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Iopamidol (Isovue-M)

Trade Name : ISOVUE-M

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 (Isovue-M) which is also known as ISOVUE-M and Manufactured by Bracco Diagnostics Inc. It is available in strength of 408 mg/mL per ml. Read more

Iopamidol (Isovue-M) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • DIAGNOSTICNONIONIC RADIOPAQUEnCONTRAST MEDIAFor Intrathecal Administration in NeuroradiologyIncluding Myelography (Lumbar, Thoracic, Cervical,TotalnColumnar) Pediatric Myelography (Lumbar, Thoracic),andnfor Contrast Enhancement of Computed Tomographic (CECT)Cisternography and Ventriculography
  • ISOVUE-M (lopamidol Injection) formulationsnare stable, aqueous, sterile, and nonpyrogenic solutions for intrathecalnadministration.
  • EachnmL of ISOVUE-M 200 (lopamidol Injection 41%) provides 408 mg iopamidolnwith 1 mg tromethamine and 0.26 mg edetate calcium disodium. The solutionncontains approximately 0.029 mg (0.001 mEq) sodium and 200 mg organicallynbound iodine per mL.
  • Each mL of ISOVUE-M 300 (lopamidol Injection 61%) provides 612 mgniopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium.nThe solution contains approximately 0.043 mg (0.002 mEq) sodium andn300 mg organically bound iodine per mL.
  • The pH of ISOVUE-M contrast media has beannadjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide.nPertinent physicochemical data are noted below. ISOVUE-M (lopamidolnInjection) is hypertonic as compared to plasma and cerebrospinal fluidn(approximately 285 and 301 mOsm/kg water, respectively).
  • lopamidol is designatednchemically as (S)-N,Nu2019-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]- 2,4,6-triiodo-5-lactamidoisophthalamide.nStructural formula:
  • The pharmacokinetics of intravenously administeredniopamidol in normal subjects conform to an open two-compartment modelnwith first order elimination (a rapid alpha phase for drug distributionnand a slow beta phase for drug elimination). The elimination serumnor plasma half-life is approximately two hours; the half-life is notndose dependent. No significant metabolism, deiodination, or biotransformationnoccurs.
  • Iopamidol isnrapidly absorbed into the bloodstream from cerebrospinal fluid (CSF);nfollowing intrathecal administration, iopamidol appears in plasmanwithin one hour and virtually all of the drug reaches the systemicncirculation within 24 hours. Iopamidol is excreted mainly throughnthe kidneys following intrathecal administration, and the drug isnessentially undetectable in the plasma 48 hours later. In patientsnwith impaired renal function, the elimination half-life is prolongedndependent upon the degree of impairment. In the absence of renal dysfunction,nthe cumulative urinary excretion for iopamidol, expressed as a percentagenof administered intravenous dose is approximately 35 to 40 percentnat 60 minutes, 80 to 90 percent at 8 hours, and 90 percent or morenin the 72- to 96-hour period after administration. In normal subjects,napproximately 1 percent or less of the administered dose appears inncumulative 72- to 96-hour fecal specimens.
  • Iopamidol displays little tendency to bindnto serum or plasma proteins.
  • No evidence of complementnactivation has been found in normal subjects.
  • Animal studies indicate that iopamidol doesnnot cross the blood-brain barrier to any significant extent followingnintravascular administration.
  • ISOVUE-M (lopamidol Injection)nis indicated for intrathecal administration in adult neuroradiologynincluding myelography (lumbar, thoracic, cervical, total columnar),nand for contrast enhancement of computed tomographic (CECT) cisternographynand ventriculography. ISOVUE-M 200 (lopamidol Injection) is indicatednfor thoraco-lumbar myelography in children over the age of two years.
  • Intrathecal administration ofncorticosteroids with iopamidol is contraindicated. Because of overdosagenconsiderations, immediate repeat myelography in the event of technicalnfailure is contraindicated (see interval recommendation under ). Myelographynshould not be performed in the presence of significant local or systemicninfection where bacteremia is likely.
  • The need for myelographic examinationnshould be carefully evaluated. Iopamidol should be administered withncaution in patients with increased intracranial pressure or suspicionnof intracranial tumor, abscess or hematoma, those with a history ofnconvulsive disorder, severe cardiovascular disease, chronic alcoholism,nor multiple sclerosis, and elderly patients.
  • Particular attention must be given to statenof hydration, concentration of medium, dose, and technique used innthese patients.
  • Contrastnmedia may promote sickling in individuals who are homozygous for sicklencell disease when injected intravenously or intra-arterially. AlthoughnISOVUE-M is not injected intravascularly, measurable plasma levelsnare attained after intrathecal administration of iopamidol.
  • If frankly bloody cerebrospinalnfluid is observed, the possible benefits of a myelographic examinationnshould be considered in terms of risk to the patient.
  • Patients on anticonvulsant medication shouldnbe maintained on this therapy.
  • Direct intracisternal or ventricular administrationnfor standard radiography (without computerized tomographic enhancement)nis not recommended. Inadvertent intracranial entry of a large or concentratednbolus of the contrast medium, which increases the risk of neurotoxicity,ncan be prevented by careful patient management. Also, effort shouldnbe directed to avoid rapid dispersion of the medium causing inadvertentnrise to intracranial levels (e.g., by active patient movement). Ifnsuch intracranial entry of the medium occurs, prophylactic anticonvulsantntreatment with diazepam or barbiturates orally for 24 to 48 hoursnshould be considered.
  • Use of medications that may lower the seizure threshold (phenothiazinenderivatives, including those used for their antihistaminic properties;ntricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics;nantipsychotic agents) should be carefully evaluated. While the contributorynrole of such medications has not been established, some physiciansnhave discontinued these agents at least 48 hours before and for atnleast 24 hours following intrathecal use.
  • Focal and generalized motor seizures havenbeen reported after intrathecal use of water-soluble contrast agentsnincluding iopamidol. In several of those cases reported with iopamidol,nhigher than recommended doses were employed. Therefore n
  • Severe CutaneousnAdverse Reactions
  • No data
  • The most frequently reported adversenreactions following intrathecal administration of iopamidol are headache,nnausea, vomiting, and musculoskeletal pain. These reactions usuallynoccur 1 to 10 hours after injection, almost all occurring within 24nhours. They are usually mild to moderate in degree, lasting for anfew hours and usually disappearing within 24 hours. Rarely, headachesnmay be severe or persist for days. Headache is often accompanied bynnausea and vomiting, and tends to be more frequent and persistentnin patients not optimally hydrated. Backache, neck stiffness, numbnessnand paresthesias, leg or sciatic-type pain occurred less frequently,noften in the form of a transient exacerbation of preexisting symptomatology.nTransient alterations in vital signs may occur and their significancenmust be assessed on an individual basis.
  • The following table of incidence of reactionsnis based on clinical studies with ISOVUE-M (lopamidol Injection) innabout 686 patients.
  • Other adverse effects reportednin clinical literature for iopamidol include facial neuralgia, tinnitus,nand sweating.
  • Majornmotor seizures have been reported in the clinical literature and sincenmarket introduction in the United States. Early onset of seizuresn(less than two hours) is indicative of early substantial intracranialnentry. Transitory EEG changes occur and usually take the form of slownwave activity.
  • Whilennot observed in controlled clinical studies with ISOVUE-M (lopamidolnInjection), the following adverse reactions may occur because theynhave been reported with ISOVUE-M and other nonionic water solublencontrast agents: cardiovascular (arrhythmias); pulmonary (apnea);nbacterial meningitis, and aseptic meningitis syndrome; allergy ornidiosyncrasy (chills, pruritus, nasal congestion, Guillain-Barre syndrome);nCNS irritation (psycho-organic syndrome: mild and transitory perceptualnaberrations such as depersonalization, anxiety, depression, hyperesthesia,ndisturbances in speech, sight, or hearing, and disorientation; innaddition, hyperreflexia or areflexia, hypertonia or flaccidity, restlessness,ntremor, echoacousia, echolalia, asterixis or dysphasia have occurred).nProfound mental disturbances have rarely been reported (various formsnand degrees of aphasia, mental confusion or disorientation); the onsetnis usually at 8 to 10 hours and lasts for about 24 hours without aftereffects.nHowever, occasionally they have been manifest as apprehension, agitationnor progressive withdrawal to the point of stupor or coma. In a fewncases, these have been accompanied by transitory hearing loss or othernauditory symptoms and visual disturbances (believed subjective orndelusional). Persistent cortical loss of vision in association withnconvulsions, and ventricular block have been reported. Rarely, persistentnthough transitory weakness in the leg or ocular muscles has been reported. have been rare and transitory. Theyninclude sensory and/or motor or nerve root disturbances, myelitis,npersistent leg muscle pain or weakness, or sixth nerve palsy, or caudanequina syndrome. Muscle cramps, fasciculation or myoclonia, spinalnconvulsion, paralysis, or spasticity are unusual.
  • Reactions known to occur with parenteral administration of iodinatednionic contrast agents (see the listing below) are possible with anynnonionic agent. Approximately 95 percent of adverse reactions accompanyingnthe use of other water-soluble intravascularly administered contrastnagents are 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 injectablencontrast media fall into two categories: chemotoxic reactions andnidiosyncratic reactions. Chemotoxic reactions result from the physicochemicalnproperties of the contrast medium, the dose, and the speed of injection.nAll hemodynamic disturbances and injuries to organs or vessels perfusednby the contrast medium are included in this category. During intrathecalnuse, there is a lower incidence of electroencephalographic changesnas well as neurotoxicity by virtue of the intrinsic properties ofnthe iopamidol molecule.
  • Idiosyncratic reactions include all other reactions. They occur morenfrequently in patients 20 to 40 years old. Idiosyncratic reactionsnmay or may not be dependent on the amount of drug injected, the speednof injection, the mode of injection, and the radiographic procedure.nIdiosyncratic reactions are subdivided into minor, intermediate, andnsevere. The minor reactions are self-limited and of short duration;nthe severe reactions are life-threatening and treatment is urgentnand mandatory.
  • The reportednincidence of adverse reactions to contrast media in patients withna history of allergy is twice that for the general population. Patientsnwith a history of previous reactions to a contrast medium are threentimes more susceptible than other patients. However, sensitivity toncontrast 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 (see ).
  • Because measurablenplasma levels are attained following the intrathecal administrationnof iopamidol, adverse reactions reported with the use of intravascularncontrast agents are theoretically possible. These include:
  • Cardiovascular:
  • Digestive:
  • Nervous:
  • Respiratory:
  • Urogenital:
  • Special Senses:
  • Endocrine:
  • Skin and Subcutaneous Tissue Disorders
  • The following reactions may alsonoccur: neutropenia, thrombophlebitis, flushing, pallor, weakness,nsevere retching and choking, wheezing, cramps, tremors, and sneezing.
  • A dose of 3000 mgl in adults andn2400 mgl in children is sufficient for most myelographic procedures.nDoses above these levels may result in an increased frequency andnseverity of adverse reactions including seizures. However, in myelography,neven use of a recommended dose can produce mental aberrations tantamountnto overdosage, if incorrect management of the patient during or immediatelynfollowing the procedure permits inadvertent early intracranial entrynof a large portion of the medium.
  • Treatment of an overdose of an injectablenradiopaque contrast medium is directed toward the support of all vitalnfunctions, and prompt institution of symptomatic therapy.
  • In a solution that isnapproximately isotonic (ISOVUE-M 200) is recommended for examinationnof the lumbar region. For movement of the contrast medium to distantntarget areas the more concentrated ISOVUE-M 300 preparation shouldnbe used to compensate for dilution of ISOVUE-M (lopamidol Injection)nwith cerebrospinal fluid.
  • The usual recommended adult dose range for iopamidol is 2000-3000nmg iodine. Iopamidol formulated to contain more than 300 mgl/mL shouldnnot be used intrathecally in adults. The minimum dose needed to performna procedure should always be used.
  • In a solutionnthat is approximately isotonic (ISOVUE-M 200) is recommended for allnintrathecal procedures. In children, loss of contrast due to mixingnon movement of the medium is less apt to occur because of their shorternspinal cord.
  • The usualnrecommended pediatric dose range for iopamidol is 1400-2400 mg iodine.nIopamidol formulated to contain more than 200 mgl/mL should not benused intrathecally in children. The minimum dose needed to performna procedure should always be used. See .
  • Anesthesia is not necessary. However, youngnchildren may require general anesthesia for technical reasons. Premedicationnwith sedatives or tranquillizers is usually not needed. In patientsnwith a history of seizure activity who are not on anticonvulsant therapy,npremedication with barbiturates or phenytoin should be considered.
  • Lumbar puncture is usually madenbetween L3 and L4; if pathology is suspected at this level, the interspacenimmediately above or below may be selected. A lateral cervical puncturenmay also be used.
  • Rate of Injection:
  • An interval of at least 48 hours should benallowed before repeat examination; however, whenever possible fivento seven days is recommended.
  • As with all radiopaque contrast agents,nonly the lowest dose of ISOVUE-M necessary to obtain adequate visualizationnshould be used. A lower dose reduces the possibility of an adversenreaction. Most procedures do not require use of either a maximum dosenor the highest available concentration of ISOVUE-M; the combinationnof dose and ISOVUE-M concentration to be used should be carefullynindividualized, and factors such as age, body size, anticipated pathologynand degree and extent of opacification required, structure(s) or areanto be examined, disease processes affecting the patient, and equipmentnand technique to be employed should be considered. n- Following are the usual recommended pediatric and adult doses ofnISOVUE-M.
  • Thenpediatric doses listed below, intended as a guideline, are based onnage rather than weight because the brain and CSF capacity is independentnof weight. Variations will depend on such factors as height, suspectednpathology, the patientu2019s condition, technique used, etc. (e.g. CTnor standard radiology or movement of the contrast media directed distalnto the site of injection).
  • Following subarachnoidninjection, conventional radiography will continue to provide goodndiagnostic contrast for at least 30 minutes. At about one hour, diagnosticndegree of contrast will not usually be available. However, sufficientncontrast for CT myelography will be available for several hours. CTnmyelography following conventional myelography should be deferrednfor at least four hours to reduce the degree of contrast.
  • Aspiration of iopamidol is unnecessarynfollowing intrathecal administration (see ).
  • Parenteral drug products should be inspectednvisually for particulate matter and discoloration prior to administration,nwhenever solution and container permit. Iopamidol solutions shouldnbe used only if clear and within the normal colorless to pale yellownrange. Discard any productnwhich shows signs of crystallization or damage to the container-closurensystem, which includes the glass container, stopper and/or crimp.
  • It is desirable that solutionsnof radiopaque diagnostic agents for intrathecal use be at body temperaturenwhen injected. Withdrawal of contrast agents from their containersnshould be accomplished under aseptic conditions with sterile syringes.nSpinal puncture must always be performed under sterile conditions.
  • Patients should be wellnhydrated prior to and following ISOVUE-M (Iopamidol Injection) administration.
  • ISOVUE-M 200 (lopamidol Injectionn41%)
  • Ten 10 mL singlendose vials (NDC 0270-1411-11)Ten 20 mL single dose vialsn(NDC 0270-1411-25)
  • ISOVUE-Mn300 (lopamidol Injection 61%)
  • Ten 15 mL single dose vials (NDC 0270-1412-15)
  • Store at 20-25u00b0 C (68-77u00b0 F).n[See USP]. Protect from light.
  • ManufacturednforBracco Diagnostics Inc.Monroe Township,nNJ 08831by BIPSO GmbH78224 Singen (Germany)
  • Revised October 2019
  • CL63A05
  • Isovue-M is a registered trademarknof Bracco Diagnostics Inc.
  • u00a0
  • Isovue-M 200:10x 10mL Box label ttttttNDCn0270-1411-11
  • u00a0
  • Isovue-M 300:10x 15mL Box label ttttttNDC 0270-1412-15

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