Moxifloxacin Injection (Fresenius Kabi Canada): Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is Moxifloxacin Injection used for?

Your doctor has prescribed Moxifloxacin Injection because you have a certain type of bacterial infection.

Antibacterial drugs like Moxifloxacin Injection treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Moxifloxacin Injection should be used exactly as directed. Misuse or overuse of Moxifloxacin Injection could lead to the growth of bacteria that will not be killed by Moxifloxacin Injection (resistance). This means that Moxifloxacin Injection may not work for you in the future. Do not share your medicine.

How does Moxifloxacin Injection work?

Moxifloxacin Injection is an antibiotic. It kills many of the types of bacteria that can infect the lungs, sinuses, abdomen, and skin.

What are the ingredients in Moxifloxacin Injection?

Medicinal ingredients: 250 mL contains 400 mg of moxifloxacin as moxifloxacin hydrochloride.

Non-medicinal ingredients: sodium acetate trihydrate, disodium sulfate (sodium sulfate, anhydrous), sulfuric acid for pH adjustment, and water for injection.

Moxifloxacin Injection comes in the following dosage form:

Intravenous infusion: ready-to-use 250 mL solution in 300 mL polyolefin (freeflex^®) latex-free flexible bags containing 400 mg of moxifloxacin (as hydrochloride). Moxifloxacin Injection is for intravenous infusion only.

Do not use Moxifloxacin Injection if:

• you are allergic to Moxifloxacin Injection (moxifloxacin hydrochloride) or other fluoroquinolone antibiotics.
• you are allergic to any other ingredients in the formulation. (see “What are the ingredients in Moxifloxacin Injection?”).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Moxifloxacin Injection. 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 Moxifloxacin Injection.”).
• 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 Moxifloxacin Injection may affect blood sugar levels. Moxifloxacin Injection 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 Moxifloxacin Injection 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 Injection. If you have diabetes, check your blood sugar levels often while taking Moxifloxacin Injection.

While taking Moxifloxacin Injection:

• 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 Moxifloxacin Injection 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:

  o are elderly

  o have or anyone in your family has had aneurysm disease

  o have an aortic aneurysm or an aortic dissection

  o have any of the following conditions: Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis or giant cell arteritis or Behcet’s disease

  o 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.

The following may interact with Moxifloxacin Injection:

• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Antidiabetic medicines (such as, insulin, glyburide, glibenclamide)
• Quinidine, procainamide, amiodarone, sotalol, cisapride ^b, erythromycin, antipsychotics, tricyclic antidepressants, diuretics (furosemide, hydrochlorothiazide).

b no longer marketed in Canada

How to take Moxifloxacin Injection:

You must take Moxifloxacin Injection exactly as prescribed by your doctor. YOU SHOULD NOT INCREASE THE PRESCRIBED DOSE.

Usual dose:

• Your doctor has decided on the best dose for you and for how long based on your needs. The usual adult dose of Moxifloxacin Injection is one 250 mL in a 300 mL freeflex^® bag once a day. Moxifloxacin hydrochloride is to be administered intravenously.
• The usual length of treatment with Moxifloxacin Injection is 5-10 days. IT IS IMPORTANT TO COMPLETE THE FULL LENGTH OF TREATMENT, EVEN IF YOU BEGIN TO FEEL BETTER.

Overdose:

Missed Dose:

If you forget to take a dose, take another as soon as you remember on the same day. If you do not take a dose on one day, take your normal dose 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

What are possible side effects from using Moxifloxacin Injection?

All medicines, including Moxifloxacin Injection, can cause side effects, although not everyone gets them.

These are not all the possible side effects you may feel when taking Moxifloxacin Injection. 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 Moxifloxacin Injection and contact your doctor if:

1. a)

   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
2. b)

   you have pain, swelling or rupture of a tendon. These side effects may last more than 30 days. You should:

   • rest
   • avoid physical exercise
3. c)

   you have neuropathy (damage to the nerves) with symptoms such as:

   • pain, burning, tingling, numbness or weakness
4. d)

   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 Moxifloxacin Injection 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.

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:

Moxifloxacin Injection should be stored:

• at room temperature (15 °C to 30 °C)
• away from heat and direct light.
• Do not refrigerate.

Keep out of reach and sight of children.

If you want more information about Moxifloxacin Injection:

• 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/dpd-bdpp/index-eng.jsp); Fresenius Kabi Canada’s website (http://www.fresenius-kabi.com/en-ca/), or by calling Fresenius Kabi Canada Ltd., at: 1-877-821-7724

Fresenius Kabi Canada Ltd.

165 Galaxy Blvd, Suite 100

Toronto, ON M9W 0C8

Last revised: March 19, 2020