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:

Blenheim Pharmacal, Inc.

INN (International Name):

Ciprofloxacin hydrochloride

Composition:

Ciprofloxacin 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin tablets 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 lower r

Product summary:

Ciprofloxacin Tablets USP, 100 mg are white, oval shaped film-coated tablets debossed with“R” on one side and “125” on other side and supplied in a cystitis pack containing 6 tablets foruse only in female patients with acute uncomplicated cystitis. Cystitis package of 6                                     NDC 55111-125-06 Ciprofloxacin Tablets USP, 250 mg are white, oval shaped film-coated tablets debossed with “R” on one side and “126” on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 x 10. Bottles of 50                                      NDC 55111-126-50 Bottles of 100                                     NDC 55111-126-01 Bottles of 500                                     NDC 55111-126-05 Unit dose package of 10 x 10             NDC 55111-126-78 Ciprofloxacin Tablets USP, 500 mg are white, oval shaped film-coated tablets debossed with “R” on one side and “127” on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 x 10. Bottles of 50                                      NDC 55111-127-50 Bottles of 100                                      NDC 55111-127-01 Bottles of 500                                   NDC 55111-127-05 Unit dose package of 10 x 10           NDC 55111-127-78 Ciprofloxacin Tablets USP, 750 mg are white, modified capsule shaped film-coated tabletsdebossed with “R” on one side and “128” on other side and are supplied in bottles of 50, 100,500 and unit dose packages of 10 x 10. Bottles of 50                                      NDC 55111-128-50 Bottles of 100                                      NDC 55111-128-01 Bottles of 500                                   NDC 55111-128-05 Unit dose package of 10 x 10           NDC 55111-128-78 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Blenheim Pharmacal, Inc.
----------
MEDICATION GUIDE
Ciprofloxacin Tablets, USP for oral use
(sip'' roe flox' a sin)
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 tablet is 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.
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 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. Av

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CIPROFLOXACIN.
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, 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)]._
INDICATIONS AND USAGE
Ciprofloxacin tablets 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 postexposure in adult and pediatric patients
(1.13)
Plague in adult and pediatric patients (1.14)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ciprofloxacin tablets and other
antibacterial drugs, ciprofloxacin tablets should be used only to
treat or p