OSMITROL Solution for injection Ref.[10896] Active ingredients: Mannitol

Source: FDA, National Drug Code (US)  Revision Year: 2018 

Product description

OSMITROL is a sterile, nonpyrogenic solution of Mannitol, USP in a single-dose flexible container for intravenous administration as an osmotic diuretic. It contains no antimicrobial agents. Mannitol is a six carbon sugar alcohol prepared commercially by the reduction of dextrose. The pH is adjusted with sodium hydroxide or hydrochloric acid. Composition, osmolarity, and pH are shown in Table 1.

Table 1 Size Composition *Osmolarity pH
(mL) Mannitol, USP
(g/L) 		(mOsmol/L)
(calc)
5%
OSMITROL 		1000 50 274 5.0
(4.5 TO 7.0)
10%
OSMITROL 		500 100 549 5.0
(4.5 TO 7.0)
15%
OSMITROL 		500 150 823 5.0
(4.5 TO 7.0)
20%
OSMITROL 		250 200 1098 5.0
(4.5 TO 7.0)
500

* Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.

The 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.

Dosage Forms and Strengths

OSMITROL Injection:

  • 5% (0.05 grams/mL): 5 grams of mannitol, USP per 100 mL in a single-dose 1000 mL flexible container.
  • 10% (0.1 grams/mL): 10 grams of mannitol, USP per 100 mL in a single-dose 500 mL flexible container.
  • 15% (0.15 grams/mL): 15 grams of mannitol, USP per 100 mL in a single-dose 500 mL flexible container.
  • 20% (0.2 grams/mL): 20 grams of mannitol, USP per 100 mL in single-dose 250 mL and 500 mL flexible containers.
How Supplied

OSMITROL injection is supplied in single-dose, flexible VIAFLEX plastic containers and is available as follows:

Code Size (mL) NDC Product Name
2D5604 1000 0338-0351-04 5% (0.05 g/mL mannitol, USP)
2D5613 500 0338-0353-03 10% (0.1 g/mL mannitol, USP)
2D5623 500 0338-0355-03 15% (0.15 g/mL mannitol, USP)
2D5632 250 0338-0357-02 20% (0.2 g/mL mannitol, USP)
2D5633 500 0338-0357-03 20% (0.2 g/mL mannitol, USP)

Do not remove container from overwrap until intended for use.

Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Drugs

Drug Countries
OSMITROL Canada, Hong Kong, Mexico, New Zealand, United States
 
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