Mannitol 250 mg/mL
MANNITOL · INJECTION, SOLUTION · ProPharma Distribution
Mannitol is a injection, solution containing mannitol at 250 mg/mL, taken intravenous. Manufactured by ProPharma Distribution.
Key Facts
- Brand Name
- Mannitol
- Generic Name
- MANNITOL
- NDC Code (Product)
84549-024- Manufacturer
- ProPharma Distribution
- Strength
- 250 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA080677
- Drug Class
- Osmotic Diuretic [EPC]
- Marketing Start
- 03/19/2000
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE For Intravenous Injection Mannitol Injection, USP is indicated for the following therapeutic uses: • The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established. • The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass. • The reduction of elevated intraocular pressure when it cannot be lowered by other means. • The promotion of urinary excretion of toxic substances. For Urologic Irrigation Mannitol solution, 2.5% is indicated as an irrigation solution in transurethral prostatic resection or other transurethral surgical procedures.
Dosage & Administration
DOSAGE AND ADMINISTRATION For Intravenous Injection General Recommendations –Give mannitol injection only intravenously. The total dosage, concentration and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement and urinary output. Usual adult dosage ranges from 50 to 200 g in 24 hours but in most instances an adequate response will be achieved at a dosage of approximately 100 g in 24 hours. The rate is usually adjusted to maintain an adequate urine flow (at least 30 to 50 mL/hr). Test Dose –In marked oliguria or inadequate renal function a test dose of mannitol should be given. The test dose may be approximately 0.2 g/kg (about 50 mL of a 25% solution) infused in three to five minutes to produce an adequate urine flow (at least 30 to 50 mL/hr). If urine flow does not increase within two or three hours a second test dose may be given. If there is an inadequate response the patient should be reevaluated. Prevention of Acute Renal Failure (Oliguria) –When used during surgery, immediately postoperatively or following trauma, 50 to100 g of mannitol as a 5 to 25% solution maybe given. The concentration and amount will depen…
Warnings
WARNINGS In severe impairment of renal function a test dose should be given (see DOSAGE AND ADMINISTRATION ). A second test dose may be given if there is an inadequate response. No more than two test doses should be attempted. Excessive loss of water and electrolytes may lead to serious imbalances. Serum sodium and potassium should be carefully monitored during mannitol therapy. The diuresis after rapid infusion of mannitol may increase preexisting hemoconcentration. With continued use of mannitol a loss of water in excess of electrolytes can cause hypernatremia. Shift of sodium-free intracellular fluid into the extracellular compartment after mannitol infusion may lower serum sodium concentration and aggravate preexisting hyponatremia. Closely monitor the urine output and discontinue mannitol infusion promptly if output is low. Inadequate urine output results in accumulation of mannitol, expansion of extracellular fluid volume and could result in water intoxication or congestive heart failure. Renal function must be closely monitored during mannitol infusion. Mannitol solution must be used with caution in patients with significant cardiopulmonary or renal dysfunction. Irrigating s…
Contraindications
CONTRAINDICATIONS • 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 therapy, including increasing oliguria and azotemia. • Progressive heart failure or pulmonary congestion after mannitol therapy is started.
Adverse Reactions
ADVERSE REACTIONS Reactions are infrequent and may include: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Metabolic: fluid and electrolyte imbalance, acidosis, dehydration. Gastrointestinal: dryness of mouth, nausea, vomiting, diarrhea. Genitourinary: osmotic nephrosis, urinary retention. Central Nervous System: headache, convulsions, dizziness. Special Senses: Blurred vision, rhinitis. Cardiovascular: pulmonary edema, edema, hypotension, hypertension, tachycardia, angina-like chest pains. Dermatologic: skin necrosis, thrombophlebitis. Hypersensitivity: urticaria. Miscellaneous: thirst, arm pain, chills, fever.
Frequently Asked Questions
What is Mannitol used for?
Mannitol contains MANNITOL. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Mannitol a controlled substance?
Mannitol is not classified as a controlled substance by the DEA.
What is the generic name for Mannitol?
The generic name for Mannitol is MANNITOL. There are 4 other brand versions of MANNITOL.
What is the NDC code for Mannitol 250 mg/mL?
The NDC (National Drug Code) for Mannitol 250 mg/mL is 84549-024, listed by ProPharma Distribution.