Moxetero

Moxetero

moxifloxacin

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Moxifloxacin HCl
Indications/Uses
Acute bacterial sinusitis. Acute bacterial exacerbation of chronic bronchitis. Community-acquired pneumonia (mild to moderate). Uncomplicated & complicated skin & skin structure infections. Mild to moderate pelvic inflammatory disease (eg, female upper genital tract infections, including salpingitis & endometritis), w/o an associated tubo-ovarian or pelvic abscess; may be given in combination w/ another antibacterial agent (eg, cephalosporin).
Dosage/Direction for Use
Adult 400 mg once daily. Duration of treatment: Acute exacerbation of chronic bronchitis - 5 days; acute sinusitis, & uncomplicated skin & skin structure infections - 7 days; community-acquired pneumonia (mild to moderate) - 10 days; mild to moderate pelvic inflammatory disease - 14 days; community-acquired pneumonia (IV-to-PO sequential therapy) - 7-14 days; complicated skin & skin structure infections (IV-to-PO sequential therapy) - 7-21 days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to moxifloxacin or other quinolones. History of quinolone-related tendon disease/disorder; symptomatic arrhythmias. Congenital or documented acquired QT prolongation, electrolyte disturbances particularly in uncorrected hypokalaemia, clinically relevant bradycardia, & heart failure w/ reduced left ventricular ejection fraction. Concurrent use w/ drugs that prolong QT interval. Patients w/ hepatic impairment (Child-Pugh C) & w/ transaminase increase >5-fold upper limit of normal. Childn & adolescents <18 yr. Pregnancy & lactation.
Special Precautions
Discontinue & initiate suitable treatment if hypersensitivity/allergic reactions occur. Patients concurrently on K level-reducing medications. Patients w/ ongoing proarrhythmic conditions (especially women & elderly) eg, acute myocardial ischemia or QT prolongation, for potential increased risk of ventricular arrhythmias (including torsade de pointes) & cardiac arrest; discontinue if signs of cardiac arrhythmia occur. Fulmitant hepatitis potentially leading to liver failure (including fatal cases). Perform liver function tests if liver dysfunction indications occur. Serious bullous skin reactions eg, Stevens-Johnson syndrome or toxic epidermal necrolysis. Patients w/ CNS disorders or w/ risk factors which may predispose to seizures or lower seizure threshold. Discontinue immediately if patient experiences peripheral neuropathy symptoms including pain, burning, tingling, numbness &/or weakness or other sensation alterations. Patient w/ psychosis, or history of psychiatric disease. Discontinue & institute appropriate measures if patient developed psychiatric reactions. Discontinue & initiate adequate therapeutic measures immediately if antibiotic-associated diarrhea & colitis are suspected or confirmed. Patients w/ myasthenia gravis. Tendon inflammation/rupture particularly in elderly & in those treated concurrently w/ corticosteroids; discontinue treatment at the 1st sign of pain or inflammation. Visual impairment. Avoid extensive UV irradiation or sunlight exposure. Patients w/ family history of, or actual G6PD deficiency; rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Patients w/ complicated pelvic inflammatory disease. May interfere w/ Mycobacterium spp causing false negative results in specimens. Not recommended for MRSA-infection treatment. Monitor blood glucose in diabetics. May impair ability to drive or use machines. Elderly w/ renal disorders.
Adverse Reactions
Mycotic superinfections; headache, dizziness; QT prolongation in patients w/ hypokalaemia; nausea, vomiting, GI & abdominal pains, diarrhea; increased transaminases; inj & infusion site reactions.
Drug Interactions
Absorption may be impaired by antacids, minerals & multivitamins. Increased Cmax of digoxin. Reduced systemic availability w/ charcoal. Increased risk of ventricular arrhythmias, including torsade de pointes in co-administration w/ anti-arrhythmics class IA (eg, quinidine, hydroquinone, disopyramide) & class III (eg, amiodarone, sotalol, dofetilide, ibutilide); antipsychotics (eg, phenothiazines, pimozide, sertindole, haloperidol, sultopride), TCAs; certain antimicrobials (eg, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine); certain antihistamines (terfenadine, astemizole, mizalostine); 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
Moxetero 400 FC tab 400 mg
Packing/Price
100's;30's
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