SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Lidocaine hydrochloride 0.2% and Glucose 5% Infusion BP as Steriflex No. 26 or freeflex.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex No.26 has the following composition:

Name	Specification Reference	%w/v
Lidocaine Hydrochloride BP	EP	0.2
Glucose Monohydrate for Parenteral Use BP	EP	5.5
Equivalent to Anhydrous Glucose BP		5.0

3. PHARMACEUTICAL FORM

Intravenous infusion.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Lidocaine reduces cardiac irritability and is given as an intravenous infusion to control ventricular arrhythmias during cardiac surgery or following myocardial infarction.

Usually, the lidocaine containing solutions are used to maintain the suppression of ectopic activity provided by a bolus injection of lidocaine.

4.2 Posology and method of administration

Adults

The volume and rate of infusion will depend upon the requirements of the individual patient and the judgement of the physician.

Following a loading dose, lidocaine containing infusions are administered at a rate of 1-4 mg of lidocaine per minute for 12-48 hours.

Children and Elderly

Doses should generally be reduced in the elderly and children. Although dosage will be dictated by clinical response as judged by ECG changes.

For intravenous infusion.

4.3 Contraindications

Patients with hypovolaemia, heart block or other conduction disturbances, bradycardia, or cardiac decompensation or hypertension not due to treatable tachyarrhythmias. Hypersensitivity to local anaesthetics.

4.4 Special warnings and precautions for use

The continuous infusion of lidocaine requires careful monitoring by electrocardiograph.

Should be given cautiously to patients with epilepsy, impaired cardiac condition or respiratory function, or with liver damage or myasthenia gravis. Because lidocaine is metabolised in the liver, it should be used with caution in any other conditions which reduce hepatic blood flow such as cardiac and circulatory failure.

The label states: Do not use unless the solution is clear and free from particles. Contains lidocaine hydrochloride.

4.5 Interactions with other medicinal products and other forms of interaction

Interactions or moderate clinical significance include those between lidocaine and beta-adrenergic blockers, cimetidine and phenytoin.

4.6 Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been assessed. The benefit to the patient should be balanced against the potential risk.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Rarely, allergic reactions may occur.

Systemic toxicity mainly involves the CNS and cardiovascular system, although early signs include numbness of the tongue and perioral region. Excitation of the CNS may be manifested by yawning, restlessness, excitement, nervousness, dizziness, tinnitus, nystagmus, blurred vision, nausea and vomiting, muscle twitching, tremors and convulsions. Excitation may be transient and be followed by CNS depression manifested by drowsiness, respiratory failure and coma.

Effects on the cardiovascular system include myocardial depression and peripheral vasodilatation resulting in hypertension and bradycardia; arrhythmias and cardiac arrest may also occur.

4.9 Overdose

Symptoms of overdosage would be manifested by adverse effects on the CNS and cardiovascular system (see 4.8).

Following discontinuation of lidocaine infusion treatment should consist in general terms of maintaining circulation and respiration and controlling convulsions. Respiration should be maintained by establishing an airway and administering oxygen. The circulation should be maintained by infusion of plasma or suitable electrolyte solution. Vasopressor agents such as metaraminol, dopamine or dobutamine may be used to maintain blood pressure. Convulsions may be controlled by the intravenous administration of diazepam.

Overdosage with a lidocaine containing infusion may produce methaemoglobinaemia which is treated by the intravenous administration of a 1% solution of methylene blue 1-4 mg/Kg bodyweight.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Lidocaine hydrochloride is a class 1 anti-arrhythmic agent, reducing cardiac irritability. It reduces membrane responsiveness, decreases conduction velocity and prolongs the action potential.

5.2 Pharmacokinetic properties

Following the intravenous injection, plasma concentrations decline rapidly with a half-life of about 10 minutes; the elimination half-life is about two hours. Anti arrhythmic concentrations are reported to range from 1.5 to 6 mg/ml. Lidocaine is rapidly distributed into the heart, brain, kidneys and other tissues. It diffuses across the placenta a few minutes after injection.

Lidocaine is rapidly de-ethylated in the liver to the active metabolite monoethylglycinexylidide which has a reduced activity but a longer elimination half-life. The products of metabolism are excreted via the urine together with less than 10 % of unchanged lidocaine.

5.3 Preclinical safety data

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Name	Specification Reference	%w/v
Water for Injections in bulk BP	EP	To 100
Hydrochloric Acid BP	EP	QS
Sodium Hydroxide BP	BP	QS

6.2 Incompatibilities

Solutions containing lidocaine hydrochloride are incompatible with amphotericin, methohexitone sodium, sulphadiazine sodium and occasionally incompatible with ampicillin depending upon the pH of the lidocaine containing solution.

Because of the nature of the plastic material of the Steriflex bag (PVC), this solution should not be used as a vehicle for the administration of drugs which maybe sorbed to the surface of the bag to varying and significant degrees.

Shelf life

500ml PVC Bags - 24 months. 500ml Polyolefin Bags - 36 months.

6.4    Special precautions for storage

Store at 2° to 25°C.

6.5    Nature and contents of container

The container is a flexible 500ml bag made of medical grade PVC.

a)    A hermetically sealed polythene bag.

b)    A rectangular pouch consisting of polyamide/polythene composite.

c)    Polyamide/polyethylene-propylene composite laminate welded to polypropylene ethylene propylene composite, plugged with a polycarbonate plug with either a bromobutyl (West 448 1/45) or gum (West 7006/45) stopper.

Or

A flexible 500ml polyolefine bag sealed in a polyolefine overwrap.

6.6 Instructions for use/handling

Opening the overwrap:

Locate the corner tabs at the end of the bag. Grip the two tabs and pull the two halves of the overwrap apart, releasing the bag onto a clean surface.

Setting up the solution:

Position the roller clamp of the giving set to just below the drip chamber and close. Hold the base of the giving set port firmly and grip the wings of the twist of tab. Twist to remove the protective cover. Still holding the base of the giving set port push the set spike fully into the port to ensure a leak proof connection. Prime the set in accordance with the manufacturer’s instructions.

MARKETING AUTHORISATION HOLDER

Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Manor Park

Runcorn

Cheshire

WA7 1NT

8.    MARKETING AUTHORISATION NUMBER

PL 8828/0081.

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05.89/9.99

10.    DATE OF REVISION OF TEXT

5th May 2004