying it with caution in subjects with severely damaged mucosa or home of inflammatory and sepsis processes that could cause excessive absorption of the active ingredient. Excessive absorption of lidocaine can cause side effects to the central nervous system and the cardiovascular system especially in children, elderly people and debilitated individuals. Therefore it is necessary to pay much attention in the use of LIDOFAST in these subjects. It is however to avoid the application for very long periods. Products for topical application, especially if used for a protracted time or repeatedly, can give rise to awareness-raising phenomena. In this case it is necessary to suspend treatment and establish suitable therapy. LIDOFAST contains: § Para hydroxybenzoati that can cause allergic reactions (also delayed), § sodium benzoate which is slightly irritating to the skin, eyes and mucous membranes.

Interactions

Propanolol and cimetidine can reduce the metabolism of lidocaine at a hepatic level, increasing plasma concentrations or halving time of the elimination phase.

Effects

Locally there may be hypersensitivity reactions characterized by pain, burning and itching. Systemic reactions are generally rare; hypersensitivity reactions may occur until anaphylactic shock. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address “www.agenziafarmaco.gov.it/it/responsabili”.

Overdosing

Overdose symptoms are characterized by neuroeccitatory manifestations (tremors, convulsions followed by depression, respiratory failure and coma) and cardiovascular alterations with hypotension and bradycardia.

Pregnancy

Studies on rats and rabbits did not highlight risks to fetus. Safety of use in the human species has not been established. This should be held before administration to pregnant women, especially during the early stages.

Food

Since lidocaine is distributed in breast milk, the use of topical preparations, especially when applied on the tracheobronchiale mucosa, must be used with caution in nursing women.

Source: Farmadati