PMS-Levofloxacin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is pms-LEVOFLOXACIN used for?

pms-LEVOFLOXACIN is used to treat bacterial infections in the:

• Skin
• Kidneys
• Urinary tract (bladder or prostate)
• Sinusitis
• Lungs

How does pms-LEVOFLOXACIN work?

pms-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. pms-LEVOFLOXACIN does not kill viruses.

What are the ingredients in pms-LEVOFLOXACIN?

Medicinal ingredients: Levofloxacin (levofloxacin hemihydrate)

Non-medicinal ingredients: Colloidal Silicon Dioxide, Copovidone, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol and Titanium Dioxide. In addition:

250 mg tablets also contain: Iron Oxide Red, Polyvinyl Alcohol (part. hydrolyzed) and Talc.

500 mg tablets also contain: Iron Oxide Red, Iron Oxide Yellow, Hypromellose, Polydextrose and Triacetin/Glycerol Triacetate.

750 mg tablets also contain: Polyvinyl Alcohol (part. hydrolyzed) and Talc.

pms-LEVOFLOXACIN comes in the following dosage forms:

Tablets: 250 mg, 500 mg, 750 mg

Do not use pms-LEVOFLOXACIN if:

• You have allergic reaction to this drug or to other quinolone antibiotics (such as ciprofloxacin, moxifloxacin).
• You have a history of tendinitis (inflammation of tendon or tendon rupture). 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 pms-LEVOFLOXACIN. Talk about any health conditions or problems you may have, including if you:

• have kidney problems.
• have epilepsy.
• have or have had seizures (convulsions).
• have had any problems with your heart rhythm, heart rate, or problems with low potassium.
• have a diabetes and are taking anti-diabetic medications (it may interfere with blood sugar levels).
• have a disease that causes muscle weakness (myasthenia gravis).
• experience any symptoms of muscle weakness, including breathing difficulties (e.g., shortness of breath).
• have a history of tendon problems associated with antibiotics.

• are pregnant or plan to become pregnant.

• are breastfeeding or plan to breastfeed. Talk to your doctor about how to feed your baby while you are taking pms-LEVOFLOXACIN.
• 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 any of the following conditions: Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis or Behcet's disease.
• Have high blood pressure.
• Have atherosclerosis, which is a hardening of your blood vessels.

Other warnings you should know about:

Blood Sugar Changes:

Medicines like pms-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 pms-LEVOFLOXACIN. If you have diabetes, check your blood sugar levels often while taking pms-LEVOFLOXACIN.

If you have diabetes, you may develop a hypoglycemic reaction (low blood sugar) with common symptoms such as:

• Dizziness
• Excessive hunger
• Lack of coordination
• Headache
• Fatigue
• Fainting

Or a hyperglycemic reaction (high blood sugar) with common symptoms such as:

• Excessive thirst.
• Excessive urination.

• Quinolones, including pms-LEVOFLOXACIN have been associated with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large peripheral aneurysm) and aortic dissection (a tear in the aorta wall).

  • 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 any of the following conditions: Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis or giant cell arteritis or Behcet’s disease
    • 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, get immediate medical help.

What are possible side effects from using pms-LEVOFLOXACIN?

Self-Limiting Side Effects:

• Feeling lightheaded
• Insomnia (difficulty sleeping)
• Nightmares

You should call your doctor if you experience any of these symptoms:

Allergic Reaction:

If you developed one of the following:

• Hives
• Itching
• Skin rush
• Difficulty breathing or swallowing
• Swelling in the face, tongue or throat
• Other symptoms of an allergic reaction

You should stop taking this medication and call your doctor.

Operating Heavy Machinery:

You should know that use of pms-LEVOFLOXACIN may cause dizziness. Please make sure that you know how to react if you are:

• driving a car

• operate any machinery at working place
• perform work that needs mental alertness or coordination

Exposure to Sunlight:

You should not expose yourself to sunlight or artificial ultraviolet light while you are taking pms-LEVOFLOXACIN. Use sunscreen and wear protective clothing if out in the sun.

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 pms-LEVOFLOXACIN:

• antacids, multi-vitamins, or products containing metals (such as aluminum, calcium, iron, magnesium or zinc). See How to take pms-LEVOFLOXACIN.
• medicines used for ulcers (such as sucralfate). See How to take pms-LEVOFLOXACIN.
• medicines used for heartburn or gout (such as probenecid, cimetidine, etc.).
• medicines used for treatment of asthma or chronic obstructive pulmonary disease (COPD) (such as theophylline).
• medications for arthritis (Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]) such as ibuprofen, naproxen).
• blood sugar medicines (such as metformin, gliclazide, insulin, etc.).
• medicines used for any heart conditions.

• blood thinner medications (such as warfarin, etc.) that used to thin the blood and prevent

  • – may predispose you to the development of bleeding problems.

This medication may interfere with certain laboratory tests (such as urine screening for opiates), possibly causing false test results.

How to take pms-LEVOFLOXACIN:

You should 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 doctor.

Do not share your medicine with anyone.

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

Ask your pharmacist about the other products you take. Some medicines will affect the way that your body absorbs pms-LEVOFLOXACIN. Take pms-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 adult dose:

You should take this medication by mouth as directed by your doctor.

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 doctor 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 pms-LEVOFLOXACIN?

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

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

Reporting Side Effects

Storage:

Store between 15˚C and 30˚C in well-closed containers.

Keep out of the 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 pms-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); or by calling Pharmascience Inc. at 1-888-550-6060.

Pharmascience Inc.

Montréal, Canada

H4P 2T4

www.pharmascience.com

Last revised: October 2, 2024