Country: United States
Language: English
Source: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
REMEDYREPACK INC.
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 750 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 (
Levofloxacin tablets are supplied as 250 mg, 500 mg, and 750 mg octagonal, biconvex, film-coated tablets. Levofloxacin tablets are packaged in bottles in the following configurations: Levofloxacin tablets should be stored 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 REMEDYREPACK INC. ---------- Medication Guide Levofloxacin Tablets (lee-voe-FLOX-ah-sin) 250 mg, 500 mg, and 750 mg 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). 2. 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. 3. 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. 4. Tendon problems can happen in people who do not have the above risk factors when they take levofloxacin tablets. 5. 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) 6. 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. 7. 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. 8. Tendon rupture can happen while you are taking or after you have finished taking levofloxacin tablets. Tendon ruptures Read the complete document
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED REMEDYREPACK INC. ---------- 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 5.14), _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 Indications and Usage – oral solution and injection dosage forms related uses removed ( 1) 07/2018 Dosage and Administration – oral solution and injection) dosage forms related uses removed ( 2) 07/2018 Warnings and Precautions -psychiatric adverse reactions ( 5.4) 10/2018 Warnings and Precautions –hypoglycemic coma or death ( 5.12) 10/2018 INDICATIONS AND USAGE Levofloxa Read the complete document