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Osmitrol in Viaflex

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Osmitrol Injection in Viaflex

OSMITROL Injection
(mannitol) Injection, USP in VIAFLEX Plastic Container

For Therapeutic Use Only

Osmitrol Injection in Viaflex

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.

Mannitol structural formula illustration

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.

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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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