MEDICATION GUIDE: CIPROFLOXACIN TABLETS, USP
Read the Medication Guide that comes with ciprofloxacin
hydrochloride tablets before you start taking it and each time you get a refill.
There may be new information. This Medication Guide 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 hydrochloride tablets? Ciprofloxacin hydrochloride tablets
belong to a class of antibiotics called fluoroquinolones. Ciprofloxacin
hydrochloride 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 hydrochloride tablets.
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
hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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
-
Worsening of myasthenia gravis (a disease which causes
muscle weakness). Fluoroquinolones like ciprofloxacin hydrochloride 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 hydrochloride tablets?” for more
information about side effects.
What are ciprofloxacin hydrochloride tablets?
Ciprofloxacin hydrochloride
tablets are 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 hydrochloride tablets. Ciprofloxacin hydrochloride tablets
should not be used as the first choice of antibiotic medicine in children under
18 years of age. Ciprofloxacin hydrochloride 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 hydrochloride tablets, do not kill
viruses.
Call your healthcare provider if you think your condition is not getting
better while you are taking ciprofloxacin hydrochloride tablets.
Who should not take ciprofloxacin
hydrochloride tablets?
Do not take ciprofloxacin hydrochloride 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
hydrochloride tablets. Ask your healthcare provider if you are not sure. See the
list of ingredients in ciprofloxacin hydrochloride tablets at the end of this
Medication Guide.
- also take a medicine called tizanidine (Zanaflex®). Serious side effects
from tizanidine are likely to happen.
What should I tell my healthcare provider before taking
ciprofloxacin hydrochloride tablets?
See “What is the most important
information I should know about ciprofloxacin hydrochloride tablets?”
Tell your healthcare provider 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 seizures
- have kidney problems. You may need a lower dose of ciprofloxacin
hydrochloride 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 hydrochloride tablets will harm your unborn child.
- are breast-feeding or planning to breast-feed. Ciprofloxacin hydrochloride
tablets passes into breast milk. You and your healthcare provider should decide
whether you will take ciprofloxacin hydrochloride 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 hydrochloride 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
hydrochloride tablets or other fluoroquinolones may increase your risk of
central nervous system effects and seizures. See “What are the
possible side effects of ciprofloxacin hydrochloride
tablets?”.
- a blood thinner (warfarin, Coumadin®, Jantoven®)
- tizanidine (Zanaflex®). You should not take ciprofloxacin hydrochloride
tablets if you are already taking tizanidine. See “Who should
not take ciprofloxacin hydrochloride tablets?”
- theophylline (Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)
- glyburide (Micronase®, Glynase®, Diabeta®, Glucovance®). See “What are the possible side effects of ciprofloxacin hydrochloride tablets?”
- 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) See “What are the possible side effects of ciprofloxacin hydrochloride 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
hydrochloride tablets?”
- methotrexate (Trexall®)
- Probenecid (Probalan®, Col-probenecid®)
- Metoclopromide (Reglan®, Reglan ODT®)
- Certain medicines may keep ciprofloxacin hydrochloride tablets from working
correctly. Take ciprofloxacin hydrochloride 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 (Carafate®)
- 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.
How should I take ciprofloxacin
hydrochloride tablets?
- Take ciprofloxacin hydrochloride tablets exactly as prescribed by your
healthcare provider.
- Take ciprofloxacin hydrochloride 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 hydrochloride tablets can be taken with or without food.
- Ciprofloxacin hydrochloride 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 hydrochloride tablets.
- Do not skip any doses, or stop taking ciprofloxacin hydrochloride 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
hydrochloride tablets?”),
-
you have a serious allergic reaction (see “What are the possible side effects of ciprofloxacin hydrochloride tablets?”), or your healthcare provider tells you to stop.
- This will help make sure that all of the bacteria are killed and lower the
chance that the bacteria will become resistant to ciprofloxacin hydrochloride
tablets. If this happens, ciprofloxacin hydrochloride tablets and other
antibiotic medicines may not work in the future.
- If you miss a dose of ciprofloxacin hydrochloride 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 hydrochloride tablets after being exposed to anthrax:
- Ciprofloxacin hydrochloride 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 hydrochloride tablets exactly as prescribed by your
healthcare provider. Do not stop taking ciprofloxacin hydrochloride tablets
without talking with your healthcare provider. If you stop taking ciprofloxacin
hydrochloride tablets too soon, it may not keep you from getting the anthrax
disease.
- Side effects may happen while you are taking ciprofloxacin hydrochloride
tablets. When taking your ciprofloxacin hydrochloride tablets to prevent anthrax
infection, you and your healthcare provider should talk about whether the risks
of stopping ciprofloxacin hydrochloride tablets too soon are more important than
the risks of side effects with ciprofloxacin hydrochloride tablets.
- If you are pregnant, or plan to become pregnant while taking ciprofloxacin
hydrochloride tablets, you and your healthcare provider should decide whether
the benefits of taking ciprofloxacin hydrochloride tablets for anthrax are more
important than the risks.
What should I avoid while taking ciprofloxacin hydrochloride tablets?
- Ciprofloxacin hydrochloride 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 hydrochloride tablets
affect you.
- Avoid sunlamps, tanning beds, and try to limit your time in the sun.
Ciprofloxacin hydrochloride 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 hydrochloride 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.
What are the possible side effects of ciprofloxacin
hydrochloride tablets?
Ciprofloxacin hydrochloride 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 hydrochloride
tablets?” Other serious side effects of ciprofloxacin hydrochloride
tablets include:
-
Central Nervous System effects
- Seizures have been reported in people who take fluoroquinolone antibiotics
including ciprofloxacin hydrochloride tablets. Tell your healthcare provider if
you have a history of seizures. Ask your healthcare provider whether taking
ciprofloxacin hydrochloride 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 hydrochloride 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 hydrochloride tablets, even after only
one dose. Stop taking ciprofloxacin hydrochloride 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 hydrochloride 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 hydrochloride tablets (a liver problem).
-
Skin rash
-
Skin rash may happen in people taking ciprofloxacin
hydrochloride tablets, even after only one dose. Stop taking ciprofloxacin
hydrochloride 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
hydrochloride tablets.
-
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
hydrochloride 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 hydrochloride 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
hydrochloride 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 hydrochloride tablets may need to be stopped
to prevent permanent nerve damage.
-
Low blood sugar (hypoglycemia)
-
People who take ciprofloxacin hydrochloride 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 hydrochloride tablets. Your
antibiotic medicine may need to be changed.
-
Sensitivity to sunlight (photosensitivity)
- See “What should I avoid while taking ciprofloxacin hydrochloride 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 hydrochloride tablets.
The most common side effects of ciprofloxacin hydrochloride 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 hydrochloride
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.
How should I store ciprofloxacin
hydrochloride tablets?
-
Ciprofloxacin hydrochloride tablets
- Store ciprofloxacin hydrochloride tablets at 20°-25°C (68°-77°F);excursions
permitted to 15°-30°C (59°-86°F).
Keep ciprofloxacin hydrochloride
tablets and all medicines out of the reach of children.
General information about
ciprofloxacin hydrochloride tablets
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use ciprofloxacin hydrochloride
tablets for a condition for which it is not prescribed. Do not give
ciprofloxacin hydrochloride 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 hydrochloride tablets. If you would like more information about
ciprofloxacin hydrochloride tablets, talk with your healthcare provider. You can
ask your healthcare provider or pharmacist for information about ciprofloxacin
hydrochloride tablets that is written for healthcare professionals. For more
information call 1-800-272-5525.
What are the ingredients in ciprofloxacin hydrochloride tablets?
-
Ciprofloxacin hydrochloride tablets:
- Active ingredient: ciprofloxacin
- Inactive ingredients: cornstarch, microcrystalline cellulose, silicon
dioxide, crospovidone, magnesium stearate, polyvinyl alcohol, talc, titanium
dioxide, polyethylene glycol and purified water
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Distributed by:
Watson Pharma, Inc.
Corona, CA 92880 USA
Item Number: 194742-1
Revised: March 2011
RedPharm Drug Inc.