Iopamidol - 200 (Isovue)

Trade Name : ISOVUE

BRACCO DIAGNOSTICS INC

INJECTION, SOLUTION

Strength 408 mg/mL

IOPAMIDOL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Iopamidol - 200 (Isovue) which is also known as ISOVUE and Manufactured by BRACCO DIAGNOSTICS INC. It is available in strength of 408 mg/mL per ml. Read more

Iopamidol - 200 (Isovue) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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ISOVUE 200, 250, 300 and 370 are NOT FORnINTRATHECAL USE.See , and sectionsnfor further detailson proper useDIAGNOSTICNONIONIC RADIOPAQUE CONTRAST MEDIAFor Angiography Throughoutnthe CardiovascularSystem, Including Cerebral and PeripheralnArteriography,Coronary Arteriography and Ventriculography,Pediatric Angiocardiography, Selective VisceralArteriographynand Aortography,Peripheral Venography (Phlebography),nandAdult and Pediatric Intravenous ExcretoryUrography and Intravenous Adult and PediatricContrastnEnhancement of Computed Tomographic(CECT) Head and BodynImaging

ISOVUE (lopamidol Injection) formulationsnare stable, aqueous, sterile, and nonpyrogenic solutions for intravascularnadministration.
Each mL of ISOVUE-200n(lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg tromethaminenand 0.26 mg edetate calcium disodium. The solution contains approximatelyn0.029 mg (0.001 mEq) sodium and 200 mg organically bound iodine pernmL.
Each mL of ISOVUE-250 (lopamidolnInjection 51%) provides 510 mg iopamidol with 1 mg tromethamine andn0. 33 mg edetate calcium disodium. The solution contains approximatelyn0.036 mg (0.002 mEq) sodium and 250 mg organically bound iodine pernmL.
Each mL of ISOVUE-300 (lopamidolnInjection 61%) provides 612 mg iopamidol with 1 mg tromethamine andn0.39 mg edetate calcium disodium. The solution contains approximatelyn0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine pernmL.
Each mL of ISOVUE-370 (lopamidolnInjection 76%) provides 755 mg iopamidol with 1 mg tromethamine andn0.48 mg edetate calcium disodium. The solution contains approximatelyn0.053 mg (0.002 mEq) sodium and 370 mg organically bound iodine pernmL.
The pH of ISOVUE contrastnmedia has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodiumnhydroxide. Pertinent physicochemical data are noted below. ISOVUEn(lopamidol Injection) is hypertonic as compared to plasma and cerebrospinalnfluid (approximately 285 and 301 mOsm/kg water, respectively).
lopamidol is designated chemicallynas (S)-N,Nu2019-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide.nStructural formula:

Intravascular injection of a radiopaque diagnostic agent opacifiesnthose vessels in the path of flow of the contrast medium, permittingnradiographic visualization of the internal structures of the humannbody until significant hemodilution occurs.
Following intravascular injection, radiopaque diagnosticnagents are immediately diluted in the circulating plasma. Calculationsnof apparent volume of distribution at steady-state indicate that iopamidolnis distributed between the circulating blood volume and other extracellularnfluid; there appears to be no significant deposition of iopamidolnin tissues. Uniform distribution of iopamidol in extracellular fluidnis reflected by its demonstrated utility in contrast enhancement ofncomputed tomographic imaging of the head and body following intravenousnadministration.
The pharmacokineticsnof intravenously administered iopamidol in normal subjects conformnto an open two-compartment model with first order elimination (a rapidnalpha phase for drug distribution and a slow beta phase for drug elimination).nThe elimination serum or plasma half-life is approximately two hours;nthe half-life is not dose dependent. No significant metabolism, deiodination,nor biotransformation occurs.
Iopamidolnis excreted mainly through the kidneys following intravascular administration.nIn patients with impaired renal function, the elimination half-lifenis prolonged dependent upon the degree of impairment. In the absencenof renal dysfunction, the cumulative urinary excretion for Iopamidol,nexpressed as a percentage of administered intravenous dose is approximatelyn35 to 40 percent at 60 minutes, 80 to 90 percent at 8 hours, and 90npercent or more in the 72- to 96-hour period after administration.nIn normal subjects, approximately one percent or less of the administeredndose appears in cumulative 72- to 96-hour fecal specimens.
ISOVUE may be visualized in the renal parenchymanwithin 30-60 seconds following rapid intravenous administration. Opacificationnof the calyces and pelves in patients with normal renal function becomesnapparent within 1 to 3 minutes, with optimum contrast occurring betweenn5 and 15 minutes. In patients with renal impairment, contrast visualizationnmay be delayed.
Iopamidol displaysnlittle tendency to bind to serum or plasma proteins.
No evidence of in vivo complement activation has been foundnin normal subjects.
Animal studiesnindicate that iopamidol does not cross the blood-brain barrier tonany significant extent following intravascular administration.
ISOVUE (lopamidol Injection) enhancesncomputed tomographic brain imaging through augmentation of radiographicnefficiency. The degree of enhancement of visualization of tissue densitynis directly related to the iodine content in an administered dose;npeak iodine blood levels occur immediately following rapid injectionnof the dose. These levels fall rapidly within five to ten minutes.nThis can be accounted for by the dilution in the vascular and extracellularnfluid compartments which causes an initial sharp fall in plasma concentration.nEquilibration with the extracellular compartments is reached in aboutnten minutes, thereafter the fall becomes exponential. Maximum contrastnenhancement frequently occurs after peak blood iodine levels are reached.nThe delay in maximum contrast enhancement can range from five to fortynminutes depending on the peak iodine levels achieved and the cellntype of the lesion. This lag suggests that radiographic contrast enhancementnis at least in part dependent on the accumulation of iodine withinnthe lesion and outside the blood pool, although the mechanism by whichnthis occurs is not clear. The radiographic enhancement of nontumoralnlesions, such as arteriovenous malformations and aneurysms, is probablyndependent on the iodine content of the circulating blood pool.
In CECT head imaging, ISOVUE (lopamidolnInjection) does not accumulate in normal brain tissue due to the presencenof the blood-brain barrier. The increase in x-ray absorption in normalnbrain is due to the presence of contrast agent within the blood pool.nA break in the blood-brain barrier such as occurs in malignant tumorsnof the brain allows the accumulation of the contrast medium withinnthe interstitial tissue of the tumor. Adjacent normal brain tissuendoes not contain the contrast medium.
In nonneural tissues (during computed tomography ofnthe body), iopamidol diffuses rapidly from the vascular into the extravascularnspace. Increase in x-ray absorption is related to blood flow, concentrationnof the contrast medium, and extraction of the contrast medium by interstitialntissue of tumors since no barrier exists. Contrast enhancement isnthus due to the relative differences in extravascular diffusion betweennnormal and abnormal tissue, quite different from that in the brain.
The pharmacokinetics of iopamidol in bothnnormal and abnormal tissue have been shown to be variable. Contrastnenhancement appears to be greatest soon after administration of thencontrast medium, and following intraarterial rather than intravenousnadministration. Thus, greatest enhancement can be detected by a seriesnof consecutive two- to three-second scans performed just after injectionn(within 30 to 90 seconds), i.e., dynamic computed tomographic imaging.

ISOVUE (lopamidol Injection) is indicatednfor angiography throughout the cardiovascular system, including cerebralnand peripheral arteriography, coronary arteriography and ventriculography,npediatric angiocardiography, selective visceral arteriography andnaortography, peripheral venography (phlebography), and adult and pediatricnintravenous excretory urography and intravenous adult and pediatricncontrast enhancement of computed tomographic (CECT) head and bodynimaging (see below).

None.

Severe Adverse Events-lnadvertentnIntrathecal Administration
Serious adverse reactions have been reported due to the inadvertentnintrathecal administration of iodinated contrast media that are notnindicated for intrathecal use.
These serious adverse reactions include: death,nconvulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis,nacute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia,nand brain edema. Special attention must be given to insure that thisndrug product is not inadvertently administered intrathecally.
Nonionic iodinated contrast media inhibitnblood coagulation, , less than ionic contrastnmedia. Clotting has been reported when blood remains in contact withnsyringes containing nonionic contrast media.
Serious, rarely fatal, thromboembolic events causingnmyocardial infarction and stroke have been reported during angiographicnprocedures with both ionic and nonionic contrast media. Therefore,nmeticulous intravascular administration technique is necessary, particularlynduring angiographic procedures, to minimize thromboembolic events.nNumerous factors, including length of procedure, catheter and syringenmaterial, underlying disease state, and concomitant medications mayncontribute to the development of thromboembolic events. For thesenreasons, meticulous angiographic techniques are recommended includingnclose attention to guidewire and catheter manipulation, use of manifoldnsystems and/or three way stopcocks, frequent catheter flushing withnheparinized saline solutions, and minimizing the length of the procedure.nThe use of plastic syringes in place of glass syringes has been reportednto decrease but not eliminate the likelihood of clotting.
Caution must be exercisednin patients with severely impaired renal function, those with combinednrenal and hepatic disease, or anuria, particularly when larger ornrepeat doses are administered.
Radiopaque diagnostic contrast agents are potentially hazardous innpatients with multiple myeloma or other paraproteinemia, particularlynin those with therapeutically resistant anuria. Myeloma occurs mostncommonly in persons over age 40. Although neither the contrast agentnnor dehydration has been proved separately to be the cause of anurianin myelomatous patients, it has been speculated that the combinationnof both may be causative. The risk in myelomatous patients is notna contraindication; however, special precautions are required.
Contrast media may promote sickling innindividuals who are homozygous for sickle cell disease when injectednintravenously or intraarterially.
Administration of radiopaque materials to patients known or suspectednof having pheochromocytoma should be performed with extreme caution.nIf, in the opinion of the physician, the possible benefits of suchnprocedures outweigh the considered risks, the procedures may be performed;nhowever, the amount of radiopaque medium injected should be kept tonan absolute minimum. The blood pressure should be assessed throughoutnthe procedure and measures for treatment of a hypertensive crisisnshould be available. These patients should be monitored very closelynduring contrast enhanced procedures.
Reports of thyroid storm following the use of iodinatednradiopaque diagnostic agents in patients with hyperthyroidism or withnan autonomously functioning thyroid nodule suggest that this additionalnrisk be evaluated in such patients before use of any contrast medium.
Severe Cutaneous AdversenReactions:

No data

Adverse reactions following the usenof iopamidol are usually mild to moderate, self-limited, and transient.
In angiocardiography (597 patients),nthe adverse reactions with an estimated incidence of one percent ornhigher are: hot flashes 3.4%; angina pectoris 3.0%; flushing 1.8%;nbradycardia 1.3%; hypotension 1.0%; hives 1.0%.
In a clinical trial with 76 pediatric patients undergoingnangiocardiography, 2 adverse reactions (2.6%) both remotely attributednto the contrast media were reported. Both patients were less thann2 years of age, both had cyanotic heart disease with underlying rightnventricular abnormalities and abnormal pulmonary circulation. In onenpatient preexisting cyanosis was transiently intensified followingncontrast media administration. In the second patient preexisting decreasednperipheral perfusion was intensified for 24 hours following the examination.n(See Section forninformation on high risk nature of these patients.)
Intravascular injection of contrast media is frequentlynassociated with the sensation of warmth and pain especially in peripheralnarteriography and venography; pain and warmth are less frequent andnless severe with ISOVUE (lopamidol Injection) than with diatrizoatenmeglumine and diatrizoate sodium injection.
The following table of incidence of reactions is basednon clinical studies with ISOVUE in about 2246 patients.
Regardless of the contrast agentnemployed, the overall estimated incidence of serious adverse reactionsnis higher with than with othernprocedures. Cardiac decompensation, serious arrhythmias, or myocardialnischemia or infarction have been reported with Isovue and may occurnduring and .
Following coronary andnventricular injections, certain electrocardiographic changes (increasednQTc, increased R-R, T-wave amplitude) and certain hemodynamic changesn(decreased systolic pressure) occurred less frequently with ISOVUEn(lopamidol Injection) than with diatrizoate meglumine and diatrizoatensodium injection; increased LVEDP occurred less frequently after ventricularniopamidol injections.
In , the risks of procedures also include injurynto the aorta and neighboring organs, pleural puncture, renal damagenincluding infarction and acute tabular necrosis with oliguria andnanuria, accidental selective filling of the right renal artery duringnthe translumbar procedure in the presence of preexisting renal disease,nretroperitoneal hemorrhage from the translumbar approach, and spinalncord injury and pathology associated with the syndrome of transversenmyelitis.
The following adversenreactions have been reported for lopamidol: : arrhythmia, arterial spasms, flushing, vasodilation, chest pain,ncardiopulmonary arrest; : confusion,nparesthesia, dizziness, temporary cortical blindness, temporary amnesia,nconvulsions, paralysis, coma; :nincreased cough, sneezing, asthma, apnea, laryngeal edema, chest tightness,nrhinitis; : injection sitenpain usually due to extravasation and/or erythematous swelling, pallor,nperiorbital edema, facial edema; : pain, hematuria; : waterynitchy eyes, lacrimation, conjunctivitis; : muscle spasm, involuntary leg movement; : tremors, malaise, anaphylactoid reaction (characterized by cardiovascular,nrespiratory and cutaneous symptoms), pain; : severe retching and choking, abdominal cramps. Some of these maynoccur as a consequence of the procedure. Other reactions may alsonoccur with the use of any contrast agent as a consequence of the proceduralnhazard; these include hemorrhage or pseudoaneurysms at the puncturensite, brachial plexus palsy following axillary artery injections,nchest pain, myocardial infarction, and transient changes in hepatorenalnchemistry tests. Arterial thrombosis, displacement of arterial plaques,nvenous thrombosis, dissection of the coronary vessels and transientnsinus arrest are rare complications.
Reactionsnknown to occur with parenteral administration of iodinated ionic contrastnagents (see the listing below) are possible with any nonionic agent.nApproximately 95 percent of adverse reactions accompanying the usenof other water-soluble intravascularly administered contrast agentsnare mild to moderate in degree. However, life-threatening reactionsnand fatalities, mostly of cardiovascular origin, have occurred. Reportednincidences of death from the administration of other iodinated contrastnmedia range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000npatients (0.01 percent). Most deaths occur during injection or 5 ton10 minutes later, the main feature being cardiac arrest with cardiovascularndisease as the main aggravating factor. Isolated reports of hypotensivencollapse and shock are found in the literature. The incidence of shocknis estimated to be 1 out of 20,000 (0.005 percent) patients.
Adverse reactions to injectable contrastnmedia fall into two categories: chemotoxic reactions and idiosyncraticnreactions. Chemotoxic reactions result from the physicochemical propertiesnof the contrast medium, the dose, and the speed of injection. Allnhemodynamic disturbances and injuries to organs or vessels perfusednby the contrast medium are included in this category.
Experience with iopamidol suggests there is much lessndiscomfort (e.g. pain and/or warmth) with peripheral arteriography.nFewer changes are noted in ventricular function after ventriculographynand coronary arteriography.
Idiosyncraticnreactions include all other reactions. They occur more frequentlynin patients 20 to 40 years old. Idiosyncratic reactions may or maynnot be dependent on the amount of drug injected, the speed of injection,nthe mode of injection, and the radiographic procedure.
Idiosyncratic reactions are subdivided intonminor, intermediate, and severe. The minor reactions are self-limitednand of short duration; the severe reactions are life-threatening andntreatment is urgent and mandatory.
The reported incidence of adverse reactions to contrast media innpatients with a history of allergy is twice that for the general population.nPatients with a history of previous reactions to a contrast mediumnare three times more susceptible than other patients. However, sensitivitynto contrast media does not appear to increase with repeated examinations.nMost adverse reactions to intravascular contrast agents appear withinnone to three minutes after the start of injection, but delayed reactionsnmay occur. Delayed reactions, usually involving the skin, may uncommonlynoccur within 2-3 days (range 1-7 days) after the administration ofncontrast (see ). Delayed allergic reactions are more frequent in patients treatednwith immunostimulants, such as interleukin-2.
In addition to the adverse drug reactions reported forniopamidol, the following additional adverse reactions have been reportednwith the use of other intravascular contrast agents and are possiblenwith the use of any water-soluble iodinated contrast agent:
Cardiovascular:
Hematologic:
Urogenital:
Special Senses:
Endocrine:
Skin and SubcutaneousnTissue Disorders:

Treatment of an overdose of an injectablenradiopaque contrast medium is directed toward the support of all vitalnfunctions, and prompt institution of symptomatic therapy.

No data

ISOVUE-200 (lopamidol Injection 41%)u00a0u00a0u00a0Ten 50 mL single dose vials (NDC 0270-1314-30)u00a0u00a0u00a0Tenn200 mL single dose bottles (NDC 0270-1314-15)
ISOVUE-250 (lopamidol Injection 51%)u00a0u00a0u00a0Ten 50 mL single dose vials (NDC 0270-1317-05)u00a0u00a0u00a0Tenn100 mL single dose bottles (NDC 0270-1317-02)u00a0u00a0u00a0Ten 150nmL single dose bottles (NDC 0270-1317-09)
ISOVUE-300 (lopamidol Injection 61%)u00a0u00a0u00a0Tenn30 mL single dose vials (NDC 0270-1315-25)u00a0u00a0u00a0Ten 50 mLnsingle dose vials (NDC 0270-1315-30)u00a0u00a0u00a0Ten 75 mL singlendose bottles (NDC 0270-1315-47)u00a0u00a0u00a0Ten 100nmL single dose bottles (NDC 0270-1315-35)u00a0u00a0u00a0Ten 150 mLnsingle dose bottles (NDC 0270-1315-50)
ISOVUE-370 (lopamidol Injection 76%)u00a0u00a0u00a0Tenn50 mL single dose vials (NDC 0270-1316-30)u00a0u00a0u00a0Ten 75 mLnsingle dose bottles (NDC 0270-1316-52)u00a0u00a0u00a0Ten 100 mL singlendose bottles (NDC 0270-1316-35)u00a0u00a0u00a0Ten 125 mL single dosenbottles (NDC 0270-1316-04)u00a0u00a0u00a0Ten 150 mL single dose bottlesn(NDC 0270-1316-37)u00a0u00a0u00a0

Isovue 200:n10x 200mL Box label ttttttNDC 0270-1314-15

Isovue 250:n10x 150mL Box label ttttttNDC 0270-1317-09

u00a0Isovuen300: 10x 150mL Box label ttttttNDC 0270-1315-35

Isovue 370:n10x 50mL Box label ttttttNDC 0270-1316-30

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Iopamidol - 200 (Isovue)

Trade Name : ISOVUE

INJECTION, SOLUTION

Delivery Process

Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Iopamidol - 200 (Isovue)

Trade Name : ISOVUE

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

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