Pol-Moxi

Pol-Moxi

moxifloxacin

Manufacturer:

Polifarma Ilac

Distributor:

Endure Medical

Marketer:

Endure Medical
Concise Prescribing Info
Contents
Moxifloxacin HCl
Indications/Uses
Bacterial infections caused by susceptible strains: acute exacerbation of chronic bronchitis caused by Strep pneumoniae, H. influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staph aureus, Moraxella catarrhalis; Strep pneumoniae (including penicillin-resistant strains with MIC of ≥2 μg/mL for penicillin), H. influenzae, Moraxella catarrhalis, Staph aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, pneumonia derived from the community including community-acquired pneumonia caused by multidrug-resistant strains; Strep pneumoniae w/ multiple drug resistance; uncomplicated skin & soft tissue infections caused by Staph aureus, Strep pyogenes; complicated skin & soft tissue infections (including diabetic foot) caused by MRSA, E. coli, Klebsiella pneumoniae, Enterobacter cloacae; complicated intraabdominal infections caused by E. coli, Bacteroides fragilis, Strep anginosus, Strep constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringensBacteroides thetaiotaomicron or Peptostreptococcus spp.
Dosage/Direction for Use
Not to exceed 250 mL once daily for 60 min. Duration: Acute exacerbation in chronic bronchitis 5 days. Community-acquired pneumonia 7-14 days (sequential oral following IV administration). Uncomplicated skin & soft tissue infection 7 days. Complicated skin & soft tissue infection 7-21 days (sequential oral following IV administration). Complicated intraabdominal infection 5-14 days (sequential oral following IV administration).
Contraindications
Hypersensitivity to moxifloxacin or other quinolones. Patients w/ history of tendon disease/disorder related to quinolone treatment; congenital or documented acquired QT prolongation; electrolyte disturbances particularly uncorrected hypokalaemia; clinically relevant bradycardia; clinically relevant heart failure w/ reduced left-ventricular ejection fraction; previous history of symptomatic arrhythmias. Not to be used concurrently w/ other drugs prolonging the QT interval. Hepatic impairment (Child-Pugh C) & patients w/ transaminases increase >5 fold ULN. Pregnancy & lactation. Childn <18 yr.
Special Precautions
Hypersensitivity & allergic reactions. Discontinue use if signs or symptoms that may be associated w/ cardiac arrhythmia w/ or w/o ECG findings occur. Patients w/ any condition predisposing to cardiac arrhythmias (eg, acute myocardial ischaemia); CNS disorders or in presence of other risk factors which may predispose to seizures or lower seizure threshold. Bullous skin reactions eg, SJS or TEN. Sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypoaesthesia, dysaesthesia or weakness. Psychiatric reactions may occur even after 1st administration. Concomitant use w/ medications reducing K levels. Fulminant hepatitis potentially leading to liver failure (including fatal cases). Not to be used during pregnancy.
Adverse Reactions
Superinfections due to resistant bacteria or fungi eg, oral & vag candidiasis; headache, dizziness; QT prolongation in patients w/ hypokalaemia; nausea, vomiting, GI & abdominal pains, diarrhoea; increase in transaminases; inj & infusion site reactions.
Drug Interactions
Additive effect on QT interval prolongation w/ other medicinal products that may prolong the QTc interval eg, class IA (eg, quinidine, hydroquinidine, disopyramide) & III (eg, amiodarone, sotalol, dofetilide, ibutilide) anti-arrhythmics, antipsychotics (eg, phenothiazines, pimozide, sertindole, haloperidol, sultopride), TCAs, certain antimicrobial agents (eg, saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (eg, terfenadine, astemizole, mizolastine) & cisapride, vincamine IV, bepridil, diphemanil.
MIMS Class
Quinolones
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Pol-Moxi soln for IV infusion 400 mg/250 mL
Packing/Price
250 mL x 1's
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