CIPROFLOXACIN- ciprofloxacin injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

CIPROFLOXACIN

Composition:

CIPROFLOXACIN 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CIPROFLOXACIN INJECTION, USP is indicated for the treatment of infections caused by susceptible isolates 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, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri (diversus), Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or vancomycin-susceptible Enterococcus faecalis . Lower Respiratory Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae , or penicillin-susceptible St

Product summary:

CIPROFLOXACIN INJECTION, USP is available as a clear, colorless to slightly yellowish solution. CIPROFLOXACIN INJECTION, USP is available in 200 mg and 400 mg strengths supplied in latex-free flexible containers as follows: FLEXIBLE CONTAINER : manufactured in Switzerland SIZE STRENGTH NDC NUMBER 100 mL 5% Dextrose Supplied in cartons of 24 200 mg, 0.2% 0781-3239-46 0781-3239-09 200 mL 5% Dextrose Supplied in cartons of 24 400 mg, 0.2% 0781-3240-48 0781-3240-09 Flexible Container: Store between 5-25°C (41-77°F). Protect from light, avoid excessive heat, protect from freezing.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN INJECTION
Sandoz Inc
----------
MEDICATION GUIDE
CIPROFLOXACIN (sip-row-FLOX-a-sin) INJECTION, USP
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.
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 inflammation of 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)
•
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 Achille

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN INJECTION
SANDOZ INC
----------
CIPROFLOXACIN INJECTION, USP
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).
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN INJECTION, USP, MAY
EXACERBATE
MUSCLE WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN
INJECTION, USP IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS
(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 is a synthetic broad-spectrum
antimicrobial agent for intravenous
(IV) 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 solution is available as 0.2%
ready-for-use infusion solution in
5% Dextrose Injection. The formula contains lactic acid as a
solubilizing agent and hydrochloric acid
for pH adjustment. The pH range for the 0.2% ready-for-use infusion
solutions is 3.5 to 4.6.
The plastic container is latex-free and is fabricated from a specially
formulated polyvinyl chloride.
Solutions in contact with the plastic container can leach out certain
of its chemical components in very
small amounts within the expiration period, for example, Cyclohex