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OSMITROL Injection (Mannitol Injection, USP)
in VIAFLEX Plastic Container
For Therapeutic Use Only
DESCRIPTION
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 is adjusted with sodium hydroxide 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 | 5.0
(4.5 TO 7.0) |
| 10% OSMITROL Injection (10% Mannitol Injection, USP) | 500 | 100 | 549 | 5.0
(4.5 TO 7.0) |
| 1000 |
| 15% OSMITROL Injection (15% Mannitol Injection, USP) | 500 | 150 | 823 | 5.0
(4.5 TO 7.0) |
| 20% OSMITROL Injection (20% Mannitol Injection, USP) | 250 | 200 | 1098 | 5.0
(4.5 TO 7.0) |
| 500 |
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
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CLINICAL PHARMACOLOGY
OSMITROL Injection (Mannitol Injection, USP) is one of the nonelectrolyte, obligatory, osmotic diuretics. It is freely filterable at the renal glomerulus, only poorly reabsorbed by the renal tubule, not secreted by the tubule, and is pharmacologically inert.
Mannitol, when administered intravenously, exerts its osmotic effect as a solute of relatively small molecular size being largely confined to the extracellular space. Only relatively small amounts of the dose administered is metabolized. Mannitol is readily diffused through the glomerulus of the kidney over a wide range of normal and impaired kidney function. In this fashion, approximately 80% of a 100 gram dose of mannitol will appear in the urine in three hours with lesser amounts thereafter. Even at peak concentrations, mannitol will exhibit less than 10% of tubular reabsorption and is not secreted by tubular cells. Mannitol will hinder tubular reabsorption of water and enhance excretion of sodium and chloride by elevating the osmolarity of the glomerular filtrate.
This increase in extracellular osmolarity effected by the intravenous administration of mannitol will induce the movement of intracellular water to the extracellular and vascular spaces. This action underlies the role of mannitol in reducing intracranial pressure, intracranial edema, and elevated intraocular pressure.
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