Indications:
To minimize the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Hydrochloride and other antibacterial drugs, Moxifloxacin Hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Bacterial culture and susceptibility tests should be performed before treatment to isolate and identify causative organisms and determine their susceptibility to Moxifloxacin Hydrochloride.

Therapy with Moxifloxacin Hydrochloride may be initiated before obtaining these test results; once results become available, appropriate therapy should be selected.

Moxifloxacin Hydrochloride Tablets are indicated for the treatment of adults (≥ 18 years) with infections caused by susceptible strains of the designated microorganisms in the following conditions:

1. Acute Bacterial Sinusitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Due to serious adverse reactions associated with fluoroquinolones (including Moxifloxacin Hydrochloride), and because acute bacterial sinusitis may be self-limiting, Moxifloxacin Hydrochloride should be used only when no alternative treatment options are available.

2. Acute Exacerbation of Chronic Bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.
Due to serious adverse reactions associated with fluoroquinolones (including Moxifloxacin Hydrochloride), and because acute exacerbation of chronic bronchitis may be self-limiting, Moxifloxacin Hydrochloride should be used only when no alternative treatment options are available.

3. Community-Acquired Pneumonia: Caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae.

4. Uncomplicated Skin and Skin Structure Infections: Caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.

5. Complicated Skin and Skin Structure Infections: Caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.

6. Complicated Intra-Abdominal Infections: Caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus spp., Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus spp., including intra-abdominal abscesses.

7. Plague: Including pneumonic and septicemic plague in adults caused by Yersinia pestis (Y. pestis), and for plague prophylaxis.
As human efficacy studies are not feasible for ethical and feasibility reasons, this indication is based solely on efficacy studies in animals.

8. Mild to Moderate Pelvic Inflammatory Disease (PID) without tubo-ovarian or pelvic abscess (i.e., infections of the female upper genital tract, including salpingitis and endometritis).
Due to increasing resistance of Neisseria gonorrhoeae to moxifloxacin, this product should not be used as monotherapy for mild to moderate PID but should be combined with another appropriate antibacterial agent (e.g., a cephalosporin), unless moxifloxacin-resistant Neisseria gonorrhoeae has been excluded.

Strength:400mg

National Drug Approval Number:H20183246