Ciprofloxacin
Lake Erie Medical DBA Quality Care Products LLC
Ciprofloxacin 500 mg
FULL PRESCRIBING INFORMATION
1718332max
CONTRAINDICATIONS ; WARNINGS; PRECAUTIONS: Drug Interactions
PRECAUTIONS
CONTRAINDICATIONS WARNINGS: PRECAUTIONS
Uses
DOSAGE AND ADMINISTRATION Urinary Tract Infections Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, Enterococcus faecalis.Acute Uncomplicated Cystitis in females Escherichia coli Staphylococcus saprophyticus.
Chronic Bacterial Prostatitis Escherichia coli Proteus mirabilis.
Lower Respiratory Tract Infections Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae. Moraxella catarrhalis
Streptococcus pneumoniae.
Acute Sinusitis Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis.
Skin and Skin Structure Infections Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes.
Bone and Joint Infections Enterobacter cloacae, Serratia marcescens, Pseudomonas aeruginosa.
Complicated Intra-Abdominal Infections Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, Bacteroides fragilis.
Infectious Diarrhea Escherichia coli Campylobacter jejuni, Shigella boydii†, Shigella dysenteriae, Shigella flexneri Shigella sonnei†
Typhoid Fever (Enteric Fever) Salmonella typhi.
Uncomplicated cervical and urethral gonorrhea Neisseria gonorrhoeae.Complicated Urinary Tract Infections and Pyelonephritis Escherichia coli.
WARNINGS, PRECAUTIONS, Pediatric Use, ADVERSE REACTIONS CLINICAL STUDIES ANIMAL PHARMACOLOGY
Inhalational anthrax Bacillus anthracis.
5 INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION
†
Pseudomonas aeruginosa
PRECAUTIONS: Drug Interactions .
Fluoroquinolones, including Ciprofloxacin Tablets, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotater cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture 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. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ciprofloxacin Tablets should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PREGNANT AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. PRECAUTIONS: Pregnancy, Nursing Mothers INDICATIONS AND USAGE ADVERSE REACTIONSANIMAL PHARMACOLOGY PRECAUTIONS: General, Information for Patients, Drug Interactions ADVERSE REACTIONS SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AND THEOPHYLLINE.
- fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome);
- vasculitis; arthralgia; myalgia; serum sickness;
- allergic pneumonitis;
- interstitial nephritis; acute renal insufficiency or failure;
- hepatitis; jaundice; acute hepatic necrosis or failure;
- anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS ).
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ciprofloxacin Tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
ANIMAL PHARMACOLOGY
Central Nervous System
WARNINGS, Information for Patients, Drug Interactions
Renal Impairment
DOSAGE AND ADMINISTRATION
Photosensitivity/Phototoxicity
ADVERSE REACTIONS/Post-Marketing Adverse Events
Ciprofloxacin, administered I.V. and/or orally, was compared to a
cephalosporin for treatment of complicated urinary tract infections (cUTI) or
pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4
years). The trial was conducted in the U.S., Canada, Argentina, Peru, Costa
Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21
days (mean duration of treatment was 11 days with a range of 1 to 88 days). The
primary objective of the study was to assess musculoskeletal and neurological
safety within 6 weeks of therapy and through one year of follow-up in the 335
ciprofloxacin- and 349 comparator-treated patients enrolled.
An
Independent Pediatric Safety Committee (IPSC) reviewed all cases of
musculoskeletal adverse events as well as all patients with an abnormal gait or
abnormal joint exam (baseline or treatment-emergent). These events were
evaluated in a comprehensive fashion and included such conditions as arthralgia,
abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain,
arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in
a joint.
The affected joints included: knee, elbow, ankle, hip, wrist, and shoulder. Within 6 weeks of treatment initiation, the rates of these events were 9.3% (31/335) in the ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients. The majority of these events were mild or moderate in intensity. All musculoskeletal events occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment.
Radiological evaluations were not routinely used to confirm resolution of the
events. The events occurred more frequently in ciprofloxacin-treated patients
than control patients, regardless of whether they received I.V. or oral therapy.
Ciprofloxacin-treated patients were more likely to report more than one event
and on more than one occasion compared to control patients. These events
occurred in all age groups and the rates were consistently higher in the
ciprofloxacin group compared to the control group. At the end of 1 year, the
rate of these events reported at any time during that period was 13.7% (46/335)
in the ciprofloxacin-treated group versus 9.5% (33/349) comparator-treated
patients.
An adolescent female discontinued ciprofloxacin for wrist pain
that developed during treatment. An MRI performed 4 weeks later showed a tear in
the right ulnar fibrocartilage. A diagnosis of overuse syndrome secondary to
sports activity was made, but a contribution from ciprofloxacin cannot be
excluded. The patient recovered by 4 months without surgical intervention
PRECAUTIONS
INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .
Changes in laboratory parameters listed as adverse events without
regard to drug relationship are listed below:
Hepatic –
Elevations of ALT (SGPT) (1.9%), AST (SGOT) (1.7%), alkaline phosphatase (0.8%),
LDH (0.4%), serum bilirubin (0.3%).
Hematologic – Eosinophilia
(0.6%), leukopenia (0.4%), decreased blood platelets (0.1%), elevated blood
platelets (0.1%), pancytopenia (0.1%).
Renal – Elevations
of serum creatinine (1.1%), BUN (0.9%), CRYSTALLURIA, CYLINDRURIA, AND
HEMATURIA HAVE BEEN REPORTED.
Other changes occurring in less than 0.1%
of courses were: elevation of serum gammaglutamyl transferase, elevation of
serum amylase, reduction in blood glucose, elevated uric acid, decrease in
hemoglobin, anemia, bleeding diathesis, increase in blood monocytes,
leukocytosis.
To report SUSPECTED ADVERSE EVENTS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
®Adults with Impaired Renal Function
Weight (kg) x (140 - age)
ADVERSE REACTIONS CLINICAL STUDIES
Ciprofloxacin Tablets USP, are available as white, round, film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with "WW927" on one side.
Ciprofloxacin Tablets, USP area also available as white, capsule shaped, film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with "WW928" on one side. The 750 mg tablet is coded with "WW929" on one side. Ciprofloxacin Tablets, USP 250 mg and 500 mg are available in bottles of 30's, 100's and 500's.
Ciprofloxacin Tablets, USP 750 mg are available in bottles of 50's and 100's and Unit Dose Boxes of 100 tablets.
Strength Tablet Identification
Bottles of 30's: 250
mg WW927
500
mg WW928
Bottles of
50's: 750
mg WW929
Bottles of
100's: 250
mg WW927
500
mg WW928
750
mg WW929
Bottles of
500's: 250
mg WW927
500
mg WW928
Unit Dose Boxes of
100 250
mg WW927
500
mg WW928
750
mg WW929
- 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 Ciprofloxacin Tablets treatment. 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.
- that antibacterial drugs including Ciprofloxacin Tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ciprofloxacin Tablets are 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 Ciprofloxacin Tablets or other antibacterial drugs in the future.
- that ciprofloxacin may be taken with or without meals and to drink fluids liberally. As with other quinolones, concurrent administration of ciprofloxacin with magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, or with other products containing calcium, iron or zinc should be avoided. Ciprofloxacin may be taken two hours before or six hours after taking these products. Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of ciprofloxacin may be significantly reduced; however, ciprofloxacin may be taken with a meal that contains these products.
- that ciprofloxacin may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.
- that photosensitivity/phototoxicity has been reported in patients receiving quinolones. Patients should 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, they should 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, patients should contact their physician.
- that peripheral neuropathies have been associated with ciprofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, they should discontinue treatment and contact their physicians.
- that ciprofloxacin may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
- that ciprofloxacin increases the effects of tizanidine (Zanaflex®). Patients should not use ciprofloxacin if they are already taking tizanidine.
- that ciprofloxacin may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
- that convulsions have been reported in patients receiving quinolones, including ciprofloxacin, and to notify their physician before taking this drug if there is a history of this condition.
- that ciprofloxacin has been associated with an increased rate of adverse events involving joints and surrounding tissue structures (like tendons) in pediatric patients (less than 18 years of age). Parents should inform their child’s physician if the child has a history of joint-related problems before taking this drug. Parents of pediatric patients should also notify their child’s physician of any joint-related problems that occur during or following ciprofloxacin therapy. (See WARNINGS, PRECAUTIONS, Pediatric Use and ADVERSE REACTIONS .)
- that 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, patients should contact their physician as soon as possible.
Ciprofloxacin Tablets, USP
Tendon rupture or swelling of the tendon (tendinitis)
- Tendons are tough cords of tissue that connect muscles to bones.
- Pain, swelling, tears, and inflammation of tendons including the back of the
ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of
all ages who take fluoroquinolone antibiotics, including Ciprofloxacin Tablets.
The risk of getting tendon problems is higher if you:
- are over 60 years of age
- are taking steroids (corticosteroids)
- have had a kidney, heart, or lung transplant.
Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
- Other reasons for tendon ruptures 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 Tablets 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 Tablets. 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 Tablets. 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
- See the section “What are the possible side effects of Ciprofloxacin Tablets?” for more information about side effects.
Call your healthcare provider if you think your condition is not getting better while you are taking Ciprofloxacin Tablets.
Do not take Ciprofloxacin Tablets 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 Tablets. Ask your healthcare provider if you are not sure. See the list of ingredients in Ciprofloxacin Tablets at the end of this Medication Guide.
- also take a medicine called tizanidine (Zanaflex®). Serious side effects from tizanidine are likely to happen.
See “What is the most important information I should know about Ciprofloxacin Tablets?”
Tell your healthcare provider about all your medical conditions, including if you:
- have tendon problems
- 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 seizures
- have kidney problems. You may need a lower dose of Ciprofloxacin Tablets if your kidneys do not work well.
- have rheumatoid arthritis (RA) or other history of joint problems
- have trouble swallowing pills
- are pregnant or planning to become pregnant. It is not known if ciprofloxacin tablets will harm your unborn child.
- are breast-feeding or planning to breast-feed. Ciprofloxacin passes into breast milk. You and your healthcare provider should decide whether you will take Ciprofloxacin Tablets or breast-feed.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. Ciprofloxacin Tablets and other medicines can affect each other causing side effects. Especially tell your healthcare provider 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 Tablets or other fluoroquinolones may increase your risk of central nervous system effects and seizures. See “What are the possible side effects of Ciprofloxacin Tablets?”
- a blood thinner (Warfarin, Coumadin®, Jantoven®)
- tizanidine (Zanaflex®). You should not take Ciprofloxacin Tablets if you are already taking tizanidine. See “Who should not take Ciprofloxacin Tablets?”
- theophylline (Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)
- glyburide (Micronase®, Glynase®, Diabeta®, Glucovance®). See “What are the possible side effects of Ciprofloxacin Tablets?”
- phenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin®, Extended Phenytoin Sodium®, Prompt Penytoin Sodium®, Phenytek®)
- products that contain caffeine
- a medicine to control your heart rate or rhythm (antiarrhythmics) See “What are the possible side effects of Ciprofloxacin Tablets?”
- 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. See “What is the most important information I should know about ciprofloxacin tablets?”
- methotrexate (Trexall®)
- Probenecid (Probalan®, Col-probenacid®)
- Metoclopromide (Reglan®, Reglan ODT®)
- Certain medicines may keep Ciprofloxacin Tablets from working correctly.
Take Ciprofloxacin Tablets 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
- didanosine (Videx®, Videx® EC).
Ask your healthcare provider 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 healthcare provider and pharmacist when you get a new medicine.
- Take Ciprofloxacin Tablets 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.
- Ciprofloxacin Tablets can be taken with or without food.
- Ciprofloxacin Tablets 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 Tablets.
- Do not skip any doses, or stop taking Ciprofloxacin Tablets even if you
begin to feel better, until you finish your prescribed treatment, unless:
- you have tendon effects (see “What is the most important information I should know about Ciprofloxacin Tablets?” ),
- you have a serious allergic reaction (see “What are the possible side effects of Ciprofloxacin Tablets?” ), or
- your healthcare provider tells you to stop.
- If you miss a dose of Ciprofloxacin Tablets, take it as soon as you remember. Do not take two doses at the same time, and do not take more than two doses in one day.
- If you take too much, call your healthcare provider or get medical help immediately.
If you have been prescribed Ciprofloxacin Tablets after being exposed to anthrax:
- Ciprofloxacin Tablets have been approved to lessen the chance of getting anthrax disease or worsening of the disease after you are exposed to the anthrax bacteria germ.
- Take Ciprofloxacin Tablets exactly as prescribed by your healthcare provider. Do not stop taking Ciprofloxacin Tablets without talking with your healthcare provider. If you stop taking ciprofloxacin tablets too soon, it may not keep you from getting the anthrax disease.
- Side effects may happen while you are taking Ciprofloxacin Tablets. When taking your Ciprofloxacin Tablets to prevent anthrax infection, you and your healthcare provider should talk about whether the risks of stopping Ciprofloxacin Tablets too soon are more important than the risks of side effects with Ciprofloxacin Tablets.
- If you are pregnant, or plan to become pregnant while taking Ciprofloxacin Tablets, you and your healthcare provider should decide whether the benefits of taking Ciprofloxacin Tablets for anthrax are more important than the risks.
- Ciprofloxacin Tablets 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 Ciprofloxacin Tablets affect you.
- Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin Tablets can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking Ciprofloxacin Tablets, 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.
- Ciprofloxacin Tablets can cause side effects that may be serious or even cause death. See “What is the most important information I should know about Ciprofloxacin Tablets?”
Other serious side effects of Ciprofloxacin Tablets include:
- Central Nervous System Effects
Seizures have been reported in people who take fluoroquinolone antibiotics including Ciprofloxacin Tablets. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Ciprofloxacin Tablets will change your risk of having a seizure.
Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of Ciprofloxacin Tablets. 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
-
Serious allergic reactions
Allergic reactions can happen in people taking fluoroquinolones, including Ciprofloxacin Tablets, even after only one dose. Stop taking Ciprofloxacin Tablets 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 Tablets 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 Tablets (a liver problem).
- Skin rash
Skin rash may happen in people taking ciprofloxacin tablets even after only one dose. Stop taking ciprofloxacin tablets 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 tablets.
- Serious heart rhythm changes (QT prolongation and torsades 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 Tablets 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 Tablets. 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 possible nerve damage (Peripheral Neuropathy)
Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including Ciprofloxacin Tablets. Talk 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
Ciprofloxacin Tablets may need to be stopped to prevent permanent nerve damage.
- Low blood sugar (hypoglycemia)
People who take Ciprofloxacin Tablets 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 Tablets. Your antibiotic medicine may need to be changed.
- Sensitivity to sunlight (photosensitivity)
See “What should I avoid while taking Ciprofloxacin Tablets?”
- 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 Tablets.
The most common side effects of Ciprofloxacin Tablets include:
- nausea
- headache
- diarrhea
- vomiting
- vaginal yeast infection
- changes in liver function tests
- pain or discomfort in the abdomen
These are not all the possible side effects of Ciprofloxacin Tablets. Tell your healthcare provider 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 FDA at 1-800-FDA-1088.
Store atKeep Ciprofloxacin Tablets and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ciprofloxacin Tablets for a condition for which it is not prescribed. Do not give Ciprofloxacin Tablets to other people, even if they have the same symptoms that you have. They may harm them.
This Medication Guide summarizes the most important information about Ciprofloxacin Tablets. If you would like more information about Ciprofloxacin Tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Ciprofloxacin Tablets that is written for healthcare professionals. For more information call 1-866-850-2876.
Active ingredient: ciprofloxacin
Inactive ingredients: colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion (methylacrylate and ethylacrylate copolymer), polyethylene glycol, purified water, simethicone emulsion, sodium starch glycolate, talc, and titanium dioxide.
Revised March 2009
This Medication Guide has been approved by the U.S. Food and Drug Administration.
West-ward Pharmaceutical Corp.
Eatontown, NJ
07724
Distributor
Manufactured by:
Hikma Pharmaceuticals
P.O. Box
182400
Amman 11118 - Jordan
Image of label
CiprofloxacinCiprofloxacin TABLET, FILM COATED
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