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:

Mylan Institutional Inc.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 500 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 containing ciprofloxacin hydrochloride, USP equivalent to 500 mg of ciprofloxacin. 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: NDC 51079-182-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Mylan Institutional Inc.
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MEDICATION GUIDE
Ciprofloxacin Tablets, USP
(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 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).
2.
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:
1.
Pain, swelling, tears and swelling of the tendons including the back
of the ankle (Achilles),
shoulder, hand, or other tendon sites.
3.
The risk of getting tendon problems while you take ciprofloxacin
tablets is higher if you:
1.
are over 60 years of age
2.
are taking steroids (corticosteroids)
3.
have had a kidney, heart or lung transplant
4.
Tendon problems can happen in people who do not have the above risk
factors when they take
ciprofloxacin tablets.
5.
Other reasons that can increase your risk of tendon problems can
include:
1.
physical activity or exercise
2.
kidney failure
3.
tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
6.
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 can also happen with othe

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
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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._
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN TABLETS, 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 TABLETS IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING
CIPROFLOXACIN TABLETS, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS
ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN TABLETS, MAY EXACERBATE
MUSCLE WEAKNESS IN PATIENTS WITH
MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN TABLETS IN PATIENTS WITH KNOWN
HISTORY OF MYASTHENIA GRAVIS (
5.5)
BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN TABLETS, HAVE BEEN
ASSOCIATED WITH SERIOUS ADVERSE
REACTIONS (5.1 TO 5.15), RESERVE CIPROFLOXACIN TABLETS FOR USE IN
PATIENTS WHO HAVE NO ALTERNATIVE
TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS:
ACUTE EXACERBATION OF CHRONIC BRONCHITIS ( 1.10)
ACUTE UNCOMPLICATED CYSTITIS ( 1.11)
ACUTE SINUSITIS ( 1.12)
RECENT MAJOR CHANGES
Boxed Warning 7/2016
Indications and Usage, Lower Respiratory Tract Infections ( 1.10)
7/2016
Indications and Usage, Urinary Tract Infections ( 1.11) 7/2016
Indications and Usage, Acute Sinusitis ( 1.12) 7/2016
Dosage and Administration, Dosage in Adults ( 2.1) 7/2016
Warnings and Precautions ( 5) 7/2016
INDICATIONS AND USAGE
Ciprofloxacin tablets are a fluoroquinolone antibacterial indicat