Details for: APO-LEVOFLOXACIN
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02284707 | APO-LEVOFLOXACIN | LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) | 250 MG | TABLET | ORAL |
| 02284715 | APO-LEVOFLOXACIN | LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) | 500 MG | TABLET | ORAL |
| 02325942 | APO-LEVOFLOXACIN | LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) | 750 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment
Summary Safety Review - Fluoroquinolones - Assessing the potential risk of aneurysm (a balloon-like bulge) and dissection (a separation or tear in the layers of the wall) of the aorta (a major blood vessel)
Summary Safety Review - Systemic and Inhaled Fluoroquinolone Antibiotics - Assessing the Potential Risk of Heart Valve Regurgitation
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-LEVOFLOXACIN is used to treat bacterial infections in the:
- Skin.
- Kidneys.
- Urinary tract (bladder or prostate).
- Sinuses.
- Lungs.
What it does
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.
When it should not be used
Do not use APO-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.
What the medicinal ingredient is
Medicinal ingredients: levofloxacin (levofloxacin hemihydrate)
What the non-medicinal ingredients are
Non-medicinal ingredients:
Tablets
250 mg: croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, methylcellulose, stearic acid,
hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, red ferric oxide .
500 mg: croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, methylcellulose, stearic acid,
hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, red ferric oxide,
yellow ferric oxide.
750 mg: croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, methylcellulose, stearic acid,
hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide.
What dosage form it comes in
Tablets
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
Warnings and precautions
Serious Warnings and Precautions
Talk to your doctor, if you:
- Have serious allergic reaction to levofloxacin or similar antibiotics such as ciprofloxacin, moxifloxacin, and others
- Have seizures (convulsions). Tell your doctor if you have any problems in the brain, including epilepsy. Your doctor will tell you whether you should use this medication.
- Have muscle problems (e.g. weakness, joint problems). Do not use levofloxacin if you have or have had myasthenia gravis.
- Have previous history of inflamed tendon (fiber that connects bones to muscles in the body) and tendon rupture. Your risk for tendon problem is greater, if you are over 60 years of age, and if you are taking steroid medication, or if you have had kidney, heart or lung transplant.
- Have family history of long QT syndrome (Prolongation of the heartbeat on an electrocardiogram test).
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 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 APO-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 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 APOLEVOFLOXACIN.
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.
Interactions with this medication
The following may interact with APO-LEVOFLOXACIN:
- antacids, multi-vitamins, or products containing metals (such as aluminum, calcium, iron, magnesium or zinc). See How to take APO-LEVOFLOXACIN.
- medicines used for ulcers (such as sucralfate). See How to take APO-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.
Proper use of this medication
How to take APO-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 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 pharmacist 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 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.
Side effects and what to do about them
Self-Limiting Side Effects
- Feeling lightheaded
- Insomnia (difficulty sleeping)
- Nightmares
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.
Operating Heavy Machinery:
You should know that use of APO-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 APO-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.
These are not all the possible side effects you may feel when taking APO-LEVOFLOXACIN. If you experience any side effects not listed here, contact your healthcare professional.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| VERY COMMON | |||
| Nausea | ✔ | ||
| Headache | ✔ | ||
| Diarrhea (having slightly soft to watery stool) | ✔ | ||
| Insomnia (lack of sleep) | ✔ | ||
| Dizzines s (drowsiness , light hea dedn ess) | ✔ | ||
| Co nstipati o n (h ard to p ass stool) | ✔ | ||
| COMMON | |||
| Abdomi nal or stom ach pain o r discomfort. | ✔ | ||
| Vomiting. | ✔ | ||
| Dys p e psia (discomfort or pain in the upp e r a bdome n). | ✔ | ||
| Dys pnea (s hortn ess of b r eath). | ✔ | ||
| Moniliasis ( yeast infection of the mouth and t hroat). | ✔ | ||
| S k i n rash. | ✔ | ||
| Prurit us (itch ing). | ✔ | ||
| Vaginal itchin g and d ischarge. | ✔ | ||
| Edem a (swel lin g ca u s e d b y excess flui d i n you r body). | ✔ | ||
| Ch est pain. | ✔ | ||
| RARE | |||
| Stomach cr a mps or pain (severe) | ✔ | ||
| Agitatio n (p urposel e s s mo v ements) | ✔ | ||
| Blisters | ✔ | ||
| confu sion | ✔ | ||
| diarrh e a (wa ter y a n d sev ere ) which may also be bloody | ✔ | ||
| feeling t h at others c an hear your though t s o r contro l yo ur b ehavior | ✔ | ||
| fever | ✔ | ||
| pain, infla mmation, or swelling in th e calve s o f th e le gs, sh o ulders , or han ds, inc lud ing tend o n rupture or swellin g o f t h e tendo n (ten dinitis) | ✔ | ||
| red ness a n d swelling of t h e sk i n | ✔ | ||
| see ing, he ar ing, or feeli ng things tha t ar e no t there | ✔ | ||
| se nsati o n of burn ing on t h e sk i n | ✔ | ||
| sever e mo o d o r menta l ch ang e s | ✔ | ||
| Ne uro pathy (pr oble m s in the nerv es such as pa in, burn ing, tingling, nu mbn ess or weakn ess) | ✔ | ||
| sk i n r ash, itching, o r r e d ness – sun se n sitivit y ( photose nsitivity) , wh ich can app ear as skin e ruption or se v e r e s unb urn | ✔ | ||
| trembli n g | ✔ | ||
| un usual beh avior | ✔ | ||
| severe/persistent headache | ✔ | ||
| vision changes | ✔ | ||
| Shaking (tremors), seizures (convulsions) | ✔ | ||
| severe dizziness, fainting, | ✔ | ||
| fast/irregular heartbeat | ✔ | ||
Mental Health Problems
|
✔ | ||
Neurological Problems:
|
✔ | ||
Rise in the pressure within your skull:
|
✔ | ||
Hypoglycemia (Low blood sugar):
|
✔ | ||
| signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark urine) | ✔ | ||
| Aortic aneurysm (abnormal bulge in a large blood vessel called the aorta) /Aortic dissection (tear in the wall of the aorta): dizziness, loss of consciousness, pulsating sensation in the abdomen, sudden, severe pain in abdomen, chest or back. | ✔ | ||
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.
How to store
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.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
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://health-products.canada.ca/dpdbdpp/index-eng.jsp). Find the Patient Medication Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: August 30, 2019