Cipro XR

Ciprofloxacin is a prescription medication used to treat a variety of bacterial infections including urinary tract infections, pneumonia, and sinus infections. Ciprofloxacin belongs to a group of antibiotics called fluoroquinolones, which work by killing the bacteria that cause infections.

This medication comes as a tablet, an oral suspension (liquid), and an intravenous (IV) solution. The tablet and suspension are usually taken twice daily, in the morning and evening, with or without food. Ciprofloxacin also comes as an extended-release tablet that is taken once a day, with or without food. Swallow ciprofloxacin tablets whole. Do not split, crush, or chew tablets.

Common side effects include nausea, vomiting, and diarrhea. Ciprofloxacin can cause dizziness. Do not drive or operate machinery until you know how ciprofloxacin affects you.

Ciprofloxacin is a prescription medication used to treat certain infections caused by certain germs called bacteria. It is used to treat a variety of infections, some of which include infections of the:

• urinary tract 
• lungs (pneumonia, bronchitis)
• sinuses 
• skin
• bone
• prostate

It is also used to reduce the incidence or progression of disease following exposure to inhaled anthrax.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with ciprofloxacin. See "Drug Precautions" section.

Common side effects include:

• nausea
• diarrhea
• changes in liver function tests
• vomiting
• rash
• vaginal yeast infection
• pain or discomfort in the abdomen
• headache

This is not a complete list of ciprofloxacin side effects. Tell your doctor about any side effect that bothers you, or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. Ciprofloxacin and other medicines can affect each other causing side effects. Especially tell your doctor if you take:

• an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take ciprofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures. 
• a blood thinner (such as warfarin, Coumadin, Jantoven).
• tizanidine (Zanaflex). You should not take ciprofloxacin if you are already taking tizanidine. 
• theophylline (such as Theo-24, Elixophyllin, Theochron, Uniphyl, Theolair) 
• glyburide (Micronase, Glynase, Diabeta, Glucovance)
• phenytoin (Fosphenytoin Sodium, Cerebyx, Dilantin-125, Dilantin, Extended Phenytoin Sodium, Prompt Phenytoin Sodium, Phenytek)
• products that contain caffeine
• a medicine to control your heart rate or rhythm (antiarrhythmics)
• an anti-psychotic medicine
• a tricyclic antidepressant
• a water pill (diuretic)
• a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. 
• methotrexate (Trexall)
• probenecid (Probalan, Col-probenecid)
• metoclopromide (Reglan, Reglan ODT)
• ropinirole (Requip)
• lidocaine (Xylocaine intravenous infusion)
• clozapine (Clozaril, Fazaclo ODT)
• pentoxifylline (Trental)
• sildenafil (Viagra, Revatio)
• cyclosporine (Gengraf, Neoral, Sandimmune, Sangcya)
• omeprazole (Prilosec)

Certain medicines may keep ciprofloxacin from working correctly. Take ciprofloxacin either 2 hours before or 6 hours after taking these products:

• an antacid, multivitamin, or other product that has magnesium, calcium, aluminum, iron, or zinc
• sucralfate (Carafate).
• didanosine (Videx, Videx EC).

Ask your doctor or pharmacist if you are not sure if any of your medicines are listed above.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Ciprofloxacin belongs to a class of antibiotics called fluoroquinolones. Ciprofloxacin can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take ciprofloxacin.

1. Tendon rupture or swelling of the tendon (tendinitis)

• Tendon problems can happen in people of all ages who take ciprofloxacin. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
  • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
• The risk of getting tendon problems while you take ciprofloxacin is higher if you:
  • are over 60 years of age
  • are taking steroids (corticosteroids)
  • have had a kidney, heart or lung transplant
• Tendon problems can happen in people who do not have the above risk factors when they take ciprofloxacin. Other reasons that can increase your risk of tendon problems can include:
  • physical activity or exercise
  • kidney failure
  • tendon problems in the past, such as in people with rheumatoid arthritis (RA)
• Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking ciprofloxacin until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons.
• Talk to your healthcare provider about the risk of tendon rupture with continued use of ciprofloxacin. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
• Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
• Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
  • hear or feel a snap or pop in a tendon area
  • bruising right after an injury in a tendon area
  • unable to move the affected area or bear weight

2. Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

Other serious side effects of ciprofloxacin include:

• You may have serious seizure and breathing problems when you take theophylline with ciprofloxacin. These problems may lead to death. Get emergency help right away if you have seizures or trouble breathing.
• Seizures have been reported in people who take fluoroquinolone antibiotics including ciprofloxacin. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking ciprofloxacin will change your risk of having a seizure. This serious side effect may happen as soon as after taking the first dose of ciprofloxacin.
• Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
  • feel dizzy
  • seizures
  • hear voices, see things, or sense things that are not there (hallucinations)
  • feel restless
  • tremors
  • feel anxious or nervous
  • confusion
  • depression
  • trouble sleeping
  • nightmares
  • feel more suspicious (paranoia)
  • suicidal thoughts or acts
• ​Allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin, even after only one dose. Stop taking ciprofloxacin and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
  • hives
  • trouble breathing or swallowing
  • swelling of the lips, tongue, face
  • throat tightness, hoarseness
  • rapid heartbeat
  • faint
  • yellowing of the skin or eyes. Stop taking ciprofloxacin and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ciprofloxacin (a liver problem).
  • skin rash (Skin rash may happen in people taking ciprofloxacin even after only one dose. Stop taking ciprofloxacin at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ciprofloxacin.)

• Serious heart rhythm changes (QT prolongation and torsade de pointes). Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous.
• The chances of this event are higher in people:
  • who are elderly
  • with a family history of prolonged QT interval
  • with low blood potassium (hypokalemia)
  • who take certain medicines to control heart rhythm (antiarrhythmics)
  • intestine infection (Pseudomembranous colitis)
• ​Pseudomembranous colitis can happen with most antibiotics, including ciprofloxacin. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

• Changes in sensation and nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin. The nerve damage may be permanent. Stop ciprofloxacin and with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
  • pain
  • burning
  • tingling
  • numbness
  • weakness
• ​Low blood sugar (hypoglycemia). People who take ciprofloxacin and other fluoroquinolone medicines with the oral anti-diabetes medicine glyburide (Micronase, Glynase, Diabeta, Glucovance) can get low blood sugar (hypoglycemia) which can sometimes be severe. Tell your healthcare provider if you get low blood sugar with ciprofloxacin. Your antibiotic medicine may need to be changed.
• Sensitivity to sunlight (photosensitivity). 
• Joint Problems. Increased chance of problems with joints and tissues around joints in children under 18 years old. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin.

Do not take ciprofloxacin if you:

• Have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in ciprofloxacin. Ask your healthcare provider if you are not sure. 
• Also take a medicine called tizanidine (Zanaflex). Serious side effects from tizanidine are likely to happen.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods.

While taking ciprofloxacin you should limit your caffeine intake as this medication may lead to the accumulation of caffeine by interfering with the body's ability to remove it. Caffeine-containing products include coffee, tea, energy drinks, soft drinks (colas), chocolate, and other foods and beverages.

Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since ciprofloxacin absorption may be significantly reduced; however, ciprofloxacin may be taken with a meal that contains these products.

Tell your doctor about all your medical conditions, including if you:

• have tendon problems
• have a disease that causes muscle weakness (myasthenia gravis)
• have central nervous system problems (such as epilepsy)
• have nerve problems
• have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
• have a history of seizure
• have kidney problems. You may need a lower dose of Cipro if your kidneys do not work well.
• have rheumatoid arthritis (RA) or other history of joint problems
• have trouble swallowing pills
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ciprofloxacin falls into category C. There are no well-controlled studies that have been done in pregnant women. Ciprofloxacin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Ciprofloxacin has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from ciprofloxacin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Take ciprofloxacin exactly as prescribed by your healthcare provider.
• Take ciprofloxacin tablets in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you can not swallow the tablet whole.
• Take ciprofloxacin oral suspension in the morning and evening at about the same time each day. Shake the ciprofloxacin oral suspension bottle well each time before use for about 15 seconds to make sure the suspension is mixed well. Close the bottle completely after use.
• Take Ciprofloxacin XR tablets one time each day at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you cannot swallow the tablet whole.
• Ciprofloxacin IV is given to you by intravenous (IV) infusion into your vein, slowly, over 60 minutes, as prescribed by your healthcare provider.
• Ciprofloxacin can be taken with or without food.
• Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
• Drink plenty of fluids while taking ciprofloxacin.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ciprofloxacin at the same time.

To be sure that all of the bacteria are killed and to lower the chance that the bacteria will become resistant to ciprofloxacin, do not skip any doses, or stop taking ciprofloxacin even if you begin to feel better. Finish your prescribed treatment, unless:

• you have tendon effects 
• you have a serious allergic reaction
• your healthcare provider tells you to stop

Take ciprofloxacin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The ciprofloxacin dose your doctor recommends will be based on the following:

• the infection being treated
• other medical conditions you have
• other medications you are taking
• your weight
• your height
• your age

Doses vary, but usually range between 250 mg to 750 mg every 12 hours. Ciprofloxacin is often prescribed for 7 to 14 days, although sometimes it can be prescribed as a single dose or for treatment lasting 60 days.

For anthrax exposure, the recommended adult ciprofloxacin dose is 500 mg every 12 hours, for 60 days.

If you take too much ciprofloxacin, call your healthcare provider or get medical help immediately.

Ciprofloxacin Tablets

• Store ciprofloxacin tablets below 86°F (30°C).

Ciprofloxacin Oral Suspension

• Store ciprofloxacin oral suspension below 86°F (30°C) for up to 14 days.
• Do not freeze.
• After treatment has been completed, any unused oral suspension should be safely thrown away.

Ciprofloxacin XR

• Store ciprofloxacin XR tablets at 59°F to 86°F (15°C to 30°C ).

Keep ciprofloxacin and all medicines out of the reach of children.

WARNING:

Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis.