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Xiflox

Xiflox

moxifloxacin

Manufacturer:

Getz Pharma

Distributor:

Getz Pharma
Concise Prescribing Info
Contents
Moxifloxacin HCl
Indications/Uses
Adult (>18 yr) w/ mild, moderate & severe infections eg, acute bacterial sinusitis; acute bacterial exacerbation of chronic bronchitis; community acquired pneumonia (including community acquired pneumonia caused by multi-drug resistant strains for FC tab); uncomplicated skin & skin structure infections; complicated intra-abdominal infections (including polymicrobial infections eg, abscesses); complicated skin & skin structure infections (including diabetic foot infections). FC tab: Uncomplicated pelvic inflammatory disease (ie, infections of female upper genital tract, including salpingitis & endometritis) in patient ≥18 yr.
Dosage/Direction for Use
FC tab Acute bacterial sinusitis 400 mg once every 24 hr for 7 days. Acute bacterial exacerbation of chronic bronchitis 400 mg once every 24 hr for 5 days. Community acquired pneumonia 400 mg once every 24 hr for 10 days. Uncomplicated skin & skin structure infections 400 mg once every 24 hr for 7 days. Complicated skin & skin structure infections 400 mg once every 24 hr for 7-21 days. Uncomplicated pelvic inflammatory disease 400 mg once every 24 hr for 14 days. Complicated intraabdominal infections 400 mg once every 24 hr for 5-14 days. Soln for inj Acute bacterial sinusitis 400 mg as IV infusion once every 24 hr for 10 days. Acute bacterial exacerbation of chronic bronchitis 400 mg as IV infusion once every 24 hr for 5 days. Community acquired pneumonia 400 mg as IV infusion once every 24 hr for 7-14 days. Uncomplicated skin & skin structure infections 400 mg as IV infusion once every 24 hr for 7 days. Complicated skin & skin structure infections 400 mg as IV infusion once every 24 hr for 7-21 days. Complicated intra-abdominal infection 400 mg as IV infusion once every 24 hr for 5-14 days.
Administration
May be taken with or without food: Swallow whole w/ sufficient liqd.
Contraindications
Hypersensitivity to moxifloxacin or other quinolones. Avoid in patients w/ known prolongation of the QT interval, uncorrected hypokalemia & patients receiving class IA (quinidine, procainamide) & class III (amiodarone, sotalol) antiarrhythmics. Pregnancy & lactation. Ped patients, adolescents (<18 yr). FC tab: Patients w/ history of tendon disease/disorder related to quinolone treatment; impaired liver function & transaminases >5 fold ULN; congenital or documented acquired QT prolongation; electrolyte disturbances; clinically relevant bradycardia & heart failure w/ reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias.
Special Precautions
Patients w/ known or suspected CNS disorders (eg, lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke) or in the presence of other risk factors that may predispose to seizures or lower the threshold. Antibiotic associated colitis; consider this diagnosis in patients who develop serious diarrhea in association w/ use. Patients w/ ongoing proarrhythmic conditions eg, clinically significant bradycardia, or acute myocardial ischemia; w/ liver cirrhosis as preexisting QT prolongation. Tendon inflammation &/or rupture risk may be increased w/ concurrent corticosteroids, particularly in elderly. Discontinue at first signs or symptoms of tendon pain. Discontinue treatment immediately if allergic/severe hypersensitivity reactions, including anaphylaxis occur or in cases of anaphylactic reactions progressed to life threatening shock. May exacerbate myasthenia gravis. Perform LFTs/investigations in cases where indications of liver dysfunction occur. FC tab: Prolonged QT interval of ECG in some patients. Patients treated concomitantly w/ drugs that prolong QT interval eg, cisapride, erythromycin, antipsychotics, & TCAs; in women & elderly who are susceptible to QTc prolonging drugs. Not recommended for patients w/ pelvic inflammatory disease (eg, associated w/ tubo-ovarian or pelvic abscess). Diabetes, as glucose regulation may be altered. Not recommended for treatment of MRSA infections. Haemolytic reactions in patients w/ family history of, or actual glucose-6-phosphate dehydrogenase deficiency when treated w/ quinolones. Peripheral neuropathy (rarely). Elderly patients w/ renal disorders who are unable to maintain adequate fluid intake, because dehydration may increase risk of renal failure. Consult an eye specialist immediately if vision becomes impaired or any effects on the eyes are experienced. May impair ability of patients to drive or operate machinery due to CNS reactions (eg, dizziness; acute, transient loss of vision) or acute & short lasting loss of consciousness. Soln for inj: Discontinue in case of antibiotic associated colitis; liver cirrhosis; tendon inflammation & rupture. Photosensitivity reactions. Avoid extensive exposure to either UV irradiation or sunlight. Bullous skin reactions like SJS or TEN. Patients for whom Na intake is of medical concern (eg, patients w/ CHF, renal failure, nephrotic syndrome).
Adverse Reactions
Mycotic superinfections; headache, dizziness; QT prolongation in patients w/ hypokalemia; nausea, vomiting, GI & abdominal pains, diarrhea; increase in transaminases. Soln for inj: Inj & infusion site reactions.
Drug Interactions
May increase risks of CNS stimulation & convulsions w/ NSAIDs. FC tab: Impaired absorption leading to lower plasma conc w/ antacids, minerals & multivit, anti-retroviral drugs (eg, didanosine), & other prep containing Mg or Al, sucralfate & agents containing Fe or Zn. Increased Cmax of digoxin. Pronounced prevention of absorption & reduced systemic availability w/ charcoal. Close monitoring of prothrombin time, INR, or other suitable anticoagulation tests w/ warfarin or its derivatives. Soln for inj: May cause increase in anticoagulant activity w/ anticoagulants. Additive effect w/ drugs that prolong QT interval eg, cisapride, erythromycin, antipsychotics & TCAs.
MIMS Class
Quinolones
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Xiflox FC tab 400 mg
Packing/Price
5's (P409.1/box)
Form
Xiflox soln for inj 1.6 mg/mL
Packing/Price
250 mL x 1's (P1,155/box)
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