MANNITOL
INJECTION, USP
25% CONCENTRATION

Rx Only

Mannitol is an osmotic diuretic. It is a 6-carbon sugar alcohol with a molecular weight of 182.17. Its molecular formula is C₆H₁₄O₆ and its structural formula is:

Mannitol occurs naturally in fruits and vegetables. Mannitol Injection, USP is a sterile, nonpyrogenic, 25 percent solution of Mannitol in Water for Injection. It is a supersaturated solution at room temperature.

Each 50 mL contains: Mannitol 12.5 g, Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. The calculated osmolarity is 1.373 milliosmols per milliliter.

After intravenous injection, Mannitol is confined to the extracellular space, metabolized only slightly and excreted rapidly by the kidneys. Approximately 80 percent of a 100 g dose appears in the urine in 3 hours. Mannitol is freely filtered by the glomeruli with less than 10 percent tubular reabsorption. It is not secreted by tubular cells. It induces diuresis by elevating the osmolarity of the glomerular filtrate and thereby hinders tubular reabsorption of water. Urinary output of water and excretion of sodium and chloride are enhanced. Mannitol is poorly absorbed from the gastrointestinal tract. Mannitol solution is free of electrolytes and is used in urology as a nonhemolytic irrigant. The amount of mannitol absorbed intravascularly during transurethral prostatic surgery is variable and depends primarily on the extent of the surgery. Such mannitol is excreted by the kidneys and produces osmotic diuresis.

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 institution of mannitol therapy.

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 adequate 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 pre-existing 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 solutions used in transurethral prostatectomy have been shown to enter the systemic circulation in relatively large volumes, exert a systemic effect and may significantly alter cardiopulmonary and renal dynamics.

Reactions are infrequent and may include:

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, hypotension, hypertension, tachycardia, angina-like chest pains.

Dermatologic: skin necrosis, thrombophlebitis.

Hypersensitivity: urticaria.

Miscellaneous: thirst, arm pain, chills, fever.

Inspect the vial visually for particulate matter and discoloration prior to use. The spans of opened containers should be used promptly and unused spans should be discarded.

Mannitol Injection, USP 25% (12.5 g/50 mL)

0517-4050-25       50 mL Single Dose Vial       packaged in boxes of 25

Store at controlled room temperature 15°-30°C (59°-86°F) (See USP).

IN4050
Rev. 1/03
MG # 14063

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967