Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Caution in administration in renal failure and pregnancy. Prior to administration, careful assessment of the condition of the cardiovascular system is required, followed by continuous monitoring of diuresis and serum electrolytes.
Administration should not be repeated to patients who remain anuric following administration of a test dose.

Patients with pre-existing renal disease, or those receiving potentially nephrotoxic drugs, are at increased risk of renal failure following administration of mannitol. Serum osmolal gap and renal function should be closely monitored and necessary action initiated, should signs of worsening renal function appear.

In patients with shock and renal dysfunction, mannitol should not be administered until volume (fluid; blood) and electrolytes have been replaced.
Patients receiving mannitol should be monitored for any deterioration in renal, cardiac or pulmonary function and treatment discontinued in the case of adverse events.

The cardiovascular status of the patient should be carefully evaluated before rapidly administering mannitol, since sudden expansion of the extracellular fluid may cause sudden congestive heart failure.

Shift of sodium-free intracellular fluid into the extracellular compartment following mannitol infusion may lower serum sodium concentration and aggravate pre-existing hyponatraemia.
Sodium may be lost in the urine. Mannitol may obscure and intensify inadequate hydration and hypovolaemia.

Urinary output, fluid balance, central venous pressure and electrolyte balance (in particular serum sodium and potassium levels) should be carefully monitored.

Accumulation of mannitol may result if urine output continues to decline during administration and this may intensify existing or latent congestive heart failure.

Precautions during administration

Avoid extravasation (risk of local necrosis).
Mannitol in the 20% solution may crystallise.
To dissolve crystals, the bottle is heated in hot water and shaken vigorously.
The solution should be infused at body temperature (see section 6.6).
It is recommended to use a haemofilter when infusing 20% mannitol solution to prevent potential infusion of mannitol microcrystals.

Effects on Driving

4.7 Effects on ability to drive and use machines

Not relevant.