Gadoterate meglumine Solution for injection
What is this medicine?
GADOTERATE MEGLUMINE (gad oh TER ate MEG loo meen) is a contrast agent. It is used to diagnose abnormalities during a MRI.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual or allergic reaction to gadoterate, contrast agents, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This does not apply.
What may interact with this medicine?
Interactions are not expected.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
burning, pain, redness at site where injected
changes in vision
feeling faint or lightheaded, falls
pain, swelling, warmth in the leg
problems with balance, talking, walking
signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
feeling of cold or heat at site where injected
loss of appetite
unusual taste in the mouth
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert