Informations for option: Lidocaine 4% M/V Oromucosal Solution, show other option

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1. Lidocaine 4% M/V Oromucosal Solution
2. Lidocaine 4% M/V Oromucosal Solution

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Lidocaine 4% m/v Oromucosal Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Lidocaine Hydrochloride 4% m/v

For excipients. see 6.1.

3 PHARMACEUTICAL FORM

Oromucosal solution Sterile aqueous solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Topical mucocutaneous anaesthesia for procedures including: bronchography, bronchoscopy and biopsy in the buccal cavity. Puncture of the maxillary sinus or polypectomy, tonsillectomy, resection of the nasal turbinates and in dentistry.

4.2 Posology and method of administration

To be applied topically.

BIOPSY:

Apply by a swab or spray 3 to 4 ml to the area for a few minutes before biopsy; adrenaline (0.05m1 of a 1:1000 solution to 5 ml of Lidocaine Oromucosal Solution) may be added to induce vasoconstriction.

PUNCTURE OF MAXILLARY SINUS OR POLYPECTOMY:

A swab soaked in the solution may be applied for 2 to 3 minutes. The addition of adrenaline is advised for this use, as described above.

BRONCHOSCOPY AND BRONCHOGRAPHY:

By use of a suitable spray, 2 to 3 ml may be applied to the mouth, pharynx, larynx and trachea.

Doses:

Adults:    Maximum dose 200 mg (5 ml).

Elderly:    Debilitated or elderly patients reduce the maximum dose.

Children:    Reduce the maximum dose to 3mg/kg body weight.

4.3 Contraindications

Known sensitivity to lidocaine or other amide local anaesthetics.

4.4 Special warnings and precautions for use

Lidocaine Oromucosal Solution is not intended for injection.

4.5 Interaction with other medicinal products and other forms of interaction

Although absorption of lidocaine from mucous membranes is marked, doses for topical anaesthesia are low. However, the following interactions should be considered: Cimetidine and propranolol may inhibit the metabolism and thus enhance lidocaine toxicity.

4.6 Pregnancy and lactation

In common with other drugs, Lidocaine Oromucosal Solution should not be used in early pregnancy unless the benefits outweigh the potential risks.

4.7 Effects on ability to drive and use machines

No or negligible influence. Lidocaine administered parenterally may cause CNS stimulation, dizziness, nausea followed by depression and drowsiness.

4.8 Undesirable effects

Allergic effects are uncommon to lidocaine but have been recorded, usually following parenteral administration. Hypersensitivity may occur in long-term topical use.

4.9 Overdose

Unlikely from topical use even if the whole contents of a bottle (1g lidocaine) has been ingested - oral bioavailability is low but hypotension and heart block may occur.

Employ appropriate resuscitation.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anaesthetics Local. Amides. ATC code: NO1B B

Lidocaine is an amide local anaesthetic agent with a fist onset, blocking peripheral nervous conduction.

5.2 Pharmacokinetic properties

a)    General characteristics: Lidocaine is readily absorbed from mucosal surfaces, especially if inflamed. The plasma half-life is about 10 minutes following an intravenous dose, with an elimination half-life around 2 hours. Lidocaine will reach all tissues including transplacental transfer.

b)    Characteristics in patients: Lidocaine undergoes first pass metabolism and is de-ethylated to monoethylglycylxylidide, glycylxylidide and 4-hydroxy-2,6-xylidine. These metabolites and unchanged lidocaine are excreted in the urine.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Amaranth Solution Water for Injections

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Store below 25 ⁰C.

6.5 Nature and contents of container

Amber glass bottle fitted with an aluminium cap and neoprene liner. The cap is sealed to the bottle with a viskring. Pack size 25 ml.

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