País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ciprofloxacin (UNII: 5E8K9I0O4U) (ciprofloxacin - UNII:5E8K9I0O4U)
Sagent Pharmaceuticals
ciprofloxacin
ciprofloxacin 2 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. Ciprofloxacin Injection is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa . Ciprofloxacin Injection is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis . Ciprofloxacin Injection is indicated in adult patients for treatment of nosocomial pneumonia caused by Haemop
Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is available in 200 mg and 400 mg strengths supplied in flexible containers as follows: Ciprofloxacin Injection, USP (ciprofloxacin) is available as a clear, colorless to slightly yellowish solution. Storage Conditions Store between 5° and 25°C (41° and 77°F). Protect from light. Avoid excessive heat. Protect from freezing. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container and container closure are not made with natural rubber latex.
Abbreviated New Drug Application
Sagent Pharmaceuticals ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. MEDICATION GUIDE CIPROFLOXACIN (sip-row-FLOX-a-sin) INJECTION, USP (in 5% Dextrose Injection) (ciprofloxacin) 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 can happen at the same time and could result in death. If you get any of the following serious side effects while you take ciprofloxacin, you should stop taking ciprofloxacin immediately and get medical help right away. 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 swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, 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). • Stop taking ciprofloxacin immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. The most common area of pain and swelling is the Achilles tendon at Leia o documento completo
CIPROFLOXACIN- CIPROFLOXACIN INJECTION, SOLUTION SAGENT PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN INJECTION. CIPROFLOXACIN INJECTION, FOR INTRAVENOUS INFUSION. INITIAL U.S. APPROVAL: 1990 WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN INJECTION (IN 5% DEXTROSE INJECTION) HAVE BEEN ASSOCIATED WITH DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER (5.1), INCLUDING: TENDINITIS AND TENDON RUPTURE (5.2) PERIPHERAL NEUROPATHY (5.3) CENTRAL NERVOUS SYSTEM EFFECTS (5.4) DISCONTINUE CIPROFLOXACIN INJECTION IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN INJECTION (IN 5% DEXTROSE INJECTION), IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1) FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN INJECTION (IN 5% DEXTROSE INJECTION), MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN INJECTION (IN 5% DEXTROSE INJECTION) IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS. (5.5) BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN INJECTION (IN 5% DEXTROSE INJECTION), HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1 TO 5.16), RESERVE CIPROFLOXACIN INJECTION (IN 5% DEXTROSE INJECTION) FOR USE IN PATIENTS WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS: ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.9) ACUTE SINUSITIS (1.11) INDICATIONS AND USAGE Ciprofloxacin Injection is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infe Leia o documento completo