Levofloxacin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

LEVOFLOXACIN tablets are from a group of antibiotics known as quinolones. LEVOFLOXACIN is used to treat adults with certain lung, sinus, skin and urinary tract infections caused by certain germs called bacteria.

What it does:

Levofloxacin tablets has been shown, in a large number of clinical trials, to be effective for the treatment of bacterial infections. Levofloxacin interferes with bacterial enzymes to prevent bacterial growth, thereby killing many types of bacteria that can infect the with lungs, sinus, skin, and urinary tract.

Sometimes, viruses rather than bacteria may infect the lungs and sinuses (for example, the common cold). LEVOFLOXACIN tablets, like other antibiotics, does not kill viruses.

When it should not be used:

You should not take LEVOFLOXACIN tablets if you have had an allergic reaction to any of the group of antibiotics known as quinolones, or to any of the nonmedicinal ingredients (see What the nonmedicinal ingredients are). This includes antibiotics such as ofloxacin, ciprofloxacin, moxifloxacin hydrochloride, gatifloxacin and norfloxacin. If you have had any reaction to quinolones, you should discuss this with your doctor.

You should not take LEVOFLOXACIN if you have had tendinitis or tendon rupture while taking quinolone antibiotics.

What the medicinal ingredient is:

LEVOFLOXACIN contains the active (medicinal) ingredient levofloxacin.

What the important nonmedicinal ingredients are:

All LEVOFLOXACIN tablets contain colloidal anhydrous silica, crospovidone, hydroxypropylcellulose, microcrystalline cellulose and sodium stearyl fumarate.

The film coating contains:

250 mg: FD&C blue #1, FD&C red #40, FD&C yellow #6, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

500 mg: iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

750 mg: polyethylene glycol, polyvinyl alcohol, titanium oxide and talc.

What dosage forms it comes in:

LEVOFLOXACIN tablets are available in 250 mg, 500 mg or 750 mg strengths. LEVOFLOXACIN tablets are pink for the 250 mg tablet, peach-coloured for the 500 mg tablet, or white to off-white for the 750 mg tablet.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

$ LEVOFLOXACIN has been shown to lengthen the heartbeat on an electrocardiogram test (QT interval prolongation).

$ Serious hypersensitivity (allergic) reactions, sometimes fatal, have been reported in some patients receiving quinolone therapy, including LEVOFLOXACIN. $ Seizures may occur with quinolone therapy. Tell your doctor if you have any central nervous system problems (ie, epilepsy). Your doctor will determine whether you should use this medication.

$ LEVOFLOXACIN should not be used by pregnant women unless the doctor determines the possible benefit outweighs the possible risk to the fetus.

$ LEVOFLOXACIN is not recommended for use by nursing mothers as the effects on the infant are unknown. Your doctor will decide whether you should discontinue nursing your baby or discontinue LEVOFLOXACIN. $ LEVOFLOXACIN is not recommended for children under the age of 18 years.

See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

BEFORE you use LEVOFLOXACIN talk to your doctor or pharmacist if:

$ you have decreased kidney function.

$ you have epilepsy or have a history of seizures

(convulsions).

$ you have had any problems with your heart rhythm, heart rate, or problems with low potassium

$ you are taking anti-diabetic medications as

LEVOFLOXACIN may interfere with blood sugar levels.

INTERACTIONS WITH THIS MEDICATION

Before taking LEVOFLOXACIN tablets, make sure you tell your doctor and pharmacist all the medications you are taking. Do not start a new medicine without first consulting a doctor or pharmacist.

It is important to let your doctor know all of the medicines you are using including some medications for arthritis (non-steroidal anti-inflammatory drugs), blood sugar medicines, drugs for any heart condition, and non-prescription drugs, because LEVOFLOXACIN tablets may react with certain medications.

Taking warfarin and LEVOFLOXACIN tablets together can further predispose you to the development of bleeding problems. If you take warfarin, be sure to tell your doctor.

Many multivitamin/mineral combinations and antacids, containing calcium, magnesium, aluminum, iron, zinc and sucralfate may interfere with the absorption of LEVOFLOXACIN tablets and may prevent it from working properly. You should take LEVOFLOXACIN tablets either two hours before or two hours after taking these products.

Some medicines such as erythromycin, clarithromycin, quinidine, procainamide, amiodarone, sotalol, cisapride, antipsychotics, tricyclic antidepressants, and other medications may produce an effect on the electrocardiogram test. The risk of developing abnormal heartbeat may be increased when LEVOFLOXACIN is taken with any of these medications. Do not take any of these medications with LEVOFLOXACIN tablets unless your doctor tells you that it is alright.

PROPER USE OF THIS MEDICATION

Usual Adult dose:

LEVOFLOXACIN tablets should be taken once a day for 3, 5, 7, 10, 14 or 28 days depending on your condition.

Each tablet should be swallowed whole and may be taken with or without food. Try to take the tablet at the same time each day and drink fluids liberally, to maintain a hydrated condition.

You may begin to feel better quickly; however, in order to make sure that you are getting the full, sustained benefits from your medication so that your infection does not return, you should complete the full course of medication.

Overdose:

If you have taken too much LEVOFLOXACIN tablets (more than prescribed by your doctor), contact your doctor, nearest Emergency Department, or Poison Control Centre.

Missed Dose:

Do not take more than the prescribed dose of LEVOFLOXACIN tablets even if you missed a dose by mistake. You should not take a double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Levofloxacin tablets are generally well tolerated. The most common side effects caused by levofloxacin tablets, which are usually mild, include nausea, vomiting, diarrhea, abdominal pain, constipation, dizziness, flatulence, rash, headache, difficulty in sleeping, and vaginitis in women. However, allergic reactions have been reported in patients receiving quinolones, including levofloxacin tablets, even after just one dose. If you develop hives, itching, skin rash, difficulty breathing or swallowing, swelling in the face, tongue or throat, or other symptoms of an allergic reaction, you should stop taking this medication and call your doctor.

Levofloxacin may be associated with dizziness. You should know how you react to this drug before you operate an automobile, or machinery, or perform other activities requiring mental alertness or co-ordination.

Pain, swelling and tears of shoulder, hand, or Achilles tendons have been reported in patients receiving quinolones, including levofloxacin tablets. The risk of tendon effects is higher if you are over 65 years old, and especially if you are taking corticosteroids. If you develop pain, swelling, or rupture of a tendon you should stop taking LEVOFLOXACIN tablets, avoid exercise and strenuous use of the affected area and contact your doctor.

Convulsions have been reported in patients receiving quinolone antibiotics including levofloxacin tablets. If you have experienced convulsions in the past, be sure to let your physician know that you have a history of convulsions.

Quinolones, including levofloxacin tablets, may also cause central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia and, rarely, suicidal thoughts or acts. If you have suicidal thoughts, contact your doctor.

Neuropathy (problems in the nerves) has been reported in patients receiving quinolones, including levofloxacin tablets. If neuropathy symptoms occur such as pain, burning, tingling, numbness, weakness, or other alterations of sensation (including feelings of vibration, temperature or touch sensitivity), you should stop taking LEVOFLOXACIN tablets and contact your doctor immediately.

Sun sensitivity (photosensitivity), which can appear as skin eruption or severe sunburn, can occur in some patients taking quinolone antibiotics after exposure to sunlight or artificial ultraviolet (UV) light (e.g. tanning beds). Levofloxacin tablets have been infrequently associated with phototoxicity. You should avoid excessive exposure to sunlight or artificial ultraviolet light while you are taking LEVOFLOXACIN tablets. Use sunscreen and wear protective clothing if out in the sun. If photosensitivity develops, contact your doctor.

If you have diabetes and you develop a hypoglycemic reaction (low blood sugar) while taking LEVOFLOXACIN tablets, you should stop taking LEVOFLOXACIN tablets and call your doctor. Hyperglycemic and hypoglycemic (high low blood sugar respectively) reactions have also been reported in patients without diabetes. Common symptoms of hyperglycemia (high blood sugar) include excessive thirst or excessive urination. Common symptoms of hypoglycemia (low blood sugar) include dizziness, excessive hunger, lack of coordination, headache, fatigue, or fainting. You should call your doctor if you experience any of these symptoms.

Problems with the liver have been reported in patients taking levofloxacin. The symptoms of hepatic impairment are non-specific and include nausea, vomiting, stomach pain, fever, weakness, abdominal pain or tenderness, loss of appetite, itching, unusual or unexplained tiredness, light coloured bowel movements and dark coloured urine. In more severe cases, these symptoms are followed by jaundice (yellowing of the skin) and/or icterus (yellowing of the eyes). Call your doctor if you experience these symptoms.

Some quinolones have been associated with lengthening of the heart beat on an electrocardiogram test, and with abnormal heart rhythm. Very rare cases of abnormal heart beat have been reported in patients while on levofloxacin, but these reports generally involved patients who had conditions that predisposed them to abnormal heart beat, or who have been taking other medicines that increase the risk of developing abnormal heart beat. If you develop heart palpitations (fast beating) or have fainting spells, you should stop taking LEVOFLOXACIN tablets and call your doctor.

Eye abnormalities and abnormal vision have been reported in patients being treated with quinolones. The relationship of the drugs to these events has not been established.

Diarrhea that usually ends after treatment is a common problem caused by antibiotics. A more serious form of diarrhea can occur during or up to 2 months after the use of antibiotics. This has been reported with all antibiotics including with levofloxacin tablets. If you develop a watery and bloody stool with or without stomach cramps and fever, contact your doctor as soon as possible.

These are not all the side effects that have been reported with levofloxacin. If you notice any side effects not mentioned in this leaflet, or you have concerns about the side effects you are experiencing, please inform your doctor.

This is not a complete list of side effects. For any unexpected effects while taking LEVOFLOXACIN, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature (15°– 30°C) in well-closed containers.

Keep out of the reach of children.

Do not use after the expiry date. Generally, all expired medications should be returned to your pharmacist

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

---------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701C

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals, at: 1-866-254-6111.

Cobalt Pharmaceuticals Inc.

6550 Kitimat Road

Mississauga, ON

L5N 2B8

Last revised: February 5, 2010.