perflutren lipid microsphere Intravenous

P

per-FLOO-tren LIP-id MYE-kroe-sfeers

Commonly used brand name(s)

In the U.S.

Definity

Available Dosage Forms:

Suspension

Therapeutic Class: Radiological Non-Ionic Contrast Media

Uses For perflutren lipid microsphere

Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. Ultrasound is a special kind of diagnostic procedure. It 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 be reflected (bounced off) by different parts of the body, like for example, the heart. As the sound waves return they are electronically converted into images on a television screen. Unlike x-rays, ultrasound does not involve ionizing radiation.

The perflutren lipid microspheres preparation contains very small gas-filled lipid microspheres that reflect the sound waves and help create a better picture. The lipid microsphere preparation is given by injection into a vein before ultrasound to help diagnose problems of the heart.

perflutren lipid microsphere is to be given only by or under the direct supervision of a doctor with specialized training in ultrasound procedures.

Before Using perflutren lipid microsphere

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to perflutren lipid microsphere 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 have not been performed on the relationship of age to the effects of perflutren lipid microsphere injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of perflutren lipid microsphere injection in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. 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 diagnostic test, 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.

Receiving this diagnostic test with any of the following medicines is not recommended. Your doctor may decide not to use this diagnostic test or change some of the other medicines you take.

Cisapride Dronedarone Mesoridazine Pimozide Sparfloxacin Thioridazine

Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfuzosin Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Azithromycin Chloroquine Chlorpromazine Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Erythromycin Flecainide Fluconazole Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Ibutilide Iloperidone Imipramine Lapatinib Levofloxacin Lopinavir Lumefantrine Mefloquine Methadone Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Posaconazole Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Ranolazine Salmeterol Saquinavir Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Telavancin Telithromycin Terfenadine Tetrabenazine Toremifene Trazodone Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone 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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

Congestive heart failure or Heart attack or Heart disease (e.g., coronary artery syndrome) or Heart rhythm problems (e.g., ventricular arrhythmia) or Respiratory distress syndrome—May increase risk for more serious side effects. Heart rhythm problems (e.g., QT prolongation)—Use with caution. May make this condition worse. Heart shunt, right-to-left, bi-directional, or transient right-to-left—Should not be used in patients with this condition. Proper Use of perflutren lipid microsphere

A doctor or other trained health professional will give you perflutren lipid microsphere. perflutren lipid microsphere is given through a needle placed in one of your veins before 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.

Precautions While Using perflutren lipid microsphere

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

perflutren lipid microsphere may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell 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 perflutren lipid microsphere.

Tell your doctor right away if you have a chest pain; fast, slow, pounding, or irregular heartbeat; lightheadedness, dizziness, or fainting; shortness of breath; or troubled breathing. These may be symptoms of heart or lung problems.

perflutren lipid microsphere Side Effects

Along with its needed effects, a medicine 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:

Rare Black, tarry stools blurred vision chest pain chills difficulty with breathing dizziness, severe or continuing fast, pounding, or irregular heartbeat or pulse hives itching lightheadedness when getting up from a lying or sitting position shortness of breath skin rash slow or irregular heartbeat swollen glands unusual bleeding or bruising Incidence not known Cough difficulty swallowing dizziness puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue tightness in the chest unusual tiredness or weakness wheezing

Some side effects 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:

Less common Back pain feeling of warmth on the skin headache nausea redness of the face, neck, arms, and occasionally, upper chest Rare Acid or sour stomach bruising diarrhea difficulty with moving dizziness dryness of the mouth feeling of constant movement of self or surroundings fever heartburn indigestion leg cramps muscle stiffness or tension pain at the injection site pain or swelling in the joints prickly or tingling sensation sneezing or runny nose stomach upset or pain

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

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

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