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Azactam (Aztreonam)

What Azactam is and what it is used for

The name of this medicine is Azactam. The active ingredient in Azactam is aztreonam. Azactam is available in two strengths and each vial contains either lg or 2g aztreonam as a powder for solution for injection or infusion. Aztreonam is an antibiotic and a member of the family of medicines called monobactams. Azactam also contains L-arginine. Azactam is for the treatment of serious infections caused by bacteria which require an antibiotic injection.

Azactam (Aztreonam)

Before you are given your medicine

Do not take Azactam if:

  • You are allergic to Aztreonam or L-arginine
  • You are pregnant or planning to become pregnant
  • You must tell your doctor if:
  • You have ever had an allergic reaction to any antibiotics
  • you have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Azactam tell your doctor as soon as possible since it may be necessary to interrupt the treatment.
  • You have any Liver problems
  • You have any Kidney problems
  • You are taking a medicine against blood clots (anticoagulants)

Taking Azactam with other medicines

Always tell your doctor or pharmacist about other medicines you may be taking or have recently taken including those obtained without a prescription. Some medicines can have an effect on each others actions.

Pregnancy and breastfeeding

If you are pregnant or may become pregnant or are breast feeding, you should speak to your doctor before being treated with Azactam.

How you will be given your medicine

The adult dose range is 1 to 8g daily. This dose can be split equally over the day meaning you may be given between one to four doses a day.

The usual daily dose in children is 30mg per kg of body weight given every 6 to 8 hours, but in severe infections this will be increased to 50mg per kg of body weight.

If you are given more Azactam than you should

It is unlikely that you will receive more Azactam than you should as it will be administered by injection into a muscle or vein by a doctor, nurse or other suitably trained person. If this does happen you will be closely monitored.

Possible side effects

Most people find that Azactam is suitable for them. However, as with all medicines, Azactam can cause unwanted effects, although not everybody gets them.

Tell your doctor immediately if you get any of the following symptoms:

  1. swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing. These may be signs of an allergic reaction.
  2. severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is rare side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation.
  3. Azactam may cause skin irritation and flaking, itchy rash, flushing, small red spots and, very rarely, burning and blistering of the skin.
  4. Mouth ulcers, altered taste, yellowing of the skin, nausea, vomiting, abdominal cramps, diarrhoea, diarrhoea with blood or mucous or inflammation / discomfort at the injection site have occurred.

Other rare side effects include fits, thrush or other vaginal irritation, fever, sweating, fall in blood pressure, general aches and pains, headache, breast tenderness, temporary increases in the levels of some chemicals in your blood, nasal congestion, sneezing, bad breath, dizziness, weakness, confusion.

Very rarely, lengthening of the time it takes for a cut to stop bleeding, spontaneous bruising and a fall in the number of infection fighting blood cells have occurred after administration of Azactam.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately. It will help if you make a note of what you experienced, when it started and how long it lasted.

How to store your medicine

Keep out of reach and sight of children.

This medicine will be stored in the pharmacy at not more than 25°C and prepared in a special area before the doctor or nurse gives it to you. This product is for single use only. The product should not be used after the expiry date shown on the vial label and on the carton.

Further Information

What Azactam contains

Each vial contains either lg or 2g aztreonam. Also contains L-arginine (780mg per g of aztreonam)

What Azactam looks like and the contents of the pack

Azactam comes in clear glass vials, closed with siliconed grey butyl rubber closure, sealed with aluminium seal, in packs of 1 x 15 ml.

Please detach before handing above section to patient information for health professionals

Below is a summary of the dosage and administration for Azactam.   Reference should be made to the Compendium for full prescribing information.

Administration:

Intramuscular or intravenous injection, or intravenous infusion.

Adults:

The dose range of Azactam is 1 to 8g daily in equally divided doses.   The usual dose is 3 to 4g daily.   The maximum recommended dose is 8g daily.   The dosage and route of administration should be determined by the susceptibility of the causative organisms, severity of infection, and the condition of the patient.

Type of Infection(1) Dosage (g) Frequency (hr) Route
Urinary tract Gonorrhoea/cy stiti s Cystic Fibrosis Severe or life-threatening infections Other infections  either or 0.5-1 12

2 1

2

8-12single dose

6-8

6-8 8

12

IMorlV IM IVIV

IM or IV

IV

(1) Because of the serious nature of infections due to Pseudomonas aeruginosa, a dose of 2g every 6 or 8 hours is recommended, at least for initial therapy in systemic infections caused by this organism.

The intravenous route is recommended for patients requiring single doses greater than lg, or those with bacterial septicaemia, localised parenchymal abscess (e.g. intra-abdominal abscess), peritonitis, meningitis or other severe systemic or life-threatening infections.

Children:

The usual dose for patients older than one week is 30mg/kg/dose every 6 or 8 hours.   For severe infections in patients 2 years of age or older, 50mg/kg/dose every 6 or 8 hours is recommended.   The total daily dose should not exceed 8g.   Dosage information is not yet available for new-borns less than 1 week old.

Elderly:

In the elderly, renal status is the major determinant of dosage.   Estimated creatinine clearance should be used to determine appropriate dosage, since serum creatinine is not an accurate measurement of renal function in these patients. Elderly patients normally have a creatinine clearance in excess of 30ml/min and therefore would receive the normal recommended dose.   If renal function is below this level, the dosage schedule should be adjusted (see Renal Impairment).

Renal Impairment: In patients with impaired renal function, the normal recommended initial dose should be given. This should be followed by maintenance doses as shown in the following table:

Estimated Creatinine Clearance (ml/min) Maintenance Dose
10-30 Half the initial dose
Less than 10 One quarter of the initial dose

The normal dose interval should not be altered. In patients on haemodialysis, a supplementary one-eighth of the initial dose should be given after each dialysis.

Reconstitution:

Azactam Powder for Solution for Injection or Infusion is supplied in 15ml vials.   Upon the addition of the diluent the contents should be shaken immediately and vigorously. Vials of reconstituted Azactam are not intended for multi-dose use, and any unused solution from a single dose must be discarded.   Depending on the type and amount of diluent, the pH ranges from 4.5 to 7.5, and the colour may vary from colourless to light straw-yellow, which may develop a slight pink tint on standing; however this does not affect the potency.

For intramuscular injections:   For each gram of aztreonam add at least 3ml Water for Injections Ph Eur or 0.9% Sodium Chloride BP and shake well.

Single-Dose Vial Size Volume of Diluent to be added
0.5g 1.5ml
1.0g 3.0ml

Azactam is given by deep injection into a large muscle mass, such as the upper outer quadrant of the gluteus maximus or the lateral part of the thigh.

For intravenous injection:

To the contents of the vial add 6 to 10ml of Water for Injections Ph Eur, and shake well.   Slowly inject directly into the vein over a period of 3 to 5 minutes.

For intravenous infusion:

For each gram of aztreonam, add at least 3ml of Water for Injections Ph Eur and shake well.   Dilute this initial solution with an appropriate infusion solution to a final concentration less than 2% w/v (at least 50ml solution per gram of aztreonam).   The infusion should be administered over 20-60 minutes.

Appropriate infusion solutions include:

0.9% Sodium Chloride Injection BP 5% Glucose Intravenous Infusion BP,   5% or 10% Mannitol Intravenous Infusion BP, Sodium Lactate Intravenous Infusion BP,   0.9%, 0.45% or 0.2% Sodium Chloride & 5% Glucose IV Infusion BP,   Compound Sodium Chloride Injection BPC 1959   (Ringer’s Solution for Injection),   Compound Sodium Lactate Intravenous Infusion BP (Hartmann’s Solution for Injection).

A volume control administration set may be used to deliver the initial solution of Azactam into a compatible infusion solution being administered.   With use of a Y-tube administration set, careful attention should be given to the calculated volume of Azactam solution required so that the entire dose will be infused. With intermittent infusion of

Azactam and another drug via a common delivery tube, the tube should be flushed before and after delivery of Azactam with any appropriate infusion solution compatible with both drug solutions.   Except for the antibiotics described below, the drugs should not be delivered simultaneously.

Reconstitution:

Intravenous infusion solution of Azactam for Injection prepared with 0.9% Sodium Chloride Injection BP or 5% Glucose Intravenous Infusion BP, in PVC or glass containers, to which clindamycin phosphate, gentamicin sulphate, tobramycin sulphate, or cephazolin sodium have been added at concentrations usually used clinically, are stable for up to 24 hours in a refrigerator (2-8°C).   Ampicillin sodium admixtures with aztreonam in 0.9% sodium chloride injection BP are stable for 24 hours in a refrigerator (2-8°C); stability in 5% Glucose Intravenous Infusion BP is eight hours under refrigeration.   Store the reconstituted solution at 2°C-8°C (under refrigeration) for not more than 24 hours.   Discard any unused solution.

If aztreonam and metronidazole are to be used together, they should be administered separately as a cherry red colour has been observed after storage of solutions containing combinations of the two products.

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