CIPROFLOXACIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

Ciprofloxacin

Composition:

Ciprofloxacin 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin injection 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. 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 influenzae, Haemophilus parainfluenzae, or Penicillin-suscepti

Product summary:

Ciprofloxacin injection is available as a clear, colorless to slightly yellowish solution. Ciprofloxacin injection is available in 200 mg and 400 mg strengths. The concentrate is supplied in vials as follows: Store between 5 - 30ºC (41 - 86ºF). Protect from light, avoid excessive heat, protect from freezing.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN INJECTION
Rebel Distributors Corp
----------
CIPROFLOXACIN INJECTION, USP
MEDICATION GUIDE
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

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN INJECTION
REBEL DISTRIBUTORS CORP
----------
CIPROFLOXACIN
INJECTION, USP
FOR INTRAVENOUS INFUSION
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, 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 and other antibacterial drugs, ciprofloxacin injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ciprofloxacin Injection 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 solution is available as sterile 1.0% aqueous
concentrates, which are intended
for dilution prior to administration. Contains 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.
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
concentrations at 12 hours were 0.1 and 0.2 mcg/mL, respectively.
STEADY-STATE CIPROFLOXACIN SERUM CONCENTRATIONS
(MCG/ML) AFTER 60-MINUTE I.V. INFUSIONS Q 12 H.
Time after starting the infusion
Dose
30 min. 1 hr
3 hr
6 hr
8 hr
12 hr
17
18
3
3
200 mg 1.7
2.1
0.6
0.3
0.2
0.1
400 mg 3.7
4.6