Osmitrol in Viaflex
"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
Osmitrol Injection in Viaflex
Osmitrol in Viaflex Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Osmitrol Injection (mannitol) is a diuretic used to force urine production in people with acute (sudden) kidney failure. It is also used to reduce swelling and pressure inside the eye or around the brain. This medication is available in generic form. Common side effects include nausea, vomiting, runny nose, dizziness, chills, or skin rash.
The total dosage, concentration, and rate of administration of Osmitrol Injection is determined by the nature and severity of the condition being treated, fluid requirement, and urinary output. The usual adult dosage ranges from 20 to 100 g in a 24-hour period. Osmitrol Injection may interact with other drugs. Tell your doctor all medications and supplements you use. Osmitrol Injection may be harmful to a fetus. Before receiving Osmitrol Injection, tell your doctor if you are pregnant. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Osmitrol Injection (mannitol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Osmitrol in Viaflex in Detail - Patient Information: Side Effects
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;
- 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.
Read the entire detailed patient monograph for Osmitrol in Viaflex (Mannitol Injection in Viaflex Plastic Container) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Osmitrol in Viaflex FDA Prescribing Information: Side Effects
Extensive use of mannitol over the last several decades has produced recorded adverse events, in a variety of clinical settings, that are isolated or idiosyncratic in nature. None of these adverse reactions have occurred with any great frequency nor with any security in attributing them to mannitol.
The inability to clearly exclude the drug related nature of such events in these isolated reports prompts the necessity to list the reactions that have been observed in patients during or following mannitol infusion. In this fashion, patients have exhibited nausea, vomiting, rhinitis, local pain, skin necrosis and thrombophlebitis at the site of injection, chills, dizziness, urticaria, hypotension, hypertension, tachycardia, fever and angina-like chest pains.
Of far greater clinical significance is a variety of events that are related to inappropriate recognition and monitoring of fluid shifts. These are not intrinsic adverse reactions to the drug but the consequence of manipulating osmolarity by any agency in a therapeutically inappropriate manner. Failure to recognize severe impairment of renal function with the high likelihood of nondiuretic response can lead to aggravated dehydration of tissues and increased vascular fluid load. Induced diuresis in the presence of preexisting hemoconcentration and preexisting deficiency of water and electrolytes can lead to serious imbalances. Expansion of the extracellular space can aggravate cardiac decompensation or induce it in the presence of latent heart failure. Pulmonary congestion or edema can be seriously aggravated with the expansion of the extracellular and therefore intravascular fluid load. Hemodilution and dilution of the extracellular fluid space by osmotic shift of water can induce or aggravate preexisting hyponatremia.
If unrecognized, such fluid and/or electrolyte shift can produce the reported adverse reactions of pulmonary congestion, acidosis, electrolyte loss, dryness of mouth, thirst, edema, headache, blurred vision, convulsions and congestive cardiac failure.
These are not truly adverse reactions to the drug and can be appropriately prevented by evaluation of degree of renal failure with a test dose response to mannitol when indicated; evaluation of hypervolemia and hypovolemia; sodium and potassium levels; hemodilution or hemoconcentration; and evaluation of renal, cardiac and pulmonary function at the onset of therapy.
Read the entire FDA prescribing information for Osmitrol in Viaflex (Mannitol Injection in Viaflex Plastic Container) »
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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