Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)
QPharma Inc
ORAL
PRESCRIPTION DRUG
Ciprofloxacin tablets 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 are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin tablets 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 are indicated in adult patients for treatment of infectious diarrhea caused
Ciprofloxacin Tablets USP, 500 mg are white, oval shaped, beveled edge film-coated tablets debossed with “R” on one side and “127” on other side and are supplied in bottles of 14. Bottles of 14 NDC 42708-146-14 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED QPharma Inc ---------- Medication Guide Ciprofloxacin Tablets, USP for oral use (sip'' roe flox' a 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 tablet, 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 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 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 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. Th Прочитајте комплетан документ
CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED QPHARMA INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN TABLETSSAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN TABLETS. 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, 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 IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS ( 5.1) • FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS(5.1) • BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1 to 5.16), RESERVE CIPROFLOXACIN 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 Dosage andAdministration ( 2.4) 5/2020 INDICATIONS AND USAGE Ciprofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections ( 1.1) Bone and Joint Infections ( 1.2) Complicated Intra-Abdominal Infections ( 1.3) Infectious Diarrhea ( 1.4) Typhoid Feve Прочитајте комплетан документ