CIPROFLOXACIN- ciprofloxacin tablet, film coated
Hikma Pharmaceuticals USA Inc.
Ciprofloxacin Tablets USP
Read this Medication Guide before you start taking ciprofloxacin tablets 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 ciprofloxacin tablets?
Ciprofloxacin tablets, 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 ciprofloxacin tablets, you should stop taking ciprofloxacin tablets 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 ciprofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
○ tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites.
• The risk of getting tendon problems while you take ciprofloxacin tablets 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 tablets.
• 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)
• Stop taking ciprofloxacin tablets 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 ciprofloxacin tablets. Tendon ruptures can happen within hours or days of taking ciprofloxacin tablets and have happened up to several months after people have finished taking their fluoroquinolone.
• Stop taking ciprofloxacin tablets immediately and 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
The tendon problems may be permanent.
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 ciprofloxacin tablets. Stop taking ciprofloxacin tablets 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:
|• pain||• numbness|
|• burning||• weakness|
Ciprofloxacin tablets may need to be stopped to prevent permanent nerve damage.
3. Central Nervous System (CNS) effects. Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, including ciprofloxacin tablets. Tell your healthcare provider if you have a history of seizures before you start taking ciprofloxacin tablets. CNS side effects may happen as soon as after taking the first dose of ciprofloxacin tablets. Stop taking ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
These changes may be permanent.
4. Worsening of myasthenia gravis (a problem that causes muscle weakness).
Fluoroquinolones like ciprofloxacin tablets 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 ciprofloxacin tablets. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
What are ciprofloxacin tablets?
Ciprofloxacin tablets are 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 ciprofloxacin tablets for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
• Ciprofloxacin tablets should not be used in people with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
• Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections caused by a certain type of bacterial called Streptococcus pneumoniae.
• Ciprofloxacin tablets are also used in children younger than 18 years of age to treat complicated 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 ciprofloxacin tablets. Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine in children under 18 years of age.
Who should not take ciprofloxacin tablets?
Do not take ciprofloxacin tablets if you:
Ask your healthcare provider if you are not sure.
What should I tell my healthcare provider before taking ciprofloxacin tablets?
Before you take ciprofloxacin tablets, tell your healthcare provider about all your medical conditions, including if you:
• have tendon problems; ciprofloxacin tablets should not be used in people who have a history of tendon problems
• have a disease that causes muscle weakness (myasthenia gravis); ciprofloxacin tablets should not be used in people who have a known history of myasthenia gravis
• have liver problems
• have central nervous system problems (such as epilepsy)
• have nerve problems. Ciprofloxacin tablets should not be used in people who have a history of a nerve problem called peripheral neuropathy have or anyone in your family has an irregular heartbeat, or heart attack, especially a condition called “QT prolongation”.
• have low blood potassium (hypokalemia) or low magnesium (hypomagnesemia).
• have or have had seizures.
• have kidney problems. You may need a lower dose of ciprofloxacin tablets if your kidneys do not work well.
• have diabetes or problems with low blood sugar (hypoglycemia).
• have joint problems including rheumatoid arthritis (RA)
• have trouble swallowing pills.
• are pregnant or plan to become pregnant. It is not known if ciprofloxacin tablets will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Ciprofloxacin passes into your breast milk.
o You should not breastfeed during treatment with ciprofloxacin tablets and for 2 days after taking your last dose of ciprofloxacin tablets. You may pump your breast milk and throw it away during treatment with ciprofloxacin tablets and for 2 days after taking your last dose of ciprofloxacin tablets.
o If you are taking ciprofloxacin tablets for inhalation anthrax, you and your healthcare provider should decide whether you can continue breastfeeding while taking ciprofloxacin tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
o a steroid medicine
o an anti-psychotic medicine
o a tricyclic antidepressant
o a water pill (diuretic)
o theophylline (such as Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)
o a medicine to control your heart rate or rhythm (antiarrhythmics)
o an oral anti-diabetes medicine
o phenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin® , Extended Phenytoin Sodium®, Prompt Phenytoin Sodium®, Phenytek®)
o cyclosporine (Gengraf®, Neoral®, Sandimmune®, Sangcya®).
o a blood thinner (such as warfarin, Coumadin®, Jantoven®)
o methotrexate (Trexall®)
o ropinirole (Requip®)
o clozapine (Clozaril®, Fazaclo® ODT®)
o a Non-Steroidal Anti-Inflammatory Drug (NSAID). 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.
o sildenafil (Viagra®, Revatio®)
o products that contain caffeine
o probenecid (Probalan®, Col-probenecid ®)
o an antacid, multivitamin, or other medicine or supplements that has magnesium, calcium, aluminum, iron, or zinc
o sucralfate (Carafate®)
o didanosine (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 ciprofloxacin tablets?
Taking all of your ciprofloxacin tablets doses will help make sure that all of the bacteria are killed. Taking all of your ciprofloxacin tablets doses will help lower the chance that the bacteria will become resistant to ciprofloxacin tablets. If you become resistant to ciprofloxacin tablets, ciprofloxacin tablets and other antibacterial medicines may not work for you in the future.
○ 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 2 doses of Ciprofloxacin Tablets at 1 time to make up for a missed dose. If you are not sure about when to take Ciprofloxacin Tablets after a missed dose, ask your healthcare provider or pharmacist.
What should I avoid while taking ciprofloxacin tablets?
What are the possible side effects of ciprofloxacin tablets?
Ciprofloxacin tablets may cause serious side effects, including:
Skin rash may happen in people taking ciprofloxacin tablets even after only 1 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.
Stop taking ciprofloxacin tablets 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 ciprofloxacin tablets (a liver problem).
Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain.
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 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) or low magnesium (hypomagnesemia).
○ who take certain medicines to control heart rhythm (antiarrhythmics).
5. Changes in blood sugar People who take ciprofloxacin tablets and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider's instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking ciprofloxacin tablets, stop taking ciprofloxacin tablets and call your healthcare provider right away. Your antibiotic medicine may need to be changed.
The most common side effects of ciprofloxacin tablets include:
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 ciprofloxacin tablets. 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 ciprofloxacin tablets?
• Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Keep ciprofloxacin tablets and all medicines out of the reach of children.
General information about the safe and effective use of ciprofloxacin tablets.
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. It 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 health professionals.
For more Information contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001.
What are the ingredients in ciprofloxacin tablets?
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
P.O. Box 182400
Amman 11118 – Jordan
Revised November 2021