Avelox

Avelox

moxifloxacin

Manufacturer:

Bayer Indonesia
Concise Prescribing Info
Contents
Moxifloxacin HCl
Indications/Uses
Treatment of adult ≥18 yr w/ bacterial infections eg, acute exacerbations of chronic bronchitis, community acquired pneumonia, acute bacterial sinusitis, complicated skin & skin structure infections; complicated intra-abdominal infections. FC tab: Mild to moderate pelvic inflammatory disease w/o associated tubo-ovarian or pelvic abscess in combination w/ another appropriate antibacterial agent eg, cephalosporin.
Dosage/Direction for Use
Adult ≥18 yr Recommended dose: 400 mg IV over 60 min or orally once daily. Duration of treatment: Acute exacerbations of chronic bronchitis 5-10 days. Community-acquired pneumonia 10 days. Acute sinusitis 7 days. Complicated skin & skin structure infections 7-21 days (sequential IV/oral). Complicated intra-abdominal infections 5-14 days (sequential IV/oral therapy). Mild to moderate pelvic inflammatory disease 14 days.
Administration
May be taken with or without food: Swallow whole.
Contraindications
Hypersensitivity to moxifloxacin or other fluoroquinolones. History of tendon disease or disorder related to fluoroquinolone treatment. Congenital or acquired QT prolongation, electrolyte disturbances, bradycardia, heart failure w/ reduced left-ventricular ejection fraction, history of symptomatic arrhythmias. Not to be used w/ other drugs that prolong the QT interval. Impaired liver function (Child Pugh C), increased transaminase >5-fold ULN, CrCl <30 mL/min/1.73 m2, undergoing renal dialysis. Pregnancy & lactation. Patient <18 yr.
Special Precautions
Hypersensitivity & allergic reactions, psychiatric reactions may occur after 1st administration. Discontinue treatment if anaphylactic reactions progress to a life threatening shock; at first sign of tendinitis; suicidal thoughts & self-injurious behavior develops. Bullous skin reactions eg, Stevens-Johnson syndrome or toxic epidermal necrolysis; pseudomembranous colitis; sensory or sensorimotor polyneuropathy eg, paraesthesias, hypoaesthesias, dysaesthesias or weakness; hypoglycemia & hyperglycemia. Consult a physician immediately prior to continuing treatment if skin &/or mucosal reactions occur; symptoms related to liver failure & neuropathy develop. Concomitant use w/ medication that reduce K & Mg level. Discontinue treatment & perform ECG if signs of cardiac arrhythmia occur during treatment. May increase the risk for ventricular arrhythmias. Patients w/ CNS disorders which may predispose to seizures or lower the seizure threshold; myasthenia gravis. Patients who develop serious diarrhoea during or after treatment. Tendinitis & tendon rupture may occur w/in the 1st 48 hr of treatment. May increase risk of tendinopathy in elderly, during strenuous physical activity, in patients concomitantly treated w/ corticosteroids, w/ renal impairment or w/ solid organ transplant. Avoid exposure to either UV irradiation or extensive sunlight during treatment. Not recommended in patients w/ complicated pelvic disease for whom an IV treatment is necessary. Not recommended for the treatment of MRSA infections. May interfere w/ Mycobacterium spp culture test causing false negative results. Psychotic patients or w/ history of psychiatric disease. Monotherapy w/ moxifloxacin should be avoided in patients w/ pelvic inflammatory disease. Carefully monitor blood glucose in diabetic patients. Patients w/ glucose-6-phosphate dehydrogenase deficiency. Consult an eye specialist in case of vision disorders. Patients for whom Na intake is of medical concern. May impair ability to drive or operate machinery due to CNS reactions & vision disorders. Fulminant hepatitis leading to liver failure. Perform liver function tests. Elderly, women. FC tab: Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp Lactose deficiency or glucose-galactose malabsorption. Patients w/ renal disorders. Maintain adequate fluid intake.
Adverse Reactions
Mycotic superinfections; headache, dizziness; QT prolongation in patients w/ hypokalaemia; nausea, vomiting, GI & abdominal pain, diarrhea; increased transaminases; inj & infusion site reactions.
Drug Interactions
Increased Cmax of digoxin. Decreased peak plasma conc of glibenclamide. Increased anticoagulant activity w/ concurrent use of anticoagulants. FC tab: Absorption may be impaired w/ antacids, minerals & multivit. Increased risk of ventricular arrhythmias w/ class IA (eg, quinidine, hydroquinidine, disopyramide) & class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, neuroleptics (eg, phenothiazines, pimozide, sertindole, haloperidol, sultopride), TCAs, sparfloxacin, erythromycin IV, bepridil, diphemanil. Reduced systemic availability w/ charcoal.
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
5's (Rp306,856/pak)
Form
Avelox infusion 400 mg/250 mL
Packing/Price
1's (Rp550,497/vial)
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