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Quality Standard: | USP, Bp |
Package: | 10 Tablets |
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Generic Name | Moxifloxacin Hydrochloride Tablets 400mg |
Strength | 400mg |
Packing | 10 tablets/box |
Origin | China |
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Product name:
Moxifloxacin Hydrochloride Tablets 400mg
Character:
This product is dark red film coating.
Indications:
Moxifloxacin hydrochloride tablets, indicated Moxifloxacin tablets are indicated for the treatment of adults (≥18 years of age) with upper and lower respiratory tract infections, such as acute sinusitis, acute episodes of chronic bronchitis, community-acquired pneumonia, and skin and soft tissue infections.
Adverse reactions:
In the subgroup of patients receiving oral or intravenous sequential therapy, the following adverse events occurred more frequently:
Common: increased gamma glutamylamine transpeptidase
Rare: ventricular tachycardia, hypotension, edema, antibiotic-induced colitis (rarely with fatal complications), seizures of all clinical manifestations (including grand mal seizures), hallucinations, kidney damage, and renal failure (due to dehydration, especially in older patients with kidney disease).
Pharmacology and toxicology:
(1) Mechanism of action
Moxifloxacin is an 8-methoxy-fluoroquinolone antibiotic with broad spectrum action and antibacterial activity. Moxifloxacin has been shown to have broad spectrum antibacterial activity in vitro against gram-positive bacteria, gram-negative bacteria, anaerobic bacteria, acid-fast bacteria, and atypical microorganisms such as mycoplasma, chlamydia, and Legionella.
The mechanism of antibacterial action was interference with topoisomerase. Topoisomerase is a key enzyme that controls DNA topology and plays a key role in DNA replication, repair and transcription.
The bactericidal curve showed that moxifloxacin had concentration dependent bactericidal activity. The minimum bactericidal concentration and the minimum bactericidal concentration are basically the same.
Moxifloxacin is also effective against beta-lactam antibiotics and macrolide resistant bacteria. The high activity of moxifloxacin in vivo was confirmed by experimental animal models of infection.
(2) Drug resistance
The resistance mechanism leading to resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracycline did not affect the antibacterial activity of moxifloxacin. There is no cross-resistance between moxifloxacin and these antimicrobials. So far, no plasmid-mediated drug resistance has been found.
The 8-methoxyl part of moxifloxacin has high activity and low selectivity for resistant mutations in gram-positive bacteria compared to the 8-hydrogen part. The large 7-position diazocyclic substituents can prevent the activity efflux, which is the mechanism of fluoroquinolone resistance. In vitro studies have shown that resistance to moxifloxacin slowly emerges after a multi-step mutation. Overall, the drug resistance rate is very low (10−7 −10 −10). Sequentially exposing bacteria to MIC concentrations below moxifloxacin only resulted in a small increase in MIC values. Cross-resistance exists between other quinolones. However, some gram-positive and anaerobic bacteria that are resistant to other quinolones are sensitive to moxifloxacin.
(3) Effect on human intestinal flora
In a study of two volunteers taking moxifloxacin, the following changes were observed: reduction of E. coli, Bacillus, Bacteroides common, Enterococcus, Klebsiella and anaerobic bacteria such as bifidobacterium, eubacillus and peptostreptococcus, these changes returned to normal within two weeks, and no clostridium difficile toxins were found.
2. Toxicology
Like other quinolones, moxifloxacin targets the blood system (decreased bone marrow cells in dogs and monkeys), the central nervous system (convulsions in monkeys), and the liver (elevated liver enzymes and single-cell necrosis in rats, dogs, and monkeys), all of which occur after high doses or long-term use of moxifloxacin.
In local tolerance studies in dogs, there were no signs of local intolerance after intravenous moxifloxacin administration. Inflammatory changes in the periarterial soft tissue were observed after intra arterial injection, suggesting that intra arterial injection of moxifloxacin should be avoided.
Storage:
Dark, sealed storage below 25ºC, moxifloxacin hydrochloride tablets should be stored in the manufacturer's original packaging.
Keep medicines out of reach of children.