Mannitol I.V. (Mannitol (mannitol (mannitol injection) injection) Injection, USP) is indicated for the following purposes
in adults and pediatric patients.
Promotion of diuresis in the prevention or treatment of the oliguric phase
of acute renal failure before irreversible renal failure becomes established.
Reduction of intracranial pressure and brain mass.
Reduction of high intraocular pressure when the pressure cannot be lowered
by other means.
Promotion of urinary excretion of toxic materials.
Measurement of glomerular filtration rate.
DOSAGE AND ADMINISTRATION
Mannitol I.V. (Mannitol (mannitol (mannitol injection) injection) 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: A test dose of mannitol should be given prior to instituting
Mannitol (mannitol (mannitol injection) injection) 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 (mannitol (mannitol injection) injection) 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/m 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 (mannitol (mannitol injection) injection) 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 (mannitol (mannitol injection) injection) . 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 (mannitol (mannitol injection) injection) 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 (mannitol (mannitol injection) injection) 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 (mannitol (mannitol injection) injection) 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.
INSTRUCTIONS FOR USE - Flexible Container
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
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
Regulate rate of administration with flow control clamp.
Do not use flexible container in series connections.
INSTRUCTlONS FOR USE - Fliptop Vial
Remove cover and cleanse stopper with antiseptic before use.
Mannitol I.V. (Mannitol (mannitol (mannitol injection) injection) Injection, USP) is supplied in single-dose containers
||% Size (mL)
||1000 Flexible Container
||1000 Flexible Container
||500 Flexible Container
||250 Flexible Container
||500 Flexible Container
||50 Fliptop Vial
NOTE: Crystals may form in mannitol (mannitol (mannitol injection) injection) 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 (mannitol (mannitol injection) injection) 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 (mannitol (mannitol injection) injection) concentrations, the administration set should include a
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. FDA revision date: