LEVOFLOXACIN 5 MG/ML SOLUTION FOR INFUSION

Active substance: LEVOFLOXACIN HEMIHYDRATE

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Package leaflet: Information for the patient
Levofloxacin 5 mg/ml Solution for infusion
Levofloxacin
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

What is in this leaflet
1.
What Levofloxacin Solution for infusion is and what it is used for
2.
Before you are given Levofloxacin Solution for infusion
3.
How you will be given Levofloxacin Solution for infusion
4.
Possible side effects
5.
How to store Levofloxacin Solution for infusion
6.
Contents of the pack and other information
1. What Levofloxacin Solution for infusion is and what it is used for
The active ingredient in the solution is levofloxacin. Levofloxacin belongs to a group of
medicines known as fluoroquinolone antibiotics, which kill bacteria.
Levofloxacin Solution for infusion is used to treat infections caused by sensitive bacteria.
Your doctor will have decided if your infection can be treated with this medicine. Some
infections, which the solution can be used to treat, are infections of the:
• lungs, in people with pneumonia.
• urinary tract, including your kidneys or bladder.
• prostate gland, where you have a long lasting infection.
• skin and underneath the skin, including muscles. This is sometimes called “soft tissue”.

2. Before you are given Levofloxacin Solution for infusion
Do not have this medicine and tell your doctor if you
• are allergic (hypersensitive) to levofloxacin, any other quinolone antibiotic such as
moxifloxacin, ciprofloxacin or ofloxacin or to any of the other ingredients of the
medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat or tongue.
• have ever had epilepsy. Otherwise, your risk of getting “fits” (convulsions) is increased.
• had ever had tendon problems (e.g. tendonitis) related to treatment with a drug that
belongs to the same class of antibiotics (i.e. fluoroquinolones).
• are pregnant, might become pregnant, or think you may be pregnant.
• are breast-feeding.
• are a child or growing teenager up to 18 years of age. It could harm the cartilage of the
growing bones. The solution is only intended for adults.
Do not have this medicine if any of the above applies to you. If you are not sure, talk to
your doctor, nurse or pharmacist before you are given Levofloxacin Solution for infusion.
Tell your doctor if you have had any problems with taking medicines in the past.
Take special care with Levofloxacin Solution for infusion
• if you are 65 years of age or older.
• if you are using corticosteroids, sometimes called steroids (see Taking other
medicines).
• if you have experienced “fits” or brain damage in the past (such as stroke or severe
brain injury). Make sure your doctor knows about your medical history, so he can give
you appropriate advice.
• when you are exposed to sunlight or UV light. Do not stay out in strong sunlight for
unnecessarily long periods and do not use a sun-lamp or solarium. Your skin may
become more sensitive to light while using this medicine (may cause sunburn–like
reactions).
• if you get pain or inflammation in your tendons. If you experience any tendon
complaints during or shortly after receiving this medicine you should seek medical
advice immediately and rest the affected limb to avoid tendon damage. Do not take the
next dose unless your doctor tells you to.
• if you have severe, persistent and/or bloody diarrhoea during or after treatment with
this medicine. This may be a sign of serious bowel inflammation (pseudomembranous
colitis) which can occur following treatment with antibiotics. Tell your doctor
immediately. It may be necessary to stop treatment and start specific therapy.
• if you have a family history of or have an actual defect in the liver enzyme called
glucose- 6-phosphate dehydrogenase (G6PD) (a rare hereditary disease). Patients
with G6PD deficiency may be prone to destruction of red blood cells (haemolysis)
when treated with quinolone antibacterial agents.

• if you suffer from kidney problems. Patients with reduced kidney activity (renal
insufficiency) may need lower doses than patients with normal kidney activity.
• if you are taking any drugs which thin the blood (known as anti–coagulants e.g.
warfarin).
• if you have a history of psychiatric disease or mental health problems. Tell your
doctor immediately if you experience a psychotic reaction.
• if you are diabetic.
• if you have ever had heart problems.
• if you were born with or have family history of prolonged QT interval (seen on ECG,
electrical recording of the heart).
• if you have salt imbalance in the blood (especially low level of potassium or
magnesium in the blood)
• if you have a very slow heart rhythm (called ‘bradycardia’).
• if you have a weak heart (heart failure).
• if you have a history of heart attack (myocardial infarction).
• if you are female or elderly or you are taking other medicines that result in abnormal
ECG changes (see section Taking other medicines).
• if you have ever had liver problems.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or
pharmacist before being given Levofloxacin Solution for infusion.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. Some medicines can
interfere with your treatment or alter blood levels of those drugs you are currently taking,
so make sure to check with your doctor or pharmacist before taking any other
medications whether prescribed by a doctor or bought by you over the counter. In
particular tell your doctor if you are taking any of the following:
• Vitamin K antagonists such as warfarin in combination with Levofloxacin Solution for
infusion may lead to an increase in bleeding.
• Non-steroidal anti-inflammatory drugs
(NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen,
fenbufen, ketoprofen and indomethacin. The risk of getting a fit (seizure) may be
increased.
• Theophylline – used for breathing problems. The risk of getting a fit (seizure) may be
increased.
• Probenecid (used to prevent gout) or cimetidine (used to treat ulcers) reduce your
kidneys’ ability to get rid of levofloxacin.
• Ciclosporin (used to treat psoriasis, dermatitis, rheumatism or after organ transplants).
The effect of ciclosporin may be prolonged if used in combination with Levofloxacin
Solution for infusion. You may also be more likely to get the side effects of ciclosporin.
• Corticosteroids, sometimes called steroids. You may be more likely to have
inflammation and/or breakage of your tendons.
• Medicines known to affect the way your heart beats. This includes medicines used for
abnormal heart rhythm (anti-arrhythmics such as quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide and ibutilide ), for depression (tricyclic

antidepressants such as amitriptyline and imipramine), for bacterial infections
(“macrolide” antibiotics such as erythromycin, azithromycine and clarithromycin) and
some antipscyhotics.
Urine tests for opiates
Urine tests may show “false-positive” results for strong painkillers called “opiates” in
people taking Levofloxacin Solution for infusion. If your doctor is due to take a urine
test, tell him you are having Levofloxacin Solution for infusion.
Pregnancy and Breast-feeding
Do not have Levofloxacin Solution for infusion if you
• are pregnant, might become pregnant or think you might be pregnant.
• are breast-feeding a baby or planning to breastfeed. It could harm your baby.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant
or breastfeeding.
Driving and using machines
Some side-effects like dizziness, drowsiness and visual disturbances may impair your
ability to concentrate and react. Do not drive, operate dangerous machinery or have
similar activities if you feel that your ability to concentrate and react is impaired.
Important information about some of the ingredients of Levofloxacin Solution for
infusion
Levofloxacin Solution for infusion contains approximately 354 mg of sodium per
maximum dose of 500 mg levofloxacin. This should be taken into consideration by
patients on a controlled sodium diet and in cases where fluid restriction is required.
3. How Levofloxacin Solution for infusion is given to you
Levofloxacin Solution for infusion is a medicine for use in hospitals. It will be given to
you by a doctor or nurse as an injection. The injection will be into one of your veins and
be given over a period of time (this is called an intravenous infusion).
For 250 mg Levofloxacin Solution for infusion, the infusion time should be 30 minutes or
more.
For 500 mg Levofloxacin Solution for infusion, the infusion time should be 60 minutes or
more. Your heart rate and blood pressure should be closely monitored. This is because an
unusual fast beating of the heart and a temporary lowering of blood pressure are possible
side effects that have been seen during the infusion of a similar antibiotic. If your blood
pressure drops noticeably while you are being given the infusion, it will be stopped
straight away.
How much Levofloxacin Solution for infusion is given
Your doctor will decide on how much Levofloxacin Solution for infusion you should
have. The dose will depend on the type of infection you have and where the infection is

in your body. The length of your treatment will depend on how serious your infection is.
The usual doses are given below.
Adults and the elderly:
Pneumonia: 500mg once or twice daily.
Urinary tract, including your kidneys or bladder: 250mg once daily (the dose can be
increased in cases of severe infection).
Prostate gland: 500mg once daily.
Skin and underneath the skin, including muscles: 500mg twice daily.
Adults with kidney problems:
Your doctor may need to give you a lower dose.
Children and Teenagers:
This medicine must not be given to children or teenagers up to 18 years of age.
If you have more Levofloxacin Solution for infusion than you should
Your doctor or nurse will ensure that you will receive the correct dose into the vein.
Symptoms of an accidental overdose might result in central nervous system symptoms
such as confusion, dizziness, impairment of consciousness, and (convulsive) fits and
heart disorders, possibly leading to abnormal heart rhythm. Consult your doctor if you
think you have been administered more Levofloxacin Solution for infusion than you
should.
If you miss a dose of Levofloxacin Solution for infusion
If you think that you may have missed a dose talk to your doctor or nurse. You should not
have a double dose to make up for a forgotten dose.
If you stop having Levofloxacin Solution for infusion
Your doctor may decide to stop treatment into a vein and ask you to continue treatment
with Levofloxacin Tablets. If you still feel unwell at the end of your prescribed course of
treatment, tell your doctor.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all other medicines Levofloxacin Solution for infusion can cause side effects
although not everybody gets them.
Severe allergic reaction is a very rare side effect of Levofloxacin Solution for infusion.
The signs may include a rash, swallowing or breathing problems, swelling of your lips,
face, throat or tongue. If you experience any of these signs, tell your doctor or nursing
staff immediately.
The following side effects have been observed with use of this medicine, arranged
according to frequency:
Common side effects (affects 1 to 10 users in 100):
• Feeling sick (nausea), diarrhoea
• Increase in blood levels of liver enzymes

• Reactions at the site of infusion
• Inflammation of a vein.
Uncommon side effects (affects 1 to 10 users in 1,000):
• Itching and rash
• Loss of appetite, stomach upset or indigestion (dyspepsia), vomiting or pain in the
stomach area, feeling bloated (flatulence), constipation
• Headache, dizziness, a spinning feeling (vertigo), drowsiness, sleeping problems,
nervousness
• Increase or decrease in the number of white blood cells
• Blood tests may show unusual results due to liver or kidney problems
• General weakness. Any antibacterial treatment that kills certain germs may lead to a
disturbance of the micro-organisms (bacteria/ fungi) that are normally found in humans.
Consequently, the number of other bacteria or fungi may increase, which in rare cases
requires treatment.
Rare side effects (affects 1 to 10 users in 10,000):
• Bloody diarrhoea which in very rare cases may be indicative of enterocolitis
(inflammation of the bowel), including pseudomembranous colitis (inflammation of
the large intestine)
• Feeling a tingling sensation, e.g. in the hands (paraesthesia), trembling, “fits”
(convulsions) and confusion
• Anxiety, depression, psychotic reactions, restlessness (agitation)
• Abnormally rapid beating of the heart, abnormally low blood pressure
• Tendon pain and inflammation (tendonitis), joint pain or muscle pain
• Decrease in the number of blood platelets leading to tendency to bruise and bleed
easily, low number of white blood cells (called neutropenia)
• Difficulty breathing or wheezing (bronchospasm)
• Shortness of breath (dyspnoea)
• Severe itching, hives (called urticaria).
Very rare side effects (affects less than 1 user in 10,000):
• Severe allergic reaction. The signs may include a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
• Sudden drop in blood pressure or collapse (shock), increased sensitivity of the skin to
sun and ultraviolet light
• Decrease in blood sugar to a too low level (hypoglycaemia) which may be of special
importance in patients treated for diabetes
• Vision and hearing disorders, disturbances of taste and smell
• Burning, tingling, pain or numbness. These may be signs of something called
“neuropathy”
• Hallucinations, psychotic reactions with risk of suicidal thoughts or actions
• Circulatory collapse (anaphylactic like shock)
• Tendon rupture (e.g. Achilles tendon), which may occur within 48 hours after starting
treatment and may be bilateral, muscular weakness, which may be of special
importance in patients with myasthenia gravis (a rare disease of the nervous system)

• Severe decrease in the number of white blood cells (agranulocytosis) leading to
symptoms such as recurrence or persistence of fever, sore throat and feeling more ill
again
• Inflammation of the liver, disturbances of kidney function and occasional kidney failure
due to allergic kidney reactions (interstitial nephritis)
• Fever
• Allergic lung reactions.
Not known (frequency cannot be estimated from the available data):
• Severe blistering reactions of the skin and mucous membranes (Steven’s Johnson
syndrome), toxic epidermal necrolysis (Lyells’ syndrome) and erythema exsudativum
multiforme. Muco-cutaneous (e.g. hives or flushing) may sometimes occur even after the
first dose
• Heart disorders
•Abnormal fast heart rhythm
• Life-threatening irregular heart rhythm
• Alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG,
electrical activity of the heart)
• Muscle reactions with muscle cell damage (rhabdomyolysis)
• Decrease in red blood cells (anaemia) due to blood cell damage, decrease in the number
of all types of blood cells
• Yellowing of the skin or whites of the eyes (jaundice)
• Severe liver injury, including cases with acute liver failure, have been reported with
levofloxacin, primarily in patients with severe underlying diseases
• Sweating too much (hyperhidrosis)
• Pain, including pain in the back, chest and extremities
• Ringing or buzzing in the ears (tinnitus)
• Exaggerated immune response (hypersensitivity).
Other undesirable effects which have been associated with fluoroquinolone
administration include:
• Extrapyramidal (neurological) symptoms and other disorders of muscular coordination
• Hypersensitivity vasculitis (inflammation of small blood vessels)
• Attacks of porphyria in patients with porphyria (a very rare metabolic disease).
If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell you doctor or your pharmacist.
5. How to store Levofloxacin Solution for infusion
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the labelling as “EXP”. The
expiry date refers to the last day of that month.
Do not freeze.

Keep bottle/bag in the outer carton/over wrap pouch in order to protect from light and
remove only immediately prior to use. No protection from light is required during
infusion.
Once the infusion has been opened (rubber stopper perforated) the solution should be
used immediately (within 3 hours) in order to prevent any bacterial contamination.
Only clear solutions practically free from particles should be used. Do not use if
container is damaged.
Discard any unused solution.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Levofloxacin Solution for infusion contains
The active substance ingredient is levofloxacin (as levofloxacin hemihydrate). Each ml of
solution for infusion contains 5 mg of levofloxacin. Each 100 ml of solution for infusion
contains 500 mg of levofloxacin.
The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment),
hydrochloric acid (for pH adjustment) and water for injections
What Levofloxacin Solution for infusion looks like and the contents of the pack:
Levofloxacin 5 mg/ml Solution for infusion is a clear, yellow to greenish-yellow solution.
The solution is available in a 100 ml glass bottle closed with a rubber stopper and flip off
seal and in 100 ml Non PVC bag.
The 100 ml bottles are available in packs of 1, 5 and 10.
The 100 ml bags are available in packs of 1, 5 and 10.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Manufacturer

Pfizer Service Company BVBA
Hoge Wei 10-B-1930 Zaventem
Belgium

This leaflet was last revised in 07/2012.
<---------------------------------------------------------------------------------------------------------
Levofloxacin 5 mg/ml Solution for infusion
Method of Administration
This medicine is intended exclusively for the slow intravenous infusion once or twice
daily.
Duration of Treatment
The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg
Levofloxacin Solution for infusion.
The following dose recommendations can be given for Levofloxacin Solution for
infusion:
Dosage in patients with normal renal function (creatinine clearance > 50 ml/min)
Indication
Community acquired pneumonia
Complicated urinary tract infections
including pyelonephritis
Chronic bacterial prostatitis
Skin and soft tissue infections

Daily dose schema (according to severity)
500 mg once or twice a day
250 mg once a day*
500 mg once daily
500 mg twice daily

*Consideration should be given to increasing the dose in cases of severe infection and
special attention should be paid to available information on resistance to levofloxacin
before commencing therapy. Because of the increasing E.coli resistance the dose 500
mg/day should be considered.
Dosage in patients with impaired renal function (creatinine-clearance ≤ 50 ml / min)
Dose regimen
250 mg/24 h
500 mg/24 h
500 mg/12 h
first dose: 250 mg
first dose: 500 mg
first dose: 500 mg
Creatinine
clearance
50 - 20 ml/min
then: 125 mg/24 h
then: 250 mg/24 h
then : 250 mg/12 h
19 - 10 ml/min
then: 125 mg/48 h
then: 125 mg/24 h
then: 125 mg/12 h
<
10
ml/mi then: 125 mg/48 h
then: 125 mg/24 h
then: 125 mg/24 h

Page 9 of 10

28-May-12

Version 03

(including
haemodialysis
and
CAPD) 1
1
No additional doses are required after haemodialysis or continuous ambulatory
peritoneal dialysis (CAPD).
For further information, see section 3 “How you will be given Levofloxacin Solution for
infusion”
Mixture with other solutions for infusion
This medicine is compatible with the following solutions for infusion:
0.9 % sodium chloride solution USP
5 % dextrose injection USP
2.5 % dextrose in Ringer solution
Combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).
Incompatibilities
Levofloxacin Solution for infusion should not be mixed with heparin or alkaline solutions
(e.g. sodium hydrogen carbonate).
Special precautions for the disposal and other handling
From a microbiological point of view, the solution for infusion should be used
immediately. If not used immediately, in-use storage times and conditions are the
responsibility of the user (refer to section 5 “How to store Levofloxacin Solution for
infusion”).
As for all medicines, any unused medicinal product should be disposed of accordingly
and in compliance with local environmental regulations.
Information about storage
See section 5 "How to store Levofloxacin Solution for infusion".

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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.

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