Pronunciation:

MAN-i-tol

Brand Names:

• Osmitrol

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Diuretic, Osmotic

Uses of This Medicine:

Mannitol injection is used to lower pressure in the head (intracranial pressure) and increased pressure in the eye (intraocular pressure). It is also used to treat swelling of the brain (cerebral edema).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mannitol injection in children. However, children younger than 2 years of age, especially preterm and term neonates, are more likely to have fluid and electrolyte abnormalities. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prochlorperazine in the elderly. However, elderly patients are more likely to have fluid and electrolyte imbalances and age-related kidney, heart, or lung problems, which may require caution in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amikacin
• Amikacin Liposome
• Arsenic Trioxide
• Droperidol
• Levomethadyl
• Sotalol
• Tobramycin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anuria (cannot pass urine) or
• Hypovolemia (low blood volume), severe or
• Intracranial bleeding, active (except during craniotomy or head surgery) or
• Lung or breathing problems, severe (eg, congestion, fluid or swelling in the lungs)—Should not be used in patients with these conditions.

• Brain problems (eg, compromised blood-brain barrier) or
• Congestive heart failure or
• Kidney disease—Use with caution. May make this condition worse.

• Fluid or electrolyte imbalance—Use with caution. Must be corrected first before receiving this medicine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so it will have to stay in place for at least 30 minutes.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to make sure this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Mannitol may increase your risk of having kidney problems, including kidney failure. Check with your doctor right away if you have blood in the urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, decreased awareness or responsiveness, severe sleepiness, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

This medicine may cause fluid or electrolyte imbalances (eg, hypernatremia, hyponatremia, hyperkalemia, hypokalemia, metabolic acidosis or alkalosis). These imbalances may cause or worsen other conditions, including an existing heart failure or dehydration. Talk to your doctor if you have concerns about this.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Agitation

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blue lips and fingernails

blurred vision

bulging soft spot on the head of an infant

change in the ability to see colors, especially blue or yellow

change in the amount or frequency of urine

changes in skin color

chest pain

chills

cloudy urine

confusion

cough

coughing that sometimes produces a pink frothy sputum

decreased awareness or responsiveness

decreased urination

depression

difficult or labored breathing

difficult, fast, or noisy breathing

difficulty swallowing

dilated neck veins

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

extreme tiredness or weakness

fainting

fast, irregular, pounding, or racing heartbeat or pulse

fever

headache

high blood pressure

hives, itching, skin rash

hostility

increase in heart rate

increased sweating

increased thirst

irregular breathing

irritability

lightheadedness

loss of appetite

loss of consciousness

mood changes

muscle pain, cramps, tremors, or twitching

nausea

nervousness

not able to pass urine

numbness or tingling in the hands, feet, or lips pain

pain in lower back or side

pain, redness, or pale skin at the injection site

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

rapid, deep breathing

restlessness

seizures

severe sleepiness

stomach cramps or pain

sunken eyes

tightness in the chest

trouble sleeping

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual weight gain or loss

vomiting

weakness or heaviness of the legs

wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Bone or muscle stiffness

difficulty in moving

general feeling of discomfort or illness

joint pain or swelling

lack or loss of strength

swelling or itching at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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