Consumer medicine information

CIFRAN Tablets

Ciprofloxacin

BRAND INFORMATION

Brand name

Cifran

Active ingredient

Ciprofloxacin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using CIFRAN Tablets.

What is in this leaflet

This leaflet answers some common questions about CIFRAN.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking CIFRAN against the benefits it is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What CIFRAN is used for

CIFRAN is used to treat certain bacterial infections such as:

  • kidney and bladder infections
  • bowel infections
  • lung infections
  • skin infections
  • bone and joint infections
  • prostate infections.

CIFRAN tablets contain the active ingredient, ciprofloxacin, which is an antibiotic belonging to a group of medicines called quinolones (pronounced KWIN-a-lones).

This medicine works by killing the bacteria which cause these infections. This helps your body to fight the infection.

This medicine will not work against viral infections such as colds or flu.

Ask your doctor if you have any questions about why CIFRAN has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

There is no evidence that CIFRAN is addictive.

This medicine is not recommended for use in children or growing teenagers.

Before you take CIFRAN

When you must not take it

Do not take CIFRAN if you have an allergy to:

  • ciprofloxacin, the active ingredient in CIFRAN
  • any of the ingredients listed at the end of this leaflet
  • any other medicines belonging to the quinolone chemical family such as moxifloxacin, norfloxacin, or nalidixic acid.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not take CIFRAN if you are also taking a medicine called tizanidine, a muscle relaxant used to treat spasticity associated with multiple sclerosis, injury or diseases of the spinal cord. CIFRAN can interfere with tizanidine and can lead to undesirable side effects such as low blood pressure and drowsiness.

Do not take this medicine after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, including aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), or any other substances such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or plan to become pregnant. CIFRAN is not recommended if you are pregnant but your doctor will assess the benefit if required. Medicines similar to CIFRAN have caused joint disease in immature animals.

Tell your doctor if you are breastfeeding. CIFRAN is excreted into the breast milk. Your doctor will tell you whether you should take it and temporarily stop breastfeeding while you are taking the tablets.

CIFRAN should be used with caution in elderly patients as they are more prone to side effects.

Tell your doctor if you:

  • suffer from epilepsy (seizures, convulsions), have had a stroke, or have kidney or liver disease
  • have arrhythmias (fast or irregular heartbeats). CIFRAN may increase the risk of arrhythmias, especially in the elderly or patients with low potassium levels
  • have previously taken corticosteroids. You may be at increased risk of swelling of the tendons. Symptoms include pain, tenderness and sometimes restricted movement
  • have myasthenia gravis, a condition where the muscles become weak. CIFRAN can worsen the symptoms of this condition
  • have a history of tendon disorders with the use of quinolones (e.g. moxifloxacin, norfloxacin, nalidixic acid)

If you have not told your doctor about any of the above, tell them before you start taking CIFRAN.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and CIFRAN may interfere with each other. These include:

  • medicines used to treat arrhythmias (fast or irregular heartbeats)
  • theophylline, a medicine to control asthma
  • oral anticoagulants, warfarin and its metabolites, medicines used to stop blood clots
  • phenytoin, a medicine used to treat epilepsy
  • oral antidiabetic agents
  • didanosine, a medicine used to treat viral infections
  • cyclosporin, a medicine used to control the body’s immune system
  • non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain, arthritis and other inflammatory conditions
  • methotrexate, a medicine used to treat certain types of cancers, severe psoriasis or severe rheumatoid arthritis
  • duloxetine, a medicine used to treat depression, anxiety, and nerve pain in people with diabetes
  • clozapine, a medicine used to treat schizophrenia
  • ropinirole, a medicine used to treat Parkinson’s disease or restless legs syndrome
  • the local anaesthetic lidocaine, a medicine used to numb pain or cause loss of sensation
  • sildenafil, a medicine used to treat erectile dysfunction

These medicines may be affected by CIFRAN, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Some medicines may interfere with the absorption of CIFRAN. These include:

  • multivitamins, mineral supplements, antacids (used for indigestion) and other medicines containing iron, zinc, magnesium, aluminium or calcium
  • sucralfate, a medicine used to treat duodenal or stomach ulcers
  • medicines used to treat HIV infection
  • probenecid, a medicine used to treat gout
  • omeprazole, a medicine used to treat stomach ulcers and other conditions where stomach produces too much acid
  • sevelamer, a medicine used to treat high blood levels of phosphorus in patients with kidney disease who are on dialysis
  • metoclopramide, a medicine used to relieve nausea and vomiting, heartburn, and stomach pain

You can still take these medicines while you are taking CIFRAN.

However, you must take CIFRAN at least 2 hours before or 2 hours after taking any of these medicines to make sure it is absorbed properly.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking CIFRAN.

How to take CIFRAN

Carefully follow all directions given to you by your doctor or pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell you how much and how often you should take CIFRAN. This will depend on the type of infection and any medical conditions you may have.

The usual adult dosage for most infections is one tablet twice daily for 7 to 14 days. You may need to take your tablets for a longer period for some type of infections. The dose will be determined by your doctor as it depends on the type of infection you have.

How to take it

Swallow the tablets whole with a full glass of water.

Avoid taking this medication at the same time as milk, yoghurt or other products that are high in calcium. These products will interfere with the absorption of CIFRAN from the stomach.

However, if the milk, yoghurt or other high calcium products are ingredients of a meal, they will not interfere with CIFRAN absorption.

When to take it

CIFRAN tablets are usually taken twice a day.

Take your tablets at the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

It does not matter if you take this medicine before or after food.

If you need to take an antacid, take it at least 2 hours before or 2 hours after your dose of CIFRAN.

How long to take it

The length of treatment may vary from 1 to 28 days or longer depending on the type of infection.

Continue taking CIFRAN until you finish the pack or for as long as your doctor tells you.

Do not stop taking your tablets because you are feeling better.

If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

Check with your doctor if you are not sure how long you should be taking it for.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much CIFRAN.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking CIFRAN

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking CIFRAN.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

CIFRAN may affect the results of certain laboratory tests. If you are about to have any tests, tell your doctor that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Drink plenty of water or fluids while taking this medicine.

This will help to prevent crystals forming in the urine which can cause kidney problems. However, this is not a common problem.

Protect your skin when you are in the sun, especially between 10 am and 3 pm, or in the presence of artificial ultraviolet (UV) light.

CIFRAN may cause your skin to be much more sensitive to sunlight and UV light than it is normally. This may cause a skin rash, itching, redness, or a severe sunburn.

If outdoors, wear protective clothing and use a 15+ sunscreen. If your skin does appear to be burning, stop taking this medicine and tell your doctor.

If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after CIFRAN has been stopped.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

Do not take any anti-diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue while taking or soon after stopping CIFRAN, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.

This may mean you have a fungal infection called thrush. Sometimes the use of this medicine allows fungi to grow and the above symptoms to occur. CIFRAN does not work against fungi.

Tell your doctor immediately if you experience symptoms of depression or self-endangering behaviour. CIFRAN should be discontinued immediately.

Things you must not do

Do not use CIFRAN to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return and be more difficult to treat.

Things to be careful of

Avoid excessive exposure to direct sun. Your skin may become more prone to sunburn. If such a reaction occurs, stop taking CIFRAN immediately and tell your doctor.

Be careful driving or operating machinery, until you know how CIFRAN affects you. This medicine may cause dizziness, light-headedness or drowsiness in some people. If you have any of these symptoms, do not drive or operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness, light-headedness or drowsiness may be worse.

Be careful when drinking beverages containing caffeine (e.g. coffee, cola drinks) while you are taking this medicine. CIFRAN tablets may increase the stimulatory effects of caffeine.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CIFRAN. This medicine helps most people with bacterial infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • nausea or vomiting
  • mild diarrhoea

The above list includes more common side effects of CIFRAN. They are usually mild and short-lived.

If any of the following happens, tell your doctor immediately, or go to Accident and Emergency at the nearest hospital:

  • severe skin rashes, peeling of the skin and/or mucosal reactions
  • signs of allergy such as rash, swelling of the face, lips, mouth, throat or other parts of the body, shortness of breath, wheezing or trouble breathing
  • fainting
  • yellowing of the skin and eyes, also called jaundice
  • severe watery or bloody diarrhoea, even if it occurs several weeks after taking your tablets
  • fits (seizures, convulsions)
  • confusion, nightmares, hallucinations and psychotic reaction (even progressing to self-endangering behaviour)
  • fast or irregular heartbeats
  • visual disturbances
  • ringing in the ear, loss of hearing
  • abdominal pain/cramps. Very rarely this can progress to a serious condition accompanied by fever and fatigue

These serious side effects are rare. If you have them, you may need urgent medical attention.

Photosensitivity (getting sunburnt very easily) can occasionally occur with CIFRAN. However, it is temporary and staying out of direct sunlight while on CIFRAN tablets will prevent it from happening.

Rarely, there can be a worsening of the symptoms of myasthenia gravis. This is a condition in which the muscles become weak and tire easily, causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs.

Rarely, the Achilles tendon (extending from the calf to the heel of the foot) or other tendons have been torn after CIFRAN therapy.

Tell your doctor immediately if you feel any discomfort, pain or inflammation of a tendon.

Rarely, you may experience hyperglycaemia (high blood sugar) or hypoglycaemia (low blood sugar). Symptoms of hyperglycaemia include increased thirst, appetite and urination. Symptoms of hypoglycaemia include weakness, shaking, sweating, light-headedness, headache, behavioural changes, confusion, numbness/pins and needles in the lips, fingers or toes, irritability and hunger. Tell your doctor if you experience these symptoms.

Contact your doctor if you experience these symptoms.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with CIFRAN:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above.

Do not take any anti-diarrhoea medicine without first checking with your doctor. You may have a serious condition affecting your bowel, and may therefore need urgent medical attention. However, this side effect is rare.

After taking CIFRAN

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C, protected from light and moisture.

Do not store CIFRAN or any other medicine in the bathroom or near a sink.

Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the tablets or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Product description

What CIFRAN looks like

CIFRAN tablets are available in three strengths, each in blister packs of 14 tablets:

  • 250 mg - white to off-white, round, film-coated tablets marked with “250” on one side and plain on the other.
  • 500 mg - white to off-white, caplet (oval)-shaped, film-coated tablets marked with “500” on one side and plain on the other.
  • 750 mg - white to off-white, caplet (oval)-shaped, film-coated tablets marked with “750” on one side and plain on the other.

Ingredients

Active ingredient:
CIFRAN tablets contain 250 mg, 500 mg or 750 mg of the active ingredient, ciprofloxacin as ciprofloxacin hydrochloride.

Inactive ingredients:
CIFRAN also contains:

  • microcrystalline cellulose
  • maize starch
  • magnesium stearate
  • purified talc
  • anhydrous colloidal silica
  • sodium starch glycollate
  • purified water
  • hypromellose
  • titanium dioxide
  • macrogol 400.

Australian Register Numbers

  • CIFRAN 250 mg tablets -
    AUST R 135660.
  • CIFRAN 500 mg tablets -
    AUST R 135661.
  • CIFRAN 750 mg tablets -
    AUST R 135662.

Sponsor

CIFRAN is supplied in Australia by:
Ranbaxy Australia Pty Ltd
9-13 Waterloo Road
Macquarie Park NSW 2113
Australia

This leaflet was prepared in December 2013.

Published by MIMS September 2014

BRAND INFORMATION

Brand name

Cifran

Active ingredient

Ciprofloxacin

Schedule

S4

 

Name of the medicine

Ciproflaxacin hydrochloride.

Excipients.

Microcrystalline cellulose, maize starch, magnesium stearate, purified talc, anhydrous colloidal silica, sodium starch glycollate, purified water, Opadry OY-S-58910 white.

Description

Chemical name:1-cyclopropyl-6-fluoro- 1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Molecular formula: C17H18FN3O3.HCl.H2O. MW: 385.8. CAS: 86393-32-0. Ciprofloxacin hydrochloride is a synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity.
A pale yellow, crystalline powder, soluble in water, slightly soluble in methanol, very slightly soluble in ethanol, practically insoluble in acetone, in ethyl acetate and in methylene chloride.

Pharmacology

Pharmacokinetics.

Ciprofloxacin tablets are rapidly and well absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism. Serum concentrations increase in a dose proportional manner and were, after multiple doses, as shown in Table 1.
Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500 or 750 mg are 0.1, 0.2 and 0.4 microgram/mL respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug. During the first 2 hours after an oral dose of 250 mg, the urine concentration of ciprofloxacin usually exceeds 200 microgram/mL. Eight to 12 hours after the same dose, urine levels are approximately 30 microgram/mL. Urinary excretion of ciprofloxacin is virtually complete within 24 hours after dosing. The renal clearance of ciprofloxacin is approximately 18 L/h which exceeds the normal glomerular filtration rate of 7.2 L/h. Thus, active tubular secretion would seem to play a significant role in its elimination. Although bile concentrations of ciprofloxacin are 3 to 4 times higher than serum concentrations after oral dosing, only a small amount of the dose administered is recovered from the bile. Approximately 20 to 35% of an oral dose is recovered from the faeces within 5 days after dosing.
Ciprofloxacin is also metabolised. Four metabolites have been identified in human urine which together account for approximately 15% of an oral dose. The metabolites have less antimicrobial activity than unchanged ciprofloxacin.
Coadministration of ciprofloxacin with food appears to lower peak serum levels and delay the absorption of ciprofloxacin, resulting in peak concentrations closer to 2 hours after dosing rather than 1 hour. The overall absorption, however, is not substantially affected. Absorption also appears to be greatly reduced by prior administration of antacids. In patients with creatinine clearance between 21 to 40 mL/min, the half-life of ciprofloxacin is only slightly prolonged. Dosage adjustments are usually not required in such cases. However, in patients with severe renal impairment, with creatinine clearance less than 20 mL/min, the half-life of ciprofloxacin is nearly doubled and dosage adjustment is necessary (see Dosage and Administration).
After oral dosing ciprofloxacin is widely distributed throughout the body. The binding of ciprofloxacin to serum proteins is 20 to 40%.

Microbiology.

Ciprofloxacin has in vitro activity against a wide range of Gram negative and Gram positive organisms. The bactericidal action of ciprofloxacin appears to result from interference with the enzyme, DNA gyrase. Ciprofloxacin is usually active against the following organisms in vitro.

Gram negative.

Escherichia coli; Klebsiella species (including Klebsiella pneumoniae and Klebsiella oxytoca); Enterobacter species; Citrobacter species; Salmonella species; Shigella species; Proteus mirabilis; Proteus vulgaris; Providencia stuartii; Providencia rettgeri (formerly Proteus rettgeri); Morganella morganii (formerly Proteus morganii); Serratia species* (including Serratia marcescens);Pseudomonas aeruginosa; Pseudomonas fluorescens; Campylobacter species; Haemophilus influenzae; Neisseria gonorrhoeae; Moraxella (Branhamella) catarrhalis.

Gram positive*

Staphylococcus aureus (including methicillin susceptible and methicillin resistant strains); coagulase negative Staphylococcus species (including Staphylococcus epidermidis); Streptococcus pyogenes (group A); Streptococcus pneumoniae; Enterococcus faecalis.

*Note.

1. Gram positive organisms are generally less sensitive to ciprofloxacin than Gram negative organisms.
2. Most strains of Streptococci are only moderately susceptible to ciprofloxacin. Clinical studies have shown the drug to be effective for urinary tract infections caused by Enterococcus faecalis; however failures and reinfections have been observed with prostatitis. Although bronchial infections caused by Streptococcus pneumoniae and skin infections caused by Streptococcus pyogenes have been shown to respond to ciprofloxacin, it is not the drug of first choice in such infections, particularly Streptococcus pneumoniae infection of the lower respiratory tract.
3. Most strains of Burkholderia cepacia and many strains of Stenotrophomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile.
4. Enterococcus faecium, Ureaplasma urealyticum and Nocardia asteroides are generally resistant. Ciprofloxacin is ineffective against Treponema pallidum.
5. The in vitro MIC of several strains of Serratia approaches or exceeds the peak plasma concentrations with the recommended doses of ciprofloxacin.
The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. This information gives only an approximate guidance whether microorganisms will be susceptible for ciprofloxacin or not.
Ciprofloxacin has been shown to be active against Bacillus anthracis both in vitro and by use of serum levels as a surrogate marker (see Pharmacology).
Ciprofloxacin is less active when tested at acidic pH and its antibacterial activity may be reduced by up to 100-fold in acidic urine. The inoculum size has little effect when tested in vitro. The minimal bactericidal concentration (MBC) is generally 2-8 times the minimal inhibitory concentration (MIC).
Resistance to ciprofloxacin in vitro develops slowly (multiple step mutation). Rapid one step development of resistance has not been observed. However, in practice resistance to ciprofloxacin may develop during the course of a treatment, particularly in a significant proportion of Pseudomonas aeruginosa infections, especially in patients with cystic fibrosis, and in Staphylococcus aureus infections.
Ciprofloxacin does not exhibit cross resistance with nonquinolone antibacterial agents such as beta-lactams and aminoglycosides. However, organisms which are resistant to other quinolone agents (e.g. nalidixic acid, cinoxacin, etc) are usually less sensitive to ciprofloxacin.
In vitro studies have shown that when ciprofloxacin is combined with other antimicrobial agents, particularly beta-lactams, the combination behaves either in an indifferent or additive manner. Synergism or antagonism have, however, been observed rarely.
Appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to ciprofloxacin and after treatment as warranted by the clinical condition. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Susceptibility tests.

Dilution or diffusion techniques: either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS).
Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. A report of susceptible indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of intermediate indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of resistant indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

Indications

Ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the conditions listed: urinary tract infections; gonorrhoeal urethritis and cervicitis; gastroenteritis; bronchial Infections; skin and skin structure infections; bone and joint infections; chronic bacterial prostatitis of mild to moderate severity.

Note.

1. Typhoid and paratyphoid infections and infections due to multiresistant Staphylococcus aureus are excluded from the above due to insufficient data.
2. Because Gram positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with Gram positive infections, such as pneumonia due to Streptococcus pneumoniae.
3. Chronic bacterial prostatitis should be demonstrated by microbiological evidence localising infection to the prostate.
Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia.
Appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to ciprofloxacin and after treatment as warranted by the clinical condition. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both Gram negative and Gram positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.

Contraindications

A history of hypersensitivity to ciprofloxacin or other quinolones, including nalidixic acid, or any of the excipients.
Concurrent administration of ciprofloxacin and tizanidine (see Interactions with Other Medicines).

Precautions

Streptococcus pneumoniae infections.

Ciprofloxacin is not recommended for treatment of pneumococcal infections due to inadequate efficacy against Streptococcus pneumoniae.

Cardiac disorders.

Ciprofloxacin is associated with cases of QT prolongation (see Adverse Effects). In general, elderly patients may be more susceptible to drug associated effects on the QT interval. Women may also be more sensitive to QT prolongation medicine compared to men as they tend to have a longer baseline QTc interval. Precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation with the QT interval (e.g. class IA or III antiarrhythmics, tricyclics antidepressants, macrolides, antipsychotics) or in patients with risk factors for torsades de pointes (e.g. congenital long QT syndrome, uncorrected electrolyte imbalance such as hypokalaemia or hypomagnesaemia and cardiac disease such as heart failure, myocardial infarction, or bradycardia).

Antibiotic associated colitis.

Antibiotic associated colitis has been rarely reported with ciprofloxacin, but it should be considered in patients who develop diarrhoea.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including ciprofloxacin. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy such as oral antibacterial agents effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil), may prolong and/or worsen the condition and should not be used.

Effects on the liver.

Cases of hepatic necrosis and life threatening hepatic failure have been reported with ciprofloxacin. In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued (see Adverse Effects). There can be temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients with previous liver damage, who are treated with ciprofloxacin.

Effects on tendons.

Tendonitis and tendon ruptures (predominantly Achilles tendon), sometimes bilateral, that required surgical repair or resulted in prolonged disability have been reported with ciprofloxacin and other quinolones. This may occur even within the first 48 hours of treatment or up to several months after discontinuation of ciprofloxacin. Patients who are elderly or have had prior systemic treatment with corticosteroids are thought to be at particular risk. Ciprofloxacin should be used with caution in patients with a history of tendon disorders related to quinolone treatment. Therapy should be discontinued if the patient experiences any sign of tendonitis (e.g. painful swelling, inflammation) or rupture of a tendon. Care should be taken to keep the affected extremity at rest and avoid any inappropriate physical exercise due to the increased risk of tendon rupture.

Superinfections.

As with other broad spectrum antimicrobial agents, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Pseudomonas aeruginosa infections in cystic fibrosis

Although clinical improvement has been observed in patients with respiratory exacerbation of cystic fibrosis associated with Pseudomonas aeruginosa, bacterial eradication is usually not achieved. Resistance to ciprofloxacin has been shown to develop in a significant proportion of Pseudomonas aeruginosa infections in cystic fibrosis patients following a single course of the drug.

Anaphylactoid reactions.

In some instances, hypersensitivity and allergic reactions may occur following a single dose, a physician should be informed immediately.
Serious, and occasionally fatal, anaphylactoid reactions, some following the first dose, have been reported in patients receiving quinolones (including ciprofloxacin). In these cases ciprofloxacin should be discontinued and appropriate medical treatment given.

Phototoxicity.

Ciprofloxacin has been shown to be phototoxic in a number of in vitro and in vivo studies. Nalidixic acid the prototype quinolone antibiotic and other quinolone antibiotics, produce photosensitivity reactions. Patients taking ciprofloxacin should avoid direct exposure to sunlight. Therapy should be discontinued if photosensitisation occurs.

Effects on the CNS.

As with other quinolones, ciprofloxacin may cause central nervous system (CNS) stimulation which may lead to transient tremor, restlessness, lightheadedness, confusion, and very rarely to hallucinations or convulsive seizures. Ciprofloxacin should be used with caution in patients with CNS disorders, such as severe cerebral arteriosclerosis or epilepsy.
In some instances, the CNS reactions may occur even after the first administration of fluoroquinolones, including ciprofloxacin. In rare cases, depression or psychosis can progress to suicidal ideations/ thoughts and self injurious behavior, such as attempted or completed suicide. In the event that the patient develops any of these reactions, ciprofloxacin should be discontinued and appropriate measures instituted.

Nervous system.

Ciprofloxacin should be used with caution in patients with myasthenia gravis because symptoms can be exacerbated. Therefore, at any clinical sign or symptom of an exacerbation of myasthenia gravis, a physician should be consulted.
Cases of sensory or sensorimotor polyneuropathy resulting in parasthesias, hypoesthesias, dysethesias, or weakness have been reported in patients receiving fluoroquinolones including ciprofloxacin. Patients under treatment with ciprofloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness or weakness develop (see Adverse Effects).

Cytochrome P450.

Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 enzymes. Care should be taken when other drugs are administered concomitantly which are metabolized via the same enzymatic pathway (e.g. tizanidine, theophylline, methylxantines, caffeine, duloxetine, clozapine, olanzapine, ropinirole). Increased plasma concentrations associated with drug specific side effects may be observed due to inhibition of their metabolic clearance by ciprofloxacin (see also Interactions with Other Medicines).

Crystalluria.

The solubility of ciprofloxacin is pH dependent and is greatly reduced between pH 5 and 9. Crystals of ciprofloxacin have been observed in the urine of laboratory animals given high doses of the drug, but also in some patients receiving standard therapeutic doses. Crystalluria seems to occur under alkaline conditions of the urine and is less likely in nonvegetarians who usually have an acidic urine. Patients receiving ciprofloxacin should be well hydrated and alkalinity of the urine should be avoided. It should, however, be noted that the activity of ciprofloxacin is significantly reduced in acid media.

Epileptic patients.

Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower seizure threshold. Ciprofloxacin should be used with caution in epileptics and in patients who have suffered from previous CNS disorders (e.g. lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke). Ciprofloxacin should only be used where the benefits of treatment exceed the risks, since these patients are endangered because of possible central nervous side effects. Cases of status epilepticus have been reported. If seizures occur, ciprofloxacin should be discontinued.

Elderly patients.

Ciprofloxacin should be used with caution in the elderly after taking into account the severity of the illness and the creatinine clearance.

Impaired renal function.

Alteration of the dosage regimen is necessary for patients with impairment of renal function (see Dosage and Administration).

Use in pregnancy.

(Category B3)
Reproduction studies have been performed in rats and mice at doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and IV doses of up to 30 mg/kg and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally, 0.4 and 1.2 times the maximum daily human dose based upon body surface area, respectively) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, intrauterine deaths and fetal retardation, but no teratogenicity was observed at either dose. After intravenous administration, at doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit and no embryotoxicity or teratogenicity was observed. There are, however, no adequate and well controlled studies in pregnant women. Like other drugs in its class, ciprofloxacin causes arthropathy in immature animals.
Ciprofloxacin should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus (e.g. potential damage to articular cartilage in the immature fetal organism).

Use in lactation.

Ciprofloxacin is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from ciprofloxacin, a decision should be made to discontinue nursing or to avoid using the drug, taking into account the importance of the drug to the mother.

Paediatric use.

Ciprofloxacin is not recommended for use in prepubertal children, except for use in inhalation anthrax (postexposure). Toxicological studies have shown that ciprofloxacin and related drugs such as nalidixic acid and cinoxacin, can produce erosions of cartilage of weight bearing joints and other signs of arthropathy in immature animals of various species. Long-term safety data, including effects on cartilage, following the administration of ciprofloxacin to paediatric patients are limited.
The safety and effectiveness of ciprofloxacin in prepubertal children except for use in inhalational anthrax (postexposure) have not been established.

Mutagenicity.

Ciprofloxacin was mutagenic in the mouse lymphoma assay and the rat primary hepatocyte culture/ DNA repair assay in vitro, but not in other mammalian systems in vitro or in microbial systems.
In a small study on the chromosomal effects of ciprofloxacin on white blood cells, the drug did not exhibit any cytogenetic effect.

Carcinogenicity.

Carcinogenecity studies in mice (oral doses up to 1090 mg/kg/day and 1455 mg/kg/day in males and females, respectively; 1.4 and 1.8 times the highest recommended human dose of 1500 mg/day based upon body surface area) and rats (241 mg/kg/day and 328 mg/kg/day in males and females, respectively; 3.1 and 4.2 times the highest recommended human dose of 1500 mg/day based upon body surface area) showed no evidence of carcinogenicity.
Results from photo cocarcinogenicity testing indicate that ciprofloxacin does not reduce the time to appearance of UV induced skin tumours as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being administered ciprofloxacin. The time to development of the first skin tumours was 50 weeks in mice treated concomitantly with UVA and ciprofloxacin (mouse dose approximately equal to maximum recommended human dose based upon mg/m2), as opposed to 34 weeks when animals were treated with both UVA and vehicle. The times to development of skin tumours ranged from 16-32 weeks in mice treated concomitantly with UVA and other quinolones. In this model, mice treated with ciprofloxacin alone did not develop skin or systemic tumours. There are no data from similar models using pigmented mice and/or fully haired mice. The clinical significance of these findings to humans is unknown.

Effects on ability to drive and use machines.

Even when taken as prescribed, this drug can alter patients' responsiveness, impairing the ability to drive or operate machinery. This is even more applicable when the drug is taken in conjunction with alcohol.

Effect on laboratory tests.

Ciprofloxacin in vitro potency may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth, causing false negative results in specimens from patients currently taking ciprofloxacin.

Interactions

Drugs known to prolong QT interval.

Ciprofloxacin, like other fluoroquinolones should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).

Theophylline.

Concurrent administration of ciprofloxacin with theophylline may lead to elevated plasma concentrations of theophylline, and prolongation of its elimination half-life. This can lead to theophylline induced side effects; in very rare cases these side effects can be life threatening or fatal. If concomitant use cannot be avoided, the plasma levels of theophylline should be monitored and dosage adjustments made appropriately.

Omeprazole.

Concomitant administration of ciprofloxacin and omeprazole results in a slight reduction of Cmax and AUC of ciprofloxacin.

Probenecid.

Coadministration of probenecid with ciprofloxacin results in a 50% reduction in the ciprofloxacin renal clearance and a 50% increase in its AUC, without altering the peak concentration, time to peak and half-life of elimination.

Caffeine.

Quinolones have also been shown to interfere with the metabolism of caffeine. It may reduce the clearance of caffeine and prolong its plasma half-life. Patients are advised that ciprofloxacin may enhance the effects of caffeine.

Anticoagulants.

Quinolones, including ciprofloxacin, have been reported to enhance the effects of oral anticoagulants, warfarin or its derivatives. When these products are administered concomitantly, prothrombin time or other suitable coagulation tests should be closely monitored. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalised ratio) is difficult to assess.

Cyclosporin.

Some quinolones, including ciprofloxacin, have been associated with transient elevations of serum creatinine in patients receiving cyclosporin concomitantly. Therefore, it is frequently (twice a week) necessary to control the serum creatinine concentrations in these patients.

Metoclopramide.

Metoclopramide accelerates the absorption of ciprofloxacin resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of ciprofloxacin.

Oral antidiabetic agents.

Hypoglycaemia has been reported when ciprofloxacin and oral antidiabetic agents, mainly sulfonylureas (e.g. glibenclamide, glimepiride), were coadministered, presumably by intensifying the action of the oral antidiabetic agent.

Nonsteroidal anti-inflammatory drugs (NSAIDs).

Animal studies have shown that the combination of very high doses of quinolones (gyrase inhibitors) and certain nonsteroidal anti-inflammatory agents (but not acetylsalicylic acid) can provoke convulsions.

Other xanthine derivatives.

On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline) containing products, raised serum concentrations of these xanthine derivatives were reported.

Phenytoin.

Altered (decreased or increased) serum levels of phenytoin were observed in patients receiving ciprofloxacin and phenytoin simultaneously. To avoid the loss of seizure control associated with decreased phenytoin levels, and to prevent phenytoin overdose related adverse effects when ciprofloxacin is discontinued in patients receiving both agents, monitoring of phenytoin therapy, including phenytoin serum concentration measurements, is recommended during and shortly after coadministration of ciprofloxacin with phenytoin.

Methotrexate.

Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate. This might increase the risk of methotrexate associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.

Other.

Iron, sucralfate or highly buffered drugs (e.g. antiretrovirals), polymeric phosphate binders (e.g. sevelamer) and antacids containing magnesium, aluminium or calcium interfere with the absorption of ciprofloxacin; concurrent administration of these agents with ciprofloxacin should be avoided.

Tizanidine.

Tizanidine serum concentrations increase with concomitant administration with ciprofloxacin. Associated with the increased serum concentrations was a potentiated hypotensive and sedative effect. Tizanidine must not be administered together with ciprofloxacin (see Contraindications).

Duloxetine.

In clinical studies, it was demonstrated that concurrent use of duloxetine with strong inhibitors of the CYP450 1A2 isoenzyme such as fluvoxamine, may result in an increase of AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration.

Ropinirole.

In a clinical study it was shown that concomitant use of ropinirole with ciprofloxacin, a medium inhibitor of the CYP450 1A2 isozyme, resulted in increases in the Cmax and AUC of ropinirole of 60% and 84%, respectively. Although ropinirole treatment was well tolerated, case reports suggest that a possible interaction with ciprofloxacin associated with side effects may occur upon concomitant administration. Ropinirole related side effects should be monitored during and shortly after coadministration with ciprofloxacin; dose adjustment is recommended if necessary.

Lidocaine.

It was demonstrated in healthy subjects that concomitant use of lidocaine with ciprofloxacin, a moderate inhibitor of CYP450 1A2 isozyme, reduces clearance of intravenous lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with ciprofloxacin associated with side effects may occur upon concomitant administration.

Clozapine.

Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after coadministration with ciprofloxacin are advised.

Sildenafil.

Cmax and AUC of sildenafil were increased approximately twofold in healthy subjects after an oral dose of 50 mg given concomitantly with 500 mg ciprofloxacin. Therefore, caution should be used prescribing ciprofloxacin concomitantly with sildenafil taking into consideration the risks and the benefits.

Adverse Effects

Adverse drug reactions (ADRs) based on all clinical studies with ciprofloxacin (oral, parenteral) sorted by CIOMS III categories of frequency are listed below (overall n = 51,721, data lock point: 15 May 2005).
Common ≥ 1% to < 10%; uncommon ≥ 0.1% to < 1%; rare ≥ 0.01% to < 0.1%; very rare < 0.01%.

Infections and infestations.

Uncommon: mycotic superinfections. Rare: antibiotic associated colitis (very rarely with possible fatal outcome).

Blood and lymphatic system disorders.

Uncommon: eosinophilia. Rare: leukopaenia, anaemia, neutropaenia, leukocytosis, thrombocytopaenia, thrombocytaemia. Very rare: haemolytic anaemia, agranulocytosis, pancytopaenia (life threatening); bone marrow depression (life threatening).

Immune system disorders.

Rare: allergic reaction, allergic oedema/ angioedema. Very rare: anaphylactic reaction, anaphylactic shock (life threatening), serum sickness-like reaction.

Metabolism and nutrition disorders.

Uncommon: decreased appetite and food intake. Rare: hyperglycemia, hypoglycemia.

Psychiatric disorders.

Uncommon: psychomotor hyperactivity/ agitation. Rare: confusion and disorientation, anxiety reaction, abnormal dreams, depression (potentially culminating in self injurious behavior, such as suicidal ideations/ thoughts and attempted or completed suicide), hallucinations. Very rare: psychotic reactions (potentially culminating in self injurious behavior, such as suicidal ideations/ thoughts and attempted or completed suicide).

Nervous system disorders.

Uncommon: headache, dizziness, sleep disorders, taste disorders. Rare: paraesthesia and dysaesthesia, hypoaesthesia, tremor, seizures (including status epilepticus), vertigo. Very rare: migraine, disturbed coordination, smell disorders, hyperesthesia, intracranial hypertension (pseudotumour cerebri).

Eye disorders.

Rare: visual disturbances. Very rare: visual color distortions.

Ear and labyrinth disorders.

Rare: tinnitus, hearing loss. Very rare: hearing impaired.

Cardiac disorders.

Rare: tachycardia.

Vascular disorders.

Rare: vasodilatation, hypotension, syncope. Very rare: vasculitis.

Respiratory, thoracic and mediastinal disorders.

Rare: dyspnoea (including asthmatic condition).

Gastrointestinal disorders.

Common: nausea, diarrhoea. Uncommon: vomiting, gastrointestinal and abdominal pains, dyspepsia, flatulence. Very rare: pancreatitis.

Hepatobiliary disorders.

Uncommon: increase in transaminases, increased bilirubin. Rare: hepatic impairment, jaundice hepatitis (noninfective). Very rare: liver necrosis (very rarely progressing to life threatening hepatic failure).

Skin and subcutaneous tissue disorders.

Uncommon: rash, pruritus, urticaria. Rare: photosensitivity reactions, blistering. Very rare: petechiae, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome (potentially life threatening), toxic epidermal necrolysis (potentially life threatening).

Musculoskeletal, connective tissue and bone disorders.

Uncommon: arthralgia. Rare: myalgia, arthritis, increased muscle tone and cramping. Very rare: muscular weakness, tendonitis, tendon rupture (predominantly Achilles tendon), exacerbation of symptoms of myasthenia gravis.

Renal and urinary disorders.

Uncommon: renal impairment. Rare: renal failure, haematuria, crystalluria, tubulointerstitial nephritis.

General disorders and administration site conditions.

Common: injection and infusion site reactions (only intravenous administration). Uncommon: unspecific pain, feeling unwell, fever. Rare: oedema, sweating (hyperhidrosis). Very rare: gait disturbance.

Investigations.

Uncommon: increase in blood alkaline phosphatase. Rare: prothrombin level abnormal, increased amylase.

Note.

The incidence of arthropathy, mentioned above, refers to data collected in studies with adults. In children, arthropathy is reported to occur commonly.
ADRs derived from postmarketing reports (status: 31 July 2005) for which a frequency could not be estimated are listed below.

Blood and lymphatic system disorders.

Pancytopaenia (life threatening), bone marrow depression (life threatening).

Immune system disorders.

Serum sickness-like reaction, anaphylactic shock (life threatening).

Nervous system disorders.

Hyperesthesia, intracranial hypertension, peripheral neuropathy and polyneuropathy.

Cardiac disorders.

QT prolongation, ventricular arrhythmia, torsades de pointes*.

Hepatobiliary disorders.

Liver necrosis (very rarely progressing to life threatening hepatic failure).

Skin and subcutaneous tissue disorders.

Erythema nodosum, Stevens-Johnson syndrome (potentially life threatening), toxic epidermal necrolysis (potentially life threatening), acute generalised exanthematous pustulosis (AGEP).

Musculoskeletal, connective tissue and bone disorders.

Exacerbation of symptoms of myasthenia gravis.

General disorders and administration site conditions.

Gait disturbance.

Investigations.

International normalised ratio (INR) increased (in patients treated with vitamin K antagonists).
*These events were reported during the postmarketing period and were observed predominantly among patients with further risk factors for QT prolongation (see Precautions).
The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment.
Common: vomiting, transient increase in transaminases, rash.
Uncommon: thrombocytopenia, thrombocytaemia, confusion and disorientation, hallucinations, paraesthesia and dysaesthesia, seizures, vertigo, visual disturbances, hearing loss, tachycardia, vasodilatation, hypotension, transient hepatic impairment, jaundice, renal failure, oedema.
Rare: pancytopenia, bone marrow depression, anaphylactic shock, psychotic reactions, migraine, smell disorders, hearing impaired, vasculitis, pancreatitis, liver necrosis, petechiae, tendon rupture.

Dosage and Administration

Urinary tract infections.

The usual adult dosage is 250 mg every 12 hours. For patients with complicated infections caused by organisms not highly susceptible, such as Enterococcus faecalis, 500 mg may be administered every 12 hours.

Bronchial infections, skin and skin structure infections.

The usual dose is 500 mg every 12 hours. For more severe or complicated infections, a dosage of 750 mg may be given every 12 hours.

Bone and joint infections.

750 mg every 12 hours.

Gastroenteritis (infectious diarrhoea).

500 mg every 12 hours.

Acute, uncomplicated gonorrhoeal urethritis.

A single dose of 250 mg.

Chronic bacterial prostatitis.

250 to 500 mg every 12 hours.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host defence mechanisms, and the status of renal function.
Because Gram positive organisms are generally less sensitive than Gram negative organisms, the use of higher doses should be considered in patients with Gram positive infections. In such cases 8 hourly administration of 500 mg ciprofloxacin may be preferable.

Duration.

The duration of treatment depends upon the severity of infection. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration is 7 to 14 days, however for severe and complicated infections more prolonged therapy may be required. Bone and joint infections may require treatment for 4 to 6 weeks or longer. Gastrointestinal infections (infectious diarrhoea) need treatment for only 5 days. Chronic bacterial prostatitis should be treated for 14 to 28 days.
In certain deep seated infections involving abscess formation, appropriate surgical drainage should be performed in conjunction with antimicrobial therapy.

Impaired renal function.

Dosage adjustments for patients with creatinine clearance between 31-60 mL/min/1.73 m2 the maximum daily dose should be 1000 mg/day for oral administration. For creatinine clearance equal or less than 30 mL/min/1.73 m2, the maximum daily dose should be 500 mg/day for oral administration.
When only data for serum creatinine are available, the following formula (Cockroft's equation) may be used to estimate creatinine clearance.

Overdosage

In the event of acute, excessive oral overdosage, reversible renal toxicity has been reported in some cases. Therefore, apart from routine emergency measures, it is recommended to monitor renal function and administer Mg or Ca containing antacids, which reduce the absorption of ciprofloxacin.
Only a small amount of ciprofloxacin (< 10%) is removed from the body after haemodialysis or peritoneal dialysis.
Contact the Poison Information Centre on 131 126 (Australia) for advice on the management of overdosage.

Presentation

Tablets (white to off white, film coated, plain on reverse), ciprofloxacin hydrochloride ≡ ciprofloxacin 250 mg (round, marked 250), 500 mg (caplet shaped, marked 500), 750 mg (caplet shaped, marked 750): 14's (PVC/PVdC/Al blister pack).

Storage

Store below 25°C. Protect from light and moisture.

Poison Schedule

S4.