Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CIPROFLOXACIN (UNII: 5E8K9I0O4U) (CIPROFLOXACIN - UNII:5E8K9I0O4U)
Sandoz Inc
CIPROFLOXACIN
CIPROFLOXACIN 2 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Les hele dokumentet
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 Les hele dokumentet