CIPROFLOXACIN- ciprofloxacin hydrochloride 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:

Cardinal Health

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin tablets are 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 tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin tablets are 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 tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isola

Product summary:

Ciprofloxacin Tablets, USP are available as white to off-white, round, unscored, biconvex film-coated tablets with “”on one side and on the other side containing 250 mg ciprofloxacin. Available: Overbagged with 10 tablets per bag, NDC 55154-2086-0. Ciprofloxacin Tablets USP, 500 mg are available as white to off-white, capsule shaped, unscored, biconvex film-coated tablets, with “”on one side and “CR 500” on the other side containing 500 mg ciprofloxacin. Available: Overbagged with 10 tablets per bag, NDC 55154-2081-0. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
Cardinal Health
----------
MEDICATION GUIDE
Ciprofloxacin (sipʺ roe flox' a sin)Tablets
for oral use
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 can happen at the same time and 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

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
CARDINAL HEALTH
----------
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 TABLETS, 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._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Central Nervous System Effects (5.4) 10/2018
Warnings and Precautions, Risk of Aortic Aneurysm
and Dissection (5.9) 5/2019
Warnings and Precautions, Blood Glucose Disturbances (5.19) 10/2018
INDICATIONS AND USAGE
Ciprofloxacin tablets are 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:
•
•
•
•
•
•
•
•
•
•
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER
(5.1), INCLUDING:
○ TENDINITIS AND TENDON RUPTURE (5.2)
○ PERIPHERAL NEUROPATHY (5.3)
○ CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE CIPROFLOXACIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING
CIPROFLOXACIN, 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 TO 5.16), RESERVE CIPROFLOXACIN FOR USE IN PATIENTS WHO
HAVE NO ALTERNATIVE TREATMENT
OPTIONS FOR THE FOLLOWING INDICATIONS:
○ ACUTE EXACERBATION OF CHRONIC