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Details for: NORFLOXACIN

Company: AA PHARMA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02229524NORFLOXACINNORFLOXACIN400 MGTABLETORAL
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
  • Norfloxacin is an antibiotic used to treat:
    • infection of the urinary tract.
    • bacterial infection (Neisseria gonorrhea) of:
      • the urethra (tube from the bladder to the penis or vaginal opening).
      • or cervix (lower part of the uterus).

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

What it does

Norfloxacin works by:

  • preventing the bacterial DNA from working, thereby preventing growth.
  • kills bacteria.
When it should not be used

Do not use NORFLOXACIN if:

  • You are allergic to norfloxacin, or any ingredients in this product or any other quinolone antibacterial agents
What the medicinal ingredient is

Norfloxacin

What the non-medicinal ingredients are

colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol and titanium dioxide

What dosage form it comes in

Tablets 400 mg

Warnings and precautions

Serious Warnings and Precautions

Fluoroquinolones, including NORFLOXACIN, are associated with disabling and long lasting effects such as:

  • tendonitis (inflamed tendon), tendon rupture.
  • peripheral neuropathy (problems in the nerves).
  • problems in the brain such as seizures, psychoses, confusion and other symptoms.
See SIDE EFFECTS AND WHAT TO DO ABOUT THEM of the Patient Medication Information section for further information and symptoms.

Talk to your doctor to see if this medication is suitable for you.

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

  • have had seizures.
  • have had tendon problems after using of quinolone antibiotics.
  • have kidney disease.
  • are pregnant or planning to become pregnant.
  • are breastfeeding or planning to breastfeed.
  • are taking any other prescription or non-prescription products.
  • 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:
  • If vision is affected with the use of NORFLOXACIN, talk to your eye specialist immediately.
  • Avoid excessive exposure to the sun when taking NORFLOXACIN. Photosensitivity skin reactions can occur with symptoms such as inflamed red skin, hives, rash, itchiness and blisters. Talk to your doctor if this occurs.
  • you have defects in the glucose-6-phosphate dehydrogenase enzyme. Using quinolone antibiotics, such as NORFLOXACIN, can rarely destroy blood cells. Discuss with your doctor.
  • Blood Sugar Changes
  • “Quinolones, including NORFLOXACIN 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 EhlersDanlos 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.
Medicines like NORFLOXACIN 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 NORFLOXACIN. If you have diabetes, check your blood sugar levels often while taking NORFLOXACIN.

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 NORFLOXACIN:

  • Probenecid (gout medication).
  • Theophylline (lung disease medication).
  • Cyclosporine (skin and joint pain medication).
  • Oral anticoagulant warfarin or its derivatives (blood thinner medication).
  • Multivitamins.
  • Products containing iron or zinc.
  • Antacids (heartburn and indigestion medication).
  • Sucralfate (intestinal disease medication).
  • Caffeine.
  • Nitrofurantoin (urinary tract infection medication).
Proper use of this medication

How to take NORFLOXACIN:

  • Take this medicine exactly as directed by your physician. Do not stop even if you feel better. Stopping too soon may cause your symptoms to return.
  • It is best to take the tablet with a full glass of water, one hour before, or two hours after eating a meal or drinking milk.
  • Drink plenty of liquids every day during NORFLOXACIN treatment (e.g. water or juice) to avoid potential side effects (e.g. crystalluria- cloudy urine).
  • NORFLOXACIN should not be taken within two hours of taking iron, zinc supplements or multivitamins containing them.

Usual Dose

Adults

The recommended dosage of NORFLOXACIN for urinary tract infections is one 400 mg tablet twice a day for 7 to 10 days.

For women with a mild urinary tract infection, the recommend dosage can be decreased to 3 days.

For adults with gonococcal infection of the urethra or cervix, the recommended dosage of NORFLOXACIN is two 400 mg tablets (800 mg) given as a single dose.

Elderly

The recommended dosage of NORFLOXACIN in elderly patients with normal renal function for their age is the same as given for adults above.

Overdose

If you think you have taken too much NORFLOXACIN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

If you forget to take a dose, take the next recommended dose as scheduled. Do not double the dose to make up for the missed dose. If you happen to take too many tablets by accident, contact your physician or pharmacist immediately.

Side effects and what to do about them

These are not all the possible side effects you may have when taking NORFLOXACIN. If you have a side effect not shown here, contact your doctor.

Stop taking NORFLOXACIN and contact your doctor right away if:

  1. You have pain, swelling or rupture of your tendon and:
  • rest
  • avoid physical exercise
Fluoroquinolones, like NORFLOXACIN, have been associated with these effects.
  • You have problems in your nerves (neuropathy) with symptoms such as:
    • pain, burning, tingling, numbness or weakness
    Fluoroquinolones, like NORFLOXACIN, have been associated with this condition. Fluoroquinolones, like NORFLOXACIN, have been associated with effects such as:
    • confusion, tremors, headache.
    • seeing things, depression, agitation.
    • difficulty sleeping, anxiety, nervousness and suicidal thoughts.

      • Contact your doctor right away if you have suicidal thoughts
    Common side effects that may occur include:
    • nausea, headache and dizziness
    Other side effects that may occur include:
    • rash, itching, muscle pain
    • vomiting, upset stomach, diarrhea, constipation
    • poor appetite
    Self-Limiting Side Effects
    • Feeling lightheaded
    • Insomnia (difficulty sleeping)
    • Nightmares

    Serious side effects, how often they happen and what to do about them
    Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
    NOT KNOWN
    allergic reactions with symptoms: swelling of the face, lips throat, hives, difficulty breathing     ✔
    pancreatitis (inflamed pancreas) with symptoms: abdominal pain, nausea, vomiting     ✔
    destruction of red blood cells (hemolytic anemia) with symptoms: fatigue, shortness of breath, yellowing of skin and eyes     ✔
    lower blood platelets (thrombocytopenia) with symptoms: increased bleeding (nose bleeds) bruising or red/purple spots on the skin     ✔
    serious skin reactions with symptoms: widespread blisters on skin, mouth and nose, peeling skin     ✔
    Hypoglycemia (Low blood sugar):
    Change in mood, change in vision, confusion, dizziness, fast heartbeat, feeling faint, headache, hunger, shaking, sweating, weakness.    		   ✔  
    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
    • Store at room temperature 15°C to 30°C
    • Store your tablets in a tightly closed container, away from direct light, and out of damp places such as the bathroom or kitchen.

    Keep out of reach and sight of children.

    Reporting side effects

    Reporting Side Effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    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.

    More information

    If you want more information about NORFLOXACIN:

    This leaflet was prepared by AA Pharma Inc. Vaughan, Ontario L4K 4N7.

    Last Revised: June 25, 2019.

    Date modified: