Jamp-Ciprofloxacin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Fluoroquinolone antibiotics, like JAMP‐Ciprofloxacin, 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

  • Fluoroquinolone antibiotics, like CIPRO:

    • 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 JAMP‐Ciprofloxacin?”

      section

Talk to your doctor to see if CIPRO is right for you.

What is JAMP‐Ciprofloxacin used for?

Antibacterial drugs like JAMP‐Ciprofloxacin treat only bacterial infections. They do not treat viral infections such as the common cold.

JAMP‐Ciprofloxacin is used to treat infections caused by bacteria. These include infections of the:

• Respiratory tract
• Urinary tract
• Prostate
• Skin and soft tissues
• Bone and joint

It is also used to remove meningococci (a type of bacteria) from the nasopharynx (upper throat area) in patients not infected with meningitis

It is also used to treat the following conditions:

• Diarrhea caused by bacterial infections
• Typhoid fever
• Uncomplicated gonorrhea

How does JAMP‐Ciprofloxacin work?

JAMP‐Ciprofloxacin is an antibiotic that kills the bacteria causing the infection.

What are the ingredients in JAMP‐Ciprofloxacin?

Medicinal ingredient: ciprofloxacin as ciprofloxacin hydrochloride.

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

JAMP‐Ciprofloxacin comes in the following dosage forms:

JAMP‐Ciprofloxacin 250 mg Tablets: White to off‐white, round circular, biconvex, film‐coated tablets, with ‘250’ debossed on one side and plain on other side. Bottles of 100 tablets.

JAMP‐Ciprofloxacin 500 mg Tablets: White to off‐white, capsule shaped, biconvex, film‐coated tablets, with ‘500’ debossed on one side and plain on other side. Bottles of 100 and 500 tablets.

JAMP‐Ciprofloxacin 750 mg Tablets: White to off‐white, capsule shaped, biconvex, film‐coated tablets, with ‘750’ debossed on one side and plain on other side. Bottles of 50 tablets.

Do not use JAMP‐Ciprofloxacin 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 JAMP‐Ciprofloxacin?”).
• you are taking tizanidine (ZANAFLEX^®), a medication that relaxes muscles. Side effects such as drowsiness, sleepiness and low blood pressure may occur.

• are currently taking agomelatine^a, a type of medication used to treat depression.

  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 JAMP‐Ciprofloxacin.

Talk about any health conditions or problems you may have, including if you:

• have a history of seizures or have any other medical conditions or are taking medicines that could cause seizures.
• have an irregular heart rhythm (such as QT prolongation).
• You are taking medications that can affect your heart rhythm such as class IA or III antiarrhythmics that can cause QT prolongation
• have hypokalemia (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 (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 (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:

Using JAMP‐Ciprofloxacin for too long or not long enough may cause the bacteria to become resistant, and your infection may not be resolved. Your doctor will tell you exactly how long you should be taking JAMP‐Ciprofloxacin for.

Blood Sugar Changes

Medicines like JAMP‐Ciprofloxacin 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 JAMP‐Ciprofloxacin. If you have diabetes, check your blood sugar levels often while taking JAMP‐Ciprofloxacin.

JAMP‐Ciprofloxacin can make your skin more sensitive to the sun. While taking JAMP‐Ciprofloxacin:

• Avoid too much sunlight or artificial ultraviolet light (such as sunlamps).

  • Stop taking JAMP‐Ciprofloxacin and contact your doctor if a sunburn or rash occurs.

• Do not drive or use machinery if you feel dizzy or lightheaded.

Quinolones, including JAMP‐Ciprofloxacin 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 an aneurysm
  • 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

• Get immediate help if you experience:

  • sudden, severe pain in your abdomen, chest or back,
  • a pulsating sensation in your abdomen, and
  • dizziness or loss of consciousness

Tendon problems can happen within the first 48 hours of treatment.

Clostridium difficile‐associated disease (CDAD)

JAMP‐Ciprofloxacin can cause infections of the colon caused by a bacteria called clostridium difficile. These infections can vary in severity from mild diarrhea to fatal colitis (inflammation of the colon). If you experience diarrhea or other symptoms of colitis, talk to your doctor. Symptoms of colitis can include stomach pain or cramping, rectal bleeding, urgency or inability to pass stool, fatigue, weight loss and fever.

Allergic Reactions

Serious allergic reactions can happen from taking JAMP‐Ciprofloxacin. Stop taking JAMP‐Ciprofloxacin and talk to your doctor if you experience any of the following allergic reactions:

• severe hypotension (low blood pressure)
• seizure
• loss of consciousness
• tingling
• angioedema (swelling of the deeper layers of the skin including swelling of the tongue, throat or face)
• shortness of breath
• hives, itching, rashes and other skin reactions.

Psychiatric (Mental) Adverse Reactions

Psychiatric (mental) adverse reactions can happen from taking JAMP‐Ciprofloxacin. Stop taking JAMP‐Ciprofloxacin and talk to your doctor if you experience any of the following allergic reactions:

• psychosis, hallucinations, paranoia (see, hear, or believe things that are not real)
• depression or suicidal thoughts
• anxiety, agitation, restlessness, or nervousness
• confusion, disorientation, or disturbances in attention
• insomnia or nightmares
• problems with your memory

Ophthalmic (Eye) Problems

If you experience any problems with your vision while taking JAMP‐Ciprofloxacin, contact an eye doctor immediately.

Peripheral Neuropathy (damaged nerves outside of the brain and spinal cord)

Nerve damage can happen from taking JAMP‐Ciprofloxacin. Stop taking JAMP‐Ciprofloxacin and talk to your doctor if you experience any of the following symptoms:

• pain, burning, tingling, numbness, weakness in your hands or feet
• decreased sensation of light touch, pain, temperature, position sense, vibration, and/or motor strength

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 JAMP‐Ciprofloxacin:

• Theophylline or VIDEX® (didanosine) chewable/buffered tablets or pediatric powder.

  Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including JAMP‐Ciprofloxacin, and theophylline.

• Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take JAMP‐Ciprofloxacin:”).
• 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, tizanidine, duloxetine, methylxanthines, sevelamer,
  • sucralfate, omeprazole, clozapine, ropinirole, lidocaine, sildenafil, probenecid,
  • ferrous sulfate, calcium‐fortified products (including food and dairy products),
  • histamine H2‐receptor antagonists
  • methotrexate, metoclopramide, cyclosporine, lanthanum carbonate, zolpidem.

How to take JAMP‐Ciprofloxacin:

• Take JAMP‐Ciprofloxacin as prescribed by your doctor at almost the same times each day. Take JAMP‐Ciprofloxacin with food or on an empty stomach.

• Do not take JAMP‐Ciprofloxacin with dairy products (like milk or yogurt) or calcium‐fortified juices alone. However, you may take JAMP‐Ciprofloxacin with a meal that contains these products (see “The following may interact with JAMP‐Ciprofloxacin :”).
• Do not take JAMP‐Ciprofloxacin with antacids that contain magnesium or aluminum
• You should avoid excessive caffeine consumption while taking JAMP‐Ciprofloxacin.
• You should drink lots of water while taking JAMP‐Ciprofloxacin.

• Swallow the JAMP‐Ciprofloxacin tablets whole, with water as needed. DO NOT SPLIT,

  CRUSH, OR CHEW THE TABLET.

• After treatment has been completed, any remaining JAMP‐Ciprofloxacin should not be reused.

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

  JAMP‐Ciprofloxacin:

  • antacids or mineral supplements containing magnesium or aluminium
  • sucralfate
  • VIDEX (didanosine) chewable/buffered tablets or paediatric powder
  • supplements containing iron or zinc
  • any product (supplement or food) with more than 800 mg calcium
• Do not use JAMP‐Ciprofloxacin for another condition or give it to others.

Although you may feel better early in treatment, JAMP‐Ciprofloxacin should be taken exactly as directed. Misuse or overuse of JAMP‐Ciprofloxacin could lead to the growth of bacteria that will not be killed by JAMP‐Ciprofloxacin (resistance). This means that JAMP‐Ciprofloxacin may not work for you in the future. Do not share your medicine.

You should take JAMP‐Ciprofloxacin 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:

If you think you, or a person you are caring for, have taken too much JAMP‐Ciprofloxacin, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take JAMP‐Ciprofloxacin and it is:

• 6 hours or more until your next scheduled dose, take your missed dose right away. Then take the next dose at your regular time.
• Less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose at your regular time.

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 JAMP‐Ciprofloxacin?

These are not all the possible side effects you may feel when taking JAMP‐Ciprofloxacin. If you have any side effects not listed here, tell your healthcare professional.

All medicines, including JAMP‐Ciprofloxacin, can cause side effects, although not everyone gets them. Stop taking JAMP‐Ciprofloxacin and contact your doctor if:

• you have sunburn‐like skin reaction when exposed to sunlight or ultraviolet light.

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

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

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

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 at room temperature 15°C‐ 30°C in a dry place.

Keep out of reach and sight of children.

If you want more information about JAMP‐Ciprofloxacin:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting Health Canada website (https://www.canada.ca/en/health‐canada/services/drugs‐health‐products/drug‐

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.

products/drug‐product‐database.html) and the manufacturer’s website www.jamppharma.com, or by calling 1‐866‐399‐9091.

JAMP Pharma Corporation.

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last Revised: May 06, 2022