Moxifloxacin Hydrochloride And Sodium Chloride Inejction

Moxifloxacin Hydrochloride And Sodium Chloride Inejction

Product name: Moxifloxacin hydrochloride and sodium chloride injection
Package: 80bottles/carton
Specification: 0.4g,250ml/2g,250ml
Certification:GMP
Standard:CP

Details

Product name: Moxifloxacin hydrochloride and sodium chloride injection

Package: 80bottles/carton

Specification: 0.4g,250ml/2g,250ml

Certification:GMP

Standard:CP

OEM: Available

Shelf Life: 3 Years

 

Product Details

Ingredients

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:

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Molecular Formula: C21H24FN3O4·HCl

Molecular weight: 437.9

Excipients: sodium chloride, hydrochloric acid, sodium hydroxide, water for injection.


Character

This product is a yellow clear liquid.


Indications

Adult (≥18 years old) upper and lower respiratory tract infections such as acute sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, and skin and soft tissue infections.

Complex abdominal infections include mixed bacterial infections such as abscesses.


Specification

250ml: Moxifloxacin 0.4g and sodium chloride 2.0g.


Dosage

Dosing method: According to the infusion rates of the Chinese healthy subjects that can be tolerated by the heart and the results of the domestic phase I, II, and III clinical studies, the recommended infusion time for this product should be 90 minutes. (Abroad recommended 0.4g moxifloxacin intravenous infusion should be greater than 60 minutes.)

Dose range (adults):

The recommended dose is once 0.4g once a day (one bottle at a time, once a day).

Course of treatment:

The course of treatment is determined by the severity of the symptoms or the clinical response. For the treatment of upper respiratory tract and lower respiratory tract infection, the following courses of treatment are usually available:

Acute exacerbation of chronic bronchitis: 5 days

Community-acquired pneumonia: The recommended total duration of treatment is 7 to 14 days for sequential administration (continuous oral administration after intravenous administration).

Acute sinusitis: 7 days

The recommended course of treatment for skin and soft tissue infections is 7 days.

Moxifloxacin can be administered intravenously at the start of treatment and then administered orally according to the patient's condition.

0.4g of moxifloxacin injection has been used for up to 14 days in clinical trials.

Dosing method:

The time for intravenous administration of 0.4 g should be 90 minutes.

Moxifloxacin can be administered alone or in combination with some compatible solutions.

The following injections and the mixture of moxifloxacin injections remain stable at room temperature for more than 24 hours and are therefore considered to be combined:

Water for Injection

0.9% Sodium Chloride Injection

1 Molar Sodium Chloride Injection

5% glucose injection

10% glucose injection

40% Glucose Injection

20% xylitol injection

Ringer's solution

Lactated Ringer's solution

Aminofusin10% (Manufacturer: Pharmacia&Upjohn)

Jonosteril D5 (Manufacturer: Fresenius Kabi)

If moxifloxacin injection is used in combination with other drugs, each drug must be administered separately (see Incompatibility).

Only clear solutions can be used.

Seniors

Elderly people do not have to adjust the dosage.

Children

The efficacy and safety of moxifloxacin in children and adolescents have not yet been determined. (see special reminders and notes)

Liver damage

There was no clinically significant difference in plasma drug concentrations between patients with impaired liver function (Child Pugh A to C) and healthy volunteers or patients with normal liver function.

Kidney damage

Patients with impaired renal function (including creatinine clearance ≤ 30 ml/min/1.73 m2) and chronic dialysis, such as hemodialysis and continuous ambulatory peritoneal dialysis do not need to adjust the dose.

Ethnic differences

Potential race-to-ethnic differences among Caucasians, Japanese, blacks, and other racial groups were tested and no clinically relevant differences in pharmacokinetics were found. Therefore, there is no need to adjust the dose of drugs among different races.


Contraindication

Known to be allergic to any moxifloxacin ingredient, or other quinolones, or any excipient.

Pregnancy and lactation women.

The use of moxifloxacin in clinical data for patients with severe hepatic impairment (Child Pugh C grade) and for patients whose transaminase elevation is greater than 5 times the upper limit of normal limits is prohibited in these patients.

Patients under the age of 18.


Precautions

Moxifloxacin can prolong the QT interval of electrocardiogram in some patients. This drug should be avoided in patients with QT prolongation, patients with uncorrectable hypokalemia, and receiving Class Ia (eg quinidine, procainamide) or Class III (eg amiodarone, Sotalol) Antiarrhythmic drug therapy in patients.

Moxifloxacin and drugs that may prolong the QT interval: cisapride, erythromycin, antipsychotics, and tricyclic antidepressants may have an additive effect when used in combination. Therefore, caution should be used in conjunction with these drugs.

Moxifloxacin should be used with caution in the presence of arrhythmogenic conditions, such as severe bradycardia or acute myocardial ischemia.

Compared with men, because women often have longer QTc intervals, they may be more sensitive to drugs that provoke QTc prolongation. Elderly patients are also more susceptible to drug-induced QT prolongation.

The extent of QT prolongation increases with increasing drug concentration. Therefore, the recommended dose should not be exceeded. However, no correlation was observed between plasma concentrations of moxifloxacin and prolongation of QT interval in patients with pneumonia. The prolongation of the QT interval can lead to an increased risk of ventricular arrhythmias including torsades de pointes. In the clinical study of more than 9000 patients treated with moxifloxacin, there was no cardiovascular morbidity or mortality due to prolonged QT interval, but certain potential conditions may increase the risk of ventricular arrhythmias.

Both women and elderly patients are more sensitive to drugs that provoke prolonged QTc intervals.

Moxifloxacin has been reported to cause fulminant hepatitis and may lead to liver failure (including deaths). If liver failure-related symptoms occur, the patient should be advised to contact the doctor immediately before continuing treatment.

Moxifloxacin-induced bullous skin reactions have been reported, such as Stevens-Johnson syndrome or toxic epidermal necrolysis. If skin and/or mucous membrane reactions occur, the patient should be advised to contact the doctor immediately before continuing treatment.

The use of quinolones can induce the onset of epilepsy, and moxifloxacin should be used in patients who are known or suspected of having a CNS disease that can cause seizures or reduce seizure thresholds.

It is possible to have tendonitis and tendon rupture in the use of quinolones therapy including moxifloxacin, especially in elderly patients and patients treated with hormones. In the event of pain or inflammation, patients need to stop taking medicine and rest their limbs.

Pseudomembranous colitis has been reported in the use of broad-spectrum antibiotics including moxifloxacin. Therefore, if severe diarrhea occurs in patients treated with moxifloxacin, it is important to consider this diagnosis. In this case, adequate treatment must be taken immediately. In patients with severe diarrhea, drugs that inhibit gastrointestinal motility are contraindicated.

Moxifloxacin should be used with caution in patients with myasthenia gravis because of aggravating symptoms.

It has been confirmed that quinolones can cause photosensitivity in patients. However, in specially designed preclinical and clinical studies, no photosensitivity of moxifloxacin was observed. In addition, there has been no clinical evidence that moxifloxacin caused photosensitivity reactions since its release. Despite this, patients should be advised to avoid excessive exposure to ultraviolet light and sunlight.

In some cases, if allergic reactions and allergies have occurred after the first dose, the doctor should be informed immediately.

Few cases after the first dose can cause life-threatening shocks caused by allergic reactions. In these cases moxifloxacin should be discontinued and given treatment (eg treatment for shock).

For the treatment of patients with complex pelvic infections (such as those associated with fallopian tube-ovarian or pelvic abscess), intravenous therapy should be considered instead of oral 400mg moxifloxacin tablets.

For those who are concerned about sodium intake in the clinic (congestive heart failure, renal failure, nephrotic syndrome, etc.), additional sodium loads should be considered.

Due to central nervous system (CNS) reactions, fluoroquinolones including moxifloxacin may impair the patient's ability to drive or operate machinery.

Insert the needle of the infusion set vertically into the center of the inner ring of the rubber stopper. Do not use excessive force to avoid damage to the rubber plug.

Storage

Shading, sealed, stored above 15 °C. Store in original packaging. Do not refrigerate or freeze. Precipitation occurs in cold storage and can be re-dissolved at room temperature. Therefore, it is recommended not to store moxifloxacin hydrochloride sodium chloride injection in the refrigerator. Keep medicines out of the reach of children.


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