Mannitol IV



What is Mannitol IV and how is it used?

Mannitol IV is a prescription medicine used to treat the symptoms of Elevated Intracranial or Intraocular Pressure. Mannitol IV may be used alone or with other medications.

Mannitol IV belongs to a class of drugs called Diuretics, Osmotic Agents.

What are the possible side effects of Mannitol IV?

Get medical help right away, if you have any of the symptoms listed above.

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Mannitol IV. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Mannitol I.V. (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of mannitol (mannitol (mannitol injection) injection) 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:

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 (mannitol (mannitol injection) injection) Injection, USP is a parenteral obligatory osmotic diuretic.

Mannitol, USP is chemically designated D-mannitol (mannitol (mannitol injection) injection) (C6H14O6), a white crystalline powder or free-flowing granules freely soluble in water. It has the following structural formula:

Mannitol  Structural Formula Illustration

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.

INDICATIONS

Mannitol I.V. (Mannitol (mannitol (mannitol injection) injection) Injection, USP) is indicated for the following purposes
in adults and pediatric patients.

Therapeutic Use

Diagnostic Use

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

Preparation for Administration (Use aseptic technique)

WARNINGS

HOW SUPPLIED

Mannitol I.V. (Mannitol (mannitol (mannitol injection) injection) Injection, USP) is supplied in single-dose containers
as follows:

List No. Conc. % Size (mL)
7712 5 1000 Flexible Container
7713 10 1000 Flexible Container
7714 15 500 Flexible Container
7715 20 250 Flexible Container
    500 Flexible Container
4031 25 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
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. FDA revision date:
11/18/2002


Mannitol  Structural Formula Illustration

SLIDESHOW

SIDE EFFECTS

Adverse reactions more commonly reported during or after the infusion of mannitol (mannitol (mannitol injection) injection)
include: Pulmonarycongestion, 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.

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 (mannitol (mannitol injection) injection) 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 .

WARNINGS

PRECAUTIONS

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 (mannitol (mannitol injection) injection) injection can cause fetal harm when given
to a pregnant woman or can affect reproduction. Mannitol (mannitol (mannitol injection) injection) 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.

OVERDOSE

Too rapid infusion of large amounts of mannitol (mannitol (mannitol injection) injection) 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, ,
and .

CONTRAINDICATIONS

CLINICAL PHARMACOLOGY

When administered intravenously mannitol (mannitol (mannitol injection) injection) 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 (mannitol (mannitol injection) injection) 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.

PATIENT INFORMATION

No information provided. Please refer to the
and sections.

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