Patient Medication Information: uses, side effects, how to take - Taro-Ciprofloxacin
Serious Warnings and Precautions
Talk to your doctor to see if TARO-CIPROFLOXACIN is right for you. |
What is TARO-CIPROFLOXACIN used for?
Antibacterial drugs like TARO-CIPROFLOXACIN treat only bacterial infections.
They do not treat viral infections such as the common cold.
TARO-CIPROFLOXACIN is used to treat infections caused by bacteria. These i nclude infections of the:
- Respi ratory tract
- Uri nary tract
- Prostate
- Skin and soft ti ssues
- 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:
- Di arrhea caused by bacterial infections
- Typhoid fever
- Uncomplicated gonorrhea
How does TARO-CIPROFLOXACIN work?
TARO-CIPROFLOXACIN is an antibiotic that kills the bacteria causing the infection.
What are the ingredients in TARO-CIPROFLOXACIN?
Medicinal ingredient: ciprofloxacin as ciprofloxacin hydrochloride.
Non-medicinal ingredients: Croscarmellose Sodium, Microcrystallie Cellulose, Povidone, Purified Water, Silicon Dioxide, Magnesium Stearate, OPADRY II White 85F18378 (which contains polyvinyl alcohol-partially hydrolyzed, titanium dioxide, PEG 3350 and talc).
TARO-CIPROFLOXACIN comes in the following dosage forms:
TARO-CIPROFLOXACIN tablets: 250 mg, 500 mg and 750 mg.
The 250 mg tablets are round and white in colour. One side is engraved with "T92" and the other side is plain.
The 500 mg tablets are oblong and white in colour. One side is engraved with “T95" and the other side is plain.
The 750 mg tablets are oblong and white to in colour. One side is engraved with “T97" and the other side is plain.
Do not use TARO-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 TARO-CIPROFLOXACIN?”).
- you are taking tizanidine (ZANAFLEX®), a medication that relaxes muscles. Side effects such as drowsiness, sleepiness and low blood pressure may occur.
- you are currently taking agomelatinea, a type of medication sued 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 TARO-CIPROFLOXACIN.
Talk about any health conditions or problems you may have, including if you:
- have a family history of fructose intolerance, glucose -galactose malabsorption or
- 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 prol ongation
- 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:
Usi ng TARO-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 TARO-CIPROFLOXACIN for.
Blood Sugar Changes
Medicines like TARO-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 TARO-CIPROFLOXACIN. If you have diabetes, check your blood sugar levels often while taking TARO-CIPROFLOXACIN.
TARO-CIPROFLOXACIN can make your skin more sensitive to the sun. While taking TARO-CIPROFLOXACIN:
Avoid too much sunlight or artificial ultraviolet light (such as sunlamps).
- Stop taking TARO-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 TARO-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,
- dizziness or loss of consciousness.
Tendon problems can happen within the first 48 hours of treatment.
Clostridium difficile-associated disease (CDAD)
TARO-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 TARO-CIPROFLOXACIN. Stop taking TARO-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. Stop taking TARO-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 TARO-CIPROFLOXACIN , contact an eye doctor immediately.
Peripheral Neuropathy (damaged nerves outside of the brain and spinal cord)
Nerve damage can happen from taking TARO-CIPROFLOXACIN. Stop taking TARO-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 TARO-CIPROFLOXACIN:
- Theophylline or VIDEX® (didanosine) chewable/buffered tablets or pediatric powder.
- Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including TARO-CIPROFLOXACIN, and theophylline.
- Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take TARO-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 TARO-CIPROFLOXACIN:
Take TARO-CIPROFLOXACIN as prescribed by your doctor at almost the same times each day. Take TARO-CIPROFLOXACIN with food or on an empty stomach.
- Do not take TARO-CIPROFLOXACIN with dairy products (like milk or yogurt) or calcium-fortified juices alone. However, you may take TARO-CIPROFLOXACIN with a meal that contains these products (see “The following may interact with TARO-CIPROFLOXACIN:”).
- Do not take TARO-CIPROFLOXACIN with antacids that contain magnesium or aluminum
- You should avoid excessive caffeine consumption while taking TARO-CIPROFLOXACIN.
- You should drink lots of water while taking TARO-CIPROFLOXACIN.
- Swallow the TARO-CIPROFLOXACIN tablets whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.
- After treatment has been completed, any remaining TARO-CIPROFLOXACIN should not be reused.
If you are taking the following medicines, take them at least 6 hours before or 2 hours after TARO-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 TARO-CIPROFLOXACIN for another condition or give it to others.
Although you may feel better early in treatment, TARO-CIPROFLOXACIN should be taken exactly as directed. Misuse or overuse of TARO-CIPROFLOXACIN could lead to the growth of bacteria that will not be killed by TARO-CIPROFLOXACIN (resistance). This means that TARO-CIPROFLOXACIN may not work for you in the future. Do not share your medicine.
You should take TARO-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 TARO-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 TARO-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 TARO-CIPROFLOXACIN?
These are not all the possible side effects you may feel when taking TARO-CIPROFLOXACIN. If you have any side effects not listed here, tell your healthcare professional.
All medicines, including TARO-CIPROFLOXACIN, can cause side effects, although not everyone gets them.
Stop taking TARO-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
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Uncommon | |||
Digestive:
| ✓ | ||
Hemic and Lymphatic:
| ✓ | ||
Musculoskeletal:
| ✓ | ||
Skin:
| ✓ | ||
Urogenital:
| ✓ | ||
| Rare | |||
Serious Side Effects and What to do About Them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Allergic Reaction:
| ✓ | ||
Cardiovascular:
| ✓ | ||
Digestive:
| ✓ | ||
Serious Side Effects and What to do About Them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Hemic and Lymphatic:
| ✓ | ||
Hepatic:
| ✓ | ||
Hyperglycemia (Increased Bl ood Sugar):
| ✓ | ||
Hypoglycemia (l ow blood sugar):
| ✓ | ||
Serious Side Effects and What to do About Them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Mental Health:
| ✓ | ||
Musculoskeletal:
| ✓ | ||
Neurological:
| ✓ | ||
| Photosensitivity Reaction: Sensitivity to light, blistering of skin. | ✓ | ||
Rise in the pressure within your skull:
| ✓ | ||
Special Senses:
| ✓ | ||
Serious Side Effects and What to do About Them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Symptoms of an Infection:
| ✓ | ||
| Tendon pain, inflammation, or rupture (These side effects may last more than 30 days) | ✓ | ||
Urogenital:
| ✓ | ||
| Very Rare | |||
Digestive:
| ✓ | ||
Hemic and Lymphatic:
| ✓ | ||
Hepatic:
| ✓ | ||
Hypersensitivity:
| ✓ | ||
Mental Health:
| ✓ | ||
Serious Side Effects and What to do About Them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Musculoskeletal:
| ✓ | ||
Neurological:
| ✓ | ||
| Unknown | |||
| Acute generalized exanthematous pustulosis (AGEP) (pustular rash) | ✓ | ||
Aortic aneurysm (abnormal bulge in a large blood vessel called the aorta) /Aortic dissection (tear in the wall of the aorta):
| ✓ | ||
Clostridium difficile colitis (severe bowel disorder):
| ✓ | ||
| Epistaxis (acute haemorrhage from nose or nosebleed) | ✓ | ||
| Gynecomastia (swelling of breast tissue in males) | ✓ | ||
| Lymphadenopathy (swollen lymph nodes) | ✓ | ||
| Neuropathy (nerve disorder): peripheral neuropathy and polyneuropathy (troubles associated with the nervous system such as pain, burning, tingling, numbness, weakness in your hands and feet | ✓ | ||
| (QT Prolongation) (heart disorder) and other cardiovascular effects: Irregular heartbeat , ventricular arrhythmia or Torsades de Pointes (abnormal heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm) | ✓ | ||
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 controlled room temperature between 15 - 30°C
Keep out of reach and sight of children.
If you want more information about TARO-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 the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.taro.ca or by contacting Taro Pharmaceuticals Inc. at 1-800-268-1975.
130 East Drive,
Brampton, Ontario
L6T 1C1
TARO is a registered trademark of Taro Pharmaceuticals Inc.
Last revised: January 04, 2022.
Reporting Side Effects
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.
