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Gadodiamide (Intravenous route)

Pronunciation:

gad-oh-DYE-a-mide

Brand Names:

  • Omniscan

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

Gadodiamide is not for intrathecal use. Inadvertent intrathecal use has caused convulsions, coma, and sensory and motor neurologic deficits. Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Do not administer to patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m(2)) or acute kidney injury. Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .

Classifications:

Therapeutic—

Radiological Non-Ionic Contrast Media

Uses of This Medicine:

Gadodiamide is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of diagnostic procedure. They use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation. Gadodiamide is a gadolinium-based contrast agent (GBCA).

Gadodiamide is given by injection before MRI to help diagnose problems in the brain, spine, chest, stomach, hip area, and other parts of your body.

This medicine is to be used only by or under the direct supervision of a 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 gadodiamide in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadodiamide in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gadodiamide.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

  • Asthma or allergies, history of or
  • Infection, severe or
  • Kidney problems, mild to moderate or
  • Seizures, history of—Use with caution. May cause side effects to become worse.
  • Diabetes or
  • Hypertension (high blood pressure)—Use with caution. May increase risk for kidney problems.
  • Kidney problems, severe (recent or long-term)—Should not be used in patients with this condition.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have an MRI scan.

Precautions While Using This Medicine:

Check with your doctor right away if you or your child have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

Make sure your doctor knows that you or your child have used this medicine. This medicine may affect the results of certain medical tests (e.g., serum iron or calcium).

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:

Less common or rare
Agitation
bloody, black, or tarry stools
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
change in consciousness
changes in skin color
chest pain or discomfort
clumsiness or unsteadiness
confusion
cough
decreased urine output
depression
difficult or labored breathing
difficulty controlling your bladder or bowels
difficulty swallowing
difficulty walking
dilated neck veins
dizziness
extreme fatigue
fainting
fast, slow, or irregular heartbeat
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
feeling sad or depressed
feeling unusually cold
flushing or redness of the skin, especially on the face and neck
forgetful
general feeling of discomfort or illness
headache
headache, severe and throbbing
hives
hostility
irregular breathing
irritability
itching
lethargy
loss of bladder control
loss of consciousness
muscle cramps
muscle twitching
nausea
numbness or tingling in your arms, legs, or face
pain or discomfort in the arms, jaw, back, or neck
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
redness of the face, neck, arms, and occasionally, upper chest
seizures
shakiness and unsteady walk
shakiness in the legs, arms, hands, or feet
shivering
shortness of breath
skin rash
slurred speech or problems swallowing
stupor
sudden sweating
sweating
swelling of the face, fingers, feet, ankles, or lower legs
tenderness
tightness in the chest
total body jerking
trembling or shaking of the hands or feet
troubled breathing
unsteadiness, trembling, or other problems with muscle control or coordination
unusual tiredness or weakness
vomiting
weight gain
wheezing
Incidence not known
Burning or itching of the skin
joint stiffness
limited range of motion in the arms and legs
muscle weakness
pain that is deep in the hip bone or ribs
partial or slight paralysis
red or dark patches on the skin
skin swelling, hardening, or tightening

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:

Less common or rare
Abdominal or stomach pain
bad, unusual, or unpleasant (after) taste
belching
bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
bloated or full feeling
change in taste
changes in vision
continuing ringing or buzzing or other unexplained noise in the ears
diarrhea
difficulty with moving
dry mouth
excess air or gas in the stomach
hearing loss
hives or welts
increased sweating
joint pain
muscle pains or stiffness
redness of the skin
runny nose
sneezing
stuffy nose
swollen joints

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.


Last Updated: 4/4/2014

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