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Definity

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Overview

What is Definity?

DEFINITYPerflutren Lipid MicrosphereInjectable Suspension is an ultrasound contrast agent. The DEFINITY vial contains components that upon activation yield perflutren lipid microspheres. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic liquid, which upon activation with the aid of a VIALMIX, provides a homogeneous, opaque, milky white injectable suspension of perflutren lipid microspheres. The suspension of activated DEFINITY is administered by intravenous injection.

The perflutren lipid microspheres are composed of octafluoropropane encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)-∝-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- ω-methoxypoly(ox-1,2-ethanediyl), monosodium salt (abbreviated MPEG5000 DPPE).

Octafluoropropane is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. It has a molecular weight of 188, empirical formula of CFand has the following structural formula:

DPPA has a molecular weight of 670, empirical formula of CHOPNa, and following structural formula:

DPPC has a molecular weight of 734, empirical formula of CHNOP, and following structural formula:

MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula CHNOPNa, contains <100ppm Ca+2 and Mg+2 and the following structural formula:

Prior to VIALMIX activation, the DEFINITY vial contains 6.52 mg/mL octafluoropropane in the headspace which was required to be confirmed by positive IR spectroscopic testing in every vial. Each mL of the clear liquid contains 0.75 mg lipid blend (consisting of 0.045 mg DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE), 103.5 mg propylene glycol, 126.2 mg glycerin, 2.34 mg sodium phosphate monobasic monohydrate, 2.16 mg sodium phosphate dibasic heptahydrate, and 4.87 mg sodium chloride in Water for Injection. The pH is 6.2-6.8.

After activating the contents of the vial in a VIALMIX, each mL of the milky white suspension contains a maximum of 1.2 × 10perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) octafluoropropane. The microsphere particle size parameters are listed in Table 2 below:



What does Definity look like?



What are the available doses of Definity?

DEFINITY is supplied as a single use 2-mL clear glass vial containing clear liquid in packages of four (4) and sixteen (16) single-use vials.

What should I talk to my health care provider before I take Definity?

How should I use Definity?

Activated DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.


What interacts with Definity?

Sorry No Records found


What are the warnings of Definity?

Sorry No Records found


What are the precautions of Definity?

Sorry No Records found


What are the side effects of Definity?

Sorry No records found


What should I look out for while using Definity?

Do not administer DEFINITY to patients with known or suspected:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration []. Most serious reactions occur within 30 minutes of administration.


What might happen if I take too much Definity?

Sorry No Records found


How should I store and handle Definity?

Store between 2-8°C (36°-46°F).Product: 50090-1085NDC: 50090-1085-0 60 TABLET, FILM COATED in a BOTTLENDC: 50090-1085-1 8 TABLET, FILM COATED in a BOTTLENDC: 50090-1085-2 6 TABLET, FILM COATED in a BOTTLEProduct: 50090-1085NDC: 50090-1085-0 60 TABLET, FILM COATED in a BOTTLENDC: 50090-1085-1 8 TABLET, FILM COATED in a BOTTLENDC: 50090-1085-2 6 TABLET, FILM COATED in a BOTTLEProduct: 50090-1085NDC: 50090-1085-0 60 TABLET, FILM COATED in a BOTTLENDC: 50090-1085-1 8 TABLET, FILM COATED in a BOTTLENDC: 50090-1085-2 6 TABLET, FILM COATED in a BOTTLEProduct: 50090-1085NDC: 50090-1085-0 60 TABLET, FILM COATED in a BOTTLENDC: 50090-1085-1 8 TABLET, FILM COATED in a BOTTLENDC: 50090-1085-2 6 TABLET, FILM COATED in a BOTTLE


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood. These physical acoustic properties of activated DEFINITY provide contrast enhancement of the left ventricular chamber and aid delineation of the left ventricular endocardial border during echocardiography.

In animal models the acoustic properties of activated DEFINITY were established at or below a mechanical index of 0.7 (1.8 MHz frequency). In clinical trials, the majority of the patients were imaged at or below a mechanical index of 0.8.

Non-Clinical Toxicology
Do not administer DEFINITY to patients with known or suspected:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration []. Most serious reactions occur within 30 minutes of administration.

See for clinically significant drug interactions with diclofenac.

Serious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias). Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY administration and monitor all patients for acute reactions.

The reported reactions include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions [].

The following serious adverse reactions are described elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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