A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Mannitol Warnings, Precautions, Pregnancy, Nursing, Abuse - Mannitol
Mannitol Warnings, Precautions, Pregnancy, Nursing, Abuse - Mannitol
WARNINGS
1. 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.
2. The obligatory diuretic response following rapid infusion of 25% mannitol
may further aggravate pre-existing hemoconcentration. Excessive loss of
water and electrolytes may lead to serious imbalances. Serum sodium and
potassium should be carefully monitored during mannitol administration.
3. 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 extracellular fluid which may intensify existing or latent congestive
heart failure.
4. 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.
5. 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.
6. Mannitol injection may increase cerebral blood wflow and the risk of
postoperative bleeding in neurosurgical patients.
7. For intravenous use only. Do not administer intramuscularly or subcutaneously.
Never add mannitol in whole blood for transfusion.
8. Mannitol may increase the cerebral blood wflow and worsen intracranial
hypertension in children who develop a generalized cerebral hyperemia
during the first 24 to 48 hours post injury.
PRECAUTIONS
1. 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.
2. Shift of sodium-free intracellular fluid into the extracellular compartment
following mannitol infusion may lower serum sodium concentration and aggravate
pre-existing hyponatremia.
3. By sustaining diuresis, mannitol administration may obscure and intensify
inadequate hydration or hypovolemia.
4. 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.
5. 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.
6. 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
See DOSAGE AND ADMINISTRATION
section. Safety and effectiveness of solutions from flexible plastic containers
in pediatric patients have not been well established.
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