Patient Medication Information: uses, side effects, how to take - PHL-Moxifloxacin
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed phl-MOXIFLOXACIN because you have a certain type of bacterial infection.
What it does:
phl-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:
Do not use phl-MOXIFLOXACIN if you are allergic to moxifloxacin, other quinolone antibiotics or to any non-medicinal ingredient in this product (see What the non-medicinal ingredients are).
What the medicinal ingredient is:
Moxifloxacin, as moxifloxacin hydrochloride
What the non-medicinal ingredients are:
Colloidal Silicon Dioxide, Croscarmellose Sodium, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Stearyl Fumarate, Talc and Titanium Dioxide.
What dosage forms it comes in:
Tablets: 400 mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- Moxifloxacin Hydrochloride 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 Moxifloxacin Hydrochloride
If you have myasthenia gravis, treatment with phl-
MOXIFLOXACIN may make your condition worse. Do not use phl-MOXIFLOXACIN if you have this condition.
- Quinolones, including phl-MOXIFLOXACIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. Speak to your doctor to determine if this medication is suitable for you.
- Seizures and toxic psychoses 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.
- phl-MOXIFLOXACIN can cause liver injury which may be fatal.
See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM
BEFORE you use phl-MOXIFLOXACIN talk to your doctor or pharmacist if any of the following apply to you:
- Some people are born with a rare condition which results in lengthening of the heartbeat on an electrocardiogram test (QT interval prolongation). If you or any of your family members have this condition, you should inform your health care professional.
- You should avoid taking phl-MOXIFLOXACIN with certain medicines used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, or sotalol. Inform your health care professional if you are taking a heart rhythm drug.
- You have or have had heart problems such as heart failure, an irregular heartbeat, or a slow heartbeat.
- Some medicines such as cisapridea, erythromycin, antipsychotics and tricyclic antidepressants may also produce an effect on an electrocardiogram test. These may increase the risk of abnormal heartbeats when taken with phl-MOXIFLOXACIN. For this reason, it is important to let your health care provider know all of the medicines that you are using (including non-prescription medicines).
- You should avoid phl-MOXIFLOXACIN if your doctor has told you that the amount of potassium in your blood is low. Low potassium can sometimes be caused by medicines called diuretics such as furosemide and hydrochlorothiazide. If you are taking a diuretic medicine you should speak with your health care professional
If you have a history of seizures, notify your doctor before
you start taking this drug.
You should tell your doctor if you are allergic to any of the
quinolone drugs or any of the non-medicinal ingredients in phl-MOXIFLOXACIN.
phl-MOXIFLOXACIN may be associated with allergic
(hypersensitivity) reactions, even after a single dose. Stop taking the drug at the first sign of a skin rash or other signs of an allergic reaction and tell your doctor.
Please tell your doctor if you are pregnant, planning to
become pregnant, or if you are breast feeding. phl-MOXIFLOXACIN is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
phl-MOXIFLOXACIN is not recommended for persons less
than18 years of age.
You should not use phl-MOXIFLOXACIN if you have a
history of tendon problems associated with the use of a quinolone antibiotic.
You have a condition known as myasthenia gravis. With this
condition, your muscles get weaker with physical activity and improve after periods of rest.
You have diabetes and are taking anti-diabetic medications.
phl-MOXIFLOXACIN may interfere with blood sugar levels. phl-MOXIFLOXACIN may also interfere with blood sugar levels in those without diabetes.
a no longer marketed in Canada
INTERACTIONS WITH THIS MEDICATION
Talk to your doctor before taking any of the following medications as drug interactions and side effects may occur and they may not be suitable for you. See WARNINGS AND PRECAUTIONS and SIDE EFFECTSAND WHAT TO DO ABOUT THEM.
Drugs that may interact with phl-MOXIFLOXACIN include:
- Antacids or vitamin/mineral supplements.
- Nonsteroidal anti-inflammatory drugs (NSAIDs).
Antidiabetic medicines (eg, 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
Usual adult dose:
You must take phl-MOXIFLOXACIN exactly as prescribed
by your doctor. YOU SHOULD NOT INCREASE THE PRESCRIBED DOSE.
The recommended adult dose of phl-MOXIFLOXACIN is
one 400 mg tablet once a day.
phl-MOXIFLOXACIN may be taken with or without food.
Do not crush or chew phl-MOXIFLOXACIN tablets.
Swallow each one whole with a drink of water.
You should drink lots of fluids while taking phl-
MOXIFLOXACIN.
- Avoid excessive sunlight or artificial ultraviolet light (e.g., sunlamps) during treatment with phl-MOXIFLOXACIN and for one day following completion of treatment. If a sunburn-like reaction or skin eruptions occur, contact your doctor.
phl-MOXIFLOXACIN may cause dizziness and
lightheadedness. You should know how you react to this drug before you operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
- If you are taking antacids or vitamin/mineral supplements while on phl-MOXIFLOXACIN treatment, you should take phl-MOXIFLOXACIN at least 4 hours before or 8 hours after taking a mineral supplement or a vitamin supplement that also contains minerals, or an antacid containing magnesium or aluminum.
The usual length of treatment with phl-MOXIFLOXACIN is
5-10 days. During the course of treatment, all tablets must be taken to make sure that all bacteria have been killed. CONTINUE TAKING THE TABLETS UNTIL THEY ARE FINISHED, EVEN IF YOU BEGIN TO FEEL BETTER.
- phl-MOXIFLOXACIN may be taken with or without food.
Overdose:
In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.
Missed Dose:
If you forget to take a dose, take another as soon as possible. Continue with the next dose 24 hours later. Do not take two doses in any 24 hour period.
Stopped Treatment:
If your doctor decides to stop the treatment, do not keep any leftover medicine unless your doctor tells you to. Please discard all unused phl-MOXIFLOXACIN tablets.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Although most people do not have a problem with side effects when taking phl-MOXIFLOXACIN, all medicines can cause unwanted side effects. Discontinue your medicine and contact your doctor at the first sign of rash, hives or skin eruptions, a rapid heartbeat, difficulty in breathing or swallowing or any other symptom of an allergic reaction. Do not take any more medicine unless your doctor tells you to do so. Your doctor may decide to stop your treatment.
Contact your health care professional and stop taking the drug if you develop an irregular heartbeat or have fainting spells.
Quinolones, a class of antibiotics including moxifloxacin hydrochloride, have been rarely associated with inflammation of the tendons. If you experience pain, swelling or rupture of a tendon,
you should stop taking phl-MOXIFLOXACIN (moxifloxacin hydrochloride), rest, avoid physical exercise and call your health professional.
Treatment with a quinolone antibiotic, including phl-MOXIFLOXACIN (moxifloxacin hydrochloride), may worsen muscle weakness in persons with myasthenia gravis. If you have myasthenia gravis, do not use phl-MOXIFLOXACIN.
Quinolones, including moxifloxacin, have been rarely associated with other central nervous system events including confusion, tremors, headache, hallucinations, depression, agitation, insomnia, anxiety, nervousness and suicidal thoughts. If you have suicidal thoughts, contact your doctor.
Neuropathy (problems in the nerves) has been reported in patients receiving quinolones, including moxifloxacin hydrochloride. If neuropathy symptoms occur such as pain, burning, tingling, numbness, or weakness, you should stop taking phl-MOXIFLOXACIN and contact your doctor immediately.
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking phl-MOXFLOXACIN and contact your healthcare professional immediately.
If your eyesight worsens or changes in any way consult your doctor and eye specialist immediately.
Other possible side effects which may occur with phl-MOXIFLOXACIN are nausea, diarrhea and dizziness. Some people may have other side effects. If you notice any unusual effects, check with your doctor or pharmacist. If you feel worse or you think your condition is not improving while taking phl-MOXIFLOXACIN, contact your doctor as soon as possible.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEYHAPPEN AND | ||
| WHAT TO DO ABOUT THEM | ||
| Symptom/ Effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention |
| Rare | ||
| Irregular heartbeat or fainting spells | √ | |
Nervous system side effects:
| √ | |
| Tendon pain, inflammation, or rupture | √ | |
Symptoms of an allergic reaction (which can be fatal):
| √ | |
| Liver problems with symptoms such as yellowing of the skin and eyes, nausea, abdominal pain, dark urine, and pale stools | √ | |
Symptoms of a severe bowel condition:
| √ | |
| Very rare | ||
| Symptoms of hypoglycemia such as fatigue, dizziness, sweating or shaking | √ | |
This is not a complete list of side effects. For any unexpected effects while taking phl-MOXIFLOXACIN, contact your doctor or pharmacist.
HOW TO STORE IT
Keep your phl-MOXIFLOXACIN tablets in a safe place where children cannot reach or see them.
phl-MOXIFLOXACIN should be stored at room temperature (between 15°C and 30°C) in a tightly closed container away from heat and direct light. Do not freeze the tablets.
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
Online at MedEffectTM
(www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program Health Canada, Postal Locator 1908C Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffectTM
(www.healthcanada.gc.ca/medeffect).
| 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
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmel Inc. at 1-888-550-6060.
Pharmel Inc.
Montreal, Quebec, Canada
H4P 2T4