Details for: APO-MOXIFLOXACIN
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02404923 | APO-MOXIFLOXACIN | MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) | 400 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
Your doctor has prescribed APO-MOXIFLOXACIN because you have a certain type of bacterial infection.
Antibacterial drugs like APO-MOXIFLOXACIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, APO-MOXIFLOXACIN should be used exactly as directed. Misuse or overuse of APO-MOXIFLOXACIN could lead to the growth of bacteria that will not be killed by APO-MOXIFLOXACIN (resistance). This means that APO-MOXIFLOXACIN may not work for you in the future. Do not share your medicine.
What it does
APO-MOXIFLOXACIN is an antibiotic. It kills many of the types of bacteria that can infect the lungs, sinuses, abdomen, and skin.
When it should not be used
- you are allergic to moxifloxacin hydrochloride or other fluoroquinolone antibiotics.
- you are allergic to any other ingredient in the formulation (see “What are the ingredients in APOMOXIFLOXACIN Tablets?”).
What the medicinal ingredient is
400 mg of moxifloxacin as moxifloxacin hydrochloride
What the non-medicinal ingredients are
Cellulose microcrystalline, sodium starch glycolate, povidone and magnesium stearate. Coating Ingredients: Opadry Pink 03B54025: It contains hypromellose, titanium dioxide, macrogol & iron oxide red.
What dosage form it comes in
400mg Tablets - Dull red coloured, modified capsule shaped, film coated tablets debossed with ‘E 18’ on one side and ‘Plain’ on the other side. Available in HDPE pack of 30’s count
Warnings and precautions
Serious Warnings and Precautions
- Fluoroquinolone antibiotics, like APO-MOXIFLOXACIN, are related to disabling and possibly long
lasting effects such as:
- inflamed tendon (tendonitis), tendon rupture.
- nerve damage (peripheral neuropathy).
- problems in the brain such as:
- convulsions
- nervous breakdown
- confusion
- and other symptoms
- Fluoroquinolone antibiotics, like APO-MOXIFLOXACIN:
- have lengthened the heartbeat (QT prolongation)
- have led to serious allergic reactions, including death
- may be related to increased tendonitis (inflamed tendon)
- may worsen myasthenia gravis (a muscle disease)
- may lead to seizures and nervous breakdowns. Tell your doctor if you have brain or spinal cord problems (such as epilepsy)
- may cause liver injury which may lead to death
- For further information and symptoms see:
- the “To help avoid side effects and ensure proper use,…” section
- the “What are possible side effects from using APO-MOXIFLOXACIN?” section
Talk to your doctor to see if APO-MOXIFLOXACIN is right for you.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APOMOXIFLOXACIN. Talk about any health conditions or problems you may have, including if you:
- have or have a family history of irregular heart rhythm (such as QT prolongation).
- have or have had heart problems such as heart failure, an irregular heartbeat, or a slow heartbeat.
- have low potassium blood levels (see “The following may interact with APO-MOXIFLOXACIN:”).
- have a history of seizures.
- are pregnant, planning to become pregnant, or if you are breast feeding.
- are less than 18 years of age.
- have a history of tendon problems (such as pain, swelling or rupture of a tendon) related to the use of fluoroquinolone antibiotics.
- have myasthenia gravis (a muscle disease).
- have diabetes as APO-MOXIFLOXACIN may affect blood sugar levels. APO-MOXIFLOXACIN may also affect blood sugar levels in those without diabetes.
- 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-MOXIFLOXACIN 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 moxifloxacin hydrochloride. If you have diabetes, check your blood sugar levels often while taking APOMOXIFLOXACIN.
While taking APO-MOXIFLOXACIN:
- Avoid too much sunlight or artificial ultraviolet light (such as sunlamps).
- Contact your doctor if a sunburn or rash occurs.
- Do not drive or use machinery if you feel dizzy or lightheaded.
Quinolones, including APO-MOXIFLOXACIN have been associated with an enlargement or “bulge” of a large blood vessel called the aorta (aortic aneurysm) and a tear in the aorta wall (aortic dissection).
- 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.
- Tendon problems can happen within the first 48 hours of treatment.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- Antacids or vitamin/mineral supplements
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Antidiabetic medicines (such as, insulin, glyburide, glibenclamide)
- Quinidine, procainamide, amiodarone, sotalol, cisaprideb , erythromycin, antipsychotics, tricyclic antidepressants, diuretics (furosemide, hydrochlorothiazide).
b no longer marketed in Canada
Proper use of this medication
- You must take APO-MOXIFLOXACIN exactly as prescribed by your doctor. YOU SHOULD NOT INCREASE THE PRESCRIBED DOSE.
- You can take APO-MOXIFLOXACIN with or without food.
- You should drink lots of fluids while taking APO-MOXIFLOXACIN.
- If your doctor decides to stop the treatment, dispose of all unused APO-MOXIFLOXACIN tablets.
Usual Dose
- Take one 400 mg APO-MOXIFLOXACIN tablet once a day.
- Swallow each APO-MOXIFLOXACIN tablet whole with a drink of water. Do not crush or chew APOMOXIFLOXACIN tablets.
- If you are taking antacids or vitamin/mineral supplements which contain magnesium or aluminium, take APO-MOXIFLOXACIN at least 4 hours before or 8 hours after taking the supplement or antacid.
- Your doctor has decided on the best dose for you and for how long based on your needs.
- The usual length of treatment with APO-MOXIFLOXACIN is 5-10 days. IT IS IMPORTANT TO COMPLETE THE FULL LENGTH OF TREATMENT, EVEN IF YOU BEGIN TO FEEL BETTER.
Overdose
If you think you have taken too much APO-MOXIFLOXACIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you forget to take your tablet you should take it as soon as you remember on the same day. If you do not take your tablet on one day, take your normal dose (one tablet) on the next day. Do not take a double dose to make up for a forgotten dose. If you are unsure about what to do, consult your healthcare professional.
Side effects and what to do about them
All medicines, including APO-MOXIFLOXACIN, can cause side effects, although not everyone gets them.
These are not all the possible side effects you may feel when taking APO-MOXIFLOXACIN. If you have any side effects not listed here or if conditions worsen or do not improve then:
- contact your healthcare professional.
- see the “To help avoid side effects and ensure proper use,…” section.
Stop taking APO-MOXIFLOXACIN and contact your doctor if:
- you have symptoms of an allergic reaction such as:
- rash, hives, blistering or other skin reaction
- swelling of the mouth, throat, limbs
- difficulty breathing
- irregular or rapid heartbeat, or fainting spells
- you have pain, swelling or rupture of a tendon. These side effects may last more than 30 days. You should:
- rest
- avoid physical exercise
- you have neuropathy (damage to the nerves) with symptoms such as:
- pain, burning, tingling, numbness or weakness
- you have severe diarrhea (bloody or watery) with or without:
- fever
- stomach pain or tenderness
You may have Clostridium difficile colitis (bowel inflammation). See your doctor right away.
Other side effects include:
- your eyesight worsens or changes. These side effects may last more than 30 days. See your doctor or eye specialist right away.
- nausea, dizziness
- worsening of myasthenia gravis (a muscle disease) with symptoms such as:
- weakness
- difficulty walking, swallowing, drooping eyelids
Do not use APO-MOXIFLOXACIN if you have this condition.
- mental problems such as:
- confusion, headache, shaking
- hallucinations, depression, agitation
- difficulty sleeping, anxiety, nervousness, suicidal thoughts
These side effects may last more than 30 days.
Contact your doctor if you have suicidal thoughts.
Self-Limiting Side Effects:
- feeling lightheaded
- insomnia (difficulty sleeping)
- nightmares
If any of these affect you severely, tell your doctor or pharmacist.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| RARE | |||
| Irregular heartbeat or fainting spells | ✔ | ||
Mental health problems:
|
✔ | ||
Neurological problems:
|
✔ | ||
Nervous system side effects:
|
✔ | ||
Rise in the pressure within your skull:
|
✔ | ||
| Tendon pain, inflammation, or rupture (these side effects may last more than 30 days | ✔ | ||
Symptoms of an allergic reaction (which may
lead to death):
|
✔ | ||
| Liver problems with symptoms such as yellowing of the skin and/or eyes, nausea, abdominal pain, dark urine, and pale stools | ✔ | ||
Symptoms of a severe bowel condition (Clostridium difficile colitis):
|
✔ | ||
| VERY RARE | |||
Hypoglycemia (low blood sugar) such as:
|
✔ | ||
| UNKNOWN | |||
Aortic aneurysm (abnormal bulge
in a large blood vessel called the
aorta) /Aortic dissection (tear in
the wall of the aorta):
|
✔ | ||
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
APO-MOXIFLOXACIN tablets should be stored:
- Store at room temperature (15°C to 30°C).
- Keep out of reach and sight of children.
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/medeffectcanada/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
- 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.
Date of Revision: August 31, 2020