Avelox (moxifloxacin) solution for infusions 400 mg. 250 ml. №1

Avelox (moxifloxacin) solution for infusions 400 mg. 250 ml. №1

$145.80

Manufacturer: Germany

Avelox (moxifloxacin) 400 mg. is used for community-acquired pneumonia, complicated infectious diseases of the skin and subcutaneous tissues.

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Description

Ingredients

active ingredient: moxifloxacin;

1 vial (250 ml of solution) contains 436 mg of moxifloxacin hydrochloride, which corresponds to 400 mg of moxifloxacin;

other components: sodium chloride, diluted hydrochloric acid, sodium hydroxide, water for injection.

Dosage form

Solution for infusion.

Basic physical and chemical properties: transparent yellow solution.

Pharmacotherapeutic group

Antimicrobials for systemic use. Antibacterial agents of the quinolone group. Code ATX J01M A14.

Pharmacodynamics

Mechanism of action

Moxifloxacin inhibits type II bacterial topoisomerases (DNA gyrase and topoisomerase IV) required for replication, transcription and repair of bacterial DNA.

Pharmacokinetics/pharmacodynamics

The ability of fluoroquinolones to destroy bacteria directly depends on their concentration. Pharmacodynamic studies of fluoroquinolones in animal models of infectious inflammatory diseases and humans show that the main determinant of efficacy is the ratio between the area under the pharmacokinetic curve (AUC24) and the minimum inhibitory concentration (MIC).

Mechanism of resistance

Resistance to fluoroquinolones can result from mutations in DNA gyrase and topoisomerase IV. Other mechanisms include overexpression of efflux pumps, impermeability, and protein-mediated protection of DNA gyrase. Cross-resistance can be expected between moxifloxacin and other fluoroquinolones.

Resistance mechanisms characteristic of antibacterial agents belonging to other classes do not affect the antibacterial efficacy of moxifloxacin.

Indications

Community-acquired pneumonia.

Complicated infectious diseases of the skin and subcutaneous tissues.

Moxifloxacin should only be used when other antibiotics commonly recommended for the initial treatment of these infections are not appropriate.

Attention should be paid to the official instructions for the proper use of antibacterial agents.

Contraindications

  • hypersensitivity to Avelox (moxifloxacin) 400 mg., other quinolone antibiotics or any of the excipients;
  • the period of pregnancy or lactation;
  • children’s age (up to 18 years);
  • a history of tendon disease/pathology associated with the use of quinolones.

During preclinical and clinical studies, after the administration of moxifloxacin, changes in the electrophysiological parameters of cardiac activity were noted, which were manifested by prolongation of the QT interval. For this reason, moxifloxacin is contraindicated in patients with:

  • congenital or acquired prolongation of the QT interval;
  • electrolyte imbalance, especially in the case of uncorrected hypokalemia;
  • clinically significant bradycardia;
  • clinically significant heart failure with a decrease in the ejection fraction of the left ventricle;
  • symptomatic arrhythmias in history.

Avelox (moxifloxacin) 400 mg. should not be used concomitantly with drugs that prolong the QT interval.

Due to insufficient clinical experience, moxifloxacin is contraindicated in patients with hepatic impairment (Child-Pugh class C) and elevated transaminase levels five times or greater.

Special security measures.

One vial is for single use only. Unused solution must be discarded.

The following solutions have been found to be compatible with moxifloxacin 400 mg solution for infusion: water for injection; sodium chloride solution 0.9%; sodium chloride solution 1 molar; glucose solution 5%, 10%, 40%; xylitol solution 20%; Ringer’s solution; complex solutions of sodium lactate (Hartmann’s solution, Ringer’s lactate solution).

Avelox (moxifloxacin) 400 mg. infusion solution should not be co-administered with other drugs.

Do not use the drug in the presence of visible solid impurities or when the solution becomes cloudy.

When stored in a cool place, precipitation may occur, which dissolves at room temperature. Therefore, it is not recommended to store the infusion solution below 15 °C.

Dosage and administration

Dosage

The recommended dosage regimen is 400 mg moxifloxacin as an infusion once daily.

Initial intravenous therapy may be continued with oral moxifloxacin 400 mg tablets when clinically indicated.

In clinical trials, most patients switched to oral moxifloxacin within 4 days (CAP) or 6 days (complicated infections of the skin and subcutaneous tissues). The recommended total duration of intravenous and oral treatment is 7–14 days for community acquired pneumonia and 7–21 days for complicated skin and subcutaneous tissue infections.

Mode of application

Avelox (moxifloxacin) 400 mg. is administered intravenously as a continuous infusion for at least 60 minutes.

If indicated, the solution for infusion can be administered through a T-shaped catheter along with compatible infusion solutions.

Impaired kidney/liver function

Patients with mild to severe renal dysfunction and patients on chronic dialysis, such as those undergoing hemodialysis and long-term ambulatory peritoneal dialysis, do not require dose adjustment.

For patients with impaired liver function, there is no sufficient information.

Other special patient groups

Elderly patients and patients with reduced body weight do not need dose adjustment.

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