Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
RedPharm Drug, Inc.
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 500 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. 1.1 Nosocomial Pneumonia 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)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [
16.1 Levofloxacin Tablets, USP •Levofloxacin Tablets USP, 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25' on one side and 'I' on the other side. They are supplied in Bottles of 50 tablets NDC 31722-721-50 Blister card of 10 Unit-dose tablets NDC 31722-721-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-721-32 •Levofloxacin Tablets USP, 500 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with '26' on one side and 'I' on the other side. They are supplied in Bottles of 50 tablets NDC 31722-72-50 Blister card of 10 Unit-dose tablets NDC 31722-722-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-722-32 •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 20 tablets NDC 31722-723-20 Blister card of 10 Unit-dose tablets NDC 31722-723-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-723-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
RedPharm Drug, Inc. ---------- MEDGUIDE 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 to se Đọc toàn bộ tài liệu
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED REDPHARM DRUG, INC. ---------- BOXED WARNING WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVISWARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OFMYASTHENIA GRAVIS • Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)], including: o Tendinitis and tendon rupture [see Warnings and Precautions (5.2)] o Peripheral neuropathy [see Warnings and Precautions (5.3)] o Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (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 [see Warnings and Precautions (5.1 to 5.14)], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: o Uncomplicated urinary tract infection [see Indications and Usage (1.12)] o Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.13)] o Acute bacterial sinusitis [see Indications and Usage (1.14)]. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safe Đọc toàn bộ tài liệu