Skip to Content

METROZOL INJECTION

Active substance(s): METRONIDAZOLE

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET:
PL 16431/0133

METROZOLTM INJECTION (METRONIDAZOLE INJECTION 0.5% w/v)
Please read this leaflet carefully. It contains a summary of product information which should be
available to both the user and the patient.
ABOUT THE MEDICINE
Product Name: METROZOLTM INJECTION (METRONIDAZOLE INJECTION 0.5% w/v)
The solution contains Metronidazole BP 0.5% w/v as the active ingredient. The solution also
contains Citric Acid Monohydrate BP 0.044% w/v (or Citric Acid Anhydrous 0.04% w/v, Sodium
Phosphate BP 0.15% w/v, Sodium Chloride BP 0.74% w/v, Water for Injection BP.
MetrozolTM Injection is a clear, pyrogen free, sterile solution for administration into a vein. It is
supplied in a PVC infusion bag containing 100ml of solution.

The Product Licence Holder is:
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU
The Manufacturer is:
Parkfields Pharmaceuticals Ltd
Pond Lane
Wolverhampton
WV2 1HL
WHAT THE PRODUCT IS USED FOR
The active ingredient, Metronidazole, is an antibacterial agent which is active against a wide range
of harmful bacteria.
MetrozolTM Injection is used for the treatment of septicaemia, blood poisoning, brain abscess, lung
infection, inflammation of the membrane lining in the abdomen, pelvic abscess and post-operative
wound infection. This product is also used for the prevention of post-operative infections.

BEFORE USING THE PRODUCT
The following points are important to note before using any of the product:
-

Patients should advise the doctor if they know they are allergic to the active ingredient,
Metronidazole, or if they are pregnant or breastfeeding.
MetrozolTM Injection should be used with great care in patients with blood disorders and
diseases of the brain or spinal cord other than brain abscess.

-

-

-

-

-

Patients receiving MetrozolTM Injection for more than 10 days should be monitored and
treatment discontinued if numbness in the limbs, weakness or fits occur.
Patients with sever liver disease will break down Metronidazole slowly leading to retention of
the active ingredient and its break down substances. A reduction in dosage of MetrozolTM
Injection should therefore be considered in such patients. A single daily intravenous infusion
may be administered.
In patients with kidney failure there is no accumulation of the active ingredient, Metronidazole,
but its break down substances are retained. The clinical significance of these retained
substances is unknown.
Patients with kidney failure who are undergoing regular dialysis should be given MetrozolTM
Injection immediately after completing dialysis as this procedure removes both Metronidazole
and the breakdown substances.
Alcohol should not be taken during treatment with MetrozolTM Injection as it may produce
reactions such as flushing, breathing difficulties, palpitations and vomiting.
MetrozolTM Injection may increase the effect of Warfarin (an anticoagulant) leading to a
requirement for a reduced dose of the anticoagulant.
MetrozolTM Injection may increase the effect of Phenytoin.
Phenobarbitone may increase the liver breakdown of Metronidazole, which may reduce its
duration of action. Certain other drugs such as Cimetidine may increase the duration of action
of Metronidazole.
Lithium treatment should be gradually reduced or withdrawn prior to administration of
MetrozolTM Injection. Giving both preparations at the same time may lead to kidney damage.
The product should not be used unless the container is undamaged and the solution is clear
and free from particles.
Any unused solution should be discarded.
Before giving MetrozolTM Injection, the doctor/nurse should check that the injection is
compatible with other infusion fluids used.

HOW TO USE THE MEDICINE
For established bacterial injections the recommended dosage is as follows:
Adults and Elderly: 500mg Metronidazole
Children:
7.5mg/kg bodyweight
Given eight hourly as an intravenous infusion at a rate of 5ml/minute.
Oral therapy should replace intravenous infusion when feasible.
The duration of treatment is about seven days but is dependent on the clinical and bacteriological
response.
For Surgical Prophylaxis (prevention of infection due to surgery)
Adults and Elderly: 500mg Metronidazole
Children:
7.5mg/kg bodyweight
Given immediately before surgery and repeated eight hourly at a rate of 5ml/minute.
The total course of treatment may range from two to four days
Treatment should be discontinued if an adverse reaction occurs.
Overdosage: There is no specific treatment for overdose. Metronidazole is readily removed from
the plasma by haemodialysis.

AFTER USING THE MEDICINE
Side effects, which occur occasionally include; nausea, vomiting, furred tongue, unpleasant metallic
taste, skin rashes, jaundice (yellowing of the skin and eyes), unusually pale skin colour, unusual
bruising, unusual bleeding, persistent sore throat and/or raised temperature, diarrhoea, itching and
swelling.
There have been rare reports of severe allergic reaction, flushing, headache, hallucinations,
confusion, dizziness, unsteadiness, drowsiness and darkening of the urine.
Prolonged treatment at relatively high doses of Metronidazole has been associated with numbness
or tingling in limbs and possible weakness or ‘fits’.
These effects usually disappear on withdrawal of the drug.
Consult a doctor if any untoward effects are noted.
HOW TO STORE THE MEDICINE
The hospital will store MetrozolTM Injection between 2°C and 20°C, protected from light. They will
not use the product beyond the use before date printed on the label. A with all medicines,
MetrozolTM Injection should be stored out of the reach of children.

Leaflet last revised: January 2011

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide