Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
Ciprofloxacin tablets, USP are 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 tablets, USP are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin tablets, USP are 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 tablets, USP are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (
Product: 50090-0864 NDC: 50090-0864-0 20 TABLET, FILM COATED in a BOTTLE Product: 50090-0868 NDC: 50090-0868-0 6 TABLET, FILM COATED in a BOTTLE
Abbreviated New Drug Application
CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED A-S Medication Solutions ---------- Medication Guide Ciprofloxacin Tablets USP (sip-roh-flok-suh-sin) 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 should get any of the following serious side effects while you take ciprofloxacin tablets, you should stop taking ciprofloxacin tablets 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 tablets. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: ○ Pain, swelling, tears and swelling 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) • Stop taking ciprofloxacin tablets 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. • Tend Lire le document complet
CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED A-S MEDICATION SOLUTIONS ---------- 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: 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 TABLETS, HAVE BEEN ASSOCIATED WITH DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER (5.1), INCLUDING: O TENDINITIS AND TENDON RUPTURE (5.2) O PERIPHERAL NEUROPATHY (5.3) O CENTRAL NERVOUS SYSTEM EFFECTS (5.4) DISCONTINUE CIPROFLOXACIN TABLETS IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN TABLETS, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1) FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN TABLETS, MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN TABLETS IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS. (5.5) BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN TABLETS, HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1-5.15), RESERVE CIPROFLOXACIN TABLETS, FOR USE IN PATIENTS WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS: O ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.10) O ACUTE UNCOMPLICATED CYSTITIS (1.11) O ACUTE SINUSITIS (1.12) RECENT MAJOR CHANGES Boxed Warning 7/2016 Indications and Usage, Lower Respiratory Tract Infections (1.10) 7/2016 Indications and Usage, Urinary Tract Infections (1.11) 7/2016 Indications and Usage, Acute Sinusitis (1.12) 7/2016 Dosage and Administration, Dosage in Adults (2.1) 7/2016 Warnings and Precautions (5) 7/2016 INDICATIONS AND USAGE Ciprofloxacin tablets USP is a fluoroquinolone antibacter Lire le document complet