Isovue 250

None.

General

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range. Discard any product which shows signs of crystallization or damage to the container-closure system, which includes the glass container, stopper and/or crimp.

It is desirable that solutions of radiopaque diagnostic agents for intravascular use be at body temperature when injected. Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes. Sterile techniques must be used with any intravascular injection, and with catheters and guidewires.

The transferring of ISOVUE from ISOVUE Pharmacy Bulk Package should be performed in a suitable work area, such as a laminar flow hood, utilizing aseptic technique. The container closure may be penetrated only one time, utilizing a suitable transfer device.

Patients should be well hydrated prior to and following ISOVUE (Iopamidol Injection) administration.

As with all radiopaque contrast agents, only the lowest dose of ISOVUE necessary to obtain adequate visualization should be used. A lower dose reduces the possibility of an adverse reaction. Most procedures do not require use of either a maximum dose or the highest available concentration of ISOVUE; the combination of dose and ISOVUE concentration to be used should be carefully individualized, and factors such as age, body size, size of the vessel and its blood flow rate, anticipated pathology and degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.

Cerebral Arteriography

ISOVUE-300 (Iopamidol Injection, 300 mgI/mL) should be used. The usual individual injection by carotid puncture or transfemoral catheterization is 8 to 12 mL, with total multiple doses ranging to 90 mL.

Peripheral Arteriography

ISOVUE-300 usually provides adequate visualization. For injection into the femoral artery or subclavian artery, 5 to 40 mL may be used; for injection into the aorta for a distal runoff, 25 to 50 mL may be used. Doses up to a total of 250 mL of ISOVUE-300 have been administered during peripheral arteriography.

Selective Visceral Arteriography and Aortography

ISOVUE-370 (Iopamidol Injection, 370 mgI/mL) should be used. Doses up to 50 mL may be required for injection into the larger vessels such as the aorta or celiac artery; doses up to 10 mL may be required for injection into the renal arteries. Often, lower doses will be sufficient. The combined total dose for multiple injections has not exceeded 225 mL.

Pediatric Angiocardiography

ISOVUE-370 should be used. Pediatric angiocardiography may be performed by injection into a large peripheral vein or by direct catheterization of the heart.

The usual dose range for single injections is provided in the following table:

The usual recommended dose for cumulative injections is provided in the following table:

Coronary Arteriography and Ventriculography

ISOVUE-370 should be used. The usual dose for selective coronary artery injections is 2 to 10 mL. The usual dose for ventriculography, or for nonselective opacification of multiple coronary arteries following injection at the aortic root is 25 to 50 mL. The total dose for combined procedures has not exceeded 200 mL. EKG monitoring is essential.

Excretory Urography

ISOVUE-250 ISOVUE-300 or ISOVUE-370 may be used. The usual adult dose for ISOVUE-250 is 50 to 100 mL, for ISOVUE-300 is 50 mL and for ISOVUE-370 is 40 mL administered by rapid intravenous injection.

Pediatric Excretory Urography

ISOVUE-250 or ISOVUE-300 may be used. The dosage recommended for use in children for excretory urography is 1.2 mL/kg to 3.6 mL/kg for ISOVUE-250 and 1.0 mL/kg to 3.0 mL/kg for ISOVUE-300. It should not be necessary to exceed a total dose of 30 grams of iodine.

Drug Incompatibilities

Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, no other pharmaceuticals should be admixed with contrast agents.

ISOVUE-250 (Iopamidol Injection 51%)
Ten 200 mL Pharmacy Bulk Packages
(NDC 0270-1317-41)

ISOVUE-300 (Iopamidol Injection 61%)
Ten 200 mL Pharmacy Bulk Packages
(NDC 0270-1315-41)
Six 500 mL Pharmacy Bulk Packages
(NDC 0270-1315-98)

ISOVUE-370 (Iopamidol Injection 76%)
Ten 200 mL Pharmacy Bulk Packages
(NDC 0270-1316-41)
Six 500 mL Pharmacy Bulk Packages
(NDC 0270-1316-98)

Storage

Store at 20-25° C (68-77° F). [See USP]. Protect from light.

Rx Only

Manufactured for
Bracco Diagnostics Inc.
Monroe Township , NJ 08831
by BIPSO GmbH
78224 Singen (Germany)

Revised March 2017

CL50606

Isovue is a registered trademark of Bracco Diagnostics Inc.

Isovue-250 Pharmacy Bulk Package

Isovue-300 Pharmacy Bulk Package

Isovue-370 Pharmacy Bulk Package

Tell your doctor if you have ever had any type of reaction to another contrast agent.

To make sure iopamidol is safe for you, tell your doctor if you have:

• liver or kidney disease;

• heart disease, including congestive heart failure;

• a history of stroke, blood clots, or coronary artery disease;

• asthma, hay fever, food allergies;

• epilepsy or other seizure disorder;

• sickle cell anemia;

• diabetes;

• an active infection;

• pheochromocytoma (tumor of the adrenal gland);

• multiple myeloma (bone cancer); or

• a thyroid disorder.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether iopamidol passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Do not allow yourself to become dehydrated during the first few days after receiving iopamidol. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.

This section provides information on the proper use of a number of products that contain iopamidol. It may not be specific to Isovue-250. Please read with care.

A doctor or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in an artery or a vein.

Drink extra fluids so you will pass more urine while you or your child are receiving this medicine. This may help prevent kidney problems.

It is very important that your doctor check the progress of you or your child closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause heart attack, stroke, and blood clotting problems during angiographic procedures. Tell your doctor right away if you or your child has chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness, coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, or problems with vision, speech, or walking after receiving this medicine.

Severe kidney problems may occur after receiving this medicine. This is more likely to occur if you receive too much of this medicine. Tell your doctor right away if you or your child have the following symptoms after receiving the medicine: agitation, confusion, decreased urine output, dizziness, headache, muscle twitching, rapid weight gain, or swelling of the face, ankles, or hands.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child has a skin rash, itching, shortness of breath, sweating, swelling of the face, tongue, and throat, or tightness in the chest after you get the injection.

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

Make sure your doctor knows if you or your child have had an allergic reaction to any dye or medicine given during a test or procedure.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Blood clots have happened with Isovue-250 when used with some heart procedures. Sometimes, blood clots may cause heart attack and stroke, which may be deadly. Talk with the doctor.
• Thyroid problems have happened after use of this medicine. Some people had to be treated for these thyroid problems. Talk with the doctor.
• A very bad and sometimes deadly reaction has happened with Isovue-250. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• If you have sickle cell disease, talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you are 65 or older, use Isovue-250 with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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:

Injection (if given into the spine):

• Headache.
• Upset stomach or throwing up.
• Muscle pain.

All other injection products:

• Feeling of warmth.
• Hot flashes.
• Upset stomach.

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.

Applies to iopamidol: injection solution

Along with its needed effects, iopamidol (the active ingredient contained in Isovue-250) 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 iopamidol:

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• feeling of warmth
• hives
• lightheadedness, dizziness, or fainting
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• slow or irregular heartbeat
• sudden sweating
• unusual tiredness or weakness

• Blue lips and fingernails
• changes in skin color
• chills
• coughing that sometimes produces a pink frothy sputum
• decrease in the frequency of urination
• decrease in urine volume
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty in passing urine (dribbling)
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives or welts, itching, or skin rash
• increased sweating
• nervousness
• numbness or tingling in the face, arms, or legs
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• painful urination
• pale skin
• pounding in the ears
• redness of the skin
• severe, unusual tiredness or weakness
• trouble speaking, thinking, or walking
• vomiting

• Double vision
• inability to move the arms, legs, or facial muscles
• pain in the chest, groin, or legs, especially the calves
• severe, sudden headache
• slow speech
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sudden, unexplained shortness of breath
• vision changes

• Change in consciousness
• heart stops
• loss of consciousness
• no breathing
• no pulse or blood pressure
• no sensation in the legs
• not able to pass urine
• pain, redness, or pale skin at the injection site
• seizures
• unable to move the legs

Some side effects of iopamidol 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:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• discouragement
• disturbed color perception
• feeling sad or empty
• halos around lights
• irritability
• loss of appetite
• loss of interest or pleasure
• loss of vision
• night blindness
• overbright appearance of lights
• stuffy nose
• trouble concentrating
• trouble sleeping
• tunnel vision
• weight loss

• Abdominal or stomach cramps
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• discharge or excessive tearing
• general feeling of discomfort or illness
• loss of memory
• problems with memory
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• sneezing
• trembling or shaking of the hands or feet