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 tablet 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 tablet is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcu
16.1 Levofloxacin Tablets Levofloxacin Tablets USP, 250 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC55' on one side and plain on other side and are supplied as follows: NDC 68382-015-18 in bottles of 50 tablets NDC 68382-015-01 in bottles of 100 tablets NDC 68382-015-05 in bottles of 500 tablets Levofloxacin Tablets USP, 500 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC56' on one side and plain on other side and are supplied as follows: NDC 68382-016-18 in bottles of 50 tablets NDC 68382-016-01 in bottles of 100 tablets NDC 68382-016-05 in bottles of 500 tablets NDC 68382-016-10 in bottles of 1000 tablets Levofloxacin Tablets USP, 750 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC57' on one side and plain on other side and are supplied as follows: NDC 68382-017-18 in bottles of 50 tablets NDC 68382-017-01 in bottles of 100 tablets NDC 68382-017-05 in bottles of 500 tablets Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as described in the USP.
Abbreviated New Drug Application
RedPharm Drug, Inc. ---------- MEDICATION GUIDE MEDICATION GUIDE Levofloxacin Tablets, USP (LEE voe FLOX a sin) Read this Medication Guide before you start taking levofloxacin and each time you get a refill. There may be new information. This Medication Guide 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 levofloxacin? Levofloxacin, 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, get medical help right away. Tendon problems can happen in people of all ages who take levofloxacin.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 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 levofloxacin. 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 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. Tendon ruptures can happen within hours or day 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 GRAVIS ... WARNING: WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA 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: Tendinitis and tendon rupture [see Warnings and Precautions (5.2)] Peripheral neuropathy [see Warnings and Precautions (5.3)] 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 (5.1-5.14)], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: Uncomplicated urinary tract infection [see Indications and Usage (1.12)] Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.13)] 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 safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 WARNING: SERIOUS ADVERSE REACTION Đọc toàn bộ tài liệu