LEVAQUIN Film-coated tablet (2011)

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BOXED WARNING SECTION

Fluoroquinolones, including LEVAQUIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, ...

1. Indications and Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN and other antibacterial drugs, LEVAQUIN should be used only to treat or prevent infections that are proven ...

2. Dosage and Administration

2.1 Dosage in Adult Patients with Normal Renal Function The usual dose of LEVAQUIN Tablets or Oral Solution is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and ...

3. Dosage Forms and Strengths

TABLETS, Film-coated, capsule-shaped: 250 mg terra cotta pink tablets, imprinted with 250 on one side and LEVAQUIN on the other 500 mg peach tablets, imprinted with 500 on one side and LEVAQUIN on the ...

4. Contraindications

LEVAQUIN is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions (5.3)].

5. Warnings and Precautions

5.1 Tendinopathy and Tendon Rupture Fluoroquinolones, including LEVAQUIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves ...

6. Adverse Reactions

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: Tendon Effects ...

6.2. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.3. Postmarketing Experience

Table 8 lists adverse reactions that have been identified during post-approval use of LEVAQUIN. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating ...

7. Drug Interactions

7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins LEVAQUIN Tablets and Oral Solution While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent ...

8.1. Pregnancy

Pregnancy Category C. Levofloxacin was not teratogenic in rats at oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended human dose based upon relative body surface ...

8.2. Lactation

Based on data on other fluoroquinolones and very limited data on LEVAQUIN , it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from ...

8.4. Pediatric Use

Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species. [see Warnings and Precautions (5.10) and Animal Toxicology and/or Pharmacology (13.2)]. ...

8.5. Geriatric Use

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as LEVAQUIN. This risk is further increased in patients ...

8.6. Renal Impairment

Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with impaired renal function (creatinine clearance <50 mL/min), requiring dosage ...

8.7. Hepatic Impairment

Pharmacokinetic studies in hepatically impaired patients have not been conducted. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected ...

10. Overdosage

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 ...

11. Description

LEVAQUIN is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-) - (S) - enantiomer of ...

12.1. Mechanism of Action

Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Clinical Pharmacology (12.4)].

12.3. Pharmacokinetics

The mean ± SD pharmacokinetic parameters of levofloxacin determined under single and steady-state conditions following oral tablet, oral solution, or intravenous (IV) doses of LEVAQUIN are summarized in ...

12.4. Microbiology

Mechanism of Action Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The mechanism of ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a lifetime bioassay in rats, levofloxacin exhibited no carcinogenic potential following daily dietary administration for 2 years; the highest dose (100 mg/kg/day) was 1.4 times the highest recommended ...

13.2. Animal Toxicology and/or Pharmacology

Levofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions (5.10)]. In immature dogs (4-5 months old), oral ...

14. Clinical Studies

14.1 Nosocomial Pneumonia Adult patients with clinically and radiologically documented nosocomial pneumonia were enrolled in a multicenter, randomized, open-label study comparing intravenous LEVAQUIN (750 ...

15. References

1. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. Approved Standard – Eighth Edition. Clinical and Laboratory Standards ...

16.1. How Supplied

16.1 LEVAQUIN Tablets LEVAQUIN Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. LEVAQUIN Tablets are packaged in bottles and in unit-dose blister strips in the following configurations: ...

16.2. Storage and Handling

LEVAQUIN Tablets should be stored at 15° to 30°C (59° to 86°F) in well-closed containers.

17. Patient Counseling Information

See FDA-Approved Medication Guide (17.5). 17.1 Antibacterial Resistance Antibacterial drugs including LEVAQUIN should only be used to treat bacterial infections. They do not treat viral infections ...