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Medication
Guide
CIPRO
®
(Sip-row)
(ciprofloxacin
hydrochloride)
Tablets
for
oral use
CIPRO
®
(Sip-row)
(ciprofloxacin
hydrochloride)
for
oral suspension
CIPRO
®
XR
(Sip-row)
(ciprofloxacin
hydrochloride)
Tablets
for
oral use
CIPRO
®
IV
(Sip-row)
(ciprofloxacin)
Injection 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 could result in death. If
you get any of the following serious side effects while
you take CIPRO, get medical
help right away.
Talk with
your healthcare provider about whether you should
continue to take CIPRO.
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
oswelling
o tears
and inflammation of 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)
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• 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)
•Call
your healthcare provider right away at the first sign of tendon pain,
swelling or
inflammation. Stop
taking CIPRO 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
CIPRO.
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 CIPRO. Tendon
ruptures have happened up to several months
after p
eople have
finished taking their fluoroquinolone.
•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.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. Call
your
healthcare
provider right away if you have any worsening muscle weakness or
breathing
problems.
See
“What are the possible side effects of
CIPRO?”
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
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•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
•plague
•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
is 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
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
•have
a disease that causes muscle weakness (myasthenia gravis)
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•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 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:
•a steroid
medicine
•an
anti-psychotic
medicine
•a tricyclic
antidepressant
•a water
pill (diuretic)
•theophylline
(such as Theo-24
®
,
Elixophyllin
®
,
Theochron
®
,
Uniphyl
®
,
Theolair)
•a medicine
to control your heart rate or rhythm (antiarrhythmics)
•an
oral anti-diabetes
medicine
•phenytoin
(Fosphenytoin Sodium
®,
Cerebyx
®,
Dilantin
-125
®,
Dilantin
®
,Extended
Phenytoin Sodium
®,
Prompt Phenytoin Sodium
®
Phenytoin
®)
•
cyclosporine
(Gengraf
®
,
Neoral
®
,
Sandimmune
®
,
Sangcya
®).
•a blood
thinner (such as warfarin, Coumadin
®,
Jantoven
®)
•methotrexate
(Trexall
®)
•ropinirole
(Requip
)
•clozapine
(Clozaril
®,
Fazaclo
®ODT
®)
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(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.
•sildenafil
(Viagra
®
,
Revatio
®)
•duloxetine
•products
that contain caffeine
•probenecid
(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.
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•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 a serious allergic reaction
.
See
“
What
are the possible side effects
of CIPRO?
”
oyour
healthcare provider tells you to stop taking CI
PRO 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:
ohives
otrouble
breathing or swallowing
oswelling
of the lips, tongue, face
ot hroat
tightness,
hoarseness
orapid
heartbeat
ofaint
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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
ounusual
tiredness
ostomach
pain
oloss
of appetite
ofever
olight
colored bowel movements
oweakness
odark
colored urine
oabdominal
pain or tenderness
oyellowing
of your skin
or the whites
of your eyes
oitching
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).
•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. Ask your
healthcare provider
whether taking CIPRO will change your risk of having a seizure.CNS
side effects may
happen as soon as after taking the first dose of CIPRO.
Talk
to your healthcare provider right away if you get any of these side
effects,
or
other changes in mood or behavior:
oseizures
otrouble
sleeping
ohear
voices, see things, or
onightmares
sense
things that are not there
ofeel lightheaded
or dizzy(hallucinations)
ofeel
more suspicious (paranoia)
ofeel
restless
osuicidal
thoughts or acts
otremors
oheadaches
that will not go away,
ofeel
anxious or nervous with
or without blurred vision
oconfusion
odepression
•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.
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ID: 3695045
Pseudomembranous
colitis can happen 2 or more months after you
have finished
your
antibacterial
medicine
.
•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. 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:
opain
oburning
otingling
onumbness
oweakness
CIPRO
may need to be stopped to prevent permanent nerve damage.
•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:
•nausea
•diarrhea
•changes
in liver function tests
•vomiting
•rash
Tell
your healthcare provider about any side effect that bothers you, or
that does not
go away.
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ID: 3695045
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 20° to 25°C (68° to 77°F); excursions permitted to 15° to
30°C
(59°
to 86°F).
CIPRO
Oral Suspension
•Store
microcapsules and diluent below 25°C (77°F); excursions are permitted
from 15°C to 30°C (59°F to 86°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:
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ID: 3695045
povidone,
methacrylic acid copolymer,
hypromellose,
magnesium stearate, and Polysorbate 20
oDiluent
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
This
Medication Guide has been approved by the U.S. Food and Drug Administration.Manufactured for
:
Bayer
HealthCare
Pharmaceuticals Inc.
Whippany
,
NJ
07981
Manufactured
in
Germany
CIPRO
is a registered trademark of Bayer Aktiengesellschaft.
Rx
Only
©2015
Bayer
HealthCare Pharmaceuticals Inc.
CIPRO
(ciprofloxacin*) 5% and 10% Oral Suspension Manufactured in Italy
CIPRO
(ciprofloxacin HCl) Tablets Manufactured in Germany
Revised:
January
2015
Reference
ID: 3695045
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