Ultravist

Pregnancy Category: B

Lactation: Excretion in breast milk unknown; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Included as part of the PRECAUTIONS section.

In the U.S.

• Ultravist

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

Iopromide injection is used to help diagnose or find problems in the brain, heart, head, blood vessels, and other parts of the body. It is an iodinated contrast agent. Contrast agents are used to create a clear picture of the different parts of the body during certain medical procedures such as CT scans and angiography.

This medicine is to be used only by or under the direct supervision of a doctor.

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 iopromide injection in children. However, safety and efficacy have not been established in children 2 years of age and younger.

Geriatric

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

Pregnancy

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.

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

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iocetamic Acid
• Iopanoic Acid
• Ipodate
• Tyropanoate Sodium

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, or history of or
• Allergy to food or
• Allergy to iodine or
• Asthma—Use with caution. May increase risk of having allergic reactions.

• Blood clotting problems (e.g., phlebitis, thrombosis) or
• Heart or blood vessel disease or
• Hyperthyroidism (overactive thyroid) or
• Pheochromocytoma (adrenal problem) or
• Sickle cell anemia (inherited blood disorder)—Use with caution. May make these conditions worse.

• Blood vessel disease, severe or
• Congestive heart failure or
• Dehydration or
• Diabetes 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.

• Dehydration (caused by prolonged fasting or use of laxatives)—Should not be given in pediatric patients with this condition.

• Homocystinuria (genetic disease)—Patients with this condition should avoid undergoing angiography because of the increase risk of having blood clotting problems.

• Kidney problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Use Ultravist as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine is given as a shot into a vein or artery only.
• You will need to be sure that you are not dehydrated before getting this medicine. Check with your doctor to see if you need to drink extra fluids before getting Ultravist (iopromide).
• Drink lots of noncaffeine liquids after using this medicine unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Feeling of warmth.
• Headache.
• Upset stomach.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store Ultravist at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Ultravist or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ultravist. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to iopromide: injection solution

Along with its needed effects, iopromide (the active ingredient contained in Ultravist) 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 while taking iopromide:

• 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
• chest pain
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• frequent strong or increased urge to urinate
• headache
• sweating

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• bluish lips or skin
• chest discomfort or tightness
• convulsions
• cough
• decreased frequency or amount of urination
• difficult or painful urination
• difficulty breathing
• excessive thirst
• fever or chills
• nausea or vomiting
• noisy breathing
• pain or discomfort in the arms, jaw, back, or neck
• pale skin at injection site
• irregular heartbeat
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

• Blistering, peeling, or loosening of the skin
• bloody urine
• blue lips and fingernails
• coughing that sometimes produces a pink frothy sputum
• diarrhea
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty with swallowing or sore throat
• dilated neck veins
• extreme fatigue
• irregular breathing
• joint or muscle pain
• loss of appetite
• lower back or side pain
• nervousness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• red skin lesions, often with a purple center
• sensitivity to heat
• skin rash, hives, or itching
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the face, fingers, feet, or lower legs
• trouble sleeping

Some side effects of iopromide 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:

• Change in taste
• changes in vision
• loss of taste

• Abdominal or stomach discomfort or pain
• acid or sour stomach
• agitation
• belching or passing of gas
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficulty with moving
• dry mouth
• excessive muscle tone
• general feeling of discomfort or illness
• lack of coordination
• loss of strength or energy
• muscle tension or tightness
• sleepiness or unusual drowsiness
• tender, swollen glands in the neck
• voice changes

• Bigger, dilated, or enlarged pupils (black part of the eye)
• burning, dry, or itching eyes
• continuing ringing or buzzing or other unexplained noise in the ears
• discharge, excessive tearing
• feeling of constant movement of self or surroundings
• headache, severe and throbbing
• hearing loss
• increased sensitivity of the eyes to light
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• sensation of spinning