Isovue-300

Name: Isovue-300

Isovue-300 (iopamidol) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, iopamidol may cause a severe drug reaction that can affect many parts of the body. This type of reaction can start several weeks after you begin using this medicine. Seek medical treatment if you have new or worsening symptoms of fever, facial swelling, a red or blistering skin rash, flu symptoms, swollen glands, feeling weak or tired, severe tingling or numbness, upper stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes), weight loss, pain or burning when you urinate, lower back pain, swelling in your legs or feet, cough, chest pain, or trouble breathing.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • swelling, rapid weight gain, little or no urinating;

  • wheezing or trouble breathing;

  • seizure (convulsions);

  • swelling in your neck or throat (enlarged thyroid);

  • thyroid symptoms--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain;

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • chest pain;

  • slow heart rate;

  • hot flashes, burning sensation;

  • flushing (warmth, redness, or tingly feeling);

  • nausea;

  • hives; or

  • dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before Using Isovue-300

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of iopamidol injection in children. However, children are more likely to have side effects, which may require caution in patients receiving this medicine.

Geriatric

Appropriate studies on the relationship of age to the effects of iopamidol injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

Interactions with 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Metformin

Interactions with Food/Tobacco/Alcohol

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:

  • Allergic rhinitis (hay fever) or
  • Allergy to a contrast agent, history of or
  • Allergy to iodine or
  • Asthma—Use with caution. May increase risk of having allergic reactions.
  • Anuria (not able to pass urine) or
  • Blood vessel disease, severe or
  • Congestive heart failure or
  • Dehydration or
  • Diabetes or
  • Diabetic nephropathy or
  • Kidney disease or
  • Multiple myeloma (cancer of plasma cells) or
  • Paraproteinemia (high amount of paraprotein in the blood)—May increase risk of having kidney failure.
  • Blood clotting problems (eg, phlebitis, thrombosis) or
  • Heart or blood vessel disease (eg, arteriosclerosis) or
  • Hyperthyroidism (overactive thyroid) or
  • Kidney disease, severe or
  • Liver disease or
  • Myasthenia gravis or
  • Pheochromocytoma (adrenal problem) or
  • Pulmonary hypertension or
  • Sickle cell anemia (inherited blood disorder)—Use with caution. May make these conditions worse.
  • Homocystinuria (genetic disease)—Patients with this condition should avoid undergoing angiography because of the increase risk of having blood clotting problems.
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