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Details for: CIPROFLOXACIN INJECTION USP

Company: PFIZER CANADA ULC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02301903CIPROFLOXACIN INJECTION USPCIPROFLOXACIN2 MG / MLSOLUTIONINTRAVENOUS
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Fluoroquinolones - Assessing the potential risk of persistent and disabling side effects
Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment
Summary Safety Review - Fluoroquinolones - Assessing the potential risk of aneurysm (a balloon-like bulge) and dissection (a separation or tear in the layers of the wall) of the aorta (a major blood vessel)
Summary Safety Review - Systemic and Inhaled Fluoroquinolone Antibiotics - Assessing the Potential Risk of Heart Valve Regurgitation

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is 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.

What it does

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.

When it should not be used

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
What the medicinal ingredient is

Each mL of CIPROFLOXACIN INJECTION USP contains 2 mg of ciprofloxacin.

What the non-medicinal ingredients are

The other ingredients are dextrose monohydrate, lactic acid solution, hydrochloric acid to adjust pH and water for injection.

What dosage form it comes in

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

Warnings and precautions

Serious Warnings and Precautions

  • Quinolone antibiotics, like CIPROFLOXACIN INJECTION USP, are related to disabling and possibly long lasting effects such as:
    • inflamed tendon (tendonitis), tendon rupture.
    • nerve damage (peripheral neuropathy).
    • problems in the brain such as:
      • convulsions
      • nervous breakdown
      • confusion
      • and other symptoms
  • Quinolone antibiotics, like CIPROFLOXACIN INJECTION USP:
    • have lengthened the heartbeat (QT prolongation)
    • have led to serious allergic reactions, including death
    • may be related to increased tendonitis (inflamed tendon)
    • may worsen myasthenia gravis (a muscle disease)
    • may lead to seizures and nervous breakdowns. Tell your doctor if you have brain or spinal cord problems (such as epilepsy)
    • may cause liver injury which may lead to death
  • For further information and symptoms see:
    • the “To help avoid side effects and ensure proper use, …” section
    • the “What are possible side effects from using CIPROFLOXACIN INJECTION USP?” section

Talk to your doctor to see if CIPROFLOXACIN INJECTION USP is right for you.

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 sucroseisomaltase 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.

Interactions with this medication

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.

Proper use of this medication

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

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

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.

Side effects and what to do about them

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. 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
  • you have sunburn-like skin reaction when exposed to sunlight or ultraviolet light.
  • you have pain, swelling or rupture of a tendon. You should:
    • rest
    • avoid physical exercise
  • you have neuropathy (damage to the nerves) with symptoms such as:
    • pain, burning, tingling, numbness or weakness
  • 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.
  • 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, includingCIPROFLOXACIN 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
    Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
    Rare
    Allergic Reaction:
    • rash
    • hives (skin eruptions)
    • swelling of the face, lips, tongue or throat
    • difficulty swallowing or breathing
    • rapid heartbeat
    		     ✔
    Central Nervous System Disorders:
    • seizures/convulsions
    • confusion
    • tremors
    • hallucinations
    • depression
    • suicidal thoughts or psychotic reactions
    		     ✔
    Photosensitivity Reaction:
    Sensitivity to light, blistering of skin     		    ✔
    Tendon pain, inflammation, or rupture     ✔
    Increased Blood Sugar:
    • frequent urination
    • thirst
    • hunger
    • tiredness
    • blurred vision
    • headache
    • trouble concentrating
    		 ✔    
    Hypoglycemia (Low Blood Sugar):
    • change in mood
    • change in vision
    • confusion
    • dizziness
    • fast heartbeat
    • feeling faint
    • headache
    • hunger
    • shaking
    • sweating
    • weakness
    		   ✔  
    Unknown
    Severe Bowel Disorder (Clostridium difficile colitis):
    • persistent diarrhea
    • bloody or watery diarrhea
    • abdominal or stomach pain/cramping
    • blood/mucus in stool
    		     ✔
    Nerve Disorder (Neuropathy):
    Pain, burning, tingling, numbness, weakness     		    ✔
    Nerve Disorder (Neuropathy):
    Pain, burning, tingling, numbness, weakness     		  ✔  
    Heart Disorder (QT Prolongation):
    Irregular heartbeat    		   ✔  
    Mental Health Problems:
    Anxiety, confusion, depression, feeling agitated, restless or nervous, suicidal thoughts or actions, hallucinations, inability to think clearly or pay attention, memory loss, paranoia or loss of touch with reality    		   ✔  
    Neurological Problems:
    Seizures (convulsions), tremors    		     ✔
    Rise in the pressure within your skull:
    Blurred or double vision, headaches, nausea    		   ✔  
    Aortic aneurysm
    (abnormal bulge in a large blood vessel called the aorta) / Aortic dissection (tear in the wall of the aorta): dizziness, loss of consciousness, pulsating sensation in the abdomen, sudden, severe pain in abdomen, chest or back    		     ✔

    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.

    How to store

    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.

    Reporting side effects

    You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

    • Report online at MedEffect
    • Call toll-free at 1-866-234-2345
    • Complete a Canada Vigilance Reporting Form and:
      • Fax toll-free to 1-866-678-6789, or
      • Mail to:
        Canada Vigilance Program
        Health Canada
        Postal Locator 0701D
        Ottawa, Ontario
        K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

    NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

    More information

    If you want more information about CIPROFLOXACIN INJECTION USP:

    This leaflet was prepared by:

    Pfizer Canada ULC
    Kirkland, Québec H9J 2M5

    Last Revised: September 25, 2019

    Date modified: