CIPROFLOXACIN- ciprofloxacin injection, solution

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Cardinal Health

INN (International Name):

CIPROFLOXACIN

রচনা:

CIPROFLOXACIN 2 mg in 1 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Ciprofloxacin Injection, USP in 5% Dextrose 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 is needed [see Dosage and Administration (2.1, 2.2) ]. Ciprofloxacin Injection, USP in 5% Dextrose is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli , Klebsiella pneumoniae, Enterobacter cloacae , Serratia marcescens , Proteus mirabilis , Providencia rettgeri , Morganella morganii , Citrobacter koseri , Citrobacter freundii , Pseudomonas aeruginosa , methicillin-susceptible Staphylococcus epidermidis , Staphylococcus saprophyticus , or Enterococcus faecalis . Ciprofloxacin Injection, USP in 5% Dextrose is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli , Klebsiella pneumoniae, Enterobacter cloacae , Proteus mirabilis , Pseudomonas aeruginosa , Haemophilus influen

পণ্য সারাংশ:

Ciprofloxacin Injection, USP in 5% dextrose is available as a clear, colorless to slightly yellowish solution. Ciprofloxacin Injection, USP in 5% dextrose is available in 200 mg and 400 mg strengths. The 2 mg/mL infusion solution is supplied in latex-free flexible containers as follows: SIZE STRENGTH NDC NUMBER 200 mL, 5% Dextrose 400 mg 55154-7828-8 Overbagged with 1 x 200 mL Single Dose per bag Storage Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Product may also be stored in a refrigerator, 2 to 8°C (36 to 46°F). Protect from light, avoid excessive heat, protect from freezing. Repackaged By: Cardinal Health Zanesville, OH 43701

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

CIPROFLOXACIN- CIPROFLOXACIN INJECTION, SOLUTION
Cardinal Health
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MEDICATION GUIDE
Ciprofloxacin (sip-row-FLOX-a-sin) Injection, USP in 5% Dextrose
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 could result in death.
If you get any of the following serious side effects while you take
ciprofloxacin, 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).
1.
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.
2.
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
3.
Tendon problems can happen in people who do not have the above risk
factors when they take
ciprofloxacin.
4.
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)
5.
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 ar

পণ্য বৈশিষ্ট্য

CIPROFLOXACIN- CIPROFLOXACIN INJECTION, SOLUTION
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CIPROFLOXACIN.
CIPROFLOXACIN INJECTION, USP IN 5% DEXTROSE FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2006
WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
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RECENT MAJOR CHANGES
Indications and Usage, Plague (1.12) 2/2015
Dosage and Administration, Adults (2.1), Pediatrics (2.2) 2/2015
INDICATIONS AND USAGE
Ciprofloxacin Injection, USP in 5% Dextrose is a fluoroquinolone
antibacterial indicated in adults (≥18 years of age) with
infections caused by designated, susceptible bacteria and in pediatric
patients where indicated.
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DOSAGE AND ADMINISTRATION
ADULT DOSAGE GUIDELINES (2)
INFE C TIO N
DO SE
FREQUENCY
USUAL DURATION
Urinary Tract
200 to 400 mg
every 12 to 8 hours
7 to 14 days
Lower
Respiratory Tract
400 mg
every 12 to 8 hours
7 to 14 days
Nosocomial Pneumonia
400 mg
every 8 hours
10 to 14 days
Skin and
Skin Structure
400 mg
every 12 to 8 hours
7 to 14 days
Bone and Joint
400 mg
every 12 to 8 hours
4 to 8 weeks
Intra-Abdominal
400 mg
every 12 hours
7 to 14 days
Acute Sinusitis
400 mg
every 12 hours
10 days
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.
(5.1)
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS WITH
MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY
OF MYASTHENIA GRAVIS. (5.2)
Urinary tract infections in adults (1.1)
Lower respiratory tract infections in adults (1.2)
Nosocomial Pneumonia (1.3)
Skin and skin structure inf