FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Mannitol Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For Intravenous Injection: Mannitol Injection, USP is indicated for:
- Promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.
- Reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass.
- Reduction of elevated intraocular pressure when it cannot be lowered by other means.
- Promotion of urinary excretion of toxic substances.
For Urologic Irrigation: Mannitol solution, 2.5 percent, is indicated for irrigation in transurethral prostatic resection or other transurethral surgical procedures.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Mannitol Manufacturers
-
American Regent, Inc.
Mannitol | American Regent, Inc.
Inspect the vial visually for particulate matter and discoloration prior to use. The contents of opened containers should be used promptly and unused contents should be discarded.
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 an hour).
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 3 to 5 minutes to produce an adequate urine flow (at least 30 to 50 mL/hr). If urine flow does not increase within 2 or 3 hours a second test dose may be given. If there is an inadequate response the patient should be re-evaluated.
Prevention of Acute Renal Failure (Oliguria): When used during surgery, immediately postoperatively or following trauma, 50 to 100 g of mannitol as a 5 to 25 percent solution may be given. The concentration and amount will depend upon the fluid requirements of the patient. Following suspected or actual hemolytic transfusion reactions 20 g of mannitol may be given intravenously over a 5 minute period to provoke diuresis. If diuresis does not occur the 20 g dose may be repeated. If there is an adequate urine flow (30 to 50 mL an hour) then intravenous fluids containing not more than 50 to 75 mEq of sodium per liter should be given in sufficient volume to match the desired urine flow (100 mL/hr) until fluids can be taken orally.
Treatment of Oliguria: The usual dose for treatment of oliguria is 50 to 100 g as a 15 to 25 percent solution.
Reduction of intracranial pressure, cerebral edema or intraocular pressure: A 25 percent solution of mannitol is recommended since its effectiveness depends on establishing intravascular hyperosmolarity. When used before or after surgery, a total dose of 1.5 to 2 g/kg can be given over a period of 30 to 60 minutes. Careful evaluation must be made of the circulatory and renal reserve prior to and during use of mannitol at this relatively high dose and rapid infusion rate. 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 may be observed within 15 minutes after starting infusion.
Maximal reduction of intraocular pressure occurs 30 to 60 minutes after injection.
Urinary excretion of toxic substances: Mannitol in 5 to 25 percent solutions is used as an infusion as long as indicated if the level of urinary output remains high. The concentration will depend upon the fluid requirement and urinary output. Intravenous water and electrolytes must be given to replace the loss of these substances in the urine, sweat and expired air. If benefits are not observed after 200 g of mannitol are given discontinue it.
PREPARATION OF SOLUTION for intravenous injection: Test dose – As supplied (25%) 5% = 50 mL of mannitol plus 200 mL of Dextrose 5% Injection
or appropriate electrolyte
vehicle 10% = 50 mL of mannitol plus 75 mL 15% = 50 mL of mannitol plus 33.3 mL 20% = 50 mL of mannitol plus 12.5 mL 25% = – As supplied –For Urological Irrigation: As 2.5 percent solution is used. The use of 2.5 percent mannitol solution minimizes the hemolytic effect of water alone, the entrance of hemolyzed blood into the circulation, and the resulting hemoglobinemia which is considered a major factor in producing serious renal complications.
Preparations of Dilutions For: Urologic Irrigation Concentration How Prepared 2.5% Add contents of two 50 mL vials (25 percent mannitol) to 900 mL Sterile Water for Injection -
General Injectables & Vaccines, Inc
Mannitol | General Injectables & Vaccines, Inc
Mannitol I.V. (Mannitol Injection, USP) should be administered only by intravenous infusion. 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. The usual adult dosage ranges from 50 to 200 g in a 24-hour period, but in most instances an adequate response will be achieved at a dosage of approximately 100 g/24 hours. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 mL/hr. The total dose should be adjusted according to the clinical response and adverse events (see WARNINGS).
Test Dose: A test dose of mannitol should be given prior to instituting Mannitol I.V. therapy for patients with marked oliguria or those believed to have inadequate renal function. In adults the dose is 0.2 g/kg body weight. In pediatric patients the dose is 0.2 g/kg body weight or 6 g/m2 body surface area. The infusion is given as a 15% to 25% solution over a period of 3 to 5 minutes to produce a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase, a second dose may be given; but if there is inadequate response, the patient should be re-evaluated.
Prevention of Acute Renal Failure (Oliguria): When used during cardiovascular or other types of surgery, 50 to 100 g of mannitol as a 5%, 10%, or 15% solution may be given. The concentration will depend on the fluid requirements of the patient.
Treatment of Oliguria: The usual dose to promote diuresis in oliguric patients: Adults, 300 to 400 mg/kg of body weight (21 to 28 g for a 70 kg patient) or up to 100 g of solution, given as a single dose (often in conjunction with furosemide); pediatric patients, 0.25 to 2 g/kg body weight or 60 g/m2 body surface area as a 15% to 20% solution over a period of 2 to 6 hours. Doses should not be repeated in patients with persistent oliguria.
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.
Adjunctive Therapy for Intoxications: As an agent to promote urinary excretion of toxic substances: Adults may receive a 5% to 25% solution for as long as indicated if urinary output remains high; pediatric patients may receive 2 g/kg of body weight of a 5% or 10% solution. The concentration will depend upon the fluid requirement and urinary output of the patient. If benefits are not observed after 200 g of mannitol are administered, discontinue the mannitol therapy. Intravenous water and electrolytes must be given to match the loss of these substances in the urine, sweat and expired air.
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.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives to the flexible container, use aseptic technique, mix thoroughly and do not store. 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).INSTRUCTIONS FOR USE - Flexible Container
To Open
Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Add Medication
1. Prepare additive port.
2. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.
3. The additive port may be protected by covering with an additive cap.
4. Mix container contents thoroughly.
Preparation for Administration
(Use aseptic technique)
1. Close flow control clamp of administration set.
2. Remove cover from outlet port at bottom of container.
3. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.
4. Suspend container from hanger.
5. Squeeze and release drip chamber to establish proper fluid level in chamber.
6. Open flow control clamp and clear air from set. Close clamp.
7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
8. Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.
INSTRUCTlONS FOR USE - Fliptop Vial
Remove cover and cleanse stopper with antiseptic before use. -
Fresenius Kabi Usa, Llc
Mannitol | Fresenius Kabi Usa, Llc
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 depend upon the fluid requirements of the patient. Following suspected or actual hemolytic transfusion reactions 20 g of mannitol may be given intravenously over a five minute period to provoke diuresis. If diuresis does not occur the 20 g dose may be repeated. If there is an adequate urine flow (30 to 50 mL/hr) then intravenous fluids containing not more than 50 to 75 mEq of sodium per liter should be given in sufficient volume to match the desired urine flow (100 mL/hr) until fluids can be taken orally.
Treatment of Oliguria–The usual dose for treatment of oliguria is 50 to 100 g as a 15 to 25% solution.
Reduction of Intracranial Pressure, Cerebral Edema or Intraocular Pressure–A 25% solution of mannitol is recommended since its effectiveness depends on establishing intravascular hyperosmolarity. When used before or after surgery, a total dose of 1.5 to 2 g/kg can be given over a period of 30 to 60 minutes. Careful evaluation must be made of the circulatory and renal reserve prior to and during use of mannitol at this relatively high dose and rapid infusion rate. 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 may be observed within 15 minutes after starting infusion.
Maximal reduction of intraocular pressure occurs 30 to 60 minutes after injection.
Urinary Excretion of Toxic Substances–Mannitol in 5 to 25% solutions is used as an infusion as long as indicated if the level of urinary output remains high. The concentration will depend upon the fluid requirement and urinary output. Intravenous water and electrolytes must be given to replace the loss of these substances in the urine, sweat and expired air. If benefits are not observed after 200 g of mannitol are given, discontinue it.
For Urologic Irrigation
A 2.5% solution is used. The use of 2.5% mannitol solution minimizes the hemolytic effect of water alone, the entrance of hemolyzed blood into the circulation, and the resulting hemoglobinemia which is considered a major factor in producing serious renal complications.
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 depend upon the fluid requirements of the patient. Following suspected or actual hemolytic transfusion reactions 20 g of mannitol may be given intravenously over a five minute period to provoke diuresis. If diuresis does not occur the 20 g dose may be repeated. If there is an adequate urine flow (30 to 50 mL/hr) then intravenous fluids containing not more than 50 to 75 mEq of sodium per liter should be given in sufficient volume to match the desired urine flow (100 mL/hr) until fluids can be taken orally.
Treatment of Oliguria–The usual dose for treatment of oliguria is 50 to 100 g as a 15 to 25% solution.
Reduction of Intracranial Pressure, Cerebral Edema or Intraocular Pressure–A 25% solution of mannitol is recommended since its effectiveness depends on establishing intravascular hyperosmolarity. When used before or after surgery, a total dose of 1.5 to 2 g/kg can be given over a period of 30 to 60 minutes. Careful evaluation must be made of the circulatory and renal reserve prior to and during use of mannitol at this relatively high dose and rapid infusion rate. 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 may be observed within 15 minutes after starting infusion.
Maximal reduction of intraocular pressure occurs 30 to 60 minutes after injection.
Urinary Excretion of Toxic Substances–Mannitol in 5 to 25% solutions is used as an infusion as long as indicated if the level of urinary output remains high. The concentration will depend upon the fluid requirement and urinary output. Intravenous water and electrolytes must be given to replace the loss of these substances in the urine, sweat and expired air. If benefits are not observed after 200 g of mannitol are given, discontinue it.
-
Cardinal Health
Mannitol | Cardinal Health
Mannitol I.V. (Mannitol Injection, USP) should be administered only by intravenous infusion. 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. The usual adult dosage ranges from 50 to 200 g in a 24-hour period, but in most instances an adequate response will be achieved at a dosage of approximately 100 g/24 hours. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 mL/hr. The total dose should be adjusted according to the clinical response and adverse events (see WARNINGS).
Test Dose: A test dose of mannitol should be given prior to instituting Mannitol I.V. therapy for patients with marked oliguria or those believed to have inadequate renal function. In adults the dose is 0.2 g/kg body weight. In pediatric patients the dose is 0.2 g/kg body weight or 6 g/m2 body surface area. The infusion is given as a 15% to 25% solution over a period of 3 to 5 minutes to produce a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase, a second dose may be given; but if there is inadequate response, the patient should be re-evaluated.
Prevention of Acute Renal Failure (Oliguria): When used during cardiovascular or other types of surgery, 50 to 100 g of mannitol as a 5%, 10%, or 15% solution may be given. The concentration will depend on the fluid requirements of the patient.
Treatment of Oliguria: The usual dose to promote diuresis in oliguric patients: Adults, 300 to 400 mg/kg of body weight (21 to 28 g for a 70 kg patient) or up to 100 g of solution, given as a single dose (often in conjunction with furosemide); pediatric patients, 0.25 to 2 g/kg body weight or 60 g/m2 body surface area as a 15% to 20% solution over a period of 2 to 6 hours. Doses should not be repeated in patients with persistent oliguria.
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.
Adjunctive Therapy for Intoxications: As an agent to promote urinary excretion of toxic substances: Adults may receive a 5% to 25% solution for as long as indicated if urinary output remains high; pediatric patients may receive 2 g/kg of body weight of a 5% or 10% solution. The concentration will depend upon the fluid requirement and urinary output of the patient. If benefits are not observed after 200 g of mannitol are administered, discontinue the mannitol therapy. Intravenous water and electrolytes must be given to match the loss of these substances in the urine, sweat and expired air.
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.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives to the flexible container, use aseptic technique, mix thoroughly and do not store.
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).
INSTRUCTIONS FOR USE - Flexible Container
To Open
Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Add Medication
Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly.Preparation for Administration
(Use aseptic technique)
Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber. Open flow control clamp and clear air from set. Close clamp. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. Regulate rate of administration with flow control clamp.WARNING: Do not use flexible container in series connections.
INSTRUCTlONS FOR USE - Fliptop Vial
Remove cover and cleanse stopper with antiseptic before use.
-
Fresenius Kabi Usa, Llc
Mannitol | Fresenius Kabi Usa, Llc
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 depend upon the fluid requirements of the patient. Following suspected or actual hemolytic transfusion reactions 20 g of mannitol may be given intravenously over a five minute period to provoke diuresis. If diuresis does not occur the 20 g dose may be repeated. If there is an adequate urine flow (30 to 50 mL/hr) then intravenous fluids containing not more than 50 to 75 mEq of sodium per liter should be given in sufficient volume to match the desired urine flow (100 mL/hr) until fluids can be taken orally.
Treatment of Oliguria–The usual dose for treatment of oliguria is 50 to 100 g as a 15 to 25% solution.
Reduction of Intracranial Pressure, Cerebral Edema or Intraocular Pressure–A 25% solution of mannitol is recommended since its effectiveness depends on establishing intravascular hyperosmolarity. When used before or after surgery, a total dose of 1.5 to 2 g/kg can be given over a period of 30 to 60 minutes. Careful evaluation must be made of the circulatory and renal reserve prior to and during use of mannitol at this relatively high dose and rapid infusion rate. 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 may be observed within 15 minutes after starting infusion.
Maximal reduction of intraocular pressure occurs 30 to 60 minutes after injection.
Urinary Excretion of Toxic Substances–Mannitol in 5 to 25% solutions is used as an infusion as long as indicated if the level of urinary output remains high. The concentration will depend upon the fluid requirement and urinary output. Intravenous water and electrolytes must be given to replace the loss of these substances in the urine, sweat and expired air. If benefits are not observed after 200 g of mannitol are given, discontinue it.
A 2.5% solution is used. The use of 2.5% mannitol solution minimizes the hemolytic effect of water alone, the entrance of hemolyzed blood into the circulation, and the resulting hemoglobinemia which is considered a major factor in producing serious renal complications.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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 depend upon the fluid requirements of the patient. Following suspected or actual hemolytic transfusion reactions 20 g of mannitol may be given intravenously over a five minute period to provoke diuresis. If diuresis does not occur the 20 g dose may be repeated. If there is an adequate urine flow (30 to 50 mL/hr) then intravenous fluids containing not more than 50 to 75 mEq of sodium per liter should be given in sufficient volume to match the desired urine flow (100 mL/hr) until fluids can be taken orally.
Treatment of Oliguria–The usual dose for treatment of oliguria is 50 to 100 g as a 15 to 25% solution.
Reduction of Intracranial Pressure, Cerebral Edema or Intraocular Pressure–A 25% solution of mannitol is recommended since its effectiveness depends on establishing intravascular hyperosmolarity. When used before or after surgery, a total dose of 1.5 to 2 g/kg can be given over a period of 30 to 60 minutes. Careful evaluation must be made of the circulatory and renal reserve prior to and during use of mannitol at this relatively high dose and rapid infusion rate. 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 may be observed within 15 minutes after starting infusion.
Maximal reduction of intraocular pressure occurs 30 to 60 minutes after injection.
Urinary Excretion of Toxic Substances–Mannitol in 5 to 25% solutions is used as an infusion as long as indicated if the level of urinary output remains high. The concentration will depend upon the fluid requirement and urinary output. Intravenous water and electrolytes must be given to replace the loss of these substances in the urine, sweat and expired air. If benefits are not observed after 200 g of mannitol are given, discontinue it.
-
Hospira, Inc.
Mannitol | Hospira, Inc.
Mannitol I.V. (Mannitol Injection, USP) should be administered only by intravenous infusion. 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. The usual adult dosage ranges from 50 to 200 g in a 24-hour period, but in most instances an adequate response will be achieved at a dosage of approximately 100 g/24 hours. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 mL/hr. The total dose should be adjusted according to the clinical response and adverse events (see WARNINGS).
Test Dose: A test dose of mannitol should be given prior to instituting Mannitol I.V. therapy for patients with marked oliguria or those believed to have inadequate renal function. In adults the dose is 0.2 g/kg body weight. In pediatric patients the dose is 0.2 g/kg body weight or 6 g/m2 body surface area. The infusion is given as a 15% to 25% solution over a period of 3 to 5 minutes to produce a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase, a second dose may be given; but if there is inadequate response, the patient should be re-evaluated.
Prevention of Acute Renal Failure (Oliguria): When used during cardiovascular or other types of surgery, 50 to 100 g of mannitol as a 5%, 10%, or 15% solution may be given. The concentration will depend on the fluid requirements of the patient.
Treatment of Oliguria: The usual dose to promote diuresis in oliguric patients: Adults, 300 to 400 mg/kg of body weight (21 to 28 g for a 70 kg patient) or up to 100 g of solution, given as a single dose (often in conjunction with furosemide); pediatric patients, 0.25 to 2 g/kg body weight or 60 g/m2 body surface area as a 15% to 20% solution over a period of 2 to 6 hours. Doses should not be repeated in patients with persistent oliguria.
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.
Adjunctive Therapy for Intoxications: As an agent to promote urinary excretion of toxic substances: Adults may receive a 5% to 25% solution for as long as indicated if urinary output remains high; pediatric patients may receive 2 g/kg of body weight of a 5% or 10% solution. The concentration will depend upon the fluid requirement and urinary output of the patient. If benefits are not observed after 200 g of mannitol are administered, discontinue the mannitol therapy. Intravenous water and electrolytes must be given to match the loss of these substances in the urine, sweat and expired air.
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.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives to the flexible container, use aseptic technique, mix thoroughly and do not store.
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).
INSTRUCTIONS FOR USE - Flexible Container
To Open
Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Add Medication
Prepare additive port.
Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.
The additive port may be protected by covering with an additive cap.
Mix container contents thoroughly.
Preparation for Administration
(Use aseptic technique)
Close flow control clamp of administration set.
Remove cover from outlet port at bottom of container.
Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.
Suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Open flow control clamp and clear air from set. Close clamp.
Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.
INSTRUCTlONS FOR USE - Fliptop Vial
Remove cover and cleanse stopper with antiseptic before use.
-
B. Braun Medical Inc.
Mannitol | B. Braun Medical Inc.
This solution is for intravenous use only.
The total dosage, concentration, and rate of administration should be governed by the nature and severity of the condition being treated, and the patient's fluid requirement and urinary output. The adult dosage ranges from 50 to 200 g in a 24-hour period, but in most cases an adequate response will be achieved at a usual dosage of approximately 100 g/24 hours. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 mL/hour. Lower mannitol concentrations and solutions containing sodium chloride are useful in preventing dehydration and electrolyte depletion. This outline of administration and dosage is only a general guide to therapy.
Dosage requirements for patients 12 years of age and under have not been established. As with adults, dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text.
Test DoseA test dose of mannitol should be given prior to instituting therapy for patients with marked oliguria or those believed to have inadequate renal function. Such test doses may be approximately 0.2 g/kg body weight (about 75 mL of a 20% solution) infused in a period of 3 to 5 minutes to produce a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase, a second test dose may be given. If response is inadequate, the patient should be reevaluated.
Prevention of Acute Renal Failure (Oliguria)When used during cardiovascular and other types of surgery, 50 to 100 g of mannitol may be given.
Treatment of OliguriaThe usual dose for treatment of oliguria is 100 g administered as a 20% solution.
Reduction of Intraocular PressureA dose of 1.5 to 2.0 g/kg as a 20% solution (7.5 to 10 mL/kg) may be given over a period as short as 30 minutes in order to obtain a prompt and maximal effect. 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.
Reduction of Intracranial PressureUsually a maximum reduction in intracranial pressure in adults can be achieved with a dose of 0.25 g/kg given not more frequently than every six to eight hours. An osmotic gradient between the blood and cerebrospinal fluid of approximately 10 mOsmol will yield a satisfactory reduction in intracranial pressure.
Adjunctive Therapy for IntoxicationsAs an agent to promote diuresis in intoxications, mannitol is indicated. The concentration will depend upon the fluid requirement and urinary output of the patient.
Measurement of glomerular filtration rate by creatinine clearance may be useful for determination of dosage.
It is recommended that 20% Mannitol Injection USP be administered through a blood filter set to ensure against infusion of mannitol crystals.
When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
This solution is intended for intravenous administration using sterile equipment.
The use of supplemental additive medication is not recommended.
Login To Your Free Account