What Is Moxifloxacin Hydrochloride?

Moxifloxacin hydrochloride tablets, the indication is moxifloxacin tablets, for the treatment of adults with upper and lower respiratory infections (18 years of age), such as: acute sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia , And skin and soft tissue infections.

Drug Name: Moxifloxacin Hydrochloride Tablets

Drug type: Prescription medicines, essential medicines, medicines for medical workers' injuries
Use classification: Synthetic antibacterials

Ingredients of Moxifloxacin Hydrochloride

Main ingredients: Moxifloxacin Chemical name: 1-cyclopropyl-7-{(S, S) -2,8-diazo-bicyclo [4.3.0] non-8-yl} -6-fluoro-8 -Methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride.
Chemical Structure:

Molecular formula: C ₂₁ H ₂₄ FN ₃ O ₄ · HCl
Molecular weight: 437.9

Characteristics of Moxifloxacin Hydrochloride Tablets

This product is a dark red film-coated tablet.

Specifications of Moxifloxacin Hydrochloride Tablets

0.4g

Dosage and Administration of Moxifloxacin Hydrochloride Tablets

Dosage range < br For any indication, oral moxifloxacin tablets 0.4 g (1 tablet) is recommended once a day.
How to take for adults < br The tablets are taken with water, and the time of taking is not affected by diet.
Duration of treatment < br The duration of treatment should be determined based on the severity of symptoms or clinical response. To treat upper and lower respiratory tract infections, follow these methods:
Acute exacerbation of chronic bronchitis: 5 days of community-acquired pneumonia: 10 days of acute sinusitis: 7 days The recommended treatment time for skin and soft tissue infections is 7 days.
Moxifloxacin 0.4g tablets have been used in clinical trials for up to 14 days.
Seniors < br The elderly do not need to adjust the dosage.
Children The efficacy and safety of temoxifloxacin in children and adolescents has not been determined.
Liver Injury < br Patients with liver damage do not need to adjust the dose of moxifloxacin (for patients with severely impaired liver function, see contraindications for Child-Pugh C).
Renal dysfunction < br Patients with any degree of impaired renal function (including creatinine clearance 30ml / min / 1.73m ² ) and chronic dialysis, such as patients with hemodialysis and continuous peritoneal dialysis, do not need to adjust moxifloxacin Star dose.
Inter-ethnic differences < br There is no need to adjust drug doses between different ethnic groups.

Adverse reactions of moxifloxacin hydrochloride tablets

Adverse reactions (ADRs) of this product are based on all clinical studies of 0.4g moxifloxacin (oral and sequential therapy), and are classified according to the frequency of CIOMSIII, (total n = 17951, including sequential therapy n = 4583, time: 2010 May) is organized as follows:
The incidence of adverse reactions (ADRs) listed under "Common", except for nausea and diarrhea, is below 3%.
Adverse reactions (ADRs) from post-market reports (time: May 2010) are printed in italics.
Within each frequency group, adverse reactions are listed in order of decreasing severity. The definition of frequency is:
Common (1 / 100 to <1/10),
Rare (1 / 1000 to <1/100),
Rare (1 / 10000 to <1/1000),
Very rare (<1/10000).

In the subgroup of patients receiving oral or intravenous sequential treatment, the following adverse reactions occurred more frequently:
Common: Increased gamma glutamyl transpeptidase Rare: ventricular tachycardia, hypotension, edema, colitis caused by antibiotics (rarely with fatal complications), seizures of various clinical manifestations (including epilepsy) Major seizures), hallucinations, kidney damage and renal failure (due to dehydration, especially in elderly patients who have already had kidney disease).

Moxifloxacin hydrochloride taboo

People who are allergic to any component of moxifloxacin, or other quinolones, or any excipient.
Pregnant and lactating women.
Due to lack of clinical data on the use of moxifloxacin in patients with severe liver impairment (Child Pugh Class C) and in patients with elevated aminotransferases greater than 5 times the upper limit of normal, the drug is contraindicated in this group of patients.
Patients under 18 years of age.

Precautions for Moxifloxacin Hydrochloride Tablets

If some patients develop hypersensitivity and allergies after the first dose, the doctor should be informed immediately.
Very few patients experience life-threatening shock from an allergic reaction after the first dose. In these cases, Baifule should be discontinued and treated accordingly (such as treatment for shock).
Moxifloxacin can extend the QT interval of ECG in some patients. Compared with men, because female patients tend to have longer QTc intervals, they may be more sensitive to drugs that cause prolonged QTc intervals. Elderly patients are also more susceptible to drugs related to the QT interval. Because the extent of QT interval prolongation may increase with increasing drug concentration. Therefore, the recommended dose and infusion rate should not be exceeded (0.4 g in 90 minutes). However, no correlation was observed between the blood concentration of Baifule and the prolongation of the QTc interval in patients with pneumonia. Prolonged QT interval can lead to increased risk of ventricular arrhythmias including apical torsional ventricular tachycardia. In clinical studies of more than 9,000 patients treated by Baifule, there was no cardiovascular morbidity or mortality due to prolonged QTc interval, but certain potential conditions can increase the risk of ventricular arrhythmias.
[u] Because of the lack of clinical experience of Baifule for the following patient populations, the use of this drug in these populations should be avoided [/ u]:
Patients with known QT interval prolongation;
· Uncorrectable hypokalemia patients;
Patients receiving class IA (eg quinidine, procainamide) or class III (eg amiodarone, sotalol) antiarrhythmic drugs.
[u] Because it is not possible to exclude the cumulative effect of Baifule on the QT interval in the following cases, you should use moxifloxacin with caution in the following cases [/ u]:
The patient received concomitant treatment with drugs that prolong the QT interval, such as cisapride, erythromycin, antipsychotics and tricyclic antidepressants;
Patients currently have conditions that can cause arrhythmias, such as clinically significant bradycardia and acute myocardial ischemia;
Patients with cirrhosis, in whom the previous QT interval cannot be ruled out;
Female and elderly patients who may be more sensitive to drugs that cause prolongation of the QTc interval.
It has been reported that Baifule can cause fulminant hepatitis and may cause liver failure (including death cases) (see [ Adverse Reactions ]). If symptoms related to liver failure occur, the patient should be advised to contact a doctor immediately before continuing treatment.
The use of quinolone can induce seizures. For patients with central nervous system disease that is known or suspected to cause seizures or lower the threshold of seizures, pay attention when using Baifule.
Antibiotic-associated enteritis has been reported with the use of broad-spectrum antibiotics including Baifule, so it is important to consider this diagnosis if patients develop severe diarrhea during the use of Baifule. In this case, adequate treatment measures should be taken immediately. In patients with severe diarrhea, the use of drugs that inhibit gastrointestinal motility is contraindicated.
It should be used with caution in patients with myasthenia gravis, as it can aggravate symptoms.
Tendonitis and tendon rupture may occur in the use of quinolones including moxifloxacin, especially in elderly patients and patients treated with corticosteroids; there have been reported cases that occurred months after the treatment was completed. Once symptoms of pain or inflammation occur, patients need to stop taking the medication and rest the affected limb.
It has been shown that quinolone drugs can cause photosensitivity in patients. However, in specially designed pre-clinical and clinical studies, no photosensitivity response was observed in Baifule. In addition, there has been no clinical evidence since the listing that Baifule caused photosensitivity. Nevertheless, patients should be advised to avoid excessive exposure to UV and sunlight.
For patients with complicated pelvic infection (such as with tubal-ovarian or pelvic abscess) treatment, intravenous administration should be considered instead of oral 0.4g Baifule tablets.
Moxifloxacin is not recommended for the treatment of MRSA infections. If MRSA infection is suspected or determined, appropriate antibiotics should be used to begin treatment.
Moxifloxacin's in vitro activity may interfere with mycobacterial culture tests by inhibiting the growth of mycobacteria, so sample results may be false negative for patients who are using byfarox.
There have been reports of polyneuropathy that led to paresthesias, hypoesthesia, dullness or weakness in sensations or sensorimotor movements in patients receiving voronone medications, including Falox. If the patient develops neurological symptoms such as pain, burning, tingling, numbness or weakness while receiving Baifule treatment, it is recommended to notify the doctor before continuing with Baifule treatment (see [ Adverse Reactions ]).
Psychiatric reactions, including moxifloxacin, can occur even after the first use of fluoxanone. Depression or psychotic reactions that develop suicidal ideation and self-harm behaviors, such as attempts to commit suicide, are seen in rare cases (see [ Adverse Reactions ]). If the patient has the above reaction, the use of Baifule should be stopped and appropriate disease treatment should be performed. Caution is advised when using Baile in patients with mental illness or with a history of mental illness.
Because Neisseria gonorrhoeae resistant to fluoroquinolone is widespread and its prevalence is increasing, patients with pelvic infectious diseases should avoid monotherapy with moxifloxacin unless it can be ruled out as resistant to fluoroquinolone. Neisseria gonorrhoeae. If a Neisseria gonorrhoeae infection that is resistant to fluoretonone cannot be ruled out, consideration should be given to adding an antibiotic (such as a cephalosporin) against Neisseria gonorrhoeae to empirical treatment with moxifloxacin.
Due to central nervous system (CNS) reactions and vision abnormalities, fluorinone drugs including moxifloxacin may impair a patient's ability to drive or operate machinery (see [ Adverse Reactions ]).

Moxifloxacin hydrochloride tablets for pregnant and lactating women

Pregnant women: The safety of human use of moxifloxacin during pregnancy has not been proven. Children taking quinolone can cause reversible joint damage. However, this effect has not been reported in the fetus of pregnant users. Animal studies have shown reproductive toxicity of moxifloxacin, but the potential danger to humans is unknown. Therefore, moxifloxacin is contraindicated in women during pregnancy.
Lactating women: Like other quinolone drugs, moxifloxacin can cause cartilage damage in weight-bearing joints in juvenile experimental animals. Preclinical studies have confirmed that small amounts of moxifloxacin can be distributed into human milk, and data for lactating women are lacking. Therefore, moxifloxacin is contraindicated in lactating women.

Moxifloxacin hydrochloride tablets for children

The efficacy and safety of moxifloxacin in children and adolescents has not been determined.

Moxifloxacin hydrochloride tablets for elderly

Elderly patients do not need to adjust the dosage.

Moxifloxacin Hydrochloride Tablets Drug Interactions

Moxifloxacin has not been clinically proven to interact with atenolol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine Probenecid. No dose adjustment is required for these drugs.
Antacids, minerals, and multivitamins: Moxifloxacin taken with antacids, minerals, and multivitamins at the same time will reduce the absorption of the drug by forming a multivalent chelate with the polyvalent cations in these substances. This will result in lower than expected levels of drug in the plasma, so antacids, antiretrovirals (such as didanosine), other preparations containing magnesium or aluminum, sucralfate, and iron or zinc containing Minerals need to be taken at least 4 hours before or 2 hours after oral moxifloxacin.
Ranitidine: Combination with ranitidine does not change the absorption parameters of moxifloxacin. A comparison of absorption parameters (Cmax, tmax, AUC) indicates that gastric pH has no effect on the absorption of moxifloxacin from the gastrointestinal tract.
Calcium supplements: When taking high-dose calcium supplements, the absorption rate is only slightly reduced without affecting the extent of absorption. It can be considered that the effect of high-dose calcium supplements on moxifloxacin has no clinical relevance.
Theophylline: Consistent with human in vitro research data, moxifloxacin has no effect on the pharmacokinetics of theophylline at steady state, suggesting that moxifloxacin has no effect on the 1A2 isoform of P450 enzymes.
Warfarin: It has been observed that co-administration of moxifloxacin with warfarin has not been found to affect pharmacokinetics, prothrombin time, and other coagulation parameters.
Changes in International Normalized Ratio (INR): It has been reported that patients taking anticoagulants and antibiotics including moxifloxacin have increased anticoagulant activity. Its risk factors include the patient's infection (and its inflammatory process), age, and general condition. Although the interaction of moxifloxacin and warfarin has not been demonstrated in clinical trials, INR should be monitored and the oral anticoagulant dose adjusted accordingly if necessary.
Oral contraceptives: Moxifloxacin was taken concurrently with oral contraceptives and no interaction was found.
Antidiabetic drugs: Glibenclamide and moxifloxacin have not been found to have clinically significant interactions.
Itraconazole: Itraconazole exposure (AUC) changed only slightly when co-administered moxifloxacin with itraconazole. Itraconazole had no significant effect on the pharmacokinetics of moxifloxacin. Concomitant administration of moxifloxacin when taking itraconazole does not require dose adjustments and vice versa.
Morphine: Parenteral administration of morphine with moxifloxacin does not reduce the bioavailability of oral moxifloxacin, and Cmax (17%) decreases only slightly.
Atenolol: Moxifloxacin has no significant effect on the pharmacokinetics of atenolol. When a single dose was given to healthy subjects, the area under the curve (AUC) at the time of the drug increased (about 4%) and the peak concentration decreased by 10%.
Probenecid: In a clinical study to observe the effects of probenecid on renal excretory function, probenecid did not find a significant effect on systemic clearance and renal clearance of moxifloxacin.
Digoxin: Moxifloxacin has no serious effect on the pharmacokinetics of digoxin and vice versa. After multiple doses of healthy subjects reached steady state, moxifloxacin increased the steady state Cmax of digoxin by about 30% without affecting AUC and trough levels.
Charcoal: At the same time, oral charcoal and 0.4g of moxifloxacin can prevent 80% of drug absorption in the body, thereby reducing the systemic use of the drug. When the drug is overdose, the application of activated carbon early in the absorption can prevent further systemic exposure of the drug. After intravenous administration, activated charcoal only slightly reduced the systemic exposure of the drug (approximately 20%).
Food and dairy products: Ingestion of food (including dairy products) does not affect the absorption of moxifloxacin. Therefore, the time of taking moxifloxacin is not affected by eating.

Moxifloxacin hydrochloride tablets overdose

The research data on overdose is very limited. The single maximum dose of 1.2g and 0.6g per day are taken orally several times. No clear adverse reaction was found in healthy volunteers for 10 consecutive days. Once overdose of moxifloxacin, appropriate support measures such as ECG should be taken according to the patient's condition.
Early in the absorption phase of moxifloxacin, oral administration of activated carbon can effectively prevent excessive increases in moxifloxacin system exposure. Intravenous administration of activated charcoal only slightly reduced systemic exposure (about 20%) of moxifloxacin and had limited effect on intravenous overdose.

Pharmacology and Toxicology of Moxifloxacin Hydrochloride Tablets

1. Pharmacological action (1) Mechanism of action Moxifloxacin is an 8-methoxyfluoroquinolone antibacterial agent with a broad spectrum of action and antibacterial activity. Moxifloxacin has shown broad-spectrum antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, anaerobic bacteria, acid-fast bacteria, and atypical microorganisms such as Mycoplasma, Chlamydia, and Legionella in vitro.
The mechanism of antibacterial action is interference topoisomerase II and IV. Topoisomerases are enzymes that control DNA topology and are critical in DNA replication, repair, and transcription.
The bactericidal curve shows that moxifloxacin has a concentration-dependent bactericidal activity. The minimum bactericidal concentration and the minimum bacteriostatic concentration were basically the same.
Moxifloxacin is also effective against -lactam antibiotics and macrolide-resistant bacteria. The experimental animal model of infection confirmed that moxifloxacin was highly active in vivo.
(2) The resistance mechanism of resistance to penicillin, cephalosporins, aminoglycosides, macrolides and tetracyclines does not affect the antibacterial activity of moxifloxacin. Moxifloxacin and these antimicrobials are not cross-resistant. To date, no emergence of plasmid-mediated resistance has been observed.
The 8-methoxy moiety of moxifloxacin has high activity against Gram-positive bacteria and low selectivity for drug-resistant mutations compared to the 8-hydrogen moiety. The large 7-position diazo heterocyclic substituent can prevent the active efflux, which is a fluoroquinolone resistance mechanism. In vitro tests show that multi-step mutations can slowly develop resistance to moxifloxacin. In short, the resistance rate is very low (10 ⁷ -10 ¹⁰ ). Sequential exposure of the bacteria to concentrations below the moxifloxacin MIC can only increase the MIC value slightly. Cross-resistance exists among other quinolones. However, some Gram-positive and anaerobic bacteria that are resistant to other quinolones are sensitive to moxifloxacin.
(3) Effects on the human intestinal flora The following changes were observed in two volunteers after taking moxifloxacin: E. coli, Bacillus, Bacteroides commonus, Enterococcus, Klebsiella, and anaerobic Reduction of bacteria such as Bifidobacterium, Eubacteria, and Digestive Streptococcus, these changes can return to normal within two weeks, no C. difficile toxin was found.
(4) Sensitive data in vitro

* / ** It has been shown to be effective against approved clinical indications caused by sensitive bacteria + Moxifloxacin is only within its sensitive range for methicillin-resistant staphylococci mediated by MecA gene. Therefore, if such strains are found, moxifloxacin is not recommended.

* / ** Has proven effective against approved clinical indications caused by sensitive bacteria

* / ** It has been shown to be effective against approved clinical indications caused by sensitive bacteria. The rate of acquired resistance to certain bacteria may vary with geography and time. Local resistance is possible, especially when treating severe infections. The above in vitro sensitivity test results can be used to guide the determination of whether the microorganism is sensitive to moxifloxacin.
Comparison of PK / PD between single-dose intravenous and oral administration of 0.4 g of moxifloxacin. AUC / MIC ₉₀ values greater than 125 and Cmax / MIC ₉₀ values of 8-10 for inpatients are expected clinically effective treatments. Parameter values for outpatients are usually low, with AUC / MIC ₉₀ greater than 30-40.
The following table compares the calculated values of PK / PD for single-dose intravenous and oral administration of 0.4 g of moxifloxacin:

1h infusion 2. Toxicology Moxifloxacin, like other quinolones, has toxic target organs that are the blood system (reduced bone marrow cells in dogs and monkeys), the central nervous system (convulsions in monkeys), and the liver (rats, dogs, and monkeys) Increased liver enzymes, single-cell necrosis), these changes occurred after high doses or long-term application of moxifloxacin.
In a study of local tolerance in dogs, no signs of local intolerance appeared after intravenous injection of moxifloxacin. After intra-arterial injection, inflammatory changes can be seen in the soft tissue around the artery, suggesting that intramuscular injection of moxifloxacin should be avoided.
Carcinogenic, mutagenic < br Although routine long-term studies on the carcinogenic effects of moxifloxacin have not yet been completed, the drug has undergone genotoxic in vivo and in vitro tests. In addition, accelerated tests (induction and promotion assays) of carcinogenesis in humans were performed in rats. Four of the five Ames tests were negative, and the HPRT mutation test of Chinese guinea pig ovary and the UDS test of rat primary liver cells were also negative. The Ames test of other quinolone TA102 was positive. In vitro tests showed that large doses (33mcg / ml) of other quinolone drugs could cause chromosomal abnormalities in V79 cells of Chinese guinea pigs. However, the nucleolus test in vivo in mice was negative. In addition, the in vivo assay was negative for the dominant lethality assay in mice. In summary, the results of the in vivo test fully reflect its genotoxicity in vivo. No evidence of carcinogenicity was found in induction and promotion assays in rats.
Phototoxicity Moxifloxacin is stable to light and has low potential phototoxicity. In vitro and animal tests have shown that moxifloxacin is less phototoxic than other quinolones. Mice were given oral quinolone drugs and irradiated with ultraviolet rays at the same time, showing that they can increase the photocarcinogenesis of ultraviolet rays. Studies on the photocarcinogenesis of moxifloxacin have not yet been performed, and it has been confirmed in volunteers' phase I trials that moxifloxacin is less phototoxic.
ECG < br High concentration of moxifloxacin can inhibit the delayed adjustment of potassium currents in the heart, thus leading to prolonged QT interval. Oral administration of moxifloxacin to dogs greater than 90 mg / kg for toxicological studies resulted in plasma concentrations greater than 16 mg / l, which caused QT intervals to prolong, but no arrhythmia was found. Only when the cumulative intravenous dose is higher than 50 times the human dose (> 0.3g / kg), can lead to a blood concentration of 0.2g / l (30 times higher than the intravenous therapeutic concentration), which can be seen as reversible Non-fatal ventricular arrhythmias.
Joint toxicity < br It is well known that quinolone can cause pathological changes of load-bearing articular cartilage in juvenile test animals. The minimum oral moxifloxacin that can cause joint toxicity in young dogs is four times the recommended maximum therapeutic dose (0.4 g / 50 kg of human body weight), and its blood concentration is 2-3 times the recommended plasma concentration.
Reproductive toxicity Reproductive studies in rats, rabbits and monkeys have shown that moxifloxacin can pass through the placenta. Tests on rats (os and iv) and monkeys (os) have shown no evidence of teratogenicity and effects on fertility after administration of moxifloxacin. Skeletal deformities were observed in rabbits given 20 mg / kg intravenously. The results of this study are consistent with the known effects of quinolone on bone development. Plasma drug concentrations were in the therapeutic concentration range, and the incidence of miscarriage in monkeys and rabbits increased. In rats, when the dose administered by the rat is 63 times the maximum recommended dosage in terms of kilogram body weight to make the blood concentration within the therapeutic dose range of humans, the weight of the young rats will decrease and the weight loss before birth will increase , Mildly prolong the pregnancy and increase the reproductive capacity of some female and male rats.

Pharmacokinetics of Moxifloxacin Hydrochloride Tablets

Absorption and bioavailability Moxifloxacin can be almost completely absorbed soon after oral administration. Absolute bioavailability totals approximately 91%.
The pharmacokinetics of a single dose of 50 to 1200 mg and 0.6 g daily for 10 days showed a linear relationship. A steady state was reached within 3 days. After oral administration of 0.4 g, the peak value was 3.1 mg / l in 0.5 to 4 hours. The peak and trough concentrations reached 0.4 mg / l and 0.6 mg / l, respectively, when they reached steady state after oral administration of 0.4 g once daily.
Giving moxifloxacin at the same time can slightly increase the peak time by about 2 hours and reduce the peak concentration by about 16%. The absorption range does not change. Since AUC / MIC mainly predicts the antibacterial effect of quinolone, this effect is not clinically related, therefore, the administration of moxifloxacin is not affected by eating.
A single dose of 0.4 g was administered intravenously. After 1 hour, the blood concentration reached a peak of approximately 4.1 mg / l, an average increase of 26% compared with oral administration. The area under the curve when the drug was exposed was approximately 39 mg * h / l, which was slightly higher than the oral (35 mg * h / l) with an absolute bioavailability of approximately 91%.
Multi-dose intravenous administration (1 hour infusion), the daily steady state peak-to-peak concentration of 0.4 g is 4.1 to 5.9 and 0.43 to 0.84 mg / l, respectively. The steady state drug exposure was approximately 30% higher than the first dose during the dosing interval. A steady-state concentration of 4.4 mg / l was observed after 1 hour of infusion.
Distribution < br Moxifloxacin can be quickly distributed to the extravascular space. The area under the curve (AUC) of the drug is high (6kg * h / l), and the apparent distribution volume Vss at the steady state is close to 2l / kg.
The concentration of drug in saliva is higher than that of blood. In vitro and in vivo tests in the range of 0.02-2mg / l show that the protein binding rate is about 45% regardless of the drug concentration. Moxifloxacin mainly binds to plasma albumin. Due to the low protein binding rate, the free peak concentration is 10 times MIC .
Moxifloxacin reaches high concentrations in the following tissues: lungs (alveolar fluid, alveolar macrophages, bronchial tissues), sinuses (ethmoidal sinus, maxillary sinus, nasal polyps) and inflammatory lesions (cancer herpes fluid), with drug concentrations exceeding Blood drug concentration. Interstitial fluid has high free drug concentrations (saliva, intramuscular, subcutaneous).
In addition, high levels of drug were detected in the tissues and fluids of the abdominal cavity and in the female reproductive tract.
The average peak concentration of the drug in human tissue after single oral and intravenous administration of 0.4 g is as follows:

Peak concentrations and plasma ratios in different target tissues indicate the comparability of the two single-dose 400 mg administration methods.
Metabolism < br Moxifloxacin is excreted in the form of sulphide (M1) and glucuronide (M2) through kidney and bile / feces after the second stage of biotransformation. M1 and M2 are only related metabolites in the human body, and they have no microbial activity. In vitro tests and phase I clinical trials have shown that no interaction between moxifloxacin and other cytochrome P450 enzymes involved in one-phase biotransformation is found. The plasma concentrations of metabolites M1 and M2 are lower than those of the parent drug and are independent of the route of administration. Full preclinical studies on metabolites have shown that metabolites are safe and tolerable.
Expulsion The average half-life of exocytosis from plasma and saliva is 12 hours. The average overall apparent clearance rate after oral administration of 400 mg of the drug was 179-246 ml / min. The renal clearance is 24-53ml / min, suggesting that the kidney can partially reabsorb the drug through the renal tubules.
Taking ranitidine and profenoxine at the same time does not affect excretion of the drug through the kidneys. (See table below)
The original form of moxifloxacin and the metabolites in the second stage can be almost completely recovered after the equilibrium is reached. The recovery rate is 96-98%, and it has nothing to do with the route of administration. The following table details this balance according to the excretion route (kidney and non-kidney, metabolic and non-metabolic) and the mode of administration.
400 mg single-dose recovery rate (arithmetic mean ± standard deviation (SD))

Elderly < br The pharmacokinetics of moxifloxacin is independent of age.
Gender < br The pharmacokinetic parameters (AUC, Cmax) of moxifloxacin between male and female subjects differed by 33%. This difference in AUC and Cmax can be attributed to different body weights rather than gender. Therefore, drug absorption is not affected by gender, and this difference has no clinical significance.
Racial differences < br Experimental tests of possible ethnic differences were performed on Caucasian, Japanese, black, and other races. Pharmacokinetic experiments showed no clinically relevant ethnic differences.
Children The pharmacokinetics of moxifloxacin has not been studied in children.
Renal Impairment There is no significant change in the pharmacokinetics of moxifloxacin in patients with impaired renal function (including creatinine clearance <30ml / min / 1.73m ² ), and there is no experience in renal dialysis patients.
Liver damage < br Patients with impaired liver function (Child Pugh A to C) have no clinically significant differences in plasma drug concentrations with healthy volunteers or patients with normal liver function.

Storage of Moxifloxacin Hydrochloride Tablets

Light-shielded, sealed and stored below 25 . Moxifloxacin hydrochloride tablets should be stored in the original packaging of the manufacturer.
Keep medicines out of the reach of children.

Packaging of Moxifloxacin Hydrochloride Tablets

Aluminum-plastic packaging. 3 tablets / box.

Validity of Moxifloxacin Hydrochloride Tablets

After 36 months, it is strictly forbidden to take.

Moxifloxacin Hydrochloride Tablets

Import drug registration standard JX20000281 ^[1]