Sulfur hexafluoride lipid type a microspheres (Injection, Intravenous)

Sulfur hexafluoride lipid type A microspheres injection is used during an echocardiogram to help diagnose or identify heart problems. It is also used to help diagnose or identify issues in the liver or urinary tract.

Sulfur hexafluoride lipid type A microspheres is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear image during an ultrasound. Ultrasound is a special type of diagnostic procedure that uses high-frequency sound waves to create images or "pictures" of certain areas inside the body. The sound waves produced by the ultrasound equipment can bounce off different parts of the body, such as the heart or liver. As the sound waves return, they are electronically turned into images on a television screen. Unlike x-rays, ultrasound does not use ionizing radiation. The lipid microspheres sonicated preparation contains very small gas-filled lipid microspheres that reflect the sound waves and help create a clearer picture.

This medicine is to be given only by or under the direct supervision of a doctor who has specialized training in ultrasound procedures.

It is very important for your doctor to monitor your or your child's progress closely while receiving this medicine. This will help your doctor determine if the medicine is working properly and if you should continue treatment.

Serious heart or lung issues may happen while you are receiving this medicine. Inform your doctor immediately if you or your child experience chest pain, a fast, slow, pounding, or irregular heartbeat, lightheadedness, dizziness, fainting, or trouble breathing.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical help. Notify your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

In deciding to use a diagnostic test, you and your doctor must consider the risks of the test compared to the benefits. Other factors may also affect the test results. For this test, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies so far have not shown any pediatric-specific problems that would limit the usefulness of sulfur hexafluoride lipid type A microsphere injection for echocardiogram, liver, and urinary tract ultrasound in children. Safety and effectiveness have been established.

Geriatric

Studies to date have not indicated any geriatric-specific problems that would limit the usefulness of sulfur hexafluoride lipid type A microsphere injection in elderly patients. However, elderly patients may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if an interaction might occur. In such cases, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime, or with specific types of food, due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may influence the use of this diagnostic test. Be sure to inform your doctor if you have any other medical conditions, especially:

• Allergy to polyethylene glycol—Should not be used in patients with this condition.

• Congestive heart failure, unstable or
• Heart attack, acute or
• Heart disease (e.g., coronary artery syndrome), acute or
• Heart rhythm problems (e.g., ventricular arrhythmia) or
• Heart shunt or
• Lung disease—May increase the risk of more serious side effects.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they could require medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

Incidence not known

• Blurred vision
• cold, clammy skin
• confusion
• cough
• difficulty breathing or swallowing
• dizziness
• faintness or lightheadedness when getting up suddenly from lying or sitting
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fast, weak pulse
• flushing, redness of the skin
• headache
• hives or welts
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lightheadedness
• nervousness
• no blood pressure or pulse
• no breathing
• noisy breathing
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• skin itching, rash, or redness
• stopping of heart
• sweating
• swelling of the face, throat, or tongue
• swelling of the hands, ankles, feet, or lower legs
• tightness in the chest
• unconsciousness
• unusual tiredness or weakness
• unusually warm skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Contact your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Rare

• Change in taste
• loss of taste
• nausea
• pain or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lumason

Available Dosage Forms:

• Powder for Suspension

Therapeutic Class: Diagnostic Agent

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins or into your bladder before the ultrasound.

Your doctor may have special instructions for you in preparation for your test. If you do not understand the instructions you receive or if you have not received such instructions, check with your doctor in advance.