Country: United States
Language: English
Source: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
RedPharm Drug, Inc.
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 250 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 tablets are indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible 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 antipseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7-14 day Treatment Regimen Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant Streptococcus p
16.1 Levofloxacin Tablets, USP Levofloxacin, USP is supplied as 250, 500 and 750 mg capsule-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: Levofloxacin tablets, USP 250 mg are pink coloured, capsule shaped, biconvex, debossed 'ML 62' on one side and plain on other side. - bottles of 50s (NDC 33342-021-08) - bottles of 100s (NDC 33342-021-11) - blister of 50s (NDC 33342-021-31) - blister of 100s (NDC 33342-021-12) Levofloxacin tablets, USP 500 mg are peach coloured, capsule shaped, biconvex, debossed 'ML 63' on one side and plain on other side. - bottles of 50s (NDC 33342-022-08) - bottles of 100s (NDC 33342-022-11) - blister of 50s (NDC 33342-022-31) - blister of 100s (NDC 33342-022-12) Levofloxacin tablets, USP 750 mg are white coloured, capsule shaped, biconvex, debossed 'ML 64' on one side and plain on other side. - bottles of 20s (NDC 33342-023-32) - bottles of 100s (NDC 33342-023-11) - blister of 50s (NDC 33342-023-31) - blister of 100s (NDC 33342-023-12) Levofloxacin tablets, USP should be stored at 20º to 25ºC (68º to 77°F); excursions permitted to 15º to 30ºC (59º to 86°F) in well-closed containers. Keep out of reach of children.
Abbreviated New Drug Application
LEVOFLOXACIN- levofloxacin tablet, film coated RedPharm Drug, Inc. ---------- MEDICATION GUIDE Medication Guide Levofloxacin Tablets (LEE-voe-FLOX-a-sin) Read this Medication Guide before you start taking levofloxacin tablets 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 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 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 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 n Read the complete document
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 •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 (5.1-5.14)], 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, 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 INF Read the complete document