- Approval Id
- a9a3333f8621b6cf
- Drug Name
- LEVORES SOLUTION FOR INFUSION 5MG/ML
- Product Name
- LEVORES SOLUTION FOR INFUSION 5MG/ML
- Approval Number
- SIN16966P
- Approval Date
- 2024-03-04
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INFUSION, SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
LEVORES should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitioneal, or subcutaneous administration.</p>
<p><strong>CAUTION: RAPID OR BOLUS INTRAVENOUS INFUSION MUST BE AVOIDED.</strong> Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. (See <strong>PRECAUTIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.)<br>
The usual dose of LEVORES is 250 mg or 500 mg administered orally or by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance >80 mL/min). For patients with altered renal function see the <strong>Patients with Impaired Renal Function</strong> subsection.</p>
<p><strong>Patients with Normal Renal Function</strong></p>
<table class="borderless-100">
<tbody>
<tr>
<td>Infection*</td>
<td>Unit Dose</td>
<td>Freq.</td>
<td>Duration**</td>
<td>Daily Dose</td>
</tr>
<tr>
<td>Acute Bacterial Exacerbation of Chronic Bronchitis</td>
<td>500 mg</td>
<td>q24h</td>
<td>7 days</td>
<td>500 mg</td>
</tr>
<tr>
<td>Community-Acquired Pneumonia</td>
<td>500 mg</td>
<td>q24h</td>
<td>7–14 days</td>
<td>500 mg</td>
</tr>
<tr>
<td>Nosocomial Pneumonia</td>
<td>750 mg</td>
<td>q24h</td>
<td>7–14 days</td>
<td>750 mg</td>
</tr>
<tr>
<td>Acute Bacterial Sinusitis</td>
<td>500 mg</td>
<td>q24h</td>
<td>10–14 days</td>
<td>500 mg</td>
</tr>
<tr>
<td>Complicated SSSI</td>
<td>750 mg</td>
<td>q24h</td>
<td>7–14 days</td>
<td>750 mg</td>
</tr>
<tr>
<td>Uncomplicated SSSI</td>
<td>500 mg</td>
<td>q24h</td>
<td>7–10 days</td>
<td>500 mg</td>
</tr>
<tr>
<td>Complicated UTI</td>
<td>250 mg</td>
<td>q24h</td>
<td>10 days</td>
<td>250 mg</td>
</tr>
<tr>
<td>Acute pyelonephritis</td>
<td>250 mg</td>
<td>q24h</td>
<td>10 days</td>
<td>250 mg</td>
</tr>
<tr>
<td>Uncomplicated UTI</td>
<td>250 mg</td>
<td>q24h</td>
<td>3 days</td>
<td>250 mg</td>
</tr>
<tr>
<td>Chronic Bacterial Prostatitis</td>
<td>500 mg</td>
<td>q24h</td>
<td>28 days</td>
<td>500 mg</td>
</tr>
</tbody>
</table>
<p><strong>* DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE)</strong><br>
** Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.</p>
<p><strong>Patients with Impaired Renal Function</strong></p>
<img src="/TGIF/Levores-Table1.png" alt="Levores Dosage Table 1" /><br><br>
<p>When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.</p>
<img src="/TGIF/Levores-Formula1.png" alt="Levores Dosage Formula 1" /><br><br>
<p>The serum creatinine should represent a steady state of renal function.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong><br>
LEVORES are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below. LEVORES is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Please see <strong>DOSAGE AND ADMINISTRATION</strong> for specific recommendations.<br>
<strong>Acute bacterial sinusitis</strong> due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.<br>
<strong>Acute bacterial exacerbation of chronic bronchitis</strong> due to <em>Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis</em>.<br>
<strong>Community-acquired pneumonia</strong> due to <em>Staphylococcus aureus, Streptococcus pneumoniae</em> (including penicillin - resistant strains, MIC value for penicillin ≥ 2 mcg/mL), <em>Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae</em> (See <strong>CLINICAL STUDIES</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
<strong>Nosocomial pneumonia</strong> due to methicillin-susceptible <em>Staphylococcus aureus, Pseudomonas aeruginosa, Seratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae</em>, or <em>Streptococcus pneumoniae</em>. Adjunctive therapy should be used as clinically indicated. Where <em>Pseudomonas aeruginosa</em> is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal ß-lactam is recommended.<br>
<strong>Complicated skin and skin structure infections</strong> due to methicillin - sensitive <em>Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes</em>, or <em>Proteus mirabilis.</em><br>
<strong>Uncomplicated skin and skin structure infections</strong> (mild to moderate) including abscesses, cellulitis, furuncles, impertigo, pyoderma, wound infections due to <em>Staphylococcus aureus</em>, or <em>Streptococcus pyogenes</em>.<br>
<strong>Complicated urinary tract infections</strong> (mild to moderate) due to <em>Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis</em>, or <em>Pseudomonas aeruginosa</em>.<br>
<strong>Acute pyelonephritis</strong> (mild to moderate) caused by <em>Escherichia coli</em>.<br>
<strong>Uncomplicated urinary tract infections</strong> (mild to moderate) due to <em>Escherichia coli, Klebsiella pneumoniae</em>, or <em>Staphylococcus saprophyticus</em>.<br>
<strong>Chronic bacterial prostatitis</strong> due to <em>Escherichia coli, Enterococcus faecalis</em>, or methicillin - susceptible <em>Staphylococcus epidermidis</em>.<br>
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.<br>
As with other drugs in this class, some strains of <em>Pseudomonas aeruginosa</em> may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.</p>
- Atc Code
- J01MA12
- Atc Item Name
- levofloxacin
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
