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Osmitrol in Aviva

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Osmitrol Injection in Aviva

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.

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 like you might pass out;
  • feeling short of...

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.

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