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.
Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )] .
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 to 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 ) ].
Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )] .
• Levofloxacin tablets, USP 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25on' 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. • Levofloxacin tablets, USP 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18'on one side and 'I' on the other side.
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.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| addb5519-f7ae-4d4e-b9ca-f782a1597fd3 | Product name | 2 | 20210610 |
| fb758c6a-fdee-40a8-99c2-46f79c3ff90c | Product name | 4 | 20200807 |
| 1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6d | Product name | 1 | 20190618 |
| aea4a616-4dfe-45f6-94bb-8b9063056ceb | Product name | 6 | 20190611 |
| 2246ce8e-a477-4dc3-b6d6-fe9973c18ed1 | Product name | 1 | 20180821 |
| 5a6c788d-375b-4565-a8ae-67c179a30c93 | Product name | 1 | 20180212 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4512-1 | Levofloxacin | 1 in 1 BOTTLE | TABLET, FILM COATED | 1 | 7 | |
| 68071-4512-2 | Levofloxacin | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | 7 | |
| 68071-4512-3 | Levofloxacin | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | 7 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4512 | LEVOFLOXACIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240612_72cb9372-e9f8-3ca1-e053-2a91aa0ad820.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-722-50 | EA - Each | 31722-722 | 4154679b-6e00-4df8-a834-d20d1cdeda0d | 1 | 2016-12-07 |
| Product NDC | Package NDC |
|---|---|
| 68071-4512 | 68071-4512-3, 68071-4512-2, 68071-4512-1 |
| 31722-722 |
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONE | FZ989GH94E | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| LEVOFLOXACIN | 6GNT3Y5LMF | ACTIM |
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 to 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 ) ].
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.
• Levofloxacin tablets, USP 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25on' 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. • Levofloxacin tablets, USP 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18'on one side and 'I' on the other side.
Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )] .
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.
Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP The molecular formula is C 18 H 20 FN 3 O 4 •1/2 H 2 O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3 >Cu +2 >Zn +2 >Mg +2 >Ca +2 . Excipients and Description of Dosage Form Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: • 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. • 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. • 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Levofloxacin tablets, USP meets USP Dissolution Test 2.
1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. Approved Standard - 9 th ed. CLSI Document M7-A9, CLSI, 950 West Valley Rd., Suite 2500, Wayne, PA, 2012. 2. CLSI. Performance Standards for Antimicrobial Susceptibility Testing; 22 nd Informational Supplement. CLSI Document M100 - S22, 2012. 3. CLSI Performance Standards for Antimicrobial Disk Susceptibility Tests. Approved Standard - 11 th ed. CLSI M2-A11, 2012. 4. CLSI. Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - 2 nd ed. CLSI Document M45-A2, 2010.
Advise the patient to read the FDA-Approved Medication Guide ( 17.6 )