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Mannitol
Overview
What is Mannitol?
Mannitol intravenous (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of mannitol in water for injection available in concentrations of 15%, 20% in flexible plastic containers and 25% in a fliptop vial for administration by intravenous infusion only.
The content and characteristics of the available concentrations are as follows:
*Concentrations up to 20% may contain sodium bicarbonate for pH adjustment; the 25% concentration may contain sodium bicarbonate and/or hydrochloric acid for pH adjustment.
The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each 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 (CHO), a white crystalline powder or free-flowing granules freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H0.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap, but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
What does Mannitol look like?
What are the available doses of Mannitol?
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What should I talk to my health care provider before I take Mannitol?
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How should I use Mannitol?
Mannitol intravenous (Mannitol Injection, USP) is indicated for the following purposes in adults and pediatric patients.
Therapeutic Use
Diagnostic Use
Measurement of glomerular filtration rate.
Mannitol intravenous (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 ).
Test Dose:
Prevention of Acute Renal Failure (Oliguria):
Treatment of Oliguria:
Reduction of Intracranial Pressure and Brain Mass:
Reduction of Intraocular Pressure:
Adjunctive Therapy for Intoxications:
Measurement of Glomerular Filtration Rate (GFR):
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 ).
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
Preparation for Administration
(Use aseptic technique)
WARNING: Do not use flexible container in series connections.
Remove cover and cleanse stopper with antiseptic before use.
What interacts with Mannitol?
- 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.
- Do not administer to patients with a known hypersensitivity to mannitol.
What are the warnings of Mannitol?
In patients with severe impairment of renal function, a test dose should be utilized (see ). A second test dose may be tried if there is an inadequate response, but no more than two test doses should be attempted.
The obligatory diuretic response following rapid infusion of 25% mannitol may further aggravate pre-existing hemoconcentration. Excessive loss of water and electrolytes may lead to serious imbalances. Serum sodium and potassium should be carefully monitored during mannitol administration.
If urine output continues to decline during mannitol infusion, the patient's clinical status should be closely reviewed and mannitol infusion suspended if necessary. Accumulation of mannitol may result in overexpansion of the extracellular fluid which may intensify existing or latent congestive heart failure.
Excessive loss of water and electrolytes may lead to serious imbalances. With continued administration of mannitol, loss of water in excess of electrolytes can cause hypernatremia. Electrolyte measurements, including sodium and potassium are therefore of vital importance in monitoring the infusion of mannitol.
Osmotic nephrosis, a reversible vacuolization of the tubules of no known clinical significance, may proceed to severe irreversible nephrosis, so that the renal function must be closely monitored during mannitol infusion.
Mannitol injection may increase cerebral blood flow and the risk of postoperative bleeding in neurosurgical patients.
For intravenous use only. Do not administer intramuscularly or subcutaneously. Never add mannitol in whole blood for transfusion.
Mannitol may increase the cerebral blood flow and worsen intracranial hypertension in children who develop a generalized cerebral hyperemia during the first 24 to 48 hours post injury.
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What are the precautions of Mannitol?
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies with solutions from flexible plastic containers have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Pregnancy Category C.
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.
Nursing Mothers:
Caution should be exercised when solutions from flexible plastic containers are administered to a nursing mother.
Pediatric Use:
(See sections.) Safety and effectiveness of solutions from flexible plastic containers in pediatric patients have not been well established.
The cardiovascular status of the patient should be carefully evaluated before rapidly administering mannitol since sudden expansion of the extracellular fluid may lead to fulminating congestive heart failure.
Shift of sodium-free intracellular fluid into the extracellular compartment following mannitol infusion may lower serum sodium concentration and aggravate pre-existing hyponatremia.
By sustaining diuresis, mannitol administration may obscure and intensify inadequate hydration or hypovolemia.
Electrolyte-free mannitol solutions should not be given conjointly with blood. If it is essential that blood be given simultaneously, at least 20 mEq of sodium chloride should be added to each liter of mannitol solution to avoid pseudoagglutination.
When exposed to low temperatures, solutions of mannitol may crystallize. If crystals are observed, the container should be warmed to redissolve, then cooled to body temperature before administering. (See under .) When infusing 20% or 25% mannitol concentrations, the administration set should include a filter. Do not infuse mannitol solution if crystals are present.
Do not administer unless solution is clear and container is undamaged. Discard unused portion. Do not administer Mannitol 25% if the fliptop vial seal is not intact.
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What are the side effects of Mannitol?
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.
What should I look out for while using Mannitol?
What might happen if I take too much Mannitol?
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 , , and ).
How should I store and handle Mannitol?
Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Mannitol intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows:NOTEProtect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]EN-408312/2015Hospira, Inc., Lake Forest, IL 60045 USAMannitol intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows:NOTEProtect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]EN-408312/2015Hospira, Inc., Lake Forest, IL 60045 USAMannitol intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows:NOTEProtect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]EN-408312/2015Hospira, Inc., Lake Forest, IL 60045 USAMannitol intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows:NOTEProtect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]EN-408312/2015Hospira, Inc., Lake Forest, IL 60045 USAMannitol intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows:NOTEProtect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]EN-408312/2015Hospira, Inc., Lake Forest, IL 60045 USAMannitol intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows:NOTEProtect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]EN-408312/2015Hospira, Inc., Lake Forest, IL 60045 USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
In vitro
Studies with solutions from flexible plastic containers have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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