CIPROFLOXACIN injection solution concentrate

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Ciprofloxacin (UNII: 5E8K9I0O4U) (Ciprofloxacin - UNII:5E8K9I0O4U)

Beschikbaar vanaf:

Pfizer Labs, Division of Pfizer Inc

INN (Algemene Internationale Benaming):

Ciprofloxacin

Samenstelling:

Ciprofloxacin 10 mg in 1 mL

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CIPROFLOXACIN - CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE
CIPROFLOXACIN - CIPROFLOXACIN INJECTION, SOLUTION
PFIZER LABS, DIVISION OF PFIZER INC
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CIPROFLOXACIN INJECTION, USP (1% W/V)
AND
CIPROFLOXACIN IN DEXTROSE (5%) INJECTION, USP
(CIPROFLOXACIN)
FOR INTRAVENOUS INFUSION
_WARNING_
Fluoroquinolones, including Ciprofloxacin Injection, USP, are
associated with an increased risk
of tendinitis 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).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ciprofloxacin
Injection, USP 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 (ciprofloxacin) 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
molecular 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 solutions are available as sterile 1.0%
aqueous concentrates, which are
intended for dilution prior to administration, and as 0.2%
ready-for-use infusion solutions in 5%
Dextrose Injection. All formulas contain lactic acid as a solubilizing
agent and hydrochloric acid for pH
adjustment. The pH range for the 1.0% aqueous concentrates in vials is
3.3 to 3.9. The pH range for the
0.2% ready-for-use infusion solutions is 3.5 to 4.6.
The plastic container is fabricated from a specially formulated
polyvinyl chloride. Solutions in contact
with the plastic container ca