Cipro: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What are CIPRO and CIPRO ORAL SUSPENSION used for?

CIPRO and CIPRO ORAL SUSPENSION are used to treat certain types of bacterial infections.

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

How does CIPRO and CIPRO ORAL SUSPENSION work?

CIPRO and CIPRO ORAL SUSPENSION are antibiotics that kill the bacteria causing the infection.

What are the ingredients in CIPRO Tablets?

Medicinal ingredients: ciprofloxacin as ciprofloxacin hydrochloride.

Non-medicinal ingredients: crospovidone, hypromellose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, silica colloidal anhydrous and titanium dioxide.

What are the ingredients in CIPRO ORAL SUSPENSION?

Medicinal ingredients: ciprofloxacin

Non-medicinal ingredients: hypromellose, magnesium stearate, medium chain triglycerides, poly acrylate dispersion, polysorbate 20, polyvidone 25, soy-lecithin, strawberry flavouring, sucrose and water.

CIPRO Tablets come in the following dosage forms:

CIPRO tablets: 250 mg, 500 mg and 750 mg.

The 250 mg tablets are round and white to slightly yellow in colour. One side is engraved with “CIP 250” and a score-line, and the other side has the Bayer cross.

The 500 mg tablets are oblong and white to slightly yellow in colour. One side is engraved with “CIP 500” and a score-line, and “BAYER” on the other side.

The 750 mg tablets are oblong and white to slightly yellow in colour. One side is engraved with “CIP 750” and “BAYER” on the other.

CIPRO ORAL SUSPENSION comes in the following dosage forms:

CIPRO ORAL SUSPENSION: 10 g/100 mL

Do not use CIPRO and CIPRO ORAL SUSPENSION if:

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

• 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 CIPRO and CIPRO ORAL SUSPENSION. 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 CIPRO ORAL SUSPENSION contains sucrose.

• have a history of seizures.
• 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 fluoroquinolone 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:

Blood Sugar Changes

Medicines like CIPRO and CIPRO ORAL SUSPENSION 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 CIPRO or CIPRO ORAL SUSPENSION. If you have diabetes, check your blood sugar levels often while taking CIPRO or CIPRO ORAL SUSPENSION.

While taking CIPRO and CIPRO ORAL SUSPENSION:

• 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 CIPRO AND CIPRO ORAL SUSPENSION 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:

  • 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.

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 CIPRO and CIPRO ORAL SUSPENSION:

• Theophylline or VIDEX^® (didanosine) chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including CIPRO and CIPRO ORAL SUSPENSION, and theophylline.
• Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take CIPRO and CIPRO ORAL SUSPENSION:”).
• 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).

• 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 CIPRO and CIPRO ORAL SUSPENSION:

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

• CIPRO and CIPRO ORAL SUSPENSION should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone; however, CIPRO or CIPRO ORAL SUSPENSION may be taken with a meal that contains these products (see “The following may interact with CIPRO and CIPRO ORAL SUSPENSION:”).
• You should avoid excessive caffeine consumption while taking CIPRO and CIPRO ORAL SUSPENSION.
• You should drink lots of water while taking CIPRO or CIPRO ORAL SUSPENSION.
• Swallow the CIPRO tablets whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.
• Shake CIPRO ORAL SUSPENSION vigorously each time before use for approximately 15 seconds. Swallow the prescribed amount of suspension. Do not chew the microcapsules. Reclose the bottle completely after use and store it in an upright position.
• After use the graduated measuring spoon should be cleaned under running water with detergent and dried thoroughly afterwards.

• If you are taking the following medicines, take them at least 6 hours before or 2 hours after CIPRO:

  • antacids 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 CIPRO or CIPRO ORAL SUSPENSION for another condition or give it to others.

You should take CIPRO or CIPRO ORAL SUSPENSION 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 (healthcare 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:

Missed Dose:

Take the normal dose as soon as possible and then continue as prescribed. 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 CIPRO and CIPRO ORAL SUSPENSION?

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

These are not all the possible side effects you may feel when taking CIPRO. 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 CIPRO 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. These side effects may last more than 30 days. 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, suicidal thoughts

These side effects may last more than 30 days.

Contact your doctor if you have suicidal thoughts.

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, unsteady walk
• gas, cramping, feeling unwell,
• loss of hearing, problems of smell and taste, loss of appetite. These side effects may last more than 30 days.
• migraine, sweating

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

  • weakness
  • difficulty walking, swallowing, drooping eyelids

Do not use CIPRO 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

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:

Tablets: Store below 30°C (86°F).

Oral Suspension: Can be kept for 14 days when stored in the refrigerator or at room temperature (5°C-25°C). Store in an upright position.

Keep out of reach and sight of children.

If you want more information about CIPRO and CIPRO ORAL SUSPENSION:

• 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; the manufacturer’s website http://www.bayer.ca or by contacting Bayer Medical Information at 1-800-265-7382 or canada.medinfo@bayer.com.

Last Revised: February 18, 2020

© 2020, Bayer Inc.

® TM see www.bayer.ca/tm-mc

All other trademarks are the property of their respective owners.

Bayer