Moloxin

Moloxin

moxifloxacin

Manufacturer:

KRKA

Distributor:

Uni Drug
Concise Prescribing Info
Contents
Moxifloxacin HCl
Indications/Uses
Susceptible resp tract [acute bacterial sinusitis & bacterial exacerbations of chronic bronchitis, community acquired pneumonia (mild to moderate)], uncomplicated & complicated skin & skin structure infections; mild to moderate pelvic inflammatory disease (ie, female upper genital tract infection, including salpingitis & endometritis), w/o an associated tubo-ovarian or pelvic abscess.
Dosage/Direction for Use
Recommended dose: 1 tab once daily. Duration of treatment: Acute exacerbation of chronic bronchitis: 5 days; acute sinusitis, uncomplicated skin & skin structure infections: 7 days; community acquired pneumonia: 10 days (mild to moderate), 7-14 days [total recommended duration for sequential therapy (IV followed by oral therapy)]; complicated skin & skin structure infections: 7-21 days (total treatment duration for sequential therapy); mild to moderate pelvic inflammatory disease: 14 days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to moxifloxacin or other quinolones. History of quinolone treatment-related tendon disease/disorder. Patients w/ congenital or documented acquired QT prolongation; electrolyte disturbances particularly in uncorrected hypokalaemia; clinically relevant bradycardia & heart failure w/ reduced left-ventricular ejection fraction; history of symptomatic arrhythmias. Concurrent use w/ other QT interval prolonging drugs. Patients w/ impaired liver function (Child Pugh C) & w/ transaminases increase >5 fold ULN. Pregnancy & lactation. Patients <18 yr.
Special Precautions
Hypersensitivity & allergic reactions after 1st administration. Not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease; in MRSA infection treatment. Can reduce K levels. Patients w/ ongoing proarrhythmic conditions (especially women & elderly) eg, acute myocardial ischaemia or QT prolongation; w/ CNS disorders or other risk factors predisposing to seizures or lower seizure threshold. Fulminant hepatitis. Perform liver function tests/investigations in case of liver dysfunction indications. Bullous skin reactions eg, Stevens-Johnson syndrome or toxic epidermal necrolysis. Immediately discontinue if symptoms of peripheral neuropathy occurs. Psychotic patients or those w/ history of psychiatric disease. Discontinue if depression or psychotic reactions progressed to suicidal thoughts & self-injurious behaviour (eg, suicide attempts). Consider antibiotic-associated diarrhoea (AAD) & antibiotic-associated colitis (AAC), including pseudomembranous colitis & Clostridium difficile-associated diarrhea in the diagnosis of patients who develop serious diarrhea during or after therapy. Discontinue use if AAD or AAC is suspected or confirmed. CI w/ peristalsis-inhibiting drugs in patients who develop serious diarrhoea. Avoid in patients w/ known myasthenia gravis history. Increased risk of tendinitis & tendon rupture in elderly & in those treated concurrently w/ corticosteroids; discontinue at the 1st sign of pain & inflammation, & rest the affected limbs. Visual impairment or any effects on the eyes. Carefully monitor blood glucose in diabetic patients. Avoid exposure to either UV irradiation or extensive &/or strong sunlight during treatment. Patients w/ family history of or actual G6PD. Not recommended in patients w/ complicated pelvic inflammatory disease (eg, associated w/ tubo-ovarian or pelvic abscess). May interfere w/ Mycobacterium spp culture test. May impair ability to drive or operate machinery due to CNS reactions. Not recommended in patients w/ severe hepatic impairment (Child Pugh C). CI in childn & adolescents <18 yr. Prolongation of QTc interval & potentially QTc-prolongation-related clinical conditions in women & the elderly. Elderly w/ renal disorders who are unable to maintain adequate fluid intake. Occurrence of dysglycemia in elderly diabetic patients concomitantly using oral hypoglycemic agent (eg, sulfonylurea) or insulin.
Adverse Reactions
Mycotic superinfections; headache, dizziness; QT prolongation in patients w/ hypokalaemia; nausea, vomiting, GI & abdominal pains, diarrhoea; increased transaminases. Increased γ-glutamyl-transferase.
Drug Interactions
Additive effect on QT interval prolongation w/ anti-arrhythmics class IA (eg, quinidine, hydroquinidine, disopyramide), anti-arrhythmics class III (eg, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (eg, phenothiazines, pimozide, sertindole, haloperidol, sultopride), TCAs, certain antimicrobials (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), cisapride, vincamine IV, bepridil, diphemanil. Caution in concomitant use w/ K level reducing drugs [eg, loop & thiazide-type diuretics, laxatives & enemas (high doses), corticosteroids, amphotericin B] or drugs associated w/ clinically significant bradycardia. Absorption may be impaired w/ bivalent or trivalent cation-containing agents (eg, Mg- & Al-containing antacids, didanosine tab, sucralfate & Fe- or Zn-containing agents). Pronounced prevention of absorption & reduced systemic availability w/ charcoal. May increase oral anticoagulant activity.
MIMS Class
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Moloxin FC tab 400 mg
Packing/Price
10's
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