CIPROFLOXACIN- ciprofloxacin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

KAISER FOUNDATION HOSPITALS

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, USP 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, USP are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. Ciprofloxacin Tablets, USP are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis. Ciprofloxacin Tablets, USP are indicated in adult patients

Product summary:

Ciprofloxacin Tablets, USP are available as white, round, film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with "WW927" on one side. Ciprofloxacin Tablets, USP are also available as white, capsule shaped, film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with "WW928" on one side. The 750 mg tablet is coded with "WW929" on one side. Ciprofloxacin tablets, USP 500 mg are available in bottles of 6’s, 14’s and 20’s . Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
----------
Hikma Medication Guide Revision
Ciprofloxacin Tablets, USP
for oral use
Read this Medication Guide before you start taking Ciprofloxacin
Tablets, USP 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, USP ?
Ciprofloxacin Tablets, USP 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 USP, get medical
help right away. Talk with your healthcare provider about whether you
should continue to take
Ciprofloxacin Tablets, USP.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take
Ciprofloxacin Tablets, USP .
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, USP 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, USP.
•
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, USP until tendinitis or tendon
rupture has been ruled out

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
----------
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, USP FOR ORAL USE.
INITIAL U.S. APPROVAL:1987
WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN TABLETS, USP, 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 TABLETS, USP MAY
EXACERBATE MUSCLE WEAKNESS IN PERSONS
WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN TABLETS, USP IN PATIENTS
WITH KNOWN HISTORY OF MYASTHENIA
GRAVIS _[SEE WARNINGS AND PRECAUTIONS (5.2)]_.
RECENT MAJOR CHANGES
Indications and Usage, Plague ( 1.14) MM/2014
Dosage and Administration, Adults ( 2.1), Pediatrics ( 2.2) MM/2014
INDICATIONS AND USAGE
Ciprofloxacin Tablets, USP are a fluoroquinolone antibacterial
indicated in adults (≥18 years of age) with infections caused
by designated, susceptible bacteria and in pediatric patients where
indicated.
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)
Plague in adult