Mannitol Injection is sterilized, non-pyrogenic solution of mannitol in water for injection available in concentrations of 5%, 10%, 15%, 20% in flexible plastic containers and 25% in a Fliptop vial for administration by intravenous infusion only.
Warnings
In patients with severe impairment of renal function, a test dose should be utilized (see DOSAGE AND ADMINISTRATION). A second test dose may be tried if there is an inadequate response, but no more than two test doses should be attempted.
The obligatory diuretic response following rapid infusion of 25% mannitol may further aggravate pre-existing hem concentration. Excessive loss of water and electrolytes may lead to serious imbalances. Serum sodium and potassium should be carefully monitored during mannitol administration.
If urine output continues to decline during mannitol infusion, the patient's clinical status should be closely reviewed and mannitol infusion suspended if necessary. Accumulation of mannitol may result in overexpansion of the extra cellular fluid which may intensify existing or latent congestive heart failure.
Excessive loss of water and electrolytes may lead to serious imbalances. With continued administration of mannitol, loss of water in excess of electrolytes can cause hypernatremia. Electrolyte measurements, including sodium and potassium are therefore of vital importance in monitoring the infusion of mannitol.
Osmotic nephrosis, a reversible vacuolization of the tubules of no known clinical significance, may proceed to severe irreversible nephrosis, so that the renal function must be closely monitored during mannitol infusion.
Mannitol injection may increase cerebral blood flow and the risk of postoperative bleeding in neurosurgical patients.
For intravenous use only. Do not administer intramuscularly or subcutaneously. Never add mannitol in whole blood for transfusion.
Mannitol may increase the cerebral blood flow and worsen intracranial hypertension in children who develop a generalized cerebral hyperemia during the first 24 to 48 hours post injury.
PRECAUTIONS
The cardiovascular status of the patient should be carefully evaluated before rapidly administering mannitol since sudden expansion of the extracellular fluid may lead to fulminating 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 hyponatremia.
By sustaining diuresis, mannitol administration may obscure and intensify inadequate hydration or hypovolemia.
Electrolyte-free mannitol solutions should not be given conjointly with blood. If it is essential that blood be given simultaneously, at least 20 mEq of sodium chloride should be added to each liter of mannitol solution to avoid pseudoagglutination.
When exposed to low temperatures, solutions of mannitol may crystalize. If crystals are observed, the container should be warmed to redissolve, then cooled to body temperature before administering. See NOTE under HOW SUPPLIED. When infusing 20% or 25% mannitol concentrations, the administration set should include a filter. Do not infuse mannitol solution if crystals are present.
Do not administer unless solution is clear and container is undamaged. Discard unused portion. Do not administer Mannitol 25% if the Fliptop vial seal is not intact.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with solutions from flexible plastic containers have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Pregnancy Category C. Animal reproduction studies have not been conducted with mannitol injection. It is also not known whether mannitol injection can cause fetal harm when given to a pregnant woman or can affect reproduction. Mannitol injection should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Caution should be exercised when solutions from flexible plastic containers are administered to a nursing mother.
Pediatric Use
Safety and effectiveness of solutions from flexible plastic containers in pediatric patients have not well hygienic.