USA

Conray® 43 (iothalamate meglumine injection USP 43%)

For more information about Conray® 43, please see the Full Prescribing Information

Conray® 43 is used for organ or tissue enhancement in certain CT, X-ray and fluoroscopy imaging procedures for which it is approved.

  • Each mL contains:
    • 430 mg of iothalamate meglumine
    • 0.110 mg of edetate calcium disodium as a stabilizer
    • 0.115 mg of monobasic sodium phosphate as a buffer
  • Solution provides 20.2% (202 mg/mL) organically bound iodine
  • Available in glass bottles and vials in a variety of fill sizes

Important Safety Information1

Not For Intrathecal Use


Indication and Usage
Conray® 43 (Iothalamate Meglumine Injection USP 43%) is a prescription diagnostic radiopaque medium indicated for use in lower extremity venography, intravenous infusion urography, contrast enhancement of computed tomographic brain images and arterial digital subtraction angiography. Conray® 43 may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT. Subsets of patients in whom delayed body CT scans might be helpful have not been identified. Inconsistent results have been reported and abnormal and normal tissues may be isodense during the same time frame used for delayed CT scanning. The risks of such indiscriminate use of contrast media are well known and such use is not recommended. At present, consistent results have been documented using dynamic CT techniques only. Conray® 43 is indicated for use in retrograde cystography, cystourethrography and retrograde pyelography.

Contraindications
Conray® 43 should not be used for myelography. Contraindications to the procedure of retrograde pyelography include obstruction to endoscopy or catheterization of the ureters, severe systemic disease which contraindicates instrumentation and acute infection of the upper urinary tract. See Warnings and Precautions concerning hypersensitivity.

Warnings and Precautions
Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to ensure that this drug product is not administered intrathecally. Serious or fatal reactions have been associated with the administration of iodine-containing radiopaque media.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.

Serious neurologic sequelae, including permanent paralysis, have been reported following cerebral arteriography, selective spinal arteriography and arteriography of vessels supplying the spinal cord. The intravascular injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects.

In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported.

  • A definite risk exists in the use of intravascular contrast agents in patients who are known to have multiple myeloma. In such instances, anuria has developed, resulting in progressive uremia, renal failure and eventually death. The risk in myelomatous patients is not a contraindication to the procedure.
  • Administration of radiopaque materials to patients known or suspected to have pheochromocytoma should be performed with extreme caution.
  • Contrast media have been shown to promote the phenomenon of sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra arterially.
  • Convulsions have occurred in patients with primary or metastatic cerebral lesions following the administration of iodine-containing radiopaque media for the contrast enhancement of CT brain images.
  • In patients with advanced renal disease, iodinated contrast media should be used with caution, and only when the need for the examination dictates, since excretion of the medium may be impaired. Patients with combined renal and hepatic disease, those with severe hypertension or congestive heart failure, and recent renal transplant recipients may present an additional risk.
  • Renal failure has been reported in patients with liver dysfunction who were given an oral cholecystographic agent followed by an intravascular iodinated radiopaque agent and also in patients with occult renal disease, notably diabetics and hypertensives. In these classes of patients there should be no fluid restriction and every attempt made to maintain normal hydration, prior to contrast medium administration, since dehydration is the single most important factor influencing further renal impairment.
  • Acute renal failure has been reported in diabetic patients with diabetic nephropathy and in susceptible non-diabetic patients (often elderly with pre-existing renal disease) following the administration of iodinated contrast agents. Therefore, careful consideration of the potential risks should be given before performing this radiographic procedure in these patients.
  • Caution should be exercised in performing contrast medium studies in patients with endotoxemia and/or those with elevated body temperatures.
  • Reports of thyroid storm occurring following the intravascular use of iodinated radiopaque agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule, suggest that this additional risk be evaluated in such patients before use of this drug.
  • Iodine containing contrast agents may alter the results of thyroid function tests which depend on iodine estimation, e.g. PBI and radioactive iodine uptake studies.
  • Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering Conray® 43 to patients with a history of a severe cutaneous hypersensitivity reaction to Conray® 43.
  • The possibility of an idiosyncratic reaction in patients who have previously received a contrast medium without ill effect should always be considered. Prior to the injection of any contrast medium, the patient should be questioned to obtain a medical history with emphasis on allergy and hypersensitivity. A positive history of bronchial asthma, hay fever or allergy, including food, a family history of allergy, a known sensitivity to iodine per se, patients with a known clinical hypersensitivity to a contrast agent may imply a greater than usual risk.
  • Angiography should be avoided whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism.
  • Following the arterial digital subtraction angiography procedure, gentle pressure hemostasis is required, followed by observation and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.

Adverse Reactions
The following adverse reactions have been observed in conjunction with the use of iodinecontaining contrast agents.

Intravascular Procedures

  • The most frequent adverse reactions are nausea, vomiting, facial flush and a feeling of body warmth.
  • Hypersensitivity reactions: Dermal manifestations of urticaria with or without pruritus, erythema maculopapular rash, dry mouth, sweating, conjunctival symptoms as well as facial, peripheral and angioneurotic edema. Symptoms related to the respiratory system include sneezing, nasal stuffiness, coughing, choking, dyspnea, chest tightness and wheezing, which may be initial manifestations of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm with or without edema, pulmonary edema, apnea and cyanosis. Rarely, these allergic-type reactions can progress into anaphylaxis with loss of consciousness and coma and severe cardiovascular disturbances.
  • Cardiovascular reactions: Generalized vasodilation, flushing and venospasm. Severe cardiovascular responses include rare cases of hypotensive shock, coronary insufficiency, cardiac arrhythmia, fibrillation and arrest.
  • Endocrine reactions: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.
  • Skin and Subcutaneous Tissue Disorders: Reactions range from mild (e.g. rash, erythema, pruritus, urticaria and skin discoloration) to severe: [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)].
  • Technique reactions: Extravasation with burning pain, hematomas, ecchymosis and tissue necrosis, paresthesia or numbness, vascular constriction due to injection rate, thrombosis and thrombophlebitis.
  • Neurological reactions: Spasm, convulsions, aphasia, syncope, paresis, paralysis resulting from spinal cord injury and pathology associated with syndrome of transverse myelitis, visual field losses which are usually transient but may be permanent, coma and death.
  • Other reactions: Headache, trembling, shaking, chills without fever and lightheadedness. Temporary renal shutdown or other nephropathy.

Serious neurological reactions with cerebral angiography include stroke, amnesia and respiratory difficulties.

Retrograde Urographic Procedures

  • Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur.
  • As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest.
  • Oliguria or anuria may occur following retrograde pyelography, especially in patients with severe pre-existing renal disease.
  • Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection.
  • In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.

Use in Specific Populations

  • Pregnancy Category C:Animal reproduction studies have not been conducted with Conray® 43. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Conray® 43 should be used in pregnant women only if clearly needed.
  • Nursing Mothers: Iothalamate salts are excreted unchanged in human milk. Because of the potential for adverse effects in nursing infants, bottle feedings should be substituted for breast feedings for 24 hours following the administration of this drug.
  • Iothalamate salts cross the placental barrier in humans and are excreted unchanged in human milk.
  • Skin and Subcutaneous Tissue Disorders: Reactions range from mild (e.g. rash, erythema, pruritus, urticaria and skin discoloration) to severe: [e.g. Stevens-Johnson syndrome and toxic epidPreparatory dehydration is dangerous and may contribute to acute renal failure in infants, young children, the elderly, patients with pre-existing renal insufficiency, patients with ad vanced vascular disease and diabetic patients.

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Physical Characteristics1

(Please see Full Prescribing Information)

Osmolarity mOsmol/l

Osmolarity mOsmol/kg

mPa*s at 25˚C

Viscosity mPa*s at 37˚C

Conray ®

800

1000

Viscosity 3

2

Packaging

Conray® 43 (iothalamate meglumine injection USP 43%), 202 mg/mL
Conray 43 25 x 50 mL vials (3183-05) 25
Conray 43 12 x 250 mL bottles (3183-50) 12




Conray® is a registered trademark of Guerbet LLC or its affiliates, and is available by prescription only.

Legal Copyright 2018 Guerbet

REFERENCES

  1. Conray 43 [package insert]. Princeton, NJ: Guerbet LLC; Mar 2017.

GU12171115-E