Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)
Cardinal Health
CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN 500 mg
ORAL
PRESCRIPTION DRUG
Ciprofloxacin tablets, USP are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below . Ciprofloxacin tablets are 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 tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis. Ciprofloxacin tablets are indicated in adult patients for treatment of l
Ciprofloxacin Tablets, USP are available containing 500 mg of ciprofloxacin, USP as the hydrochloride salt. The 500 mg tablets are white film-coated, modified capsule-shaped, unscored tablets debossed with G on one side of the tablet and CF 500 on the other side. They are available as follows: Available overbagged with 10 tablets per bag, NDC 55154-5376-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED Cardinal Health ---------- MEDICATION GUIDE CIPROFLOXACIN TABLETS, USP (sip" roe flox' a sin) 500 mg Read this Medication Guide before you start taking ciprofloxacin tablets 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 tablets? Ciprofloxacin tablets, 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 tablets, get medical help right away. Talk with your healthcare provider about whether you should continue to take ciprofloxacin tablets. • Tendon rupture or swelling of the tendon (tendinitis). • Tendon problems can happen in people of all ages who take ciprofloxacin tablets. • 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 tablets 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 tablets. • 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 tablets until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exer Прочитайте повний документ
CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED CARDINAL HEALTH ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN TABLETS USP. CIPROFLOXACIN 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 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 AND PRECAUTIONS (5.2)]._ Urinary tract infections ( 1.1) and Acute uncomplicated cystitis ( 1.2) Chronic bacterial prostatitis ( 1.3) Lower respiratory tract infections ( 1.4) Acute sinusitis ( 1.5) Skin and skin structure infections ( 1.6) Bone and joint infections ( 1.7) Complicated intra-abdominal infections ( 1.8) Infectious diarrhea ( 1.9) Typhoid fever (enteric fever) ( 1.10) Uncomplicated cervical and urethral gonorrhea ( 1.11) Complicated urinary tract infections and pyelonephritis in pediatric patients ( 1.12) Inhalational anthrax post-exposure in adult and pediatric patients ( 1.13) Pl Прочитайте повний документ