Levofloxacin Solution

LEVOFLOXACIN BIOTECH contains a medicine called levofloxacin. This belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic. It works by killing the bacteria that causes infections in your body.

LEVOFLOXACIN BIOTECH may be used to treat the following:

• Infection of the sinuses (sinusitis).
• Infections of the lungs (chronic bronchitis or pneumonitis).
• Infection of prostate gland, where you have a long-lasting infection.
• Urinary tract infections, including your kidneys or bladder.
• Infections of the skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’.
• Infections in the stomach (intra-abdominal infections).

Do not use LEVOFLOXACIN BIOTECH if:

• You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or any of the other ingredients of LEVOFLOXACIN BIOTECH (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have ever had convulsion.
• You have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your skeleton.
• You are a child or growing adolescent.
• You are pregnant, might become pregnant, or think you might be pregnant.
• You are breastfeeding.
• Your heart's mitral valve or aortic valve doesn't close tightly, allowing blood to flow backward in your heart.
• You are on treatment for high blood pressure with medicines called angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs).

Warnings and precautions: You should not take fluoroquinolone/quinolone antibacterial medicines, including receiving levofloxacin, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

Talk to your doctor, nurse or pharmacist before you receive LEVOFLOXACIN BIOTECH:

• If you are 60 years of age or older.
• If you are using corticosteroids, sometimes called steroids.
• If you have ever had a fit (seizure).
• If you have had damage to your brain due to a stroke or other brain injury.
• If you have kidney problems.
• If you have something known as glucose 6-phosphate dehydrogenase (G6PD) deficiency (a rare hereditary disease). You are more likely to have serious problems with your blood when receiving LEVOFLOXACIN BIOTECH.
• If you have ever had mental health problems.
• If you have ever had heart problems: caution should be taken when using this kind of medicine, if you were born with or any member of your family has had (family history of) prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), 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 been diagnosed with an enlargement or bulge of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
• If you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
• If you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis).
• If you are diabetic.
• If you have ever had liver problems.
• If you have myasthenia gravis.
• If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.
• Caution should be taken while taking medicine from the group ACE inhibitors/ARBs (types of antihypertensive medicines) and fluoroquinolone, including levofloxacin, as there is risk of acute kidney injury with concomitant use of both medicine groups.
• You should not take fluoroquinolone/quinolone antibacterial medicines, including levofloxacin, if your heart's mitral valve or aortic valve doesn't close tightly. A thorough cardiovascular examination including electrocardiogram should be performed before consuming fluoroquinolone/quinolone class of medicines.

LEVOFLOXACIN BIOTECH 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 LEVOFLOXACIN 250 BIOTECH, the infusion time should be 30 minutes or more.
• For LEVOFLOXACIN 500 BIOTECH, 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 BIOTECH is given:

• If you are not sure why you are being given LEVOFLOXACIN BIOTECH or have any questions about how much LEVOFLOXACIN BIOTECH is being given to you, speak to your doctor, nurse or pharmacist.
• Your doctor will decide on how much levofloxacin 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.

Adults and the elderly:

• Sinusitis: 500 mg once daily for 10 days
• Acute exacerbation of chronic bronchitis: 500 mg once daily for 5 - 10 days
• Pneumonia: 500 mg once or twice daily for 10 - 14 days
• Prostatitis: 500 mg once a day for 28 days.
• Complicated urinary tract infections and acute pyelonephritis: 250 mg once daily for 10 days
• Uncomplicated urinary tract infections in women: 250 mg once daily for 3 days
• Complicated skin and skin structure infections: 500 mg twice daily for 10 - 14 days
• Intra-abdominal infections: 500 mg once daily in combination with an antibiotic with anaerobic coverage for 10 - 14 days.

Above indications when bacteraemia or septicaemia is present: 500 mg twice daily for 10 - 14 days.

If you have kidney problems: Your doctor may need to give you a lower dose.

If you are elderly or have liver problems: Your doctor does not need to adjust the dose.

Protect your skin from sunlight: Keep out of direct sunlight while using LEVOFLOXACIN BIOTECH and for 2 days after stopping. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:

• Make sure you use high factor sun cream.
• Always wear hat and clothes which cover your arms and legs.
• Avoid sun beds.

If you receive more LEVOFLOXACIN BIOTECH than you should: It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine. Receiving too much LEVOFLOXACIN BIOTECH may cause the following effects to happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, having tremor and heart problems – leading to uneven heart beats as well as feeling sick (nausea).

If you miss a dose of LEVOFLOXACIN BIOTECH: Since a health care provider will have instructions on when to give you this medicine, it is unlikely that you will not be given LEVOFLOXACIN BIOTECH as it has been prescribed. However, if you do think you have missed a dose, tell your health care provider.

If you stop receiving LEVOFLOXACIN BIOTECH: Your health care provider will continue giving you LEVOFLOXACIN BIOTECH, even if you feel better. If it is stopped too soon, your condition may get worse or the bacteria may become resistant to LEVOFLOXACIN BIOTECH. After a few days treatment with the solution for infusion, your doctor may decide to switch you to a tablet form of levofloxacin to complete your course of treatment.

LEVOFLOXACIN BIOTECH can have side effects. Not all side effects reported for LEVOFLOXACIN BIOTECH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving LEVOFLOXACIN BIOTECH, please consult your health care professional for advice.

If any of the following happens, stop administration of LEVOFLOXACIN BIOTECH and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. These are all very serious side effects. If you have them, you may have had a serious reaction to LEVOFLOXACIN BIOTECH. You may need urgent medical attention.
• Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• Watery diarrhoea which may have blood in it, possibly with stomach cramps and a high temperature. These could be signs of a severe bowel problem.
• Pain and inflammation in your tendons or ligaments which could lead to rupture. The Achilles tendon is affected most often.
• Fits (convulsions).
• Burning, tingling, pain, or numbness. These may be signs of something called neuropathy.
• Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the liver.
• Persistent headache with or without blurred vision (benign intracranial hypertension).
• Increase of your blood sugar levels (hyperglycaemia) or lowering of your blood sugar levels (hypoglycaemia) leading to coma (hypoglycaemic coma). This is important for people that have diabetes.
• Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions.
• Unusual fast beating of your heart (tachycardia).
• Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, alteration of the heart rhythm (called prolongation of QT interval, seen on ECG, electrical activity of the heart).
• Shortness of breath (dyspnoea) or difficulty breathing or wheezing (bronchospasm).
• If your eyesight becomes impaired or if you have any other eye disturbances whilst taking LEVOFLOXACIN BIOTECH, consult an eye specialist immediately.
• Pancreatitis, inflammation of the liver (hepatitis).
• Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis.
• Muscle weakness. This is important in people with myasthenia gravis (a disease of the nervous system).
• Muscle rupture and muscle destruction (rhabdomyolysis). These are all serious side effects. You may need urgent medical attention.

Tell your doctor immediately if you notice any of the following:

Frequent side effects:

• Sleeping problems.
• Headache, feeling dizzy.
• Feeling sick (nausea, vomiting) and diarrhoea.
• Increase in the level of some liver enzymes in your blood.
• Reactions at the site of infusion.
• Inflammation of a vein.

Less frequent side effects:

• Infection by fungi named Candida (yeast infections) and resistance of certain microorganisms.
• Changes in the number of white blood cells (leukopenia, eosinophilia, neutropenia, agranulocytosis). This may result in fever, sore throat and a general feeling of being unwell that does not go away.
• Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia).
• Loss of appetite (anorexia).
• Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy, trembling, a spinning feeling (vertigo).
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares.
• Changes in the way things smell or taste, loss of smell or taste (parosmia, anosmia, dysgeusia, ageusia).
• Tingly feeling in your hands and feet (paraesthesia).
• Problems with eyesight (blurred vision) or temporary loss of vision.
• Problems with your hearing (tinnitus), impairment or loss of hearing.
• Low blood pressure (hypotension).
• Loss of appetite, stomach upset or indigestion (dyspepsia), pain in your stomach area, feeling bloated (flatulence) or constipation.
• Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine increased) problems.
• Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis).
• Joint pain or muscle pain.

Side effect of unknown frequency:

• Lowering in red blood cells (anaemia): this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia).
• Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).
• Temporary loss of consciousness or posture (syncope).
• Problems moving and walking (dyskinesia, extrapyramidal disorders).
• Joint redness and swelling (arthritis).
• Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis).
• Inflammation of the tissue inside the mouth (stomatitis).
• Pain, including pain in the back, chest and extremities.
• Attacks of porphyria in people who already have porphyria (a metabolic disease).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LEVOFLOXACIN BIOTECH.

Store at or below 25 °C. Keep container in the outer carton to protect from light. Do not use after expiry date stated on the carton. Any unused solution must be discarded. Do not dispose of unused medicine in drains or sewerage systems; return them to your doctor or pharmacist.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN