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...

Read All Potential Side Effects and See Pictures of Osmitrol Injection in Viaflex


Osmitrol Injection in Viaflex Patient Information Including Side Effects

Brand Names: Osmitrol

Generic Name: mannitol (Pronunciation: MAN it ol)

  • What is mannitol (Osmitrol Injection in Viaflex)?
  • What are the possible side effects of mannitol (Osmitrol Injection in Viaflex)?
  • What is the most important information I should know about mannitol (Osmitrol Injection in Viaflex)?
  • What should I discuss with my health care provider before receiving mannitol (Osmitrol Injection in Viaflex)?
  • How is mannitol given (Osmitrol Injection in Viaflex)?
  • What happens if I miss a dose (Osmitrol Injection in Viaflex)?
  • What happens if I overdose (Osmitrol Injection in Viaflex)?
  • What should I avoid while receiving mannitol (Osmitrol Injection in Viaflex)?
  • What other drugs will affect mannitol (Osmitrol Injection in Viaflex)?
  • Where can I get more information?

What is mannitol (Osmitrol Injection in Viaflex)?

Mannitol is a diuretic.

Mannitol is used to force urine production in people with acute (sudden) kidney failure. Increased urine production helps prevent the kidneys from shutting down, and also speeds up elimination of certain toxic substances in the body.

Mannitol is also used to reduce swelling and pressure inside the eye or around the brain.

Mannitol may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mannitol (Osmitrol Injection in Viaflex)?

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 breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • if you stop urinating.

Less serious side effects may include:

  • nausea, vomiting;
  • runny nose;
  • dizziness;
  • chills; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mannitol (Osmitrol Injection in Viaflex)?

You should not be treated with this medication if you are allergic to mannitol, or if you have severe or long-term kidney disease, lung swelling or congestion, severe dehydration, bleeding in your brain not caused by surgery, or if your kidneys have already shut down and you are unable to urinate.

To be sure mannitol is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine how long to treat you with mannitol. Your heart function will also need to be tested.

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