Refer to the “Also Known As” section to reference different products that include the same medication as Cipro.
Brand Name: Cipro
Generic Name: CIPROFLOXACIN
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: SOLUTION, CONCENTRATE
Data Current As Of: 2018-10-05
indications & usage
skin & skin structure infections
CIPRO IV is indicated in adult patients for treatment of skin and skin structure infectionscaused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.
bone & joint infections
CIPRO IV is indicated in adult patients for treatment of bone and joint infectionscaused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
complicated intra-abdominal infections
CIPRO IV is indicated in adult patients for treatment of complicated intra-abdominal infections(used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
CIPRO IV is indicated in adult patients for treatment of nosocomial pneumoniacaused by Haemophilus influenzae or Klebsiella pneumoniae.
empirical therapy for febrile neutropenic patients
CIPRO IV is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium [see Clinical Studies (14.1)].
inhalational anthrax (post-exposure)
CIPRO IV is indicated in adults and pediatric patients from birth to 17 years of age for treatment of inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see Clinical Studies (14.3)].
CIPRO IV is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.4)].
chronic bacterial prostatitis
CIPRO IV is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.
lower respiratory tract infections
CIPRO IV is indicated in adult patients for treatment of lower respiratory tract infectionscaused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniaeCIPRO IV is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumonia.
CIPRO IV is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.
Because fluoroquinolones, including CIPRO IV, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.15)] and for some patients AECB is self-limiting, reserve CIPRO IV for treatment of AECB in patients who have no alternative treatment options.
urinary tract infections
urinary tract infection in adults
CIPRO IV is indicated in adult patients for treatment of urinary tract infectionscaused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.
complicated urinary tract infections & pyelonephritis in pediatric patients
CIPRO IV is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see Use in Specific Populations (8.4)].
Although effective in clinical trials, CIPRO IV is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. CIPRO IV, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see Warnings and Precautions (5.12), Adverse Reactions (6.1), Use in Specific Populations (8.4), and Nonclinical Toxicology (13.2)].
CIPRO IV is indicated in adult patients for treatment of acute sinusitiscaused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.
Because fluoroquinolones, including CIPRO IV, have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.15)] and for some patients acute sinusitis is self-limiting, reserve CIPRO for treatment of acute sinusitis in patients who have no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO IV and other antibacterial drugs, CIPRO IV should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with CIPRO IV may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.
As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
patient counseling information
Advise the patient to read the FDA-approved patient labeling(Medication Guide)
Serious Adverse Reactions
Advise patients to stop taking CIPRO if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.
Inform patients of the following serious adverse reactions that have been associated with CIPRO IV or other fluoroquinolone use:
- Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of CIPRO IV and may occur together in the same patient. Inform patients to stop taking CIPRO immediately if they experience an adverse reaction and to call their healthcare provider.
- Tendon Disorders: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue CIPRO treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
- Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with ciprofloxacin use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue CIPRO and tell them to contact their physician.
- Central nervous system effects (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure): Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including CIPRO IV. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to CIPRO before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.
- Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.
- Hypersensitivity Reactions: Inform patientsthat ciprofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
- Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking CIPRO IV. Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine.
- Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.
- Prolongation of the QT Interval: Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Instruct patients to notify their physician if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.
- Musculoskeletal Disorders in Pediatric Patients: Instruct parents to inform their child’s physician if the child has a history of joint-related problems before taking this drug. Inform parents of pediatric patients to notify their child’s physician of any joint-related problems that occur during or following ciprofloxacin therapy [see Warnings and Precautions (5.12) and Use in Specific Populations (8.4)].
- Tizanidine: Instruct patients not to use ciprofloxacin if they are already taking tizanidine. CIPRO increases the effects of tizanidine (Zanaflex®).
- Theophylline: Inform patients that CIPRO IV may increase the effects of theophylline. Life-threatening CNS effects and arrhythmias can occur. Advise the patients to immediately seek medical help if they experience seizures, palpitations, or difficulty breathing.
- Caffeine: Inform patients that CIPRO IV may increase the effects of caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
- Photosensitivity/Phototoxicity: Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones. Inform patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, instruct them to wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, instruct patients to contact their physician.
Inform patients that antibacterial drugs including CIPRO IV should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When CIPRO IV prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CIPRO IV or other antibacterial drugs in the future.
Inform patients to drink fluids liberally while taking CIPRO to avoid formation of highly concentrated urine and crystal formation in the urine.
Drug Interactions Oral Antidiabetic Agents
Inform patients that hypoglycemia has been reported when ciprofloxacin and oral antidiabetic agents were co-administered; if low blood sugar occurs with CIPRO IV, instruct them toconsult their physician and that their antibacterial medicine may need to be changed.
Anthrax and Plague Studies
Inform patients given CIPRO IV for this condition that efficacy studies could not be conducted in humans for ethical and feasibility reasons. Therefore, approval for these conditions was based on efficacy studies conducted in animals.
for oral use
for oral suspension
CIPRO® XR (Sip-row)
for oral use
CIPRO® IV (Sip-row)
for intravenous infusion
Read this Medication Guide before you start taking CIPRO and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about CIPRO?
CIPRO, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.
If you get any of the following serious side effects while you take CIPRO, you should stop taking CIPRO immediately and get medical help right away.
1. Tendon rupture or swelling of the tendon (tendinitis).
- Tendon problems can happen in people of all ages who take CIPRO. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
- oPain, swelling, tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
- The risk of getting tendon problems while you take CIPRO is higher if you:
- oare over 60 years of age
- oare taking steroids (corticosteroids)
- ohave had a kidney, heart or lung transplant
- Tendon problems can happen in people who do not have the above risk factors when they take CIPRO.
- Other reasons that can increase your risk of tendon problems can include:
- ophysical activity or exercise
- okidney failure
- otendon problems in the past, such as in people with rheumatoid arthritis (RA)
- Stop taking CIPRO immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. 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.
- Tendon rupture can happen while you are taking or after you have finished taking CIPRO. Tendon ruptures can happen within hours or days of taking CIPRO and have happened up to several months after people have finished taking their fluoroquinolone.
- Stop taking CIPRO immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
- ohear or feel a snap or pop in a tendon area
- obruising right after an injury in a tendon area
- ounable to move the affected area or bear weight
- 2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including CIPRO. Stop taking CIPRO immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
| || |
- CIPRO may need to be stopped to prevent permanent nerve damage.
- 3. Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including CIPRO. Tell your healthcare provider if you have a history of seizures before you start taking CIPRO. CNS side effects may happen as soon as after taking the first dose of CIPRO. Stop taking CIPRO immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
- 4. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like CIPRO may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking CIPRO. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
What is CIPRO?
CIPRO is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
- urinary tract infection
- chronic prostate infection
- lower respiratory tract infection
- sinus infection
- skin infection
- bone and joint infection
- nosocomial pneumonia
- intra-abdominal infection, complicated
- infectious diarrhea
- typhoid (enteric) fever
- cervical and urethral gonorrhea, uncomplicated
- people with a low white blood cell count and a fever
- inhalational anthrax
- Studies of CIPRO for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
- CIPRO should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
- CIPRO should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.
- CIPRO is also used in children younger than 18 years of age to treatcomplicated urinary tract and kidney infections or who may have breathed in anthrax germs, have plague or have been exposed to plague germs.
- Children younger than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking CIPRO. CIPRO should not be used as the first choice of antibacterial medicine in children under 18 years of age.
- CIPRO XR is only used in adults 18 years of age and older to treat urinary tract infections (complicated and uncomplicated), including kidney infections (pyelonephritis).
- It is not known if CIPRO XR is safe and effective in children under 18 years of age.
Who should not take CIPRO?
Do not take CIPRO if you:
- Have ever had a severe allergic reaction to an antibacterial medicine known as a fluoroquinolone, or are allergic to ciprofloxacin hydrochloride or any of the ingredients in CIPRO. See the end of this Medication Guide for a complete list of ingredients in CIPRO.
- Also take a medicine called tizanidine (Zanaflex®).
Ask your healthcare provider if you are not sure.
What should I tell my healthcare provider before taking CIPRO?
Before you take CIPRO, tell your healthcare provider if you:
- have tendon problems; CIPRO should not be used in patients who have a history of tendon problems
- have a disease that causes muscle weakness (myasthenia gravis); CIPRO should not be used in patients who have a known history of myasthenia gravis
- have liver problems
- have central nervous system problems (such as epilepsy)
- have nerve problems; CIPRO should not be used in patients who have a history of a nerve problem called peripheral neuropathy
- have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
- have or have had seizures
- have kidney problems. You may need a lower dose of CIPRO if your kidneys do not work well.
- have joint problems including rheumatoid arthritis (RA)
- have trouble swallowing pills
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if CIPRO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. CIPRO passes into breast milk. You and your healthcare provider should decide whether you will take CIPRO or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- CIPRO and other medicines can affect each other causing side effects.
- Especially tell your healthcare provider if you take:
- oa steroid medicine
- oan anti-psychotic medicine
- oa tricyclic antidepressant
- oa water pill (diuretic)
- otheophylline (such as Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)
- oa medicine to control your heart rate or rhythm (antiarrhythmics)
- oan oral anti-diabetes medicine
- ophenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin®, Extended Phenytoin Sodium®, Prompt Phenytoin Sodium®, Phenytek®)
- ocyclosporine (Gengraf®, Neoral®, Sandimmune®, Sangcya®).
- oa blood thinner (such as warfarin, Coumadin®, Jantoven®)
- omethotrexate (Trexall®)
- oropinirole (Requip®)
- oclozapine (Clozaril®, Fazaclo® ODT®)
- oa Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take CIPRO or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
- osildenafil (Viagra®, Revatio®)
- oproducts that contain caffeine
- oprobenecid (Probalan®, Col-probenecid ®)
- Certain medicines may keep CIPRO Tablets, CIPRO Oral Suspension from working correctly. Take CIPRO Tablets and Oral Suspension either 2 hours before or 6 hours after taking these medicines, vitamins, or supplements:
- oan antacid, multivitamin, or other medicine or supplements that has magnesium, calcium, aluminum, iron, or zinc
- osucralfate (Carafate®)
- odidanosine (Videx®, Videx EC®)
Ask your healthcare provider for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take CIPRO?
- Take CIPRO exactly as your healthcare provider tells you to take it.
- Your healthcare provider will tell you how much CIPRO to take and when to take it.
- Take CIPRO 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 cannot swallow the tablet whole.
- Take CIPRO Oral Suspension in the morning and evening at about the same time each day. Shake the CIPRO 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 CIPRO XR 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.
- CIPRO IV is given to you by intravenous (IV) infusion into your vein, slowly, over 60 minutes, as prescribed by your healthcare provider.
- CIPRO can be taken with or without food.
- CIPRO 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 CIPRO.
- Do not skip any doses of CIPRO, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:
- oyou have tendon problems. See “What is the most important information I should know about CIPRO?”
- oyou have nerve problems. See “What is the most important information I should know about CIPRO?”
- oyou have central nervous system problems. See “What is the most important information I should know about CIPRO?”
- oyou have a serious allergic reaction. See “What are the possible side effects of CIPRO?”
- oyour healthcare provider tells you to stop taking CIPRO
- Taking all of your CIPRO doses will help make sure that all of the bacteria are killed. Taking all of your CIPRO doses will help lower the chance that the bacteria will become resistant to CIPRO. If you become resistant to CIPRO, CIPRO and other antibacterial medicines may not work for you in the future.
- If you take too much CIPRO, call your healthcare provider or get medical help right away.
What should I avoid while taking CIPRO?
- CIPRO can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how CIPRO affects you.
- Avoid sunlamps, tanning beds, and try to limit your time in the sun. CIPRO can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get a severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take CIPRO, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.
What are the possible side effects of CIPRO?
CIPRO may cause serious side effects, including:
- See, “What is the most important information I should know about CIPRO?”
- Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking fluoroquinolones, including CIPRO, even after only 1 dose. Stop taking CIPRO and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
- otrouble breathing or swallowing
- oswelling of the lips, tongue, face
- othroat tightness, hoarseness
- orapid heartbeat
- oskin rash
- Skin rash may happen in people taking CIPRO even after only 1 dose. Stop taking CIPRO 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 CIPRO.
- Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take CIPRO. Call your healthcare provider right away if you have unexplained symptoms such as:
- onausea or vomiting
- ostomach pain
- oabdominal pain or tenderness
- ounusual tiredness
- oloss of appetite
- olight colored bowel movements
- odark colored urine
- oyellowing of your skin or the whites of your eyes
Stop taking CIPRO and tell your healthcare provider right away if you have 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 CIPRO (a liver problem). Intestine infection (Pseudomembranous colitis). Pseudomembranous colitis can happen with many antibacterial medicines, including CIPRO. 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 antibacterial medicine.
- 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. CIPRO 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:
- owho are elderly
- owith a family history of prolonged QT interval
- owith low blood potassium (hypokalemia)
- owho take certain medicines to control heart rhythm (antiarrhythmics)
- Joint Problems. Increased chance of problems with joints and tissues around joints in children under 18 years old can happen. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with CIPRO.
- Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking CIPRO?”
The most common side effects of CIPRO include:
- changes in liver function tests
Tell your healthcare provider about any side effect that bothers you, or that does not go away.
These are not all the possible side effects of CIPRO. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store CIPRO?
- CIPRO Tablets
- Store at room temperature between 20° to 25°C (68° to 77°F).
CIPRO Oral Suspension
- Store microcapsules and diluent below 25°C (77°F).
- Do not freeze.
- After your CIPRO treatment is finished, safely throw away any unused oral suspension.
- CIPRO XR
- Store CIPRO XR between 59°F to 86°F (15°C to 30°C).
Keep CIPRO and all medicines out of the reach of children.
General Information about the safe and effective use of CIPRO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIPRO for a condition for which it is not prescribed. Do not give CIPRO to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about CIPRO. If you would like more information about CIPRO, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIPRO that is written for healthcare professionals.
For more information call 1-888-842-2937.
What are the ingredients in CIPRO?
- CIPRO Tablets:
- Active ingredient: ciprofloxacin hydrochloride
- Inactive ingredients: cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol
- CIPRO Oral Suspension:
- Active ingredient: ciprofloxacin hydrochloride
- Inactive ingredients:
- o Microcapsules contains: povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20
- o Diluent contains: medium-chain triglycerides, sucrose, soy-lecithin, water, and strawberry flavor
- CIPRO XR:
- Active ingredient: ciprofloxacin hydrochloride
- Inactive ingredients: crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide
- CIPRO IV:
- Active ingredient: ciprofloxacin
- Inactive ingredients: lactic acid as a solubilizing agent, hydrochloric acid for pH adjustment
- Manufactured for :
- Bayer HealthCare Pharmaceuticals Inc.
- Whippany, NJ 07981
- Manufactured in Germany
CIPRO is a registered trademark of Bayer Aktiengesellschaft.
©1987 Bayer HealthCare Pharmaceuticals Inc.
CIPRO (ciprofloxacin*) 5% and 10% Oral Suspension Manufactured in Italy
CIPRO (ciprofloxacin HCl) Tablets Manufactured in Germany
- This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised:7/2016
also known as