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 Online, Description, Chemistry, Ingredients - Mannitol
Mannitol Online, Description, Chemistry, Ingredients - Mannitol
DESCRIPTION
Mannitol I.V. (Mannitol Injection, USP) is a sterile, nonpyrogenic 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.
The content and characteristics of the available concentrations are as
follows:
| Conc. (%) |
g/100 ml |
mOsmol/liter (calc.) |
pH* |
| 5 |
5 |
274 |
6.3 (4.5 to 7.0) |
| 10 |
10 |
549 |
6.3 (4.5 to 7.0) |
| 15 |
15 |
823 |
6.3 (4.5 to 7.0) |
| 20 |
20 |
1098 |
6.3 (4.5 to 7.0) |
| 25 |
25 |
1372 |
5.9 (4.5 to 7.0) |
*Concentrations up to 20% may contain sodium bicarbonate for pH adjustment;
the 25% concentration may contain sodium bicarbonate and/or hydrochloric
acid for pH adjustment.
The solutions contain no bacteriostat, antimicrobial agent or added buffer
(except for pH adjustment) and each is intended only as a single-dose
injection. When smaller doses are required the unused portion should be
discarded.
Mannitol Injection, USP is a parenteral obligatory osmotic diuretic.
Mannitol, USP is chemically designated D-mannitol (C6H14O6),
a white crystalline powder or free-flowing granules freely soluble in
water.
Water for Injection, USP is chemically designated H20.
The flexible plastic container is fabricated from a specially formulated
polyvinylchloride. Water can permeate from inside the container into the
overwrap, but not in amounts sufficient to affect the solution significantly.
Solutions in contact with the plastic container may leach out certain
chemical components from the plastic in very small amounts; however, biological
testing was supportive of the safety of the plastic container materials.
Exposure to temperatures above 25°C/77°F during transport and storage
will lead to minor losses in moisture content. Higher temperatures lead
to greater losses. It is unlikely that these minor losses will lead to
clinically significant changes within the expiration period.
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