If you are taking URIZONE 2 g or URIZONE 3 g Granules, you are using an antibiotic medicine that contains fosfomycin trometamol. It is taken by mouth after mixing the granules with water. URIZONE is used as a single-dose treatment for certain uncomplicated lower urinary tract infections in women and female children over 5 years, when the infection is caused by sensitive E. coli bacteria. It is also used in adult men to help prevent infection around certain diagnostic or surgical procedures through the urethra.
SCHEDULING STATUS: S4
What it is and what it is used for
What URIZONE contains
URIZONE contains the active ingredient fosfomycin, in the form of fosfomycin trometamol.
The two strengths are:
| Product | Active ingredient amount | Fosfomycin strength | Sugar content |
|---|---|---|---|
| URIZONE 2 g | 3,754 g fosfomycin trometamol | Equivalent to fosfomycin 2 g | 2,100 g sucrose per sachet |
| URIZONE 3 g | 5,631 g fosfomycin trometamol | Equivalent to fosfomycin 3 g | 2,213 g sucrose per sachet |
URIZONE is classified as a broad and medium spectrum antibiotic. This means it is designed to act against certain types of bacteria.
What URIZONE is used for
URIZONE is used for:
- Acute uncomplicated lower urinary tract infections caused by sensitive E. coli bacteria:
- in women
- in female children over the age of 5 years
- Prevention of infection in adult men having:
- diagnostic transurethral procedures
- surgical transurethral procedures
“Transurethral” means the procedure is done through the urethra, the tube that carries urine out of the body.
Warning: URIZONE is only indicated for the uses listed above. It is not specified in the source as a treatment for other infections.
How it works
URIZONE works by helping to kill certain bacteria that can cause lower urinary tract infections.
Bacteria need a strong outer wall to survive and multiply. Fosfomycin interferes with the building of this bacterial cell wall. Without being able to make this wall properly, the bacteria cannot continue growing in the same way, and the medicine can help clear the infection.
After you take URIZONE, fosfomycin is mainly removed from the body through the kidneys into the urine. This is helpful because the medicine reaches high levels in the urinary tract, where lower urinary tract infections occur.
The source states that fosfomycin usually provides useful levels of the active medicine in the urine for 36 hours or more after a single dose. It also says high urinary concentrations are usually reached within two to four hours.
Note: Laboratory sensitivity does not always mean the medicine will work in the body. The source specifically says that in vitro sensitivity does not necessarily imply in vivo efficacy.
Who should NOT use this medicine
Do not use URIZONE if you:
- have a known allergy or hypersensitivity to fosfomycin trometamol
- have severe renal insufficiency, meaning severe kidney impairment, with creatinine clearance below 10 ml/min
- are breastfeeding
- are a child under 5 years of age, because safety and efficacy in this age group have not been established
Warning: If you have kidney disease, do not assume this medicine is suitable for you. The source specifically lists severe renal insufficiency as a contraindication.
Warnings and precautions
Read before use
Before taking URIZONE, check whether any of the following apply to you:
- you have had an allergic reaction to fosfomycin trometamol before
- you have severe kidney problems
- you are breastfeeding
- you are pregnant or may be pregnant
- the medicine is being considered for a child under 5 years
- you are taking metoclopramide
- you need to manage your sugar intake because the sachets contain sucrose
Use in children
URIZONE may be used in female children over 5 years for the specific urinary tract infection indication described in the source.
The source states that safety and efficacy in children under 5 years have not yet been established.
Kidney function
URIZONE must not be used in severe renal insufficiency where creatinine clearance is less than 10 ml/min.
The source also notes that in patients with moderately reduced kidney function, including the reduction that may occur with ageing, the half-life of fosfomycin is prolonged, but urinary levels remain adequate. However, the source wording gives the creatinine clearance as greater than 80 ml/min, and no further practical dosing adjustment is provided.
Note: Any decision about using URIZONE with kidney concerns should be made with a doctor or pharmacist.
Driving and using machines
URIZONE may cause dizziness in some people, as dizziness is listed as a common side effect.
The source does not give a specific instruction about driving, operating machinery, or avoiding these activities. If you feel dizzy after taking URIZONE, it would be sensible not to drive or do tasks that need full alertness until you feel well again.
Alcohol
Not specified in the source.
The source does not say whether alcohol should be avoided with URIZONE. Ask your doctor or pharmacist if you are unsure, especially if you are feeling unwell with a urinary tract infection.
Food and timing
Food delays and reduces the absorption of fosfomycin trometamol. This can lead to lower levels of the medicine in the blood and urine.
For this reason, URIZONE should be taken at least two hours before the next meal.
Pregnancy, planning pregnancy, and breastfeeding
Pregnancy
The source states that no evidence has been found in animals or humans to show adverse effects of URIZONE in pregnancy.
However, it also states that the safety and efficacy of single-dose therapy has not been established for URIZONE in pregnancy.
If you are pregnant, think you may be pregnant, or are planning pregnancy, speak to your doctor or pharmacist before using URIZONE.
Breastfeeding
URIZONE should not be given to breastfeeding women.
The source states that fosfomycin has been shown to pass into breast milk.
Warning: Do not use URIZONE while breastfeeding unless a healthcare professional has assessed your situation and advised you appropriately. The source says it should not be given to lactating women.
Interactions
Medicine interactions
URIZONE should not be taken together with metoclopramide.
Metoclopramide is a medicine often used for nausea, vomiting, or stomach-emptying problems. The source states that taking metoclopramide at the same time has been shown to lower fosfomycin levels in both the blood and urine. This may reduce how well URIZONE works.
If you are taking metoclopramide, tell your doctor or pharmacist before using URIZONE.
Food interaction
Food delays and reduces the absorption of URIZONE.
To help the medicine work as intended, take URIZONE at least two hours before your next meal.
Alcohol interaction
Not specified in the source.
Medical tests or procedures
URIZONE is used for prophylaxis in adult men undergoing diagnostic or surgical transurethral procedures. The source does not specify any interactions with laboratory tests.
How to take URIZONE step by step
Before you take it
Before taking URIZONE, make sure:
- the correct strength has been prescribed or supplied
- you know whether you are taking it for treatment or procedure-related prevention
- you are not allergic to fosfomycin trometamol
- you are not breastfeeding
- you do not have severe renal insufficiency
- you are not taking metoclopramide at the same time
- the dose is suitable for your age and reason for use
How to prepare the dose
URIZONE is taken by mouth after being mixed with water.
The source does not specify the exact amount of water to use.
When to take it
Take URIZONE at least two hours before the next meal.
This matters because food can delay and reduce absorption, which may lower the medicine levels in your urine.
Dose for women with uncomplicated lower urinary tract infection
For women, including elderly women up to 75 years, the recommended dose is:
- one single 3 g dose
This is for uncomplicated urinary tract infections as described in the source.
Dose for female children over 5 years
For female children over the age of 5 years, the recommended dose is:
- one single 2 g dose
Safety and efficacy for children under 5 years have not been established.
Dose for adult men having transurethral procedures
For adult men, including elderly men, when URIZONE is used to help prevent infection before diagnostic or surgical transurethral procedures, the recommended dosing is:
- 3 g taken three hours before surgery
- 3 g taken twenty-four hours after surgery
This means a total of two 3 g doses are used for this purpose.
Missed dose
Not specified in the source.
If you forget to take URIZONE at the correct time, especially before a procedure, contact your doctor, pharmacist, clinic, or hospital for advice.
Overdose
If too much URIZONE is taken, the source states that urinary elimination of the medicine can be accelerated by giving enough oral fluids.
In plain language, drinking fluids may help your body pass the medicine out in urine. However, an overdose should still be taken seriously. Contact a doctor, pharmacist, poison information service, clinic, or emergency centre for advice.
Warning: Do not try to manage a significant overdose on your own, especially in a child, an older person, or anyone with kidney problems.
Practical adherence tips
Because URIZONE is often used as a single dose, timing is important.
You may find it helpful to:
- check the sachet strength before taking it
- take it when you can avoid eating for the required timing period
- write down the procedure-related dose times if you are taking two doses
- keep the sachet in its carton until you need it
- ask your pharmacist if you are unsure how to mix the granules with water
Dosing table
| User group or situation | Dose | Frequency | Maximum daily dose |
|---|---|---|---|
| Women with acute uncomplicated lower urinary tract infection caused by sensitive E. coli, including elderly women up to 75 years | 3 g | Single dose | Not specified in the source |
| Female children over 5 years with acute uncomplicated lower urinary tract infection caused by sensitive E. coli | 2 g | Single dose | Not specified in the source |
| Adult men having diagnostic or surgical transurethral procedures, including elderly men | 3 g before procedure and 3 g after procedure | First dose 3 hours before surgery; second dose 24 hours after surgery | Not specified in the source |
Note: Only the dosing above is specified in the source. Do not change the dose or repeat it unless a healthcare professional tells you to.
Possible side effects
URIZONE is described in the source as generally well tolerated. Like all medicines, it can still cause side effects.
The side effects below are listed according to the frequency categories given in the source.
Very common side effects
Very common means these may affect more than 1 in 10 people.
You may experience:
- diarrhoea
- nausea
- headache
Diarrhoea means passing loose or watery stools. Nausea means feeling sick or wanting to vomit. Headache may feel like pressure, throbbing, or pain in the head.
If these effects are mild, they may settle. If they are severe, persistent, or worrying, speak to your doctor or pharmacist.
Common side effects
Common means these may affect more than 1 in 100 but fewer than 1 in 10 people.
Possible common side effects include:
- vaginitis
- dysmenorrhoea
- nausea
- abdominal pain
- dyspepsia, such as heartburn or indigestion
- dizziness
- back pain
- pharyngitis, meaning sore throat
- rhinitis, meaning a runny or blocked nose
- skin rash
- pain that is not localised
- asthenia, meaning weakness or lack of energy
Some of these effects may be mild, but they can still be uncomfortable. If you develop a rash, dizziness, severe stomach symptoms, or symptoms that do not improve, get medical advice.
Less common side effects
No uncommon, rare, or very rare side effects are specifically listed in the source.
Serious — seek urgent help
The source does not provide a specific list of serious emergency symptoms.
However, URIZONE must not be used by anyone with known hypersensitivity to fosfomycin trometamol. A skin rash is listed as a common side effect. If you develop symptoms that suggest an allergic reaction, seek urgent medical help.
Warning: Get urgent medical advice if you feel seriously unwell after taking URIZONE, especially if you have swelling, trouble breathing, a severe rash, faintness, or worsening symptoms. These specific symptoms are not listed in the source, but urgent assessment is appropriate for a suspected serious reaction.
Storage and disposal
How to store URIZONE
Store URIZONE at room temperature, 25 °C.
Keep it out of reach of children.
Moisture, light, and special storage conditions
Not specified in the source.
The source does not provide instructions about protecting the sachets from moisture or light.
Expiry guidance
Not specified in the source.
Do not use a medicine if the expiry date has passed. Ask your pharmacist how to dispose of medicines you no longer need.
Disposal
Not specified in the source.
For safe disposal in South Africa, it is best to ask a pharmacist what to do with unused or expired medicine.
What the medicine contains
Active ingredient
URIZONE contains fosfomycin trometamol, which provides fosfomycin.
- URIZONE 2 g contains 3,754 g fosfomycin trometamol, equivalent to fosfomycin 2 g
- URIZONE 3 g contains 5,631 g fosfomycin trometamol, equivalent to fosfomycin 3 g
Important excipients
URIZONE contains sucrose.
- URIZONE 2 g contains 2,100 g sucrose per sachet
- URIZONE 3 g contains 2,213 g sucrose per sachet
Note: If you have diabetes or need to control sugar intake, ask your doctor or pharmacist about the sucrose content before using URIZONE.
Other ingredients
Not specified in the source.
Pack information and appearance
What URIZONE looks like
Each sachet contains a white granular powder.
The powder has a characteristic citrus odour.
Pack size
URIZONE is supplied in a carton containing one sachet.
Strengths
URIZONE is available as:
- URIZONE 2 g Granules
- URIZONE 3 g Granules
Registration information
The source lists the following registration numbers:
| Product | Registration number |
|---|---|
| URIZONE 2 g | 28/20.1.1/0479 |
| URIZONE 3 g | 28/20.1.1/0480 |
Holder of the certificate of registration
The holder listed in the source is:
Adcock Ingram Limited
1 New Road
Erland Gardens
Midrand, 1685
Private Bag X69
Bryanston 2021
The source also states that it is under licence from Zambon S.p.A.
Sources :
Written by: RxZest Editorial Team
Editorial review: Checked for readability, structure, and source alignment
Based on SAHPRA-approved information : URIZONE
Last updated: [03/05/2026]
Practical FAQs
Can I use URIZONE for any urinary tract infection?
No. The source states that URIZONE is indicated as a single dose for acute uncomplicated lower urinary tract infections caused by sensitive E. coli in women and female children over 5 years.
It is not specified for all urinary tract infections or for complicated infections.
Can a child take URIZONE?
URIZONE may be used in female children over 5 years for the indication described in the source.
The source says safety and efficacy in children under 5 years have not been established.
Can men take URIZONE?
The source states that URIZONE is indicated for prophylaxis in adult men undergoing diagnostic and surgical transurethral procedures.
It does not specify URIZONE as treatment for uncomplicated urinary tract infections in men.
How many doses do I take for a urinary tract infection?
For women with the indicated uncomplicated urinary tract infection, including elderly women up to 75 years, the recommended dose is a single 3 g dose.
For female children over 5 years, the recommended dose is a single 2 g dose.
How do I take URIZONE before a transurethral procedure?
For adult men, including elderly men, the source recommends two 3 g doses:
- one 3 g dose three hours before surgery
- one 3 g dose twenty-four hours after surgery
Should I take URIZONE with food?
No specific “with food” instruction is given. The source says URIZONE should be taken at least two hours before the next meal.
Food can delay and reduce absorption, which may reduce the levels of the medicine in the blood and urine.
Can I take metoclopramide with URIZONE?
No. The source says taking metoclopramide at the same time lowers fosfomycin levels in the blood and urine and should be avoided.
Tell your doctor or pharmacist if you are using metoclopramide.
Can I take URIZONE if I am pregnant?
The source says no evidence has been found in animals or humans to show adverse effects in pregnancy. However, it also says the safety and efficacy of single-dose therapy has not been established for URIZONE in pregnancy.
Speak to your doctor or pharmacist before using it if you are pregnant or planning pregnancy.
Can I take URIZONE while breastfeeding?
No. The source says URIZONE should not be given to lactating women because fosfomycin has been shown to pass into breast milk.
What should I do if I take too much URIZONE?
The source says that in overdose, urinary elimination can be accelerated by adequate oral fluids.
You should still contact a healthcare professional, especially if the overdose involves a child, an older person, or someone with kidney problems.
