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ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (ciprofloxacin - UNII:5E8K9I0O4U)
PuraCap Laboratories LLC dba Blu Pharmaceuticals
ciprofloxacin hydrochloride
ciprofloxacin 500 mg
ORAL
PRESCRIPTION DRUG
Ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. Ciprofloxacin 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 is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. Ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis. Ciprofloxacin is indicated in adult patients for treatment of lower respiratory tract infections caused by Esche
Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP are available as round, biconvex white to slightly yellowish film coated tablets containing 250 mg of ciprofloxacin. The 250 mg tablet is embossed with the word “P” on one side and “250” on reverse side. Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP is also available as capsule shaped, white to slightly yellowish film coated tablets containing 500mg of ciprofloxacin. The 500 mg tablet is embossed with the word “P” on one side and “500” on reverse side. Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP is also available as capsule shaped, white to slightly yellowish film coated tablets containing 750 mg of ciprofloxacin. The 750 mg tablet is embossed with the word “P” on one side and “750” on reverse side. Strength NDC Code Tablet Identification Bottles of 20: 500 mg NDC 24658-185-20 P 500 Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CIPROFLOXACIN- CIPROFLOXACIN TABLET PuraCap Laboratories LLC dba Blu Pharmaceuticals ---------- MEDICATION GUIDE Medication Guide for Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg 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. 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 co 전체 문서 읽기
CIPROFLOXACIN- CIPROFLOXACIN TABLET PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS ---------- 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 (HYDROCHLORIDE) TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1987 WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • RECENT MAJOR CHANGES Indications and Usage, Plague (1.14) 03/2015 Dosage and Administration, Adults (2.1), Pediatrics (2.2) 03/2015 INDICATIONS AND USAGE Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated. • • • • • • • • • • • • • • DOSAGE AND ADMINISTRATION ADULT DOSAGE GUIDELINES (2) INFECTION (2) DOSE (2) FREQUENCY (2) DURATION (2) Urinary Tract (2) 250 mg - 500 mg (2) every 12 hours (2) 7 to 14 days (2) Acute Cystitis (2) 250 mg (2) every 12 hours (2) 3 days (2) Chronic Bacterial Prostatitis (2) 500 mg (2) every 12 hours (2) 28 days (2) Lower Respiratory Tract (2) 500 mg - 750 mg (2) every 12 hours (2) 7 to 14 days (2) Acute Sinusitis (2) 500 mg (2) every 12 hours (2) 10 days (2) Skin and Skin Structure (2) 500 mg - 750 mg (2) every 12 hours (2) 7 to 14 days (2) Bone and Joint (2) 500 mg - 750 mg (2) every 12 hours (2) 4 to 8 weeks (2) 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 AND PRECAUTIONS (5.1)]._ FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS _[SEE_ _WARNINGS A 전체 문서 읽기