Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Proficient Rx LP
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 750 mg
ORAL
PRESCRIPTION DRUG
Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae . Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)] . Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae,
•Levofloxacin Tablets USP, 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18' on one side and 'I' on the other side. They are supplied in Bottles of 5 tablets NDC 63187-833-05 Bottles of 7 tablets NDC 63187-833-07 Bottles of 10 tablets NDC 63187-833-10 Bottles of 30 tablets NDC 63187-833-30 Bottles of 60 tablets NDC 63187-833-60 Bottles of 90 tablets NDC 63187-833-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
Proficient Rx LP ---------- MEDICATION GUIDE Levofloxacin (LEE-voe-FLOX-a-sin) Tablets USP What is the most important information I should know about levofloxacin tablets? Levofloxacin tablets, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you have any of the following serious side effects while you take levofloxacin tablets, you should stop taking levofloxacin 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 levofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Some tendon problems include: o pain o swelling o 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 levofloxacin tablets is higher if you: o are over 60 years of age o are taking steroids (corticosteroids) o 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 levofloxacin tablets. • Other reasons that can increase your risk of tendon problems can include: o physical activity or exercise o kidney failure o tendon problems in the past, such as in people with rheumatoid arthritis (RA) • Stop taking levofloxacin tablets immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. Avoid exercise and using the affected area. • 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. You may need a different antibiotic that is not a fluoroquinolone to treat your infection. • Tendon rupture can happen while you are taking or after you have finished taking levofloxacin tablets. Tendon ruptures can happen within hours or days of taking levofloxacin tablets and have happened up Læs hele dokumentet
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVOFLOXACIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN TABLETS. LEVOFLOXACIN TABLET, FILM COATED FOR ORAL USE INITIAL U.S. APPROVAL: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15). RECENT MAJOR CHANGES Boxed Warning 06/2016 Indications and Usage (1) 06/2016 Dosage and Administration (2) 06/2016 Warnings and Precautions (5) 06/2016 INDICATIONS AND USAGE Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). • Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) • Skin and Skin Structure Infections: Complicated (1.4) and Uncomplicated (1.5) • Chronic bacterial prostatitis (1.6) • Inhalational Anthrax, Post-Exposure (1.7) • Plague (1.8) • Urinary Tract Infections: Complicated (1.9, 1.10) and Uncomplicated (1.12) • Acute Pyelonephritis (1.11) • Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) • Acute Bacterial Sinusitis (1.14) DOSAGE AND ADMINISTRATION • Dosage in patients with normal renal function (2.1) TYPE OF INFECTION DOSE EVERY 24 HOURS DURATION (DAYS) Nosocomial Pneumonia (1.1) 750 mg 7-14 Community Acquired Pneumonia (1.2) 500 mg 7-14 Community Acquired Pneumonia (1.3) 750 mg 5 Complicated Skin and Skin Structure Infections (SSSI) (1.6) 750 mg 7-14 Uncomplicated SSSI (1.7) 500 mg 7-10 Chronic Bacterial Prostatitis (1.8) 500 mg 28 Inhalational Anthrax (Post- Exposure) (1.13) Adults and Pediatric Patients > 50 kg 500 mg 8 mg/kg BID (not to exceed 250 mg/dose) 60 60 kg Pediatric Patients < 50 kg and ≥ 6 months of age Plague (1.14) Adults Læs hele dokumentet