Osmitrol Injection in Aviva (Mannitol Injection in Aviva Plastic Container) Drug Overview and Uses for Patients and Caregivers at RxList

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May 27, 2012

Osmitrol in Aviva

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Osmitrol Injection in Aviva

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OSMITROL
(mannitol) Injection, USP in AVIVA Plastic Container

For Therapeutic Use Only

DRUG 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 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.

OSMITROL Injection (Mannitol Injection, USP) Structural Formula Illustration

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.

Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.