Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Aurobindo Pharma Limited
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
Levofloxacin tablets are indicated in adult patients 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 tablets are indicated in adult patients 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, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2 )]. MDRSP i
Levofloxacin Tablets USP, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side. Bottles of 50 NDC 65862-536-50 Bottles of 1,000 NDC 65862-536-99 10 x 10 Unit-dose Tablets NDC 65862-536-10 Levofloxacin Tablets USP, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side. Bottles of 50 NDC 65862-537-50 Bottles of 1,000 NDC 65862-537-99 10 x 10 Unit-dose Tablets NDC 65862-537-10 Levofloxacin Tablets USP, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side. Bottles of 20 NDC 65862-538-20 Bottles of 500 NDC 65862-538-05 10 x 10 Unit-dose Tablets NDC 65862-538-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers.
Abbreviated New Drug Application
LEVOFLOXACIN - LEVOFLOXACIN TABLET, FILM COATED Aurobindo Pharma Limited ---------- MEDICATION GUIDE Levofloxacin Tablets USP (lee'' voe flox' a sin) 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: • 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 levofloxacin tablets are 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 levofloxacin 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 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 hap Citiți documentul complet
LEVOFLOXACIN - LEVOFLOXACIN TABLET, FILM COATED AUROBINDO PHARMA LIMITED ---------- 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 TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1996 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 LEVOFLOXACIN, HAVE BEEN ASSOCIATED WITH DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER (5.1), INCLUDING: • TENDINITIS AND TENDON RUPTURE (5.2) • PERIPHERAL NEUROPATHY (5.3) • CENTRAL NERVOUS SYSTEM EFFECTS (5.4) DISCONTINUE LEVOFLOXACIN IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1) FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN IN PATIENTS WITH A KNOWN HISTORY OF MYASTHENIA GRAVIS _[SEE WARNINGS AND_ _PRECAUTIONS (5.5)]._ BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1 TO 5.15), RESERVE LEVOFLOXACIN FOR USE IN PATIENTS WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS: • UNCOMPLICATED URINARY TRACT INFECTION (1.12) • ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13) • ACUTE BACTERIAL SINUSITIS (1.14) RECENT MAJOR CHANGES Warnings and Precautions, Central Nervous System Effects (5.4) 10/2018 Warnings and Precautions, Risk of Aortic Aneurysm and Dissection (5.9)5/2019 Warnings and Precautions, Blood Glucose Disturbances (5.13) 10/2018 INDICATIONS AND USAGE Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designat Citiți documentul complet