MANNITOL- mannitol injection, solution
General Injectables & Vaccines, Inc
Mannitol intravenous (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of mannitol in water for injection available in a concentration of 25% in a fliptop vial for administration by intravenous infusion only.
The content and characteristics are as follows:
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.
Mannitol Injection, USP is a parenteral obligatory osmotic diuretic.
Mannitol, USP is chemically designated D-mannitol (C6H14O6), a white crystalline powder or free-flowing granules freely soluble in water. It has the following structural formula:
When administered intravenously mannitol is confined to the extracellular space, only slightly metabolized and rapidly excreted by the kidney. Approximately 80% of a 100 g dose appears in the urine in 3 hours. The drug is freely filtered by the glomeruli with less than 10% tubular reabsorption; it is not secreted by tubular cells. Mannitol induces diuresis by elevating the osmolarity of the glomerular filtrate and thereby hindering tubular reabsorption of water. Excretion of sodium and chloride is also enhanced.
Mannitol intravenous (Mannitol Injection, USP) is indicated for the following purposes in adults and pediatric patients.
Measurement of glomerular filtration rate.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Mannitol Injection (USP) have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Animal reproduction studies have not been conducted with mannitol injection. It is also not known whether mannitol injection can cause fetal harm when given to a pregnant woman or can affect reproduction. Mannitol injection should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when mannitol is administered to a nursing woman.
Adverse reactions more commonly reported during or after the infusion of mannitol include: Pulmonary congestion, fluid and electrolyte imbalance, acidosis, electrolyte loss, dryness of mouth, thirst, marked diuresis, urinary retention, edema, headache, blurred vision, convulsions, nausea, vomiting, rhinitis, arm pain, skin necrosis, thrombophlebitis, chills, dizziness, urticaria, dehydration, hypotension, tachycardia, fever and angina-like chest pains.
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Too rapid infusion of large amounts of mannitol 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).
Reduction of Intracranial Pressure and Brain Mass: In adults a dose of 0.25 to 2 g/kg body weight as a 15% to 25% solution administered over a period of 30 to 60 minutes; pediatric patients 1 to 2 g/kg body weight or 30 to 60 g/m2 body surface area over a period of 30 to 60 minutes. In small or debilitated patients, a dose of 500 mg/kg may be sufficient. Careful evaluation must be made of the circulatory and renal reserve prior to and during administration of mannitol at the higher doses and rapid infusion rates. Careful attention must be paid to fluid and electrolyte balance, body weight, and total input and output before and after infusion of mannitol. Evidence of reduced cerebral spinal fluid pressure must be observed within 15 minutes after starting infusion.
Reduction of Intraocular Pressure: In adults a dose of 0.25 to 2 g/kg body weight as a 15% to 25% solution administered over a period of 30 to 60 minutes; pediatric patients 1 to 2 g/kg body weight or 30 to 60 g/m2 body surface area over a period of 30 to 60 minutes. In small or debilitated patients, a dose of 500 mg/kg may be sufficient. When used preoperatively, the dose should be given one to one and one-half hours before surgery to achieve maximal reduction of intraocular pressure before operation.
Measurement of Glomerular Filtration Rate (GFR): 100 mL of a 20% solution (20 g) should be diluted with 180 mL of sodium chloride injection (normal saline) or 200 mL of a 10% solution (20 g) should be diluted with 80 mL of sodium chloride injection (normal saline). The resulting 280 mL of 7.2% solution is infused at a rate of 20 mL per minute. The urine is collected by catheter for a specific period of time and analyzed for mannitol excreted in mg per minute. A blood sample is drawn at the start and at the end of the time period and the concentration of mannitol determined in mg/mL of plasma. GFR is the number of mL of plasma that must have been filtered to account for the amount excreted per minute in the urine. Normal clearance rates are approximately 125 mL/minute for men; 116 mL/minute for women.
Additives may be incompatible. Consult with pharmacist, if available.
Do not place 25% Mannitol Injection, USP in polyvinylchloride bags; a white flocculent precipitate may form from contact with PVC surfaces. Parenteral drug products should be inspected visually for particulate matter and discoloration; whenever container and solution permit (see PRECAUTIONS).
Mannitol Intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows:
NOTE: Crystals may form in mannitol solutions especially if the solutions are chilled. To dissolve the crystals, warm the bottle in hot water at 80°C and periodically shake vigorously. 25% Mannitol Injection, USP may be autoclaved at 121°C for 20 minutes at 15 psi. Remove cover from fliptop vial and cleanse stopper with antiseptic before use. Cool to body temperature or less before administering. When infusing 25% mannitol concentrations, the administration set should include a filter.
Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
mannitol injection, solution
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