- Approval Id
- bcbc61de91e921ad
- Drug Name
- MOXIFCIN FILM COATED TABLET 400MG
- Product Name
- MOXIFCIN FILM COATED TABLET 400MG
- Approval Number
- SIN17209P
- Approval Date
- 2025-03-18
- Registrant
- YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
- Licence Holder
- YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Recommended Dose:</strong><br>
Dose (adults):<br>
The recommended dose for Moxifloxacin is 400 mg once daily (1 film coated tablet) for the above mentioned indications and should not be exceeded.</p>
<p>For complicated skin and skin structure infections, therapy should usually be initiated with intravenous formulation. When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with intravenous moxifloxacin may be switched to Moxifloxacin Tablets when clinically indicated at the discretion of the physician.</p>
<p>Duration of treatment:</p>
<p>The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations are made:</p>
<p>Acute exacerbation of chronic bronchitis: 5 days<br>
Acute sinusitis: 7 days<br>
Uncomplicated skin and skin structure infections: 7 days<br>
Community acquired pneumonia (mild to moderate in severity): 10 days<br>
Community acquired pneumonia: total recommended duration for sequential administration (intravenous followed by oral therapy) is 7–14 days<br>
Complicated skin and skin structure infections: total treatment duration for sequential therapy (intravenous followed by oral therapy) is 7–21 days<br>
Mild to moderate pelvic inflammatory disease: 14 days</p>
<p>The recommended duration of treatment for the indication being treated should not be exceeded. Moxifloxacin 400 mg film-coated tablets and Moxifloxacin 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).<br>
If a dose is missed, it should be taken anytime but not later than 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.</p>
<p><em>Children and adolescents:</em> Efficacy and safety of Moxifloxacin in children and adolescents have not been established (see “Contraindications”).</p>
<p><em>Geriatric patients:</em> No adjustment of dosage is required in elderly.</p>
<p><em>Ethnic differences:</em> No adjustment of dosage is required in ethnic groups.</p>
<p><em>Patients with hepatic impairment:</em> No dosage adjustment is required in patients with mild or moderate impaired liver function. The use of Moxifloxacin is not recommended in patients with severe hepatic impairment (Child Pugh C) (see “Warnings and Precautions” in Child Pugh C patients – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Patients with renal impairment:</em> No dose adjustment is required in patients with any degree of renal impairment (including creatinine clearance < 30 mL/min/1.73m<sup>2</sup>) and in patients on chronic dialysis i.e. hemodialysis and continuous ambulatory peritoneal dialysis.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indication:</strong><br>
Moxifcin Film Coated Tablet 400mg is indicated for the treatment of the following bacterial infections caused by susceptible strains:</p>
<ul>
<li>Respiratory tract infection:
<ul class="dash">
<li>Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.</li>
<li>Acute Bacterial Exacerbation of Chronic Bronchitis caused by <em>Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis</em>.</li>
<li>Community Acquired Pneumonia (of mild to moderate severity) caused by <em>Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Moraxella catarrhalis</em>.</li></ul></li>
<li>Uncomplicated skin and skin structure infections caused by <em>Staphylococcus aureus</em> or <em>Streptococcus pyogenes</em>.</li>
<li>Complicated skin and skin structure infections caused by methicillin-susceptible <em>Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobactercioacae</em>.</li>
<li>Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.</li>
</ul>
<p>Moxifcin Film Coated Tablet 400mg is not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (eg. a cephalosporin) due to increasing Moxifloxacin resistance of Neisseria gonorrhoeae.<br>
Moxifcin Film Coated Tablet 400mg is indicated for the treatment of the above infections if they are caused by bacteria susceptible to Moxifloxacin.</p>
- Contraindications
- <p><strong>Contraindication:</strong></p>
<ul>
<li>Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.</li>
<li>Pregnancy and lactation.</li>
<li>Patients below 18 years of age.</li>
<li>Patients with a history of tendon disease/disorder related to quinolone treatment.</li>
</ul>
<p>Changes in cardiac electrophysiology have been observed following exposure to Moxifloxacin, in the form of QT prolongation. For reasons of drug safety, Moxifloxacin is therefore contraindicated in patients with:</p>
<ul class="dash">
<li>Congenital or documented acquired QT prolongation</li>
<li>Electrolyte disturbances, particularly in uncorrected hypokalaemia</li>
<li>Clinically relevant bradycardia</li>
<li>Clinically relevant heart failure with reduced left-ventricular ejection fraction</li>
<li>Previous history of symptomatic arrhythmias</li>
</ul>
<p>Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also “Interactions with Other Medicines and Other Forms of Interaction” – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
Moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5 fold ULN.</p>
- Atc Code
- J01MA14
- Pharma Manufacturer Name
- YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
