CIPROFLOXACIN tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Cardinal Health 107, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. 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, Klebsi

Resumen del producto:

Ciprofloxacin Tablets USP, 500 mg are white, oval shaped, beveled edge film-coated tablets debossed with “R” on one side and “127” on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 x 10. Overbagged with 10 tablets per bag, NDC 55154-7283-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Cardinal Health 107, LLC
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Medication Guide
Ciprofloxacin Tablets, USP for oral use
(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 tablet, 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:
1.
Pain, swelling, tears and swelling of the tendons including the back
of the ankle (Achilles), shoulder,
hand, or other tendon sites.
2.
The risk of getting tendon problems while you take ciprofloxacin
tablets is higher if you:
3.
are over 60 years of age
4.
are taking steroids (corticosteroids)
5.
have had a kidney, heart or lung transplant
6.
Tendon problems can happen in people who do not have the above risk
factors when they take
ciprofloxacin tablets.
7.
Other reasons that can increase your risk of tendon problems can
include:
8.
physical activity or exercise
9.
kidney failure
10.
tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
11.
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

Fitxa tècnica

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
----------
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, 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, 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(5.1)
• BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN
ASSOCIATED WITH SERIOUS
ADVERSE REACTIONS (5.1-5.16), RESERVE CIPROFLOXACIN 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
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 fluoroquinolone antibacterial indicated in
adults (18 years of age and older) with
the following infections caused by designated, susceptible bacteria
and in pediatric pat