CIPROFLOXACIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 500 mg

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

Product summary:

NDC: 71335-0070-1: 14 Tablets in a BOTTLE NDC: 71335-0070-2: 30 Tablets in a BOTTLE NDC: 71335-0070-3: 20 Tablets in a BOTTLE NDC: 71335-0070-4: 60 Tablets in a BOTTLE NDC: 71335-0070-5: 6 Tablets in a BOTTLE NDC: 71335-0070-6: 10 Tablets in a BOTTLE NDC: 71335-0070-7: 28 Tablets in a BOTTLE NDC: 71335-0070-8: 100 Tablets in a BOTTLE NDC: 71335-0070-9: 40 Tablets in a BOTTLE NDC: 71335-0070-0: 7 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN TABLET
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Ciprofloxacin (sip"row flox"a sin) Tablets USP 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,
thumb, 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 can a

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLET
BRYANT RANCH PREPACK
----------
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 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:
O TENDINITIS AND TENDON RUPTURE (5.2)
O PERIPHERAL NEUROPATHY (5.3)
O CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE CIPROFLOXACIN 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, 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 (5.1-5.16), RESERVE CIPROFLOXACIN TABLETS
FOR USE IN PATIENTS
WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING
INDICATIONS:
O ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.10)
O ACUTE UNCOMPLICATED CYSTITIS (1.11)
O ACUTE SINUSITIS (1.12)
RECENT MAJOR CHANGES
Dosage and Administration, Important Administration Instructions
(2.4) 11/2021
INDICATIONS AND USAGE
Ciprofloxacin is 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:
Skin and Skin Structure Infections (1.1)
Bone and Joint Infections (1.2)
Complicated Intra-Abdominal Infections (1.3)
Infectious Diarrh