NTP-Levofloxacin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

What it does:

Levofloxacin 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 of the types of bacteria that can infect the lungs, sinus, skin and urinary tract.

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

When it should not be used:

You should not take NTP-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 NTP-LEVOFLOXACIN tablets if you have had tendonitis or tendon rupture while taking quinolone antibiotics.

What the medicinal ingredient is:

levofloxacin (levofloxacin hemihydrate)

What the nonmedicinal ingredients are:

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.

What dosage forms it comes in:

Tablets

NTP-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.

NTP-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.

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

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 (i.e., epilepsy). Your doctor will determine whether you should use this medication.
• Fluoroquinolones, including levoflxacin, may worsen muscle weakness in persons with myasthenia gravis. Do not use levoflxacin if you have or have had myasthenia gravis.
• Fluoroquinolones, including levoflxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

BEFORE you use NTP-LEVOFLOXACIN tablets, 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 medication as NTP-

  LEVOFLOXACIN may interfere with blood sugar levels

• you have a disease that causes muscle weakness (myasthenia

  gravis).

• you experience any symptoms of muscle weakness, including

  breathing difficulties (e.g., shortness of breath).

INTERACTIONS WITH THIS MEDICATION

Before taking your NTP-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 NTP-LEVOFLOXACIN tablets may react with certain medications.

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

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

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

* No longer marketed in Canada

PROPER USE OF THIS MEDICATION

Usual adult dose:

NTP-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:

In case of drug overdose, contact a healthcare practitioner (e.g., doctor), hospital emergency department, or regional poison control centre, even if there are no symptoms.

Missed Dose:

Do not take more than the prescribed dose of NTP-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 is generally well tolerated. The most common side effects caused by levofloxacin, 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, 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.

NTP-LEVOFLOXACIN tablets may be associated with dizziness. You should know how you react to this drug before you operate an automobile, or machinery, or performing 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. The risk of tendon effects is higher if you are over 65 years old, and especially of you are taking corticosteroids. If you develop pain, swelling, or rupture of a tendon you should stop taking NTP-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. If you have experienced convulsions in the past, be sure to let your physician know that you have a history of convulsions.

Quinolones, including NTP-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 NTP-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 has been infrequently associated with phototoxicity. You should avoid excessive exposure to sunlight or artificial ultraviolet light while you are taking NTP-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 NTP-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, including fatal cases, 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 NTP-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. If you develop a watery and bloody stool with or without stomach cramps and fever, contact your doctor as soon as possible.

Fluoroquinolones like NTP-LEVOFLOXACIN tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. If you have or have had myasthenia gravis, do not use NTP-LEVOFLOXACIN tablets.

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 NTP-LEVOFLOXACIN TABLETS contact your doctor or pharmacist.

HOW TO STORE IT

NTP-LEVOFLOXACIN tablets should be stored at 15-30EC in well-closed containers.

Keep out of 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 0701E

    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.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting,

Teva Canada Ltd. at:

1-800-268-4127 ext. 1255005 (English); 1-877-777-9117 (French) or druginfo@tevacanada.com

Teva Canada Ltd.

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Date of Revision: September 26, 2013