"The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
GCTB generally occurs in a"...
(mannitol) Injection, Solution
Flexible Plastic Container
Mannitol I.V. (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of mannitol (mannitol (mannitol injection) injection) in water for injection available in concentrations of 5%, 10%, 15%, 20% in flexible plastic containers and 25% in a Fliptop vial for administration by intravenous infusion only.
The content and characteristics of the available concentrations are as follows:
|Conc. (%)||g/100 mL||mOsmol/liter (calc.)||pH*|
|5||5||274||6.3 (4.5 to 7.0)|
|10||10||549||6.3 (4.5 to 7.0)|
|15||15||823||6.3 (4.5 to 7.0)|
|20||20||1098||6.3 (4.5 to 7.0)|
|25||25||1372||5.9 (4.5 to 7.0)|
|*Concentrations up to 20% may contain sodium bicarbonate for pH adjustment; the 25% concentration may contain sodium bicarbonate and/or hydrochloric acid for pH adjustment.|
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 (mannitol (mannitol injection) injection) Injection, USP is a parenteral obligatory osmotic diuretic.
Mannitol, USP is chemically designated D-mannitol (mannitol (mannitol injection) injection) (C6H14O6), a white crystalline powder or free-flowing granules freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H20.
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.
Last reviewed on RxList: 9/30/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Mannitol IV Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.