מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
Ciprofloxacin (UNII: 5E8K9I0O4U) (Ciprofloxacin - UNII:5E8K9I0O4U)
Rebel Distributors Corp
Ciprofloxacin
Ciprofloxacin 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 קרא את המסמך השלם
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 קרא את המסמך השלם