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Avelox

Avelox

moxifloxacin

Manufacturer:

Bayer Indonesia
Information is sourced from publicly available references. The information is for educational purpose of healthcare professionals and we are not liable for any loss or damage.
Core Prescribing Info
Contents
1 single bottle of 250 mL infusion solution containing 400 mg moxifloxacin (as hydrochloride).
Indications/Uses
Avelox IV is only for patients that can not take oral administration or clinically proven have to take parenteral administration.
Avelox infusions 400 mg are indicated for the treatment of adults (≥18 years of age) for the following bacterial infections: Acute exacerbations of chronic bronchitis.
Community acquired pneumonia.
Acute bacterial sinusitis (adequately diagnosed).
Complicated skin and skin structure infections who require initial parenteral therapy; followed by oral; in patients who are intolerance to alternative agents (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.
Complicated intra-abdominal infections due to polymicrobial infections in patients who are intolerance to alternative agents; caused by organisms known to be susceptible to moxifloxacin.
Avelox infusions 400 mg are indicated for the treatment of the above infections if they are caused by bacteria susceptible to moxifloxacin.
Consideration should be given of official guidance on the appropriate use of antibacterial agents. Avelox may only be used on prescription and under the constant supervision of doctor.
Dosage/Direction for Use
Range of Dose: The recommended dose for Avelox is 400 mg once daily.
No adjustment of dosage is required in the elderly.
Efficacy and safety in children and adolescents have not been established.
No dose adjustment in patients with any degree of renal impairment (including creatinine clearance ≤30 mL/min/1.73 m2).
For treatment of complicated skin and skin structure infections requiring initial intravenous therapy followed by oral tablet administration of 400 mg moxifloxacin tablet.
For treatment of complicated intra-abdominal infections requiring initial intravenous therapy followed by oral administration of 400 mg moxifloxacin tablet.
Administration
Method of Administration: The infusion solution should be infused intravenously over 60 minutes.
It can be administered directly or together with compatible infusion solutions.
The following co-infusions were found to form stable mixtures over a period of 24 hours at room temperature with moxifloxacin infusion solution, and can therefore be considered as compatible: Water for Injections; Sodium Chloride 0.9%; Sodium Chloride 1 molar; Glucose 5%; Glucose 10%; Glucose 40%; Xylit 20%; Ringer Solution; Lactated Ringer Solution; Aminofusin 10% (manufacturer: Pharmacia & Upjohn); Jonosteril D5 (manufacturer: Fresenius Kabi).
If Avelox infusion solution is to be given with another drug, each drug should be given separately.
Only clear solutions are to be used.
Duration of administration: Avelox infusion 400 mg and tablet should be used for the following treatment durations: Acute exacerbation of chronic bronchitis: 5-10 days.
Community acquired pneumonia: 10 days.
Acute sinusitis: 7 days.
Complicated skin and skin structure infections: 7-21 days (sequential IV/oral therapy).
Complicated intra-abdominal infections: 5-14 days (sequential IV/oral therapy).
In clinical trials in patients with complicated skin and skin structure infections the mean duration of intravenous therapy was approximately 6 days with an overall mean treatment duration of approximately 13 days.
Moxifloxacin can be administered intravenously as initial intravenous administration, followed by oral tablet administration when allowed by the patient's condition.
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
Intravenous therapy may be limited for up to two to five days in therapy in the very ill patients and should be changed to oral therapy whenever possible as determined by the physician.
Contraindications
Known hypersensitivity to any component of the infusions or other quinolones.
Pregnancy and lactation.
Patients below 18 years of age.
Patient with a history of tendon disease/disorder related to fluoroquinolone treatment.
Both in pre-clinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reason of the drug safety, Avelox is therefore contra-indicated in patients with: Congenital or documented acquired QT prolongation.
Electrolyte disturbances, particularly in hypokalaemia.
Clinically relevant bradycardia.
Clinically relevant heart failure with reduced left-ventricular ejection fraction.
Previous history of symptomatic arrhythmias.
Avelox should not be used concurrently with other drugs that prolong the QT interval in particular Class IA (example: quinidine, procainamide) and Class III antiarrhythmic agents (example: amiodarone, sotalol). Due to a lack of data, Avelox is also contra-indicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase >5 fold ULN.
MIMS Class
Quinolones
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Avelox FC tab 400 mg
Packing/Price
1's
Form
Avelox infusion 400 mg/250 mL
Packing/Price
1's
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