Osmitrol Injection (Mannitol Injection, USP) is a sterile, nonpyrogenic solution
of Mannitol, USP in a single dose container for intravenous administration.
It contains no antimicrobial agents. Mannitol** is a six carbon sugar alcohol
prepared commercially by the reduction of dextrose. Although virtually inert
metabolically in humans, it occurs naturally in fruits and vegetables. Mannitol
is an obligatory osmotic diuretic. The pH may have been adjusted with sodium
hydroxide and/or hydrochloric acid. Composition, osmolarity, and pH are shown
in Table 1.
Table 1
| |
|
Composition |
|
Size
(mL) |
**Mannitol,
USP (g/L) |
*Osmolarity
mOsmol/L)
(calc) |
pH |
| 5% OSMITROL Injection (5% Mannitol Injection, USP) |
1000 |
50 |
274 |
5.5
(4.5 TO 7.0) |
| 10% OSMITROL Injection (10% Mannitol Injection, USP) |
500 |
100 |
549 |
5.5
(4.5 TO 7.0) |
| 1000 |
| 15% OSMITROL Injection (15% Mannitol Injection, USP) |
500 |
150 |
823 |
5.5
(4.5 TO 7.0) |
20% OSMITROL
Injection (20% Mannitol Injection, USP) |
250 |
200 |
1098 |
5.5(4.5 TO 7.0) |
| 250 |
| *Normal physiologic osmolarity range is approximately
280 to 310 m0smol/L. |
Administration of substantially hypertonic solutions ( ≥ 600 m0smol/L) may
cause vein damage.
The flexible container is made with non-latex plastic materials specially designed
for a wide range of parenteral drugs including those requiring delivery in containers
made of polyolefins or polypropylene. For example, the AVIVA container system
is compatible with and appropriate for use in the admixture and administration
of paclitaxel. In addition, the AVIVA container system is compatible with and
appropriate for use in the admixture and administration of all drugs deemed
compatible with existing polyvinyl chloride container systems. The solution
contact materials do not contain PVC, DEHP, or other plasticizers.
The suitability of the container materials has been established through biological
evaluations, which have shown the container passes Class VI U.S. Pharmacopeia
(USP) testing for plastic containers. These tests confirm the biological safety
of the container system.
The flexible container is a closed system, and air is prefilled in the container
to facilitate drainage. The container does not require entry of external air
during administration.
The container has two ports: one is the administration outlet port for the
attachment of an intravenous administration set and the other port has a medication
site for addition of supplemental medication (See Directions
for Use). The primary function of the overwrap is to protect the container
from the physical environment.
What are the possible side effects of mannitol (Osmitrol)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have any of the following symptoms. Some of these may be caused by your kidney condition and are not side effects of mannitol:
- dry mouth, increased thirst, blurred vision, or seizure (convulsions);
- swelling, pain, or skin changes where the medicine was injected;
- chest pain, fast heart rate;
- feeling...
Read All Potential Side Effects and See Pictures of Osmitrol Injection in Aviva »
Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.