Ciprofloxacin Injection (Baxter): Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is CIPROFLOXACIN INJECTION used for?

CIPROFLOXACIN INJECTION is used to treat certain types of bacterial infections.

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

How does CIPROFLOXACIN INJECTION work?

CIPROFLOXACIN INJECTION is an antibiotic that kills the bacteria causing the infection.

What are the ingredients in CIPROFLOXACIN INJECTION?

Medicinal ingredients: ciprofloxacin lactate.

Non-medicinal ingredients: Each mL contains 2 mg of ciprofloxacin in bags of 100 mL and 200 mL.

CIPROFLOXACIN INJECTION comes in the following dosage forms:

CIPROFLOXACIN INJECTION is supplied in a clear 100 mL & 200 mL plastic bag with the twist off port (TOP) and the Extra Medication Port (EMP).

Do not use CIPROFLOXACIN INJECTION if:

• you are allergic to ciprofloxacin or other quinolone antibiotics
• you are allergic to any other ingredient in these products (see “What are the ingredients in CIPROFLOXACIN INJECTION?”).
• you are taking tizanidine (ZANAFLEX^®). Side effects such as drowsiness, sleepiness and low blood pressure may occur.

• you are currently taking agomelatine^a. Agomelatine concentrations may increase and may cause further side effects such as liver toxicity.

  ^aCurrently not marketed in Canada

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

• have a family history of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase

  • deficiency as CIPROFLOXACIN INJECTION contains dextrose.
• have a history of seizures.
• have an irregular heart rhythm (such as QT prolongation).
• have low potassium blood levels.
• have a disease of the brain arteries in which the blood vessel walls are thickened.
• have epilepsy.
• have liver or kidney disease or damage.
• are taking theophylline (bronchodilator drug).
• already had diarrhea after taking antibacterial drugs.

• are pregnant, planning to become pregnant, breast feeding or planning to breast feed.

• 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 a quinolone antibiotic.
• have myasthenia gravis (a muscle disease).

Other warnings you should know about:

While taking CIPROFLOXACIN 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.

• Blood Sugar Changes:

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

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 INJECTION:

• Theophylline or didanosine chewable / buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including CIPROFLOXACIN INJECTION, and theophylline.
• Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take CIPROFLOXACIN INJECTION:”).
• Antidiabetic agents (such as glyburide, glibenclamide, glimepiride, insulin); the combination of any of these agents with ciprofloxacin may cause lower blood sugar.
• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) (such as fenbufen)
• Caffeine (such as coffee) and other xanthine derivatives (such as pentoxifylline).
• Certain heart medications known as antiarrhythmics (such as quinidine, procainamide, amiodarone, sotalol).

• Other medications including:

  • oral anticoagulants (like warfarin and acenocoumarol),
  • phenytoin, duloxetine, methylxanthines, sevelamer,
  • sucralfate, clozapine, ropinirole, lidocaine, sildenafil, probenecid,
  • methotrexate, metoclopramide, cyclosporine, lanthanum carbonate, zolpidem.

How to take CIPROFLOXACIN INJECTION:

• CIPROFLOXACIN INJECTION should be taken as prescribed at almost the same times each day with food or on an empty stomach.

• CIPROFLOXACIN INJECTION should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone; however, CIPROFLOXACIN INJECTION may be taken with a meal that contains

  • these products (see “The following may interact with CIPROFLOXACIN INJECTION”).
• You should avoid excessive caffeine consumption while taking CIPROFLOXACIN INJECTION.
• You should drink lots of water while taking CIPROFLOXACIN INJECTION.

• If you are taking the following medicines, take them at least 2 hours before or 6 hours after CIPROFLOXACIN INJECTION;

  • antiacids or mineral supplements containing magnesium or aluminium
  • sucralfate
  • supplements containing iron or zinc
  • any product (supplement or food) with more than 800 mg calcium
• Do not use CIPROFLOXACIN INJECTION for another condition or give it to others.

You should take CIPROFLOXACIN INJECTION for as long as your doctor prescribes it, even after you start to feel better. Stopping an antibiotic too early may result in failure to cure your infection.

Usual dose:

Your doctor (health care provider) will tell you how much of the medicine to take and for how long.

This information does not take the place of discussions with your doctor or health care professional about your medication or treatment.

Overdose:

What are possible side effects from using CIPROFLOXACIN INJECTION?

All medicines, including CIPROFLOXACIN INJECTION, can cause side effects, although not everyone gets them.

These are not all the possible side effects you may feel when taking CIPROFLOXACIN INJECTION. If you have any side effects not listed here or if conditions worsen or do not improve then:

• contact your health care professional.
• see the “To help avoid side effects and ensure proper use…” section.

Stop taking CIPROFLOXACIN 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 face, lips, tongue or throat
   • difficulty breathing
   • irregular or rapid heartbeat, or fainting spells
2. b) you have sunburn-like skin reaction when exposed to sunlight or ultraviolet light
3. c)

   you have pain, swelling or rupture of a tendon. You should:

   • rest
   • avoid physical exercise
4. d)

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

   • pain, burning, tingling, numbness or weakness
5. e)

   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.

1. f)

   you have mental problems such as:

   • confusion, headache, shaking

If you think you have taken too much CIPROFLOXACIN INJECTION, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

• hallucinations, depression, agitation
• difficulty sleeping, anxiety, nervousness, suicidal thoughts Contact your doctor if you have suicidal thoughts.

Other side effects include:

• your eyesight worsens or changes. See your doctor or eye specialist right away.
• nausea, dizziness, unsteady walk
• gas, cramping, feeling unwell, loss of hearing, problems of smell and taste, loss of appetite
• migraine, sweating

• worsening of myasthenia gravis (a muscle disease) with symptoms such as:

  • weakness
  • difficulty walking, swallowing, drooping eyelids

Do not use CIPROFLOXACIN INJECTION if you have this condition.

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.

Storage:

Store between 15°C and 25°C. Protect from light, excessive heat and freezing. Use promptly when pouch is opened.

As with all parenteral drug products, injections / intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration, whenever solution and container permits. Solutions showing haziness, particulate matter, precipitate or leakage should not be used. Discard unused portion.

Keep out of reach and sight of children.

If you want more information about CIPROFLOXACIN INJECTION:

• a. Talk to your healthcare professional.
• b. 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); the manufacturer’s website (https://www.baxter.ca) or by calling 1-888-719-9955

Last revised: June 3, 2019

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/health- canada/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.