Description

Fosfomycin 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 Fosfomycin 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.

Method of administration: Fosfomycin Sodium is intended for intravenous administration. The duration of infusion should be at least 30 minutes for the 4 gm pack size. Use only clear solutions. Preparation of the solution for infusion: Fosfomycin Sodium must be reconstituted and diluted prior to administration. Water for Injections and Glucose Infusion 50 mg/ml (5%) or Glucose Infusion 100 mg/ml (10%) may be used as solvent for the reconstitution and dilution. Sodium Chloride containing solvents must not be used. Reconstitution: Shake the vial prior to the reconstitution to loosen up the powder. Reconstitute the 4 gm vials with 20 ml of solvent. Shake well to dissolve. A slight degree of warming occurs when the powder is dissolved. Dilution: Transfer the reconstituted contents of 4 gm vials into an infusion container with further 80 ml of solvent. The resulting solution for infusion is clear and colorless to slightly yellowish. Duration of treatment: Treatment duration should take into account the type of infection, the severity of the infection as well as the patient's clinical response.

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 Fosfomycin 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.

No clinical data on pregnancies are available. Fosfomycin should therefore not be prescribed to pregnant women unless the benefit outweighs the risk. After the administration of Fosfomycin, low quantities of fosfomycin were found in human milk. Fosfomycin should therefore not be administered during lactation unless the benefit outweighs the risk.

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.