Levofloxacin 25 mg/mL
Levofloxacin · SOLUTION · ANI Pharmaceuticals, Inc.
Levofloxacin is a fluoroquinolone antibiotic used to treat bacterial infections including pneumonia, bronchitis, and urinary tract infections. This oral solution form allows for flexible dosing and may be easier to take than tablets for some patients.
Key Facts
- Brand Name
- Levofloxacin
- Generic Name
- Levofloxacin
- NDC Code (Product)
70954-852- Manufacturer
- ANI Pharmaceuticals, Inc.
- Strength
- 25 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091678
- Drug Class
- Fluoroquinolone Antibacterial [EPC]
- Marketing Start
- 03/26/2024
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
AuroMedics Pharma LLC
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Akorn, Inc.
CGMP Deviations:
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Actavis Inc
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
AuroMedics Pharma LLC
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE 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 Bacterial Sinusitis (1.14) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15). 1.1 Nosocomial Pneumonia Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseu…
Dosage & Administration
2 DOSAGE & ADMINISTRATION • Administer Levofloxacin Tablets to pediatric patients weighing 30 kg and greater only (2.1, 2.2). • 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 (2.2). Dosage in Adult and Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute (2.1. 2.2) Type of Infection Dose Every 24 hours Duration (days) Nosocomial Pneumonia (1.1) 750 mg 7 to 14 Community Acquired Pneumonia (1.2) 500 mg 7 to 14 Community Acquired Pneumonia (1.3) 750 mg 5 Complicated SSSI (1.4) 750 mg 7 to 14 Uncomplicated SSSI (1.5) 500 mg 7 to 10 Chronic Bacterial Prostatitis (1.6) 500 mg 28 Inhalational Anthrax (Post-Exposure) (1.7) Adults and Pediatric Patients 50 kg or greater Pediatric Patients 30 kg to less than 50 kg (2.2) 500 mg 250 mg every 12 hours 60 60 Plague (1.8) Adults and Pediatric Patients 50 kg or greater Pediatric Patients 30 kg to less than 50 kg (2.2) 500 mg 250 mg every 12 hours 10 to 14 10 to 14 Complicated UTI (1.9) or Acute Pyelonephritis (1.1…
Contraindications
4 CONTRAINDICATIONS Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )]. Known hypersensitivity to levofloxacin or other quinolones ( 4 , 5.7 )
Drug Interactions
7 DRUG INTERACTIONS 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 multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. Tablets with antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine may substantially interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. These agent…
Adverse Reactions
6 ADVERSE REACTIONS 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 Effects [see Warnings and Precautions ( 5.4)] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5)] • Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions ( 5.6)] • Hypersensitivity Reactions [see Warnings and Precautions (5.7)] • Hepatotoxicity [see Warnings and Precautions ( 5.8)] • Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9 )] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ( 5.10 …
Frequently Asked Questions
What is Levofloxacin used for?
Levofloxacin is a fluoroquinolone antibiotic used to treat bacterial infections including pneumonia, bronchitis, and urinary tract infections. This oral solution form allows for flexible dosing and may be easier to take than tablets for some patients.
Is Levofloxacin a controlled substance?
Levofloxacin is not classified as a controlled substance by the DEA.
What is the generic name for Levofloxacin?
The generic name for Levofloxacin is Levofloxacin. There are 2 other brand versions of Levofloxacin.
What is the NDC code for Levofloxacin 25 mg/mL?
The NDC (National Drug Code) for Levofloxacin 25 mg/mL is 70954-852, listed by ANI Pharmaceuticals, Inc..
Other Levofloxacin Dosages
- Levofloxacin500 mg/180425-0008
- Levofloxacin250 mg/10904-6351
- Levofloxacin750 mg/131722-723
- Levofloxacin750 mg/143063-459
- Levofloxacin250 mg/150090-3245
- Levofloxacin250 mg/151655-947
- Levofloxacin250 mg/155111-279
- Levofloxacin750 mg/30mL55150-157
- Levofloxacin500 mg/100mL55150-244
- Levofloxacin750 mg/150mL55150-245
Other Levofloxacin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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