"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Too rapid infusion of large amounts of mannitol (mannitol (mannitol injection) injection) will cause a shift of intracellular water into the extracellular compartment resulting in cellular dehydration and overexpansion of the intravascular space with hyponatremia, congestive heart failure and pulmonary edema. Repeated doses should not be given to patients with persistent oliguria as this can produce a hyperosmolar state and precipitate congestive heart failure and pulmonary edema due to volume overload. Dosage must be carefully monitored and adjusted in accordance with the clinical situation to avoid the consequences of overdosage. See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and DOSAGE AND ADMINISTRATION.
- Well established anuria due to severe renal disease.
- Severe pulmonary congestion or frank pulmonary edema.
- Active intracranial bleeding except during craniotomy.
- Severe dehydration.
- Progressive renal damage or dysfunction after institution of mannitol (mannitol (mannitol injection) injection) therapy, including increasing oliguria and azotemia.
- Progressive heart failure or pulmonary congestion after institution of mannitol (mannitol (mannitol injection) injection) therapy.
- Do not administer to patients with a known hypersensitivity to mannitol.
Last reviewed on RxList: 9/30/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Mannitol IV Information
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