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:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin is 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 is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin is 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 is indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella

Product summary:

Ciprofloxacin Tablets USP (white to off-white round tablets) containing 250 mg of Ciprofloxacin and engraved with Bottle of 100.............................................................................(NDC 61442-222-01) Bottle of 1,000..........................................................................(NDC 61442-222-10) Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 500 mg of ciprofloxacin and engraved with Bottle of 100.............................................................................(NDC 61442-223-01) Bottle of 500.............................................................................(NDC 61442-223-05) Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 750 mg of ciprofloxacin and engraved with Bottle of 50...............................................................................(NDC 61442-224-50) Bottle of 100.............................................................................(NDC 61442-224-01) Bottle of 400.............................................................................(NDC 61442-224-04) 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 HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
----------
Medication Guide
CIPROFLOXACIN TABLETS
(Sip roe flox a sin)
for oral use
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, you should stop taking
Ciprofloxacin 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. 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)
•
Stop taking Ciprofloxacin 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 other tendons.
•
Tendon rupture can happen while you are taking or after

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
----------
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 (CIPROFLOXACIN HYDROCHLORIDE) TABLET 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, 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- 5.15), RESERVE CIPROFLOXACIN 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
07/2016
Indications and Usage ( 1.10, 1.11, 1.12)
07/2016
Dosage and Administration, Dosage in Adults ( 2.1)
07/2016
Warnings and Precautions ( 5.1)
07/2016
INDICATIONS AND USAGE
Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone
antibacterial indicated in adults (≥18 years of age)
with the following infections caused by designated, susceptible
bacteria and in ped