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Erythromycin Lactobionate for Intravenous Infusion 1g

What Erythromycin Lactobionate for Intravenous Infusion is and what it is used for

Erythromycin Lactobionate for Intravenous Infusion is an antibiotic (a medicine used to treat infections caused by bacteria) in the form of a powder for concentrate for solution for infusion (a powder which is made into a concentrated solution which is then diluted further into a solution which can be given as a slow injection via a drip).

The medicine is presented in glass containers called vials. Each vial contains 1 g of erythromycin. It is available in packs containing 1 vial or 10 vials.

Erythromycin is used to treat infections caused by a number of different bacteria. It is used to treat infections of the nose, ear, mouth, throat, chest (airways) and skin. It can also be used to treat other infections such as sexually transmitted diseases, and infections of the lining and valves of the heart. It can also be given when a patient cannot take penicillin to treat an infection.

Before Erythromycin Lactobionate for Intravenous Infusion is used

Erythromycin Lactobionate for Intravenous Infusion should not be used:

  • if you have shown signs of hypersensitivity (severe allergy) to erythromycin on previous occasions
  • if you are taking the following medicines:
    • astemizole or terfenadine (anti-histamine medicines which can be taken for allergic reactions e.g. hayfever)
    • cisapride (medicine used for gut problems)
    • pimozide (medicine used to treat schizophrenia)
    • simvastatin or lovastatin (medicine used to lower your cholesterol)

if you are pregnant or breast feeding

Special care will be taken:

to give erythromycin as a slow injection

  • if you have any problems with your liver or kidneys
  • if you have myasthenia gravis
  • if erythromycin is given for a long time as you may be more likely to get another infection
  • if urine tests or liver function test based on colour measurements are taken, as the results may be affected
  • if you are taking certain other medicines, such as:
    • penicillin (an antibiotic medicine)
    • digoxin (medicine for heart problems)
    • warfarin and acenocoumarol (medicines used to thin your blood)
    • carbamazepine, valproate, phenytoin and hexobarbitone (medicines which can be used to treat epilepsy)
    • theophylline (used to treat asthma)
    • vinblastine (an anti-cancer medicine)
    • cyclosporin (used after receiving a transplant)
    • ergot (used for treatment of migraine or in obstetric procedures)
    • other statins such  as atorvastatin  (drugs  used  to  lower your cholesterol)
    • alfentanil (a painkiller usually used when receiving an anaesthetic)
    • bromocriptine (a drug used in Parkinson’s disease, in acromegaly, in benign breast disease and to suppress lactation)
    • midazolam and triazolam (sedative or calming drugs)
    • tacrolimus (used in severe eczema and after a transplant)
    • verapamil (used for particular heart conditions)
    • clozapine (used in psychiatric conditions)
    • medications causing specific changes on your EGC (heart trace) (prolongation of the QT interval)

Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.

How Erythromycin Lactobionate for Intravenous Infusion is used

The dose of medicine given to you will depend upon your medical condition, your age, your body weight and how well your liver and kidneys are working.

The medicine will be dissolved with sterile Water for Injections. It will be further diluted with sodium chloride (a weak salt solution that mixes well with body fluids) before it is given to you. It will be given into a vein as a slow injection via a drip (infusion). It can be given over 20 to 60 minutes every 6 hours or by continuous infusion over 24 hours.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or pharmacist if you have any concerns.

Possible side-effects

Like all medicines, erythromycin can have side-effects. If any of the following happen, tell the doctor immediately:

  • severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
  • a very severe, painful skin rash involving the eyes, mouth and genitals which may have blisters and the skin may peel off in sheets (Toxic Epidermal Necrolysis)
  • skin rashes which may have blisters and involve the mouth, throat, eyes and genitals (Stevens-Johnson syndrome)

These are very serious side-effects. You may need urgent medical attention. All of these very serious side-effects are rare.

If you experience any of the following tell your doctor as soon as possible:

  • pain, swelling, redness or tenderness at the site of the injection
  • changes in the normal heartbeat may occur giving rise to palpitations
  • temporary deafness
  • mild allergic skin reactions e.g. hives
  • skin rashes with fever (these skin rashes are usually red, itchy and patchy in appearance)
  • another type of rash which may occur shows symptoms of red or purplish-red differently sized patches, sometimes with blisters, and are scattered or grouped around the body
  • abdominal discomfort and cramp, nausea, vomiting and diarrhoea. The diarrhoea may be mild or severe, may have blood in it and may develop some days after stopping the erythromycin (pseudomembranous colitis)
  • severe abdominal pain with or without vomiting (this may be pancreatitis – inflammation of the pancreas)

Your doctor will do tests to check for abnormalities developing in the blood. If you notice any side-effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Storing Erythromycin Lactobionate for Intravenous Infusion

Before purchase Erythromycin Lactobionate , you must read how to store

Keep out of the reach and sight of children.

The vials should not be stored above 25°C.

Keep container in the outer carton.

This medicine should not be used after the expiry date printed on the vial label.

Erythromycin should not be reconstituted with inorganic salt solutions. Use only Water for Injections.

The stability of solutions of erythromycin lactobionate is adversely affected below pH 5.5. 5 ml of sterile 8.4% sodium bicarbonate solution will neutralise 1 litre of Glucose Injection B.P. 5% and should be added to the bag prior to addition of erythromycin lactobionate.

Preparation Instructions

Subsequent dilution into infusion fluids should be made prior to administration. Recommended fluids are Sodium Chloride Injection B.P. 0.9% or Dextrose 5% Injection B.P.

Erythromycin lactobionate vials labelled as containing 1 gram of erythromycin should be initially reconstituted by adding 20 ml of sterile Water for Injections B.P. without preservative, to provide a solution containing 50 mg per ml. No other diluent should be used to prepare this initial solution. It is important to ensure that the product is completely dissolved by vigorous shaking before transferring to infusion containers. Prior to administration the concentrated solution should be further diluted in glass or flexible plastic containers of 0.9% Sodium Chloride Injection. If, for clinical reasons, 0.9% saline is not suitable, then neutralised Glucose Intravenous Infusion B.P. 5% w/v may be used. Neutralised glucose solution is prepared by the addition of 5 ml of sterile 8.4% w/v sodium bicarbonate solution to each litre of Glucose Intravenous Injection B.P. 5% w/v.

It is necessary to buffer the glucose solution in this way because the stability of erythromycin lactobionate is adversely affected below pH 5.5.

It is recommended that a clarifying filter is used to minimise the particulate levels in resultant infusions.

Dosage and Administration

For continuous intravenous infusion the concentrated solution should be diluted to a concentration of 1 mg per ml. If required, solution strengths up to 5 mg/ml (0.5% solution) may be used, but should not be exceeded. Higher concentrations may result in pain along the vein. Bolus injection is not recommended.

For intermittent intravenous infusion the appropriate daily dose can be given as 4 doses once every 6 hours. The erythromycin concentration should not exceed

5 mg per ml and the infusion should be administered over 60 minutes, as a rapid infusion is more likely to be associated with arrhythmias or hypotension (see Warnings). A longer period of infusion should be used in patients with risk factors or previous evidence of arrhythmias. Not less than 100 ml of diluent should be used for preparing intermittent intravenous solutions.

Intravenous therapy should be replaced by oral administration at the appropriate time.

Erythromycin Lactobionate For Intravenous Infusion 1 g

The active substance is erythromycin (present as the lactobionate salt)

There are no other ingredients

The marketing authorisation holder and company responsible for batch release in the European Union is Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK

The manufacturer is Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia.

Adults: The usual adult dose is the equivalent of 25-50 mg/kg per day in divided doses of erythromycin, by intravenous infusion every 6 hours, or the equivalent of 1 to 2 g of erythromycin daily by intermittent intravenous infusion over 20 to 60 minutes every 6 hours or by infusion over 24 hours. The equivalent of 4 gram daily has been recommended for severe infections. Small volume intravenous infusion, minimum volume 100 ml, is the preferred method so as to minimise venous irritation.

Children: 25-50 mg per kg by intravenous injection, daily in divided doses.

Elderly: Use adult dosage with care, taking into consideration any impairment in liver or biliary functions.

Patients with impaired hepatic function: In the presence of normal hepatic  I function, erythromycin is concentrated in the liver and excreted in the bile. Although the effect of hepatic dysfunction on the excretion of erythromycin and its half-life in such patients is not known, caution should be exercised in administering the antibiotic in such cases.

Patients with impaired renal function: The low proportion of renal excretion would suggest that dosage modification in patients with impaired renal function may not be necessary. In severely impaired patients however, toxicity has been reported and dosage adjustment in these cases may be warranted.

Warnings

Prolongation of the QT interval and development of ventricular arrhythmias (some of which have been fatal), including atypical ventricular tachycardia (torsades de pointes) have been reported with the intravenous administration of erythromycin. Limited data suggest that these adverse effects may be associated with abnormally elevated serum erythromycin concentrations following rapid administration. Erythromycin therefore must not be administered rapidly by direct intravenous injection (intravenous push).

Concomitant use of erythromycin with the following products is contraindicated: astemizole, terfenadine, cisapride, pimozide, simvastatin and lovastatin.

Erythromycin is a known inhibitor of the CYP3A4 isoenzyme which can lead to drug interaction with a number of medicinal products (see section 4.4 and 4.5 of SmPC).

Overdose

The toxicity is low. Overdosage may be associated with ototoxicity. No specific treatment has been proposed other than general supportive measures.

Storage

As packaged for sale: Do not store above 25°C. Keep the container in the outer carton.

After reconstitution/dilution – Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at a temperature not exceeding 25°C.

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