Details for: PRIVA-CIPROFLOXACIN
Company: PHARMAPAR INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02445344 | PRIVA-CIPROFLOXACIN | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) | 500 MG | TABLET | ORAL |
Summary Reports
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
Priva-CIPROFLOXACIN is used to treat certain types of bacterial infections.
What it does
Priva-CIPROFLOXACIN is antibiotic that kill the bacteria causing the infection.
When it should not be used
Do not use Priva-CIPROFLOXACIN if you:
- are allergic to ciprofloxacin, other quinolone antibiotics or to any non-medicinal ingredients in these products (see What the Nonmedicinal ingredients are).
- are currently taking tizanidine (ZANAFLEX®) for the management of spasticity. Tizanidine concentrations may increase and cause further side effects such as drowsiness, sleepiness and low blood pressure.
What the medicinal ingredient is
ciprofloxacin as ciprofloxacin hydrochloride.
What the non-medicinal ingredients are
Colloidal Anhydrous Silica, Crospovidon, Hypromellose, Magnesium Stearate, Maize starch, Microcrystalline Cellulose, Pregelitinized starch, Polyethlene Glycol, Purified Talc, and Titanium Dioxide.
What dosage form it comes in
Priva-CIPROFLOXACIN 500 mg Tablets: White to off-white, capsule shaped, biconvex, film-coated tablets, with score line on one side and plain on other side. Bottles of 100 and 500 tablets.
Warnings and precautions
Serious Warnings and Precautions
- Priva-CIPROFLOXACIN has been shown to lengthen the heartbeat on an electrocardiogram test (QT interval prolongation).
- Serious hypersensitivity (allergic) reactions have been reported in some patients receiving quinolone therapy, including Priva- CIPROFLOXACIN.
- If you have myasthenia gravis, treatment with Priva-CIPROFLOXACIN may make your condition worse. Do not use Priva- CIPROFLOXACIN if you have this condition.
- Quinolones, including Priva- CIPROFLOXACIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. Speak to your doctor to determine if this medication is suitable for you.
- Seizures and toxic psychoses may occur with quinolone therapy. Tell your doctor if you have any central nervous system problems (ie, epilepsy). Your doctor will determine whether you should use this medication.
- Priva-CIPROFLOXACIN can cause liver injury which may be fatal.
BEFORE you can use Priva-CIPROFLOXACIN talk to your doctor or pharmacist if you:
- Have a history of seizures
- Have a heart condition known as “QT prolongation”
- Have low levels of potassium in your blood
- Have liver or kidney disease or damage
- Are pregnant, planning to become pregnant, breast feeding or planning to breast-feed. Priva- CIPROFLOXACIN is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
- Are less than 18 years of age.
- Have a history of tendon problems associated with the use of a quinolone antibiotic.
- Have a condition known as myasthenia gravis.
You may become sensitive to the sun and ultraviolet
light while taking Priva-CIPROFLOXACIN. Exposure
to sunlight and ultraviolet light , such as that used in
tanning salons, should be minimized until you know how
you respond.
Driving and using machines: Before you perform tasks
which may require special attention, wait until you know
how you respond to Priva-CIPROFLOXACIN as it can
cause dizziness.
Interactions with this medication
As with most medicines, interactions with other drugs are
possible. Tell your doctor, nurse, or pharmacist about all
the medicines you take, including drugs prescribed by
other doctors, vitamins, minerals, natural supplements, or
alternative medicines.
Drugs that may interact with Priva-CIPROFLOXACIN
include:
- Theophylline or VIDEX® (didanosine) chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including Priva- CIPROFLOXACIN, and theophylline.
- Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc, all of which can interfere with the absorption of Priva-CIPROFLOXACIN and may prevent them from working. You should take Priva-CIPROFLOXACIN either 2 hours before or 6 hours after taking these products.
- Antidiabetic agents (eg, glyburide, glibenclamide, glimepiride, insulin) as the combination of any of these agents with ciprofloxacin may cause lower blood sugar.
- Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
- Caffeine (e.g. coffee) and other xanthine derivatives (e.g. pentoxifylline). Excessive caffeine intake should be avoided while taking Priva- CIPROFLOXACIN.
- Certain heart medications known as antiarrhythmics (eg, quinidine, procainamide, amiodarone, sotalol)
- Other medications including oral anticoagulants (like warfarin and acenocoumarol), phenytoin, duloxetine, tizanidine, methylxanthines, sevelamer, sucralfate, clozapine, ropinirole, lidocaine, sildenafil, probenecid, methotrexate, metoclopramide, cyclosporine, and lanthanum carbonate
Proper use of this medication
- Priva-CIPROFLOXACIN should be taken as prescribed at approximately the same times each day with food or on an empty stomach.
- Priva-CIPROFLOXACIN should not be taken with dairy products (like milk or yogurt) or calciumfortified juices alone; however, Priva- CIPROFLOXACIN may be taken with a meal that contains these products (see Interactions With This Medication).
- You should avoid excessive caffeine consumption while taking Priva-CIPROFLOXACIN.
- You should drink lots of water while taking Priva- CIPROFLOXACIN
- Swallow the Priva-CIPROFLOXACIN tablets whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.
You should take Priva-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.
Remember:
- Take your dose of Priva-CIPROFLOXACIN as prescribed
- Complete the course of Priva-CIPROFLOXACIN even if you are feeling better.
- Do not use Priva-CIPROFLOXACIN for another condition or give it to others.
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 Priva-CIPROFLOXACIN per day, even if you missed a dose.
Side effects and what to do about them
Side effects may include:
- Nausea and vomiting
- Diarrhea
- Rash, blistering of skin
- Stomach pain/discomfort, gas
- Cramping
- Coordination problems (unsteady walk)
- Feeling unwell
- Increased muscle tone, inflammation of joints, muscle pain
- Loss of appetite
- Loss of hearing (tinnitus)
- Migraine
- Sleeping problems
- Problems with smell and taste
- Sweating
- Visual disturbances (eyesight problems)
If your eyesight worsens or changes in any way, consult
your doctor and eye specialist immediately.
If you experience symptoms such as severe diarrhea
(bloody or watery) with or without fever, abdominal pain,
or tenderness, you may have Clostridium difficile colitis
(bowel inflammation). If this occurs, stop taking Priva-
CIPROFLOXACIN and contact your healthcare
professional immediately.
If any of these affect you severely, tell your doctor or
pharmacist.
| 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 seek 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 | ✔ | ||
| Low Blood Sugar: dizziness, weakness, headache, sweating, hunger | ✔ | ||
| Unknown | |||
| Severe Bowel Disorder: Persistent diarrhea, bloody or watery diarrhea, abdominal or stomach pain/cramping, blood/mucus in stool | ✔ | ||
| Nerve Disorder (Neuropathy): Pain, burning, tingling, numbness, weakness | ✔ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite, pale stools | ✔ | ||
| Heart Disorder (QT Prolongation): Irregular heartbeat | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Priva- CIPROFLOXACIN, contact your doctor or pharmacist.
How to store
Tablets: Store at room temperature 15°C- 30°C in a dry
place.
Keep out of reach and sight of children.
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 three ways:
- Report online at www.healthcanada.gc.ca/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 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/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
This document plus the full product monograph,
prepared for health professionals can be found by
contacting Pharmapar Inc.
This leaflet was prepared by:
Pharmapar Inc.
100-5950, Ch. de la Côte de Liesse
Mont-Royal
Qc, H4T 1E2
Phone# (514) 731-2003; Fax: (514) 731-2004
Date of Revision: August 22, 2019