CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated
HHS/Program Support Center/Supply Service Center
Ciprofloxacin Tablets belongs to a class of antibiotics called fluoroquinolones. Ciprofloxacin Tablets 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 Tablets.
2. Worsening of myasthenia gravis (a disease which causes muscle weakness).
Fluoroquinolones like Ciprofloxacin Tablets 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.
See the section "What are the possible side effects of Ciprofloxacin Tablets?" for more information about side effects.
Ciprofloxacin Tablets are a fluoroquinolone antibiotic medicine used to treat certain infections caused by certain germs called bacteria.
Children less than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking Ciprofloxacin Tablets. Ciprofloxacin Tablets should not be used as the first choice of antibiotic medicine in children under 18 years of age.
Ciprofloxacin Tablets should not be used in children under 18 years old, except to treat specific serious infections, such as complicated urinary tract infections and to prevent anthrax disease after breathing the anthrax bacteria germ (inhalational exposure).
Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including Ciprofloxacin Tablets, do not kill viruses.
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:
Tell your healthcare provider about all your medical conditions, including if you:
have a disease that causes muscle weakness (myasthenia gravis)
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:
Lidocaine (Xylocaine® intravenous infusion)
Clozapine (Clozaril®, Fazaclo® ODT®)
Sildenafil (Viagra®, Revatio®)
Cyclosporine (Gengraf®, Neoral®, Sandimmune®, Sangcya®)
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.
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.
Other serious side effects of CiprofloxacinTablets include:
You may have serious seizure and breathing problems when you take theophylline with CiprofloxacinTablets. These problems may lead to death. Get emergency help right away if you have seizures or trouble breathing.
• Central Nervous System effects
Seizures have been reported in people who take fluoroquinolone antibiotics including CiprofloxacinTablets. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking CiprofloxacinTablets 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 CiprofloxacinTablets. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
• Feel dizzy
• Hear voices, see things, or sense things that are not there (hallucinations)
• Feel restless
• Feel anxious or nervous
• Trouble sleeping
• Feel more suspicious (paranoia)
• Suicidal thoughts or acts
• Serious allergic reactions
Allergic reactions, including death, can happen in people taking fluoroquinolones, including CiprofloxacinTablets, even after only one dose. Stop taking CiprofloxacinTablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
• Trouble breathing or swallowing.
• Swelling of the lips, tongue, face.
• Throat tightness, hoarseness.
• Rapid heartbeat.
• Yellowing of the skin or eyes. Stop taking CiprofloxacinTablets 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 CiprofloxacinTablets (a liver problem).
• Skin rash
Skin rash may happen in people taking CiprofloxacinTablets even after only one dose. Stop taking CiprofloxacinTablets 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 CiprofloxacinTablets.
• 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. CiprofloxacinTablets 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 CiprofloxacinTablets. 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 CiprofloxacinTablets. 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:
Weakness CiprofloxacinTablets may need to be stopped to prevent permanent nerve damage.
• Low blood sugar (hypoglycemia)
People who take CiprofloxacinTablets 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 CiprofloxacinTablets. 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 CiprofloxacinTablets.
The most common side effects of CiprofloxacinTablets include:
• Changes in liver function tests
• Vaginal yeast infection
• Pain or discomfort in the abdomen
These are not all the possible side effects of CiprofloxacinTablets. 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.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CiprofloxacinTabletsfor a condition for which it is not prescribed. Do not give CiprofloxacinTabletsto 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 CiprofloxacinTablets. If you would like more information about CiprofloxacinTablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CiprofloxacinTablets that is written for healthcare professionals. For more information call 1-877-233-2001.
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 January 2012
This Medication Guide has been approved by the U.S. Food and Drug Administration.
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
HHS Supply Service Center
Perry Point, MD 21902