Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)
Liberty Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Ciprofloxacin 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 is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin 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 is indicated in adult patients for treatment of i
Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 250 mg of ciprofloxacin and engraved with Bottle of 800………………………………………………..(NDC 0440-6290-85) 500 mg of ciprofloxacin and engraved with Bottle of 10.............................................................................(NDC 0440-6291-10) Bottle of 14.............................................................................(NDC 0440-6291-14) Bottle of 20............................................................................(NDC 0440-6291-21) Bottle of 30.............................................................................(NDC 0440-6291-30) Bottle of 60.............................................................................(NDC 0440-6291-60) Bottle of 100............................................................................(NDC 0440-6291-01) Bottle of 120.............................................................................(NDC 0440-6291-91) Bottle of 300.............................................................................(NDC 0440-6291-81) Bottle of 500............................................................................(NDC 0440-6291-05) 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 HYDROCHLORIDE TABLET, FILM COATED Liberty Pharmaceuticals, Inc. ---------- Medication Guide CIPROFLOXACIN TABLETS (Sip roe flox a sin) for oral use 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, you should stop taking Ciprofloxacin immediately and get medical help right away. 1. Tendon rupture or swelling of the tendon (tendinitis). 2. 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) • 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 the back of your ankle. This can also happen with other tendons. • Tendon rupture can happen while you are takin Прочитайте повний документ
CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED LIBERTY PHARMACEUTICALS, INC. ---------- 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, USP (CIPROFLOXACIN HYDROCHLORIDE) TABLET FOR ORAL USE INITIAL U.S. APPROVAL: 1987 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._ • • • RECENT MAJOR CHANGES Boxed Warning 07/2016 Indications and Usage ( 1.10, 1.11, 1.12) 07/2016 Dosage and Administration, Dosage in Adults ( 2.1) 07/2016 Warnings and Precautions ( 5.1) 07/2016 INDICATIONS AND USAGE Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are 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: • • • • • • • • • • FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN ASSOCIATED WITH DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER (5.1), INCLUDING:DISCONTINUE CIPROFLOXACIN IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1) • • • TENDINITIS AND TENDON RUPTURE(5.2) PERIPHERAL NEUROPATHY (5.3) CENTRAL NERVOUS SYSTEM EFFECTS(5.4) FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS. (5.5) BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1- 5.15), RESERVE CIPROFLOXACIN FOR USE IN PATIENTS WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS: Прочитайте повний документ