Osmitrol in Viaflex
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Osmitrol Injection in Viaflex
OSMITROL Injection
(mannitol) Injection, USP in VIAFLEX 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 is adjusted with sodium hydroxide 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 | 5.0 (4.5 TO 7.0) |
| 10% OSMITROL Injection (10% Mannitol Injection, USP) |
500 | 100 | 549 | 5.0 (4.5 TO 7.0) |
| 1000 | ||||
| 15% OSMITROL Injection (15% Mannitol Injection, USP) |
500 | 150 | 823 | 5.0 (4.5 TO 7.0) |
| 20% OSMITROL Injection (20% Mannitol Injection, USP) |
250 | 200 | 1098 | 5.0 (4.5 TO 7.0) |
| 500 | ||||
| *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions ( > 600 mOsmol/L) may cause vein damage. | ||||
 |
The VIAFLEX 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.
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 Viaflex »
Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Osmitrol Injection in Viaflex 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.
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