Fosfomax

Fosfomax IV Infusion is indicated for the treatment of the following infections in adults and children including neonates:

• Osteomyelitis
• Complicated urinary tract infections
• Nosocomial lower respiratory tract infections
• Bacterial meningitis

Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above

... Read more Fosfomax IV Infusion is indicated for the treatment of the following infections in adults and children including neonates:

• Osteomyelitis
• Complicated urinary tract infections
• Nosocomial lower respiratory tract infections
• Bacterial meningitis

Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above

Fosfomax should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of the infections listed above, or when these alternative antibacterial agents have failed to demonstrate efficacy.

Fosfomycin exerts a bactericidal effect on proliferating pathogens by preventing the enzymatic synthesis of the bacterial cell wall. Fosfomycin inhibits the first stage of intracellular bacterial cell wall synthesis by blocking peptidoglycan synthesis.

The daily dose of Fosfomycin is determined based on the indication, severity and site of the infection, susceptibility of the pathogen(s) to fosfomycin and the renal function.In children,it is also determined by age and body weight. Adults and adolescents >12 years of age (>40 kg) : Fosfomycin is primarily excreted renally unchanged. The general dosage guidelines for adults with estimated creatinine clearance >80 ml/min are as follows:

Osteomyelitis: 12-24 gm in 2-3 divided doses

Complicated urinary tract infection: 12-16 gm in  3 divided dose

Nosocomial lower respiratory tract infection: 12-24 gm in 2-3 divided dose

Bacterial meningitis: 16-24 gm in 3-4 divided doses

Individual doses must not exceed 8 gm. The high-dose regimen in 3 divided doses should be used in severe infections expected or known to be caused by less susceptible bacteria. There are limited safety data in particular for doses in excess of 16 g/day. Special caution is advised when such doses are prescribed.

No drug-drug interaction studies have been performed with fosfomycin.

Hypersensitivity to the active substance, fosfomycin, or to any of the excipients.

The most commonly reported adverse reactions during treatment are gastrointestinal disturbances and injection site reactions. Other important adverse reactions include hypokalaemia and/or hypernatraemia.

To avoid potential development of cross resistance co-administration of Fosfomax with other antibiotics is preferred.

A high sodium load associated with the use of fosfomycin may result in decreased levels of potassium in serum or plasma. A low-sodium diet is recommended during treatment. The substitution of potassium may be necessary in some cases. Serum electrolyte levels and water balance must be monitored during therapy. Caution is advised when fosfomycin is used in patients with cardiac insufficiency, hypertension, hyperaldosteronism, hypernatraemia or pulmonary edema.

Acute, potentially life-threatening hypersensitivity reactions (anaphylactic shock) may occur in very rare cases. At the first signs (including sweating, nausea, cyanosis), the infusion of fosfomycin must be immediately discontinued.

Experience regarding the overdose of fosfomycin is limited. Cases of hypotonia, somnolence, electrolytes disturbances, thrombocytopenia and hypoprothrombinemia have been reported with parenteral use of fosfomycin.

Store below 30° C temperature, protect from light & moisture. Keep out of the reach of children. After being mixed with solvent this medicine should be used immediately or stored in a refrigerator (at 2-8°C) protected from light for up to 24 hours.