Sanofos IV

Sanofos IV

fosfomycin

Manufacturer:

Able Medical

Distributor:

Universal Medical Industry
Concise Prescribing Info
Contents
Fosfomycin Na
Indications/Uses
Osteomyelitis; complicated UTI; nosocomial lower resp tract infections. Bacterial meningitis. Bacteremia in association w/ or suspected to be associated w/ the mentioned infections in adults & childn. Should be used only when commonly recommended initial treatment is inappropriate & when alternative antibacterial failed.
Dosage/Direction for Use
IV infusion Administer at least 15 min for 2 g & at least 30 min for 4 g. Adult & adolescent >12 yr weighing >40 kg w/ CrCl >80 mL/min Max individual dose: 8 g. High-dose regimen in 3 divided doses is used in severe infections expected or known to be caused by less susceptible bacteria (Max dose: 16 g/day). Osteomyelitis, nosocomial lower resp tract infection 12-24 g in 2-3 divided doses. Complicated UTI 12-16 g in 2-3 divided doses. Bacterial meningitis 16-24 g in 3-4 divided doses. Paed High-dose regimen is used for severe &/or serious infections (eg, meningitis) when known or suspected to be caused by organism w/ moderate susceptibility. Childn 1-12 yr & infant weighing 10-40 kg 200-400 mg/kg in 3-4 divided doses; infant 1-12 mth weighing up to 10 kg 200-300 mg/kg in 3 divided doses; neonate 40-44 wk 200 mg/kg in 3 divided doses; premature neonate <40 wk 100 mg/kg in 2 divided doses. Patient w/ impaired renal function 1st dose: 100% of appropriate dose in normal renal function as loading dose (Max dose: 8 g); patient w/ CrCl 40 mL/min 70% of appropriate dose in normal renal function in 2-3 divided doses; 30 mL/min 60% of appropriate dose in normal renal function in 2-3 divided doses; 20 mL/min 40% of appropriate dose in normal renal function in 2-3 divided doses; 10 mL/min 20% of appropriate dose in normal renal function in 1-2 divided doses. Patient undergoing chronic intermittent dialysis every 48 hr 2 g at the end of each dialysis session.
Contraindications
Special Precautions
Immediately discontinue at 1st signs of acute, potentially life-threatening hypersensitivity reactions. Low Na diet is recommended during treatment. Monitor serum electrolyte levels & water balance; monitor blood K levels during prolonged treatment w/ high doses, particularly in digitalized heart failure patients. Patients w/ cardiac insufficiency, HTN, hyperaldosteronism, hypernatraemia or pulmonary oedema. Antibacterial agent-associated colitis & pseudo-membranous colitis; patient w/ diarrhoea during or subsequent to the administration of fosfomycin. Discontinue therapy & start treatment for Clostridium difficile. Should not give concomitantly w/ drugs that inhibit peristalsis. May impair ability to drive & use machines. Severe renal insufficiency (CrCl ≤40 mL/min). Pregnancy & lactation.
Adverse Reactions
Hypernatraemia &/or hypokalaemia; retching, stomach ache; erythematous eruption; inj site phlebitis.
MIMS Class
ATC Classification
J01XX01 - fosfomycin ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Form
Sanofos IV powd for infusion 4 g
Packing/Price
1's
Form
Sanofos IV powd for infusion 2 g
Packing/Price
1's
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