CIPROFLOXACIN- ciprofloxacin tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Cardinal Health

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Sammensetning:

CIPROFLOXACIN 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ciprofloxacin tablets, USP are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below . Ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli , Klebsiella pneumoniae , Enterobacter cloacae , Serratia marcescens , Proteus mirabilis , Providencia rettgeri , Morganella morganii , Citrobacter koseri , Citrobacter freundii , Pseudomonas aeruginosa , methicillin-susceptible Staphylococcus epidermidis , Staphylococcus saprophyticus , or Enterococcus faecalis . Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis. Ciprofloxacin tablets are indicated in adult patients for treatment of l

Produkt oppsummering:

Ciprofloxacin Tablets, USP are available containing 500 mg of ciprofloxacin, USP as the hydrochloride salt. The 500 mg tablets are white film-coated, modified capsule-shaped, unscored tablets debossed with G on one side of the tablet and CF 500 on the other side. They are available as follows: Available overbagged with 10 tablets per bag, NDC 55154-5376-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Cardinal Health
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MEDICATION GUIDE
CIPROFLOXACIN TABLETS, USP
(sip" roe flox' a sin)
500 mg
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 could result in death.
If you get any of the following serious side effects while you take
ciprofloxacin tablets, get medical help
right away. Talk with your healthcare provider about whether you
should continue to take ciprofloxacin
tablets.
•
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 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 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)
•
Call your healthcare provider right away at the first sign of tendon
pain, swelling or
inflammation. Stop taking ciprofloxacin tablets until tendinitis or
tendon rupture has been
ruled out by your healthcare provider. Avoid exer

Preparatomtale

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN
TABLETS USP.
CIPROFLOXACIN TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Indications and Usage, Plague ( 1.14) 03/2015
Dosage and Administration, Adults ( 2.1), Pediatrics ( 2.2) 03/2015
INDICATIONS AND USAGE
Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults
(≥ 18 years of age) with infections caused by designated,
susceptible bacteria and in pediatric patients where indicated.
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DOSAGE AND ADMINISTRATION
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, ARE ASSOCIATED WITH AN
INCREASED RISK OF TENDINITIS AND
TENDON RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN OLDER
PATIENTS USUALLY OVER 60 YEARS OF
AGE, IN PATIENTS TAKING CORTICOSTEROID DRUGS, AND IN PATIENTS WITH
KIDNEY, HEART OR LUNG TRANSPLANTS
_[SEE WARNINGS AND PRECAUTIONS (5.1)]._
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS WITH
MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY
OF MYASTHENIA GRAVIS _[SEE_
_WARNINGS AND PRECAUTIONS (5.2)]._
Urinary tract infections ( 1.1) and Acute uncomplicated cystitis (
1.2)
Chronic bacterial prostatitis ( 1.3)
Lower respiratory tract infections ( 1.4)
Acute sinusitis ( 1.5)
Skin and skin structure infections ( 1.6)
Bone and joint infections ( 1.7)
Complicated intra-abdominal infections ( 1.8)
Infectious diarrhea ( 1.9)
Typhoid fever (enteric fever) ( 1.10)
Uncomplicated cervical and urethral gonorrhea ( 1.11)
Complicated urinary tract infections and pyelonephritis in pediatric
patients ( 1.12)
Inhalational anthrax post-exposure in adult and pediatric patients (
1.13)
Pl