Mannitol Injection

Product Description

Mannitol intravenous (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of mannitol in water for injection available in concentrations of 15%, 20% in flexible plastic containers and 25% in a fliptop vial for administration by intravenous infusion only.Concentrations up to 20% may contain sodium bicarbonate for pH adjustment; the 25% concentration may contain sodium bicarbonate and/or hydrochloric acid.

The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Mannitol Injection, USP is a parenteral obligatory osmotic diuretic.Mannitol, USP is chemically designated D-mannitol (C6H14O6), a white crystalline powder or free-flowing granules freely soluble in water.

It has the following structural formula.The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap, but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.