Osmitrol Injection in Aviva

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 may have been adjusted with sodium hydroxide and/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 5.5
(4.5 TO 7.0)
10% OSMITROL Injection (10% Mannitol Injection, USP) 500 100 549 5.5
(4.5 TO 7.0)
1000
15% OSMITROL Injection (15% Mannitol Injection, USP) 500 150 823 5.5
(4.5 TO 7.0)
20% OSMITROL
Injection (20% Mannitol Injection, USP)
250 200 1098 5.5(4.5 TO 7.0)
250
*Normal physiologic osmolarity range is approximately 280 to 310 m0smol/L.

Administration of substantially hypertonic solutions ( ? 600 m0smol/L) may cause vein damage.

OSMITROL Injection (Mannitol Injection, USP)    Structural Formula Illustration

The flexible container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP, or other plasticizers.

The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system.

The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration.

The container has two ports: one is the administration outlet port for the attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (See Directions for Use). The primary function of the overwrap is to protect the container from the physical environment.

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 Aviva


Osmitrol Injection in Aviva Patient Information Including Side Effects

Brand Names: Osmitrol

Generic Name: mannitol (Pronunciation: MAN it ol)

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

What is mannitol (Osmitrol Injection in Aviva)?

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 Aviva)?

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 Aviva)?

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.

Related Drug Centers
  • Osmitrol in Aviva
  • Osmitrol in Viaflex


Related Drugs Index: