CIPROFLOXACIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ciprofloxacin (UNII: 5E8K9I0O4U) (ciprofloxacin - UNII:5E8K9I0O4U)

Available from:

Sagent Pharmaceuticals

INN (International Name):

ciprofloxacin

Composition:

ciprofloxacin 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa . Ciprofloxacin 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 is indicated in adult patients for treatment of nosocomial pneumonia caused by Haemop

Product summary:

Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is available in 200 mg and 400 mg strengths supplied in flexible containers as follows: Ciprofloxacin Injection, USP (ciprofloxacin) is available as a clear, colorless to slightly yellowish solution. Storage Conditions Store between 5° and 25°C (41° and 77°F). Protect from light. Avoid excessive heat. Protect from freezing. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container and container closure are not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sagent Pharmaceuticals
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
MEDICATION GUIDE
CIPROFLOXACIN (sip-row-FLOX-a-sin) INJECTION, USP
(in 5% Dextrose Injection)
(ciprofloxacin)
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, thumb, 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

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
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 INFUSION.
INITIAL U.S. APPROVAL: 1990
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 INJECTION (IN 5% DEXTROSE
INJECTION) 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 INJECTION IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN INJECTION (IN 5% DEXTROSE
INJECTION), IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN INJECTION (IN 5% DEXTROSE
INJECTION), MAY
EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID
CIPROFLOXACIN
INJECTION (IN 5% DEXTROSE INJECTION) IN PATIENTS WITH KNOWN HISTORY OF
MYASTHENIA
GRAVIS. (5.5)
BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN INJECTION (IN 5%
DEXTROSE
INJECTION), HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1
TO 5.16),
RESERVE CIPROFLOXACIN INJECTION (IN 5% DEXTROSE INJECTION) 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)
INDICATIONS AND USAGE
Ciprofloxacin 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 Infe