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Gadopentetate (Intravenous route)

Pronunciation:

gad-oh-PEN-te-tate dye-MEG-loo-meen

Brand Names:

  • Magnevist

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF), in patients with impaired elimination of the drugs (ie, chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury. 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. 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. 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:

Gadopentetate 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. Gadopentetate is a gadolinium-based contrast agent (GBCA).

Gadopentetate is given by injection before MRI to help diagnose problems in the brain, spine, head, neck, 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 gadopentetate 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—

No information is available on the relationship of age to the effects of gadopentetate in geriatric patients.

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
  • Patients who have had prior reactions to contrast media—Use with caution. May increase the likelihood of an allergic reaction.
  • Diabetes or
  • Hypertension (high blood pressure)—Use with caution. May increase your likelihood of having reduced kidney function.
  • Kidney disease, mild or moderate—Use with caution. May increase the likelihood of serious side effects.
  • Kidney problems, severe (acute 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 or your child 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:

It is very important that your doctor check the progress of you or your child while you are receiving this medicine and during the MRI scan. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

The risk of having a very serious disease called nephrogenic systemic fibrosis (NSF) is increased in patients with severe kidney disease. Even if you have severe kidney problems, your doctor may decide that it is still important to use 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, swelling, hardening, or tightening of the skin, 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 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.

Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.

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, bilirubin, or transaminase levels).

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:

Rare
Arm, back, or jaw pain
bluish color
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
changes in skin color
chest pain or discomfort
chest tightness or heaviness
chills
confusion
cough
difficult or labored breathing
difficulty with swallowing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fainting
fast, pounding, or irregular heartbeat or pulse
fever
headache
headache, severe and throbbing
hives
irritation of the throat
itching
loss of bladder control
loss of consciousness
nausea
nervousness
noisy breathing
pain or swelling of the treated skin
paleness of the skin
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red or irritated eyes
redness, tenderness, itching, burning, or peeling of the skin
runny nose
seizures
shortness of breath
skin rash
slow or fast heartbeat
sneezing
sore throat
stuffy nose
sweating
swelling of the foot or leg
swelling or puffiness of the face
tenderness
total body jerking
unusual tiredness or weakness
wheezing
Incidence not known
Agitation
blistering, peeling, or loosening of the skin
bluish color of the fingernails, lips, skin, palms, or nail beds
burning or itching of the skin
change in consciousness
coma
coughing that sometimes produces a pink frothy sputum
decreased urine output
depression
diarrhea
difficult, fast, or noisy breathing, sometimes with wheezing
difficulty with speaking
frequent strong or increased urge to urinate
hoarseness
hostility
increased sweating
irritability
joint or muscle pain
joint stiffness
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lethargy
limited range of motion in the arms and legs
muscle twitching or weakness
no blood pressure or pulse
no breathing
pain that is deep in the hip bone or ribs
pain, redness, or swelling in the arm or leg
rapid weight gain
red or dark patches on the skin
shakiness in the legs, arms, hands, or feet
skin swelling, hardening, or tightening
slow or irregular breathing
sores, ulcers, or white spots in the mouth or on the lips
spots on your skin resembling a blister or pimple
stopping of heart
stupor
swelling of the face, ankles, or hands
tenderness
tightness in the chest
trembling or shaking of the hands or feet
troubled breathing
unconsciousness

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
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
Rare
Abdominal or stomach discomfort or pain
bad, unusual, or unpleasant (after) taste
burning, dry, or itching eyes
change in taste
continuing ringing or buzzing or other unexplained noise in the ears
decrease or change in vision
difficulty having a bowel movement (stool)
discharge or excessive tearing
double vision
dry mouth
ear pain
eye pain
feeling cold or warm
hearing loss
hives or welts
hyperventilation
increased salivation
lack or loss of strength
loss of appetite
nervousness
pain in the tooth
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
restlessness
seeing double
skin rash
sleepiness or unusual drowsiness
tearing of the eyes
thirst
trouble sleeping
uncontrolled eye movements
vomiting
weight loss
Incidence not known
Blurred or loss of vision
change in sense of smell
difficulty with moving
disturbed color perception
double vision
halos around lights
muscle pain or stiffness
night blindness
overbright appearance of lights
poor hearing
tunnel vision

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: 11/4/2014

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