Apo-Levofloxacin: Uses, Side Effects and Dosage

What is APO-LEVOFLOXACIN used for?

APO-LEVOFLOXACIN is used in adults to treat bacterial infections in the:

• Skin.
• Kidneys.
• Urinary tract (bladder or prostate).

Serious Warnings and Precautions

• Sinuses.

• Lungs.

  Antibacterial drugs like APO-LEVOFLOXACIN treat only bacterial infections. They do not treat viral infections such as the common cold.

How does APO-LEVOFLOXACIN work?

APO-LEVOFLOXACIN is in a group of antibiotics called quinolones (kwin-o-lones) that:

• Stop growth of bacteria.
• Kill the bacteria.
• Reduce the infection.

Some infections are caused by viruses, such as the common cold. APO-LEVOFLOXACIN does not kill viruses.

What are the ingredients in APO-LEVOFLOXACIN?

Medicinal ingredients: levofloxacin (levofloxacin hemihydrate)

Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, ferric oxide red (250 mg and 500 mg), ferric oxide yellow (500 mg), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, polyethylene glycol, stearic acid and titanium dioxide.

APO-LEVOFLOXACIN comes in the following dosage forms:

APO-LEVOFLOXACIN 250 mg tablets are supplied as terra cotta pink tablets

APO-LEVOFLOXACIN 500 mg tablets are supplied as peach coloured tablets

APO-LEVOFLOXACIN 750 mg tablets are supplied as white to off white tablets

Do not use APO-LEVOFLOXACIN if:

• You have had an allergic reaction to this drug or to any of the group of antibiotics known as quinolones, or to any of the nonmedicinal ingredients (see What are the ingredients in APO-LEVOFLOXACIN, Non-medicinal ingredients). 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 healthcare professional.
• You have had tendinitis or tendon rupture while taking quinolone antibiotics. This condition causes pain and tenderness just outside of joint in shoulders, elbows, wrists, knees, heels, etc.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-LEVOFLOXACIN. Talk about any health conditions or problems you may have, including if you:

• have a diabetes and are taking anti-diabetic medication (it may interfere with blood sugar levels)
• have an aortic aneurysm which is an abnormal bulge in a large blood vessel called the aorta
• have or if anyone in your family has a condition called aneurysm disease which is an abnormal bulge in any large blood vessel in the body
• have an aortic dissection, which is a tear in the wall of the aorta
• have problems with the valves inside your heart (also known as leaky valves) or have had a heart infection (infective endocarditis)
• have any of the following conditions: Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis or Behcet's disease, Turner syndrome, rheumatoid arthritis, Sjögren’s syndrome
• have high blood pressure
• have atherosclerosis, which is a hardening of your blood vessels
• have diarrhea or usually get diarrhea when taking antibiotics or have ever suffered from problems with your stomach or intestines (e.g. colitis)
• have decreased kidney function
• have history of seizures
• have a history of tendon problems associated with the use of quinolone antibiotics
• have had any problems with your heart rhythm, heart rate, or problems with low potassium
• have a disease that causes muscle weakness (myasthenia gravis)
• experience any symptoms of muscle weakness, including breathing difficulties (e.g., shortness of breath)

• are pregnant or planning to become pregnant

• are breastfeeding or planning to breastfeed. Levofloxacin can be transferred to your baby through breastmilk. Talk to your healthcare professional about how to feed your baby while taking APO-LEVOFLOXACIN.

Other warnings you should know about:

Joint Pain, Swelling or Inflammation

If you experience pain, swelling or inflammation around your joints, stop taking APO-LEVOFLOXACIN immediately. APO-LEVOFLOXACIN has been linked to tendinitis and tendon rupture, which may require surgery. This may happen while you are taking APO-LEVOFLOXACIN or up to several months afterwards. If you experience symptoms of tendinitis and tendon rupture, rest and avoid strenuous activity until you’ve talked to your healthcare professional. The risk of tendon effects is higher if you are over 60 years old, if you are taking corticosteroids, if you’ve had a kidney, heart or lung transplant, or if you have any joint related issues (rheumatoid arthritis).

Aortic Aneurism and Dissection

Quinolones, including APO-LEVOFLOXACIN have been associated with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm) and aortic dissection (a tear in the aorta wall). A tear in a blood vessel is more common if you are also taking corticosteroids. The risk of these problems is higher if you:

• are elderly
• have or anyone in your family has had aneurysm disease
• have an aortic aneurysm or an aortic dissection
• have heart valve regurgitation/incompetence
• have any of the following conditions: Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis or giant cell arteritis or Behcet's disease, Turner syndrome, rheumatoid arthritis, Sjögren’s syndrome
• have high blood pressure or atherosclerosis

If you experience sudden, severe pain in your abdomen, chest or back, a pulsating sensation in your abdomen, dizziness or loss of consciousness, sudden trouble breathing, sudden fast heartbeat, or swelling in your legs or your trunk, get immediate medical help.

Blood Sugar Changes

Medicines like APO-LEVOFLOXACIN can cause blood sugar levels to rise and drop in patients with diabetes. Serious cases of hypoglycemia (low blood sugar levels) that caused coma or death have been seen with medicines like APO-LEVOFLOXACIN. If you have diabetes, check your blood sugar levels often while taking APO-LEVOFLOXACIN. Hyperglycemic and hypoglycemic (high and low blood sugar respectively) reactions have also been reported in patients without diabetes.

Driving or Operating Machinery

APO-LEVOFLOXACIN may cause light-headedness or dizziness. Wait to see how you react to APO-LEVOFLOXACIN before starting activities that may require you to be coordinated or alert.

Sensitivity to Light

Sun sensitivity (photosensitivity) can occur in some patients taking quinolone antibiotics after exposure to sunlight or artificial ultraviolet (UV) light (e.g., tanning beds). You should avoid excessive exposure to sunlight or artificial ultraviolet light while you are taking APO-LEVOFLOXACIN. Use sunscreen and wear protective clothing if out in the sun. If photosensitivity develops, contact your healthcare professional.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-LEVOFLOXACIN:

• Antidiabetic agents
• Digoxin used to treat heart conditions
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) used to relieve pain, reduce inflammation or reduce fevers
• Probenecid^¶ used to treat gout
• Cimetidine used to treat heartburn and ulcers
• Theophylline used to treat asthma and other lung diseases
• Warfarin used to prevent blood clots (blood thinner)
• Some medicines such as erythromycin, clarithromycin, quinidine, procainamide, amiodarone, sotalol, cisapride^¶, antipsychotics, tricyclic antidepressants, and other medications may increase the risk of developing abnormal heartbeat when taken with APO-LEVOFLOXACIN. Do not take any of these medications with APO-LEVOFLOXACIN unless your healthcare professional tells you that it is alright.
• Many multi-vitamin/mineral combinations and antacids, containing calcium, magnesium, aluminum, iron, zinc and sucralfate may prevent APO-LEVOFLOXACIN from working properly. You should take APO-LEVOFLOXACIN either two hours before or two hours after taking these products.
• APO-LEVOFLOXACIN may affect the results of tuberculosis or opioid urine screening tests. Tell your healthcare professional that you are taking APO-LEVOFLOXACIN if you are being tested for tuberculosis or screened for opioids.

^¶ No longer marketed in Canada

How to take APO-LEVOFLOXACIN:

• Swallow the whole tablet with or without food.

• Try to take the tablet at the same time and drink plenty of fluids while taking this medicine unless otherwise directed by your healthcare professional.
• Do not share your medicine with anyone.

Antibacterial drugs like APO-LEVOFLOXACIN treat only bacterial infections. They do not treat viral infections. Although you may feel better early in the treatment, APO-LEVOFLOXACIN should be used exactly as directed. Misuse or overuse of APO-LEVOFLOXACIN could lead to the growth of bacterial that will not be killed by APO-LEVOFLOXACIN (resistance). This means that APO-LEVOFLOXACIN may not work in the future.

Ask your healthcare professional about the other products you take. Some medicines will affect the way that your body absorbs APO-LEVOFLOXACIN. Take APO-LEVOFLOXACIN at least 2 hours before or 2 hours after taking these medicines. Some examples include: vitamins/minerals (including iron and zinc supplements), and products containing magnesium, aluminum, or calcium (such as antacids, calcium supplements).

Usual dose:

Adults:

You should take this medication by mouth as directed by your healthcare professional.

The dosage and length of the treatment depends on your kidney function, medical condition, and response to treatment. It may last for 3, 5, 7, 10, 14 or 28 days depending on your condition.

Tell your healthcare professional if your condition does not improve.

Overdose:

Symptoms of overdose may include: severe dizziness.

Missed Dose:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

What are possible side effects from using APO-LEVOFLOXACIN?

These are not all the possible side effects you may have when taking APO-LEVOFLOXACIN. If you experience any side effects not listed here, tell your healthcare professional.

Side Effects Include:

• abdominal pain
• constipation
• difficulty in sleeping
• dizziness
• flatulence
• headache
• nausea
• nightmares
• rash
• vaginitis in women
• vomiting

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15°C to 30°C) in well-closed containers and protect from light.

Keep out of reach and sight of children.

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

If you want more information about APO-LEVOFLOXACIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: FEB 14, 2025