Ciprofloxacin Injection USP: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is CIPROFLOXACIN INJECTION USP used for?

CIPROFLOXACIN INJECTION USP is used to treat certain types of bacterial infections in patients over 18 years of age and is administered by the healthcare professional. Antibacterial drugs like CIPROFLOXACIN INJECTION USP 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 USP should be taken exactly as directed. Misuse or overuse of CIPROFLOXACIN INJECTION USP could lead to the growth of bacteria that will not be killed by CIPROFLOXACIN INJECTION USP (resistance). This means that CIPROFLOXACIN INJECTION USP may not work for you in the future. Do not share your medicine.

How does CIPROFLOXACIN INJECTION USP work?

CIPROFLOXACIN INJECTION USP is an antibiotic that kills bacteria causing infection. You should contact your doctor if your condition has not improved or if it has worsened while taking CIPROFLOXACIN INJECTION USP.

What are the ingredients in CIPROFLOXACIN INJECTION USP?

Each mL of CIPROFLOXACIN INJECTION USP contains 2 mg of ciprofloxacin. The other ingredients are dextrose monohydrate, lactic acid solution, hydrochloric acid to adjust pH and water for injection.

CIPROFLOXACIN INJECTION USP comes in the following dosage forms:

CIPROFLOXACIN INJECTION USP is available in ready-to–use minibags of 100 mL or 200 mL, Each mL contains 2 mg of ciprofloxacin.

Do not use CIPROFLOXACIN INJECTION USP if:

• you are allergic to any other ingredient in these products (see “What are the ingredients in CIPROFLOXACIN INJECTION USP?”).
• you have ever had a severe reaction to any of the ingredients contained within this medication or to the group of antibiotics known as “quinolones.” Before taking this medication, tell your doctor if you have a history of seizures.
• you are taking tizanidine for the management of spasticity. Tizanidine concentrations may increase and cause further side effects such as drowsiness, sleepiness and low blood pressure.

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

  ^a Currently not marketed in Canada

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

• have a family history of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency as CIPROFLOXACIN INJECTION USP contains sucrose.
• have a history of seizures or epilepsy.
• have an irregular heart rhythm (such as QT prolongation).
• have low potassium blood levels.
• have liver or kidney disease or damage.

• 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 quinolone antibiotics.
• have myasthenia gravis (a muscle disease).
• 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:

While taking CIPROFLOXACIN INJECTION USP:

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

• Quinolones, including CIPROFLOXACIN INJECTION USP 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 INJECTION USP:

• Theophylline or didanosine chewable/buffered tablets or pediatric powder.

  Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including CIPROFLOXACIN INJECTION USP, and theophylline.

• Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take CIPROFLOXACIN INJECTION USP:”).
• 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).
• Caffeine (such as coffee) and other xanthine derivatives (such as pentoxifylline).
• Certain heart medications known as antiarrhythmics (such as quinidine, procainamide, amiodarone, sotalol).
• Foods fortified with calcium and dairy products

• Other medications including:

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

How to take CIPROFLOXACIN INJECTION USP:

CIPROFLOXACIN INJECTION USP can be prescribed only by a licensed physician. Your doctor has prescribed CIPROFLOXACIN INJECTION USP only for you. Your healthcare professional will give you CIPROFLOXACIN INJECTION USP by injection into a vein.

Usual dose:

CIPROFLOXACIN INJECTION USP will be administered according to your doctor’s instructions, usually for 7-14 days, depending on the infection.

Stopping an antibiotic too early may result in failure to cure your infection.

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

Overdose:

Missed Dose:

Should you forget to take it at the usual time, you may take your dose later in the day. Do not take more than two doses of CIPROFLOXACIN INJECTION USP per day, even if you missed a dose.

What are possible side effects from using CIPROFLOXACIN INJECTION USP?

• All medicines, including CIPROFLOXACIN INJECTION USP, can cause side effects, although not everyone gets them. These are not all the possible side effects you may feel when taking CIPROFLOXACIN INJECTION USP. CIPROFLOXACIN INJECTION USP is generally well-tolerated. The most common side effects, which are usually mild, include nausea and diarrhea. Antibiotics of the quinolone class may also cause vomiting, rash, and abdominal pain/discomfort. If these symptoms persist, call your health care professional. 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 CIPROFLOXACIN INJECTION USP 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
   • hallucinations, depression, agitation
   • difficulty sleeping, anxiety, nervousness and 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
• injection site pain/reaction

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

  • weakness
  • difficulty walking, swallowing, drooping eyelids.

Do not use CIPROFLOXACIN INJECTION USP if you have this condition.

Self-Limiting Side Effects:

• Feeling lightheaded
• Insomnia (difficulty sleeping)
• Nightmares

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

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

• stop taking CIPROFLOXACIN INJECTION USP.
• contact your doctor immediately.

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

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 Suspected Side Effects

Storage:

Keep out of reach and sight of children.

Protect from light, excessive heat and freezing. Store at 20°C to 25°C. Use promptly when container is opened. Single use, discard unused portion.

As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permits.

If you want more information about CIPROFLOXACIN INJECTION USP:

• 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); the manufacturer’s website www.pfizer.ca or by calling 1-800-463-6001.

Pfizer Canada ULC

Kirkland, Québec H9J 2M5

Last Revised: September 25, 2019