HUAPONT PHARM.
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Moxifloxacin Hydrochloride Tablets
Category：
English Name：
Moxifloxacin Hydrochloride Tablets
Strength:
0.4g（Calculated on C21H24FN3O4）
Package：
Aluminum-plastic blister coated in Aluminum-plastic bag. 6 tablets/plate/box, 6tablets/plate× 2 plates/box
Approval Number：
H20193406
Detail
Indications:
Reference Listed Drug during bioequivalence study of this medication is AVELOX® by Bayer.
This medication is indicated for the treatment of adults (≥18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae.
Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.
Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.
Complicated Intra-Abdominal Infections caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.
Plague
Moxifloxacin Tablets are indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague caused by Yersinia pestis, and prophylaxis of plague in adult patients. Efficacy studies of moxifloxacin could not be conducted in humans with plague for feasibility reasons. Therefore, this indication is determined based on an efficacy study conducted in animals.
Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Because fluoroquinolones, including Moxifloxacin Tablets, have been associated with serious adverse reactions and for some patients ABS is self-limiting, reserve Moxifloxacin Tablets for treatment of ABS in patients who have no alternative treatment options.
Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.
Because fluoroquinolones, including Moxifloxacin Tablets, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve Moxifloxacin Tablets for treatment of ABECB in patients who have no alternative treatment options.
Mild-to-Moderate Pelvic Inflammatory Disease Without a Tubo-Ovarian Abscess or Pelvic Abscess (Upper genital tract infections, including salpingitis and endometritis) Due to the increased resistance of Neisseria gonorrhoeae to moxifloxacin, this product is not recommended as monotherapy for the treatment of mild to moderate pelvic inflammatory disease.
Instead, it should be combined with another appropriate antibacterial (e.g., cephalosporin) unless moxifloxin-resistant Neisseria gonorrhoeae can be excluded.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Tablets and other antibacterial drugs, Moxifloxacin Tablets should be used only to treat or prevent 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.
Other information such as dosage, contraindications, and adverse reactions is detailed in the instructions.
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