CIPROFLOXACIN - ciprofloxacin tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

Beschikbaar vanaf:

A-S Medication Solutions

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Ciprofloxacin is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli , Klebsiella pneumoniae , Enterobacter cloacae , Proteus mirabilis , Proteus vulgaris , Providencia stuartii , Morganella morganii , Citrobacter freundii , Pseudomonas aeruginosa , methicillin-susceptible Staphylococcus aureus , methicillin-susceptible Staphylococcus epidermidis , or Streptococcus pyogenes . Ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. Ciprofloxacin is indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni

Product samenvatting:

Product: 50090-2265 NDC: 50090-2265-0 14 TABLET in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

CIPROFLOXACIN - CIPROFLOXACIN TABLET
A-S Medication Solutions
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MEDICATION GUIDE
Medication Guide
Ciprofloxacin (sip"row flox"a sin) Tablets USP for oral use
Read this Medication Guide before you start taking ciprofloxacin 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 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:
•
Pain, swelling, tears and swelling of the tendons including the back
of the ankle
(Achilles), shoulder, hand, 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 h

Productkenmerken

CIPROFLOXACIN - CIPROFLOXACIN TABLET
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN
TABLETS .
CIPROFLOXACIN TABLET, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION
OF
MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED
TOGETHER(5.1), INCLUDING:
O TENDINITIS AND TENDON RUPTURE (5.2)
O PERIPHERAL NEUROPATHY (5.3)
O CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE CIPROFLOXACIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN
TABLETS, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE
REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PATIENTS WITH
MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY
OF MYASTHENIA GRAVIS. (5.5)
BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN
ASSOCIATED WITH SERIOUS ADVERSE
REACTIONS (5.1-5.15), RESERVE CIPROFLOXACIN TABLETS FOR USE IN
PATIENTS WHO HAVE NO ALTERNATIVE TREATMENT
OPTIONS FOR THE FOLLOWING INDICATIONS:
O ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.10)
O ACUTE UNCOMPLICATED CYSTITIS (1.11)
O ACUTE SINUSITIS (1.12)
RECENT MAJOR CHANGES
Warnings and Precautions (5.15) 07/2017
INDICATIONS AND USAGE
Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults
(18 years of age and older) with the following infections
caused by designated, susceptible bacteria and in pediatric patients
where indicated:
Skin and Skin Structure Infections (1.1)
Bone and Joint Infections (1.2)
Complicated Intra-Abdominal Infections (1.3)
Infectious Diarrhea (1.4)
Typhoid Fever (Enteric Fe