Teva-Levofloxacin (Teva Canada, PM 00052271): Uses, Side Effects and Dosage

What is TEVA-LEVOFLOXACIN used for?

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

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

How does TEVA-LEVOFLOXACIN work?

TEVA-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. Teva-Levofloxacin does not kill viruses.

Serious Warnings and Precautions

What are the ingredients in TEVA-LEVOFLOXACIN?

Medicinal ingredients: levofloxacin (levofloxacin hemihydrate)

Non-medicinal ingredients:

Tablets

250 mg: crospovidone, FD&C blue #2, FD&C yellow #6, FD&C red #40, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.

500 mg: crospovidone, hydroxypropyl methylcellulose, glycerol triacetate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.

750 mg: crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

TEVA-LEVOFLOXACIN comes in the following dosage forms:

Tablets

TEVA-LEVOFLOXACIN 250 mg tablets are supplied as terra cotta pink tablets, modified rectangular, film-coated, engraved with “N” on one side and “250" on the other side.

TEVA-LEVOFLOXACIN 500 mg tablets are supplied as peach tablets, modified rectangular, film-coated, engraved with “N” on one side and “500" on the other side.

TEVA-LEVOFLOXACIN 750 mg tablets are supplied as white to off-white tablets, modified rectangular, film-coated, engraved with “N” on one side and “750” on the other side.

Do not use TEVA-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 Teva-Levofloxacin. Talk about any health conditions or problems you may have, including if you:

• have kidney problems.
• have epilepsy.
• have or have had a 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 medication (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 TEVA-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 TEVA-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 TEVA-LEVOFLOXACIN. If you have diabetes, check your blood sugar levels often while taking TEVA-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 TEVA-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)

  • 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 TEVA-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 develop one of the following:

-Hives.

-Itching.

-Skin rash.

-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 TEVA-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 TEVA-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 TEVA-LEVOFLOXACIN:

• antacids, multi-vitamins, or products containing metals (such as aluminum, calcium, iron, magnesium or zinc). See How to take Teva-Levofloxacin.
• medicines used for ulcers (such as sucralfate). See How to take Teva-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 (nonsteroidal 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 clots – 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 TEVA-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 TEVA-LEVOFLOXACIN treat only bacterial infections. They do not treat viral infections. Although you may feel better early in the treatment, TEVA-LEVOFLOXACIN should be used exactly as directed. Misuse or overuse of TEVA-LEVOFLOXACIN could lead to the growth of bacterial that will not be killed by TEVA-LEVOFLOXACIN (resistance). This means that TEVA-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 TEVA-LEVOFLOXACIN. Take TEVA-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 TEVA-LEVOFLOXACIN?

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

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, talk to your healthcare professional.

Reporting Side Effects

Storage:

TEVA-LEVOFLOXACIN tablets should be stored at 15-30°C in well-closed containers.

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 TEVA-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; the manufacturer’s website www.tevacanada.com, or
• by calling 1-800-268-4127 ext. 3.
• By e-mail: : druginfo@tevacanada.com
• Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada

M1B 2K9

www.tevacanada.com

Last Revised July 17, 2019