Sanofos IV

Sanofos IV Special Precautions



Able Medical


Universal Medical Industry


Able Medical
Full Prescribing Info
Special Precautions
Consideration should be given to co-administering intravenous fosfomycin with another antibacterial agent, taking into account the remaining susceptibilities of the pathogen(s) under treatment. As it is unknown whether the development of antibacterials should also be considered in order to prevent the emergence of resistance.
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 oedema. During prolonged treatment with high doses, blood potassium levels should be monitored in particular in digitalized heart failure patients (possible hypokalaemia, see Adverse Reactions).
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. The intravenous line should be left in place. Depending upon the clinical situation, appropriate emergency measures may need to be initiated.
Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents including fosfomycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patient who present with diarrhoea during or subsequent to the administration of fosfomycin.
Discontinuation of therapy with fosfomycin and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
In patients with severe renal insufficiency (creatinine clearance ≤ 40 ml/min), the elimination of fosfomycin is substantially slowed. See Dosage & Administration for appropriate dosing of fosfomycin in renal insufficiency.
Effects on ability to drive and use machine: Occasionally, even if the product is correctly administered, side effects may occur which impair the ability to drive and use machines (see also Adverse Reactions).
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