"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
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Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.
Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of Colyte. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.
To report suspected adverse events contact Meda Pharmaceuticals Inc. at toll free 1-888-317-0001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Read the CoLyte (peg electrolytes solution) Side Effects Center for a complete guide to possible side effects
Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities
Use caution when prescribing Colyte for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizures, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate (see PRECAUTIONS) in patients taking these concomitant medications.
Potential for Altered Drug Absorption
Oral medication administered within one hour of the start of administration of Colyte may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.
Last reviewed on RxList: 8/29/2013
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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