Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4074
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Mannitol (Injection, Solution)
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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/mbody 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/mbody
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/mbody 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/mbody
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.<br/>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.
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| dailymed-instance:descripti... |
Mannitol I.V. (Mannitol Injection, USP) is a sterile, nonpyrogenic
solution of mannitol in water for injection available in concentrations of
5%, 10%, 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.
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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.
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| dailymed-instance:supply |
Mannitol I.V. (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 crystals in the flexible container,
warm the unit to 70��C with agitation. Heat solution by using a dry-heat
cabinet with overwrap intact. The use of a water bath is not recommended.
To dissolve the crystals in the fliptop vial, 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 20% or 25% mannitol
concentrations, the administration set should include a filter. Exposure
of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Protect from freezing. It is recommended that the flexible containers be stored
at room temperature (25��C), however, brief exposure up to 40��C does
not adversely affect the product. Store Fliptop vials at controlled room temperature,
15��to 30��C (59��to 86��F). [See USP.] HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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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.<br/>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.<br/>Nursing Mothers:: Caution should be exercised when solutions from flexible
plastic containers are administered to a nursing mother.<br/>Pediatric Use:: See DOSAGE AND ADMINISTRATION sections. Safety and effectiveness
of solutions from flexible plastic containers in pediatric patients have not
been well established.
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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.
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Mannitol
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Mannitol (Injection, Solution)
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| dailymed-instance:adverseRe... |
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.
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| dailymed-instance:indicatio... |
Mannitol I.V. (Mannitol Injection, USP) is indicated for
the following purposes in adults and pediatric patients. Therapeutic Use Diagnostic Use Measurement
of glomerular filtration rate.
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Mannitol
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