CIPROFLOXACIN injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

CIPROFLOXACIN (UNII: 5E8K9I0O4U) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

Tilgængelig fra:

Hospira, Inc.

INN (International Name):

CIPROFLOXACIN

Sammensætning:

CIPROFLOXACIN 2 mg in 1 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Ciprofloxacin Injection (in 5% Dextrose Injection) 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 Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin Injection (in 5% Dextrose Injection) 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 Injection (in 5% Dextrose Injection) is ind

Produkt oversigt:

Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is available as a clear, colorless to slightly yellowish solution. Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is available in the 400 mg strength. The 2 mg/mL infusion solution is supplied in latex-free flexible containers as follows: Storage Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Product may also be stored in a refrigerator, 2 to 8°C (36 to 46°F). Protect from light, avoid excessive heat, protect from freezing.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

CIPROFLOXACIN- CIPROFLOXACIN INJECTION, SOLUTION
Hospira, Inc.
----------
MEDICATION GUIDE
CIPROFLOXACIN (SIP-ROW-FLOX-A-SIN)
INJECTION, USP IN 5% DEXTROSE
FOR INTRAVENOUS INFUSION
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 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, 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 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 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 ca

Produktets egenskaber

CIPROFLOXACIN- CIPROFLOXACIN INJECTION, SOLUTION
HOSPIRA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN
INJECTION.
CIPROFLOXACIN INJECTION, FOR INTRAVENOUS 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 – 5.16), RESERVE CIPROFLOXACIN FOR USE IN PATIENTS
WHO HAVE NO ALTERNATIVE TREATMENT
OPTIONS FOR THE FOLLOWING INDICATIONS:
ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.9)
ACUTE SINUSITIS (1.11)
RECENT MAJOR CHANGES
Warnings and Precautions, Risk of Aortic Aneurysm and Dissection (5.9)
5/2019
INDICATIONS AND USAGE
Ciprofloxacin Injection (in 5% Dextrose Injection) is a
fluoroquinolone antibacterial indicated in adults (≥18 years of age)
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)
Nosocomial Pneumonia (1.4)
Em