CIPROFLOXACIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. Ciprofloxacin is 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 is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. Ciprofloxacin is indicated in

Product summary:

Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP is also available as capsule shaped, white to slightly yellowish film coated tablets containing 500mg of ciprofloxacin. The 500 mg tablet is embossed with the word P on one side and 500 on reverse side. NDC 68071-4122-1 Bottles of 10 NDC 68071-4122-4 Bottles of 14 NDC 68071-4122-7 Bottles of 21 NDC 68071-4122-3 Bottles of 30 NDC 68071-4122-6 Bottles of 60 Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- ciprofloxacin tablet
NuCare Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
Medication Guide for
Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg
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?
Ciprofloxacin 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, get medical help right away.
Talk with your healthcare provider about whether you should continue
to take ciprofloxacin.
1.
Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take
ciprofloxacin. 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 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.
•
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 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

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLET
NUCARE PHARMACEUTICALS,INC.
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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 (HYDROCHLORIDE) TABLETS 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)]._
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.
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 and pediatric patients ( 1.14)
To reduce the development of drug-resistant bacteria an