Metronidazole belongs to the group of medicines called anti-microbials. Mopizale® Infusion is used in the treatment and prevention of severe infections that are caused by anaerobic bacteria, particularly species of Bacteroides, anaerobic Streptococci, Fusobacteria, Clostridia, etc. It works by killing bacteria and parasites that cause infection in your body.

If you need any further information on your illness, speak to your doctor.

Your medicine will be administered to you by a doctor or nurse. The length of your course of treatment will depend on your needs and the illness being treated.

•  Metronidazole is administered into a vein using a drip at a rate of 5 ml/minute.

•  Other antibiotics can be administered using the same minibag as Metronidazole to help treat your infection.

•  The dose of Metronidazole will depend on your needs and the illness being treated.

•  The length of your treatment will depend on the type of infection you have and how bad it is.

•  As soon as possible after starting your treatment with Metronidazole, your doctor will suggest changing to a medicine taken by mouth.

 

The usual dose for adults and children is given below:

 

To treat bacterial infection Adults

•  You will be given 500 mg (100 ml) Mopizale® every 8 hours.

Children

•  Your doctor will work out how much your child should be given depending on their weight.

•  The dose will be repeated every 8 hours.

•  If your child is a baby under 8 weeks of age, your doctor will give them one daily dose or two separate doses 12 hourly.

 

 

 

To prevent infections from happening after surgery Adults

•  You will be given 500 mg (100 ml) Mopizale® shortly before your operation.

•  The dose will be repeated every 8 hours.

 

Children

•  Your doctor will work out how much your child should be given depending on their weight.

•  Your child will receive Mopizale® 1–2 hours before their operation.

 

People having kidney dialysis

Kidney dialysis removes Metronidazole from your blood. If you are having kidney dialysis you must have this medicine after your dialysis treatment.

 

People with liver problems

Your doctor may lower your dose or use the medicine less often.

 

If you take more Metronidazole than you should

 

Your doctor will carefully calculate how much Mopizale®you should get. Therefore it is unlikely

 

your doctor or nurse will give you too much of this medicine. But, if you think that you have been

given too much or too little Metronidazole, tell your doctor or nurse.

If you forget to take Mopizale®

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you may have missed a dose, then talk to your doctor or nurse.

If you stop taking Mopizale®

You should only stop taking Mopizale®   if your doctor tells you to. It is essential to take the medicine and not to stop and start as this could cause unwanted side effects.

 

 

• If you are sensitive or allergic to metronidazole or any of the ingredients . Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • If you are pregnant or breast feeding or think you might be pregnant. • If you are suffering or have ever suffered from any liver or kidney disease • If you are suffering or have ever suffered from any diseases of the nervous system.

There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) with the use of Metronidazole. Symptoms of which may include: flu-like symptoms followed by a painful red or purplish rash that spreads and blisters. It may also include ulcers in the mouth, throat, nose or genitals. If you develop any of the above you must stop taking your medicine and inform your doctor straight away .

 

This medicinal product contains 0.31 g of sodium per 100 ml dose. To be taken into consideration by patients on a controlled sodium diet.

 

Please tell your doctor if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Mopizale® can affect the way some medicines work. Also, some other medicines can affect the way

 

Mopizal®

works.

 

In particular tell your doctor if you are taking any of the following medicines:

•  Medicines used to thin the blood, such as warfarin.

•  Lithium (used to treat depression).

•  Disulfiram (used to treat alcoholism).

•  Phenobarbital or Phenytoin (used to treat epilepsy).

•  Cyclosporin (used to treat arthritis and some skin conditions).

•  5-flourouracil (used in the treatment of cancer).

•  Busulfan (used in the treatment of leukaemia).

Taking Mopizale® with food and drink

Do not drink any alcohol while you are taking Mopizale® and for 48 hours after finishing your course. Drinking alcohol while using Metronidazole might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heart beat (palpitations) and headache.

 

 

Tell your doctor before taking Mopizale® if:

•  You are pregnant, might become pregnant or think you may be pregnant. Metronidazole should not be taken during pregnancy unless considered absolutely necessary.

•  If you are breast-feeding. It is better not to use Mopizale® if you are breast-feeding. This is because small amounts may pass into the mother’s milk.

 

Whilst taking Mopizale® you may feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems (such as blurred or double vision). If this happens, do not drive or use any machinery or tools.

Like all medicines, Mopizale® can cause side effects, although not everybody gets them.

Tell your doctor straight away if you notice any of the following side effects:

•  You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Mopizale®.

•  You experience blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’.

•  You have a severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis’.

•  A serious but very rare side effect is a brain disease (encephalopathy). Symptoms vary but you might get a fever, stiff neck, headache, see or hear things that aren’t there. You might also have problems using your arms and legs, problems with speaking or feel confused.

•  You develop symptoms such as abnormal sensitivity to light, abdominal pain, fever these could

be symptoms of meningitis.

•  Yellowing of the skin and eyes. This could be due to a liver problem (jaundice).

•  Unexpected infections, mouth ulcers, bruising, bleeding gums, severe tiredness or weakness.

This could be caused by a blood problem.

•  Severe stomach pain which may reach through to your back (pancreatitis).

Tell your doctor if you notice any of the following side effects:

•  Fits (convulsions).

•  Mental problems such as feeling confused or seeing or hearing things that are not there (hallucinations).

 

 

•  Problems with your eyesight such as blurred or double vision, changes in colour vision.

•  Tingling or burning pain in your eye.

•  Skin rash, flushing, itching.

•  Headache.

•  Darkening of the urine.

•  Diarrhoea.

•  Feeling sleepy or dizzy.

•  Pains in the muscles or joints.

•  Fever

•  Numbness, tingling, pain or a feeling of weakness in the arms or legs.

•  Unpleasant taste in the mouth.

•  Furred tongue, dry mouth.

•  Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhoea.

•  Loss of appetite, anorexia.

•  Depression.

All medicines may have unwanted effects which are not mentioned in the product leaflet. If you notice any other changes in your health whilst taking this medicine, tell your doctor immediately.

 

To reports any side effect(s):

·         Saudi Arabia:

 

National Pharmacovigilance and Drug Safety Centre (NPC) : ·         Fax: +966-11-205-7662 ·         Call NPC at +966-11-2038222 , Ext 2317-2356-2340 ·         SFDA Call Center: 19999 ·         E-mail: npc.drug@sfda.gov.sa ·         Website: www.sfda.gov.sa

 

 

 

 

 

 

 

 

·         Other GCC States:

 

-       Please contact the relevant competent authority.

 

Symptoms

In cases of overdose in adults, the clinical symptoms are usually limited to nausea, vomiting, ataxia and slight disorientation. In a preterm newborn, no clinical or biological sign of toxicity developed. Treatment

There is no specific treatment for Metronidazole overdose, Metronidazole infusion should be discontinued. Patients should be treated symptomatically.

 

 

ATC code:  J01XD01

Mechanism of action

Metronidazole has antibacterial and antiprotozoal actions and is effective against anaerobic bacteria and against Trichomonas vaginalis and other protozoa including Entamoeba histolytica and Giardia lamblia.

Distribution: After administration of a single 500 mg dose, mean Metronidazole peak plasma concentrations of ca. 14 – 18 μg/ml are reached at the end of a 20 minute infusion. 2-hydroxy- metabolite peak plasma concentrations of ca. 3 μg/ml are obtained after a 1 g single i.v. dose. Steady state Metronidazole plasma concentrations of about 17 and 13 μg/ml are reached after administration of Metronidazole every 8 or 12 hours, respectively.

Plasma protein binding is less than 10%, and the volume of distribution 1.1 ± 0.4 l/kg. Metabolism: Metronidazole is metabolised in the liver by hydroxylation, oxidation and glucuronidation. The major metabolites are a 2-hydroxy- and an acetic acid metabolite. Elimination: More than 50% of the administered dose is excreted in the urine, as unchanged Metronidazole (ca. 20% of the dose) and its metabolites. About 20% of the dose is excreted with

faeces. Clearance is 1.3 ± 0.3 ml/min/kg, while renal clearance is about 0.15 ml/min/kg. The plasma elimination half-life of Metronidazole is ca. 8 hours, and of the 2-hydroxy-metabolite ca. 10 hours. Special patient groups: The plasma elimination half-life of Metronidazole is not influenced by renal impairment, however this may be increased for 2-hydroxy- and an acetic acid metabolite. In the case of haemodialysis, Metronidazole is rapidly excreted and the plasma elimination half-life is decreased to ca. 2.5 h. Peritoneal dialysis does not appear to affect the elimination of Metronidazole or its metabolites.

In patients with impaired liver function, the metabolism of Metronidazole is expected to decrease, leading to an increase in the plasma elimination half-life. In patients with severe liver impairment, clearance may be decreased up to ca. 65%, resulting in an accumulation of Metronidazole in the body.

 

Metronidazole has been shown to be non-mutagenic in mammalian cells in vitro and in vivo. Metronidazole and a metabolite have been shown to be mutagenic is some tests with non mammalian cells.

Although Metronidazole has been shown to be carcinogenic in certain species of mice, it was not carcinogenic in either rats or guinea pigs. There is no suspicion of carcinogenicity in man.

Further preclinical data on repeated toxicity and toxicity to reproduction add no relevant knowledge for the prescriber.

 

 

 

Disodium hydrogen phosphate (Dried), Sodium hydroxide, Sodium Chloride, Citric acid and Water for Injection.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal product except for those mentioned in 6.6.

2 years

Do not store above 30°C, protect from light.

Class (II) vial 100ml with Rubber stopper 32 mm

Use only if the solution is clear, without visible particles and if the container is undamaged.

Administer immediately following the insertion of infusion set.

Do not remove unit from overpouch until ready for use.

The inner bag maintains the sterility of the product.

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

In patients maintained on intravenous fluids, Metronidazole 500mg/100ml Intravenous Infusion may be diluted with appropriate volumes of 0.9% sodium chloride solution, dextrose 5% - 0.9% sodium chloride solution, dextrose 5% w/v or potassium chloride infusions (20 and 40 mmol/litre). Using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In the case of adverse reaction, infusion must be stopped immediately.

The product should be used immediately after opening.

Discard after single use. Discard any unused portion.

Do not reconnect partially used bags.