Patient Medication Information: uses, side effects, how to take - Ciprofloxacin Tablets USP
Serious Warnings and Precautions
Talk to your doctor to see if CIPROFLOXACIN TABLETS USP are right for you |
What is CIPROFLOXACIN TABLETS USP used for?
.
Antibacterial drugs like CIPROFLOXACIN TABLETS USP treat only bacterial infections. They do not treat viral infections such as the common cold.
CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP work?
CIPROFLOXACIN TABLETS USP are antibiotics that kill the bacteria causing the infection.
What are the ingredients in CIPROFLOXACIN TABLETS USP?
Medicinal ingredients: ciprofloxacin hydrochloride.
Non-medicinal ingredients: Colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.
CIPROFLOXACIN TABLETS USP come in the following dosage forms:
CIPROFLOXACIN TABLETS USP: 100 mg, 250 mg, 500 mg and 750 mg.
CIPROFLOXACIN TABLETS USP 100 mg, are white, oval shaped, film coated tablets debossed with ‘R’ on one side and ‘125’ on other side.
CIPROFLOXACIN TABLETS USP 250 mg, are white, oval shaped, film coated tablets debossed with ‘R’ on one side and ‘126’ on other side.
CIPROFLOXACIN TABLETS USP 500 mg, are white, oval shaped, beveled edge film coated tablets debossed with ‘R’ on one side and ‘127’ on other side.
CIPROFLOXACIN TABLETS USP 750 mg, are white, modified capsule shaped, film coated tablets debossed with ‘R’ on one side and ‘128’ on other side.
Do not use CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP?”).
- 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 agomelatinea, 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 CIPROFLOXACIN TABLETS USP.
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 CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP for.
Blood Sugar Changes
Medicines like CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP. If you have diabetes, check your blood sugar levels often while taking CIPROFLOXACIN TABLETS USP.
CIPROFLOXACIN TABLETS USP can make your skin more sensitive to the sun. While taking CIPROFLOXACIN TABLETS USP.
Avoid too much sunlight or artificial ultraviolet light (such as sunlamps).
- Stop taking CIPROFLOXACIN TABLETS USP and contact your doctor if a sunburn or rash occurs.
Do not drive or use machinery if you feel dizzy or lightheaded.
Quinolones, including CIPROFLOXACIN TABLETS USP 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)
CIPROFLOXACIN TABLETS USP can cause infections of the colon caused by a bacteria called clostridium difficile. These infections can vary in severity from mild diarrhe a 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 CIPROFLOXACIN TABLETS USP. Stop taking CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP. Stop taking CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP, contact an eye doctor immediately.
Peripheral Neuropathy (damaged nerves outside of the brain and spinal cord)
Nerve damage can happen from taking CIPROFLOXACIN TABLETS USP. Stop taking CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP:
- Theophylline or VIDEX® (didanosine) chewable / buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including CIPROFLOXACIN TABLETS USP and theophylline.
- Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take CIPROFLOXACIN TABLETS USP:”).
- 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 CIPROFLOXACIN TABLETS USP:
Take CIPROFLOXACIN TABLETS USP as prescribed by your doctor at almost the same times each day. Take CIPROFLOXACIN TABLETS USP with food or on an empty stomach.
- Do not take CIPROFLOXACIN TABLETS USP with dairy products (like milk or yogurt) or calcium-fortified juices alone. However, you may be take CIPROFLOXACIN TABLETS USP with a meal that contains these products (see “The following may interact with CIPROFLOXACIN TABLETS USP:”).
- Do not take CIPROFLOXACIN TABLETS USP with antacids that contain magnesium or aluminum
- You should avoid excessive caffeine consumption while taking CIPROFLOXACIN TABLETS USP.
- You should drink lots of water while taking CIPROFLOXACIN TABLETS USP.
- Swallow the CIPROFLOXACIN TABLETS USP whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.
- After treatment has been completed, any remaining CIPROFLOXACIN TABLETS USP should not be reused.
If you are taking the following medicines, take them at least 6 hours before or 2 hours after CIPROFLOXACIN TABLETS USP:
- 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 CIPROFLOXACIN TABLETS USP for another condition or give it to others.
Although you may feel better early in treatment, CIPROFLOXACIN TABLETS USP should be taken exactly as directed. Misuse or overuse of CIPROFLOXACIN TABLETS USP could lead to the growth of bacteria that will not be killed by CIPROFLOXACIN TABLETS USP (resistance). This means that CIPROFLOXACIN TABLETS USP may not work for you in the future. Do not share your medicine.
You should take CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP, 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 CIPROFLOXACIN TABLETS USP 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 CIPROFLOXACIN TABLETS USP?
These are not all the possible side effects you may feel when taking CIPROFLOXACIN TABLETS USP. If you have any side effects not listed here, tell your healthcare professional.
All medicines, including CIPROFLOXACIN TABLETS USP can cause side effects, although not everyone gets them.
Stop taking CIPROFLOXACIN TABLETS USP 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 | ||||||
Allergic Reaction:
| ✓ | |||||
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 | ||
|---|---|---|---|
| |||
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:
| |
| ✓ | |
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 | ||
|---|---|---|---|
| |||
Hepatic:
| ✓ | ||
Hyperglycemia (Increased Blood Sugar):
| ✓ | ||
Hypoglycemia (low 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:
(These side effects may last more than 30 days) | ✓ | ||
Musculoskeletal:
| ✓ | ||
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 | ||
|---|---|---|---|
| |||
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:
| ✓ | ||
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 | ||
|---|---|---|---|
| Very Rare | |||
Digestive:
| ✓ | ||
Hemic and Lymphatic:
| ✓ | ||
Hepatic:
| ✓ | ||
Hypersensitivity:
| ✓ | ||
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:
| ✓ | ||
| 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):
| ✓ | ||
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 | ||
|---|---|---|---|
| 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.
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. |
Storage:
Tablets: Store at controlled room temperature between 15°C and 25°C.
Keep out of reach and sight of children.
If you want more information about CIPROFLOXACIN TABLETS USP:
- 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 www.drreddys.com or by 1-855-845-1739.
Manufactured By:
Dr. Reddy’s Laboratories Inc.,
New Jersey – 08540 United States
Imported and Distributed By:
Dr. Reddy’s Laboratories Canada Inc.
Mississauga, ON L4W 4Y1
Canada
Last Revised: February 3, 2022.
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