Terlev-750 Tablets

Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). • Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) • Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) • Chronic bacterial prostatitis (1.6) • Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) • Plague in adult and pediatric patients (1.8) • Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) • Acute Pyelonephritis (1.11) • Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) • Acute …

• Administer Levofloxacin Tablets to
• Pediatric patients weighing 30 kg and greater only . • Levofloxacin Tablets cannot be administered to
• Pediatric patients who weigh less than 30 kg because of the limitations of the available strengths
• Alternative formulations of levofloxacin may be considered for
• Pediatric patients who weigh less than 30 kg
• Dosage in Adult and
• Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute Type of Infection Dose Every 24 hours Duration (days) Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia 500 mg 7 to 14 Community Acquired Pneumonia 750 mg 5 Complicated SSSI 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 10 Chronic Bacterial Prostatitis 500 mg 28 Inhalational Anthrax (Post-Exposure)
• Adults and
• Pediatric Patients 50 kg or greater
• Pediatric Patients 30 kg to less than 50 kg 500 mg 250 mg every 12 hours 60 60 Plague
• Adults and
• Pediatric Patients 50 kg or greater
• Pediatric Patients 30 kg to less than 50 kg 500 mg 250 mg every 12 hours 10 to 14 10 to 14 Complicated UTI or Acute Pyelonephritis 750 mg 5 Complicated UTI or Acute Pyelonephritis 250 mg 10 Uncomplicated UTI 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 • Adjust dose for creatinine clearance less than 50 mL/minute Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance ≥ 50 mL/minute The usual dose of …

• 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. • 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. …

• Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species. [see Warnings and Precautions and Animal Toxicology and/or Pharmacology ]
• Inhalational Anthrax (Post-Exposure) Levofloxacin is indicated
• Pediatric patients 6 months of age and older, for inhalational anthrax (post-exposure)
• The risk-benefit assessment indicates that administration of levofloxacin to
• Pediatric patients is appropriate. …

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as levofloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Serious Adverse Reactions Advise patients to stop taking levofloxacin if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug
• Inform patients of the following serious adverse reactions that have been associated with levofloxacin or other fluoroquinolone use: • Disabling and Potentially Irreversible Serious Adverse Reactions That May Occur Together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and cen …

• Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ]
• Known hypersensitivity to levofloxacin or other quinolones

Interacting Drug Interaction Multivalent cation-containing products including antacids, metal cations or didanosine Absorption of levofloxacin is decreased when the tablets are taken within 2 hours of these products. (2.4, 7.1) Warfarin Effect may be enhanced. Monitor prothrombin time, INR and watch for bleeding (7.2) Antidiabetic agents Carefully monitor blood glucose (5.13, 7.3) 7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of levofloxacin tablets with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and …

Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose ( 4 , 5.7 ) Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses ( 5.6 ) Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur ( 5.8 ) Clostridium difficile -associated colitis: evaluate if diarrhea occurs ( 5.10 ) Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. …

The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Serious and Otherwise Important Adverse Reactions The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: • Disabling and Potentially Irreversible Serious Adverse Reactions [ see Warnings and Precautions (5.1)] • Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2)] • Peripheral Neuropathy [see Warnings and Precautions (5.3)] • Central Nervous System Effect …

8.1 Pregnancy Pregnancy Category C. Levofloxacin was not teratogenic in rats at doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended oral human dose based upon relative body surface area. The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality. …

In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis. Levofloxacin exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of levofloxacin: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally and 250 mg/kg IV produced significant mortality in rodents.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.