CIPROFLOXACIN injection, solution, concentrate

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Rebel Distributors Corp

INN (International Adı):

CIPROFLOXACIN

Kompozisyon:

CIPROFLOXACIN 400 mg in 40 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Ciprofloxacin Injection, USP is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration offers a route of administration advantageous to the patient. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Adult Patients:   Urinary Tract Infections caused by Escherichia coli (including cases with secondary bacteremia), Klebsiella pneumoniae subspecies pneumoniae , Enterobacter cloacae , Serratia marcescens , Proteus mirabilis , Providencia rettgeri , Morganella morganii , Citrobacter diversus , Citrobacter freundii , Pseudomonas aeruginosa , methicillin-susceptible Staphylococcus epidermidis , Staphylococcus saprophyticus , or Enterococcus faecalis . Lower Respiratory Infections caused by Escherichia coli , Klebsiella pneumoniae subspecies pneumoniae , Enterobacter cloacae , Proteus mirabilis , Pseudomonas aeruginosa , Haemophilus

Ürün özeti:

Ciprofloxacin Injection, USP is available as a clear, colorless to slightly yellowish solution. Ciprofloxacin Injection, USP is available in 400 mg strengths. The concentrate is supplied in vials as follows: VIAL: manufactured by Hospira, Inc., Lake Forest, IL 60045 USA. 40 mL 400 mg 21695-914-40 STORAGE   Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light, avoid excessive heat, protect from freezing.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

CIPROFLOXACIN- CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE
Rebel Distributors Corp
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MEDICATION GUIDE
Ciprofloxacin Injection, for Intravenous Infusion
Read the Medication Guide that comes with ciprofloxacin before you
start taking it and each time you get
a refill. There may be new information. This Medication Guide 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 belongs to a class of antibiotics called
fluoroquinolones. Ciprofloxacin can cause side
effects that may be serious or even cause death. If you get any of the
following serious side effects, get
medical help right away. Talk with your healthcare provider about
whether you should continue to take
ciprofloxacin.
Tendon rupture or swelling of the tendon (tendinitis)
•
Tendons are tough cords of tissue that connect muscles to bones.
Pain, swelling, tears, and inflammation of tendons including the back
of the ankle (Achilles),
shoulder, hand, or other tendon sites can happen in people of all ages
who take fluoroquinolone
antibiotics, including ciprofloxacin. The risk of getting tendon
problems is higher if you:
are over 60 years of age
are taking steroids (corticosteroids)
have had a kidney, heart, or lung transplant.
Swelling of the tendon (tendinitis) and tendon rupture (breakage) have
also happened in patients
who take fluoroquinolones who do not have the above risk factors.
Other reasons for tendon ruptures can include:
physical activity or exercise
kidney failure
tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
Call your healthcare provider right away at the first sign of tendon
pain, swelling or inflammation.
Stop taking ciprofloxacin until tendinitis or tendon rupture has been
ruled out by your healthcare
provider. Avoid exercise and using the affected area. The most common
area of pain and swelling
is the Achilles tendon at the back of your ankle. This can als

Ürün özellikleri

CIPROFLOXACIN- CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE
REBEL DISTRIBUTORS CORP
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CIPROFLOXACIN
INJECTION, USP
FOR INTRAVENOUS INFUSION
Rx only
_WARNING:_
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN ARE ASSOCIATED WITH AN
INCREASED RISK OF
TENDONITIS AND TENDON RUPTURE IN ALL AGES. THIS RISK IS FURTHER
INCREASED IN OLDER PATIENTS
USUALLY OVER 60 YEARS OF AGE, IN PATIENTS TAKING CORTICOSTEROID DRUGS,
AND IN PATIENTS WITH
KIDNEY, HEART OR LUNG TRANSPLANTS (SEE _WARNINGS_).
FLUOROQUINOLONES, INLCUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS
WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN
HISTORY OF MYASTHENIA
GRAVIS (SEE _WARNINGS_).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ciprofloxacin
and other antibacterial drugs, Ciprofloxacin Injection, USP should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ciprofloxacin Injection, USP is a synthetic broad-spectrum
antimicrobial agent for intravenous (I.V.)
administration. Ciprofloxacin, a fluoroquinolone, is
1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-
piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C
H FN O and its chemical
structure is:
Ciprofloxacin is a faint to light yellow crystalline powder with a
molecular weight of 331.4. It is
soluble in dilute (0.1N) hydrochloric acid and is practically
insoluble in water and ethanol.
Ciprofloxacin Injection, USP is available as a sterile 1% aqueous
concentrate, which is intended for
dilution prior to administration. The formula contains lactic acid as
a solubilizing agent and
hydrochloric acid for pH adjustment. The pH range for the 1% aqueous
concentrate in vials is 3.3 to
3.9.
CLINICAL PHARMACOLOGY
ABS ORPTION
Following 60-minute intravenous infusions of 200 mg and 400 mg
ciprofloxacin to normal volunteers,
the mean maximum serum concentrations achieved were 2.1 and 4.6
mcg/mL, respectively; the
17
18
3
3
the mean maximum serum concentratio