Mannitol
Generic Name: mannitol
Brand Names:
Mannitol
DESCRIPTION Mannitol is a 6-carbon sugar alcohol and has the following structure: C 6 H 14 O 6 182.17 Mannitol occurs naturally in fruits and vegetables, and is metabolically inert in humans. Mannitol Injection, USP, 25%, an osmotic diuretic, is a sterile, nonpyrogenic solution of mannitol in Water for Injection. It is a supersaturated solution at room temperature. Each mL contains: Mannitol 250 mg; Water for Injection q.s. The osmolar concentration is 1372 mOsmol/L (calc.).
Overview
DESCRIPTION Mannitol is a 6-carbon sugar alcohol and has the following structure: C 6 H 14 O 6 182.17 Mannitol occurs naturally in fruits and vegetables, and is metabolically inert in humans. Mannitol Injection, USP, 25%, an osmotic diuretic, is a sterile, nonpyrogenic solution of mannitol in Water for Injection. It is a supersaturated solution at room temperature. Each mL contains: Mannitol 250 mg; Water for Injection q.s. The osmolar concentration is 1372 mOsmol/L (calc.).
Uses
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
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.
Side Effects
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.
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. 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.
Storage
HOW SUPPLIED: Mannitol Injection, USP, 25% Unit of Sale Strength Each NDC 84549-024-25 250 mg per mL 50 mL Single Dose Flip-off Top Vial Use only if solution is clear and seal intact and undamaged. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preservative Free. Discard unused portion.
Frequently Asked Questions
What is Mannitol used for?▼
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.
What are the side effects of Mannitol?▼
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.
What are the important warnings for Mannitol?▼
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. 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.