Lidocaine 4% M/V Oromucosal Solution
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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.
Special precautions for disposal
Apply using a swab or by spray.
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MARKETING AUTHORISATION HOLDER
Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG
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MARKETING AUTHORISATION NUMBER(S)
PL 00289/0766
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29 August 1997
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