Ciprofloxacin Intravenous Infusion, BP: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is CIPROFLOXACIN INTRAVENOUS INFUSION used for?

Ciprofloxacin Intravenous Infusion is used to treat certain bacterial infections.

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

How does CIPROFLOXACIN INTRAVENOUS INFUSION work?

Ciprofloxacin helps prevent the action of bacterial substances needed for growth. This kills the bacteria and reduces the infection.

What are the ingredients in CIPROFLOXACIN INTRAVENOUS INFUSION?

Medicinal ingredients: Ciprofloxacin, USP

Non-medicinal ingredients: dextrose monohydrate EP, lactic acid solution EP, and hydrochloric acid to adjust the pH.

CIPROFLOXACIN INTRAVENOUS INFUSION comes in the following dosage forms:

Solution for Injection

2 mg/mL in 5.5% dextrose (available in 200 mg/100 mL and 400 mg/200 mL).

Do not use CIPROFLOXACIN INTRAVENOUS INFUSION if you are:

• allergic to ciprofloxacin.
• allergic to quinolone medications.
• allergic to any of the non-medicinal ingredients in this medication.

• taking tizanidine. This may increase the effect of tizanidine and increase your chances of having the following side effects:

  • low blood pressure.
  • sleepiness.
  • drowsiness.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CIPROFLOXACIN INTRAVENOUS INFUSION. Talk about any health conditions or problems you may have, including if you:

• have a history of seizures.
• have a history of tendon problems when using quinolone antibiotics.
• have a disease of the brain arteries in which the blood vessel walls are thickened.
• have epilepsy or kidney disease.
• are taking theophylline (bronchodilator drug).
• already had diarrhea after taking antibacterial drugs.

• are pregnant or planning to become pregnant.

• are breast feeding or planning to breastfeed. Ciprofloxacin is passed to human breast milk. Discuss with your doctor how to feed your baby.

• are a child under the age of 18.

• 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:

• Ciprofloxacin may cause:

  • dizziness.
  • sleepiness.
  • light-headedness.

If this occurs, do not drive or operate machinery.

• Ciprofloxacin may cause a reaction to light (e.g. sunburn), so:

  • avoid too much time in the sun, sunlamps and tanning beds.

  • Stop taking this product and talk to your doctor if you get:

    • sunburn, blisters, rash or swelling of the skin.

Other warnings that you should know about:

• Blood Sugar Changes:

Medicines like CIPROFLOXACIN INTRAVENOUS INFUSION 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 CIPROFLOXACIN INTRAVENOUS INFUSION. If you have diabetes, check your blood sugar levels often while taking CIPROFLOXACIN INTRAVENOUS INFUSION.

• Quinolones, including CIPROFLOXACIN INTRAVENOUS INFUSION, BP have been associated with an enlargement or "bulge'' of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm) and aortic dissection (a tear in the aorta wall)

  • 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.

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 CIPROFLOXACIN INTRAVENOUS INFUSION:

• Theophylline (serious reactions reported).
• Caffeine.
• Cyclosporine.
• Warfarin.
• Probenecid.
• Fenbufen.
• Glyburide and methotrexate.

How to take CIPROFLOXACIN INTRAVENOUS INFUSION:

Usual dose:

Your doctor will tell you how much medicine to take. This depends on what type of infection you have and how serious it is.

Overdose:

As CIPROFLOXACIN INTRAVENOUS INFUSION is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. You may need urgent medical attention.

What are the possible side effects from using CIPROFLOXACIN INTRAVENOUS

INFUSION?

These are not all the possible side effects you may feel when taking CIPROFLOXACIN INTRAVENOUS INFUSION. If you have any side effects not listed here or if your condition gets worse or does not improve then:

• contact your healthcare professional.
• see the section “To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CIPROFLOXACIN INTRAVENOUS INFUSION. Talk about any health conditions or problems you may have, including if you:”

Stop taking CIPROFLOXACIN INTRAVENOUS INFUSION 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. 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. 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 CIPROFLOXACIN INTRAVENOUS INFUSION if you have this condition.

• mental problems such as:

  • confusion, headache, shaking.
  • hallucinations, depression, agitation.
  • difficulty sleeping, anxiety, nervousness and suicidal thoughts.

Contact your doctor if you have suicidal thoughts.

• injection site pain.
• diarrhea, gas, stomach pain, cramping, feeling unwell.
• loss of hearing, problems of smell and taste, loss of appetite.
• difficulty sleeping, migraine, rash, sweating.

Common side effects include:

• injection site reaction.
• rash.
• diarrhea.

Self-Limiting Side Effects:

• Feeling lightheaded
• Insomnia (difficulty sleeping)
• Nightmares

Neuropathy (problems in the nerves) has been reported in patients receiving quinolones, including CIPROFLOXACIN INTRAVENOUS INFUSION.

If neuropathy symptoms occur such as pain, burning, tingling, numbness, or weakness, you should:

• stop taking CIPROFLOXACIN INTRAVENOUS INFUSION.
• contact your doctor immediately.

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:

CIPROFLOXACIN INTRAVENOUS INFUSION will be stored in the pharmacy or in the ward. The product is kept at controlled room temperature 15°C to 25°C, protected from light and excessive heat and freezing.

Keep out of reach and sight of children.

If you want more information about CIPROFLOXACIN INTRAVENOUS INFUSION:

• 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last Revised: July 8, 2019