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iothalamate meglumine
Overview
What is Conray 43?
Conray 43 is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray 43 contains 43% w/v iothalamate meglumine which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt), and has the following structural formula:
Each milliliter contains 430 mg of iothalamate meglumine, 0.110 mg edetate calcium disodium as a stabilizer and 0.115 mg of monobasic sodium phosphate as a buffer. The solution provides 20.2% (202 mg/mL) organically bound iodine. Conray 43 has an osmolarity of approximately 800 mOsmol per liter, an osmolality of approximately 1000 mOsmol per kilogram and is, therefore, hypertonic under conditions of use. The viscosity (cps) is approximately 3 at 25°C and 2 at 37°C. The pH is 6.6 to 7.6.
Conray 43 is a clear solution containing no undissolved solids. Crystallization does not occur at normal room temperatures. It is supplied in containers from which the air has been displaced by nitrogen.
What does Conray 43 look like?
What are the available doses of Conray 43?
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What should I talk to my health care provider before I take Conray 43?
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How should I use Conray 43?
Conray 43 is 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 (s
). 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.
What interacts with Conray 43?
Conray 43 should not be used for myelography.
Refer to , concerning hypersensitivity.
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.
What are the warnings of Conray 43?
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What are the precautions of Conray 43?
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What are the side effects of Conray 43?
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What should I look out for while using Conray 43?
Conray 43 should not be used for myelography.
Refer to , concerning hypersensitivity.
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.
What might happen if I take too much Conray 43?
Overdosage may occur. The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular system. The symptoms may include cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma and cardiac arrest. Treatment of an overdose is directed toward the support of all vital functions and prompt institution of symptomatic therapy.
Iothalamate salts are dialyzable.
The intravenous LD value of various concentrations of Iothalamate Meglumine (in grams of iodine/kilogram body weight) varied from 5.7 to 8.9 g/kg in mice and 9.8 to 11.2 g/kg in rats. The LD values decrease as the rate of injection increases.
How should I store and handle Conray 43?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Following intravascular injection, Conray 43 is rapidly transported through the circulatory system to the kidneys and is excreted unchanged in the urine by glomerular filtration. The pharmacokinetics of intravascularly administered radiopaque contrast media are usually best described by a two compartment model with a rapid alpha phase for drug distribution and a slower beta phase for drug elimination. In patients with normal renal function, the alpha and beta half-lives of Conray 43 were approximately 10 and 90 minutes, respectively.
Arteriography and venography may be performed following injection into an appropriate vessel and will permit visualization until significant hemodilution occurs.
Following infusion of Conray 43, the upper and lower urinary tract is opacified. Renal accumulation is sufficiently rapid that maximum radiographic density in the calyces and pelves occurs by the time the infusion is complete. In patients with impaired renal function, diagnostic opacification frequently is achieved only after prolonged periods.
Injectable iodinated contrast agents are excreted either through the kidneys or through the liver. These two excretory pathways are not mutually exclusive, but the main route of excretion seems to be related to the affinity of the contrast medium for serum albumin. Iothalamate salts are poorly bound to serum albumin, and are excreted mainly through the kidneys.
The liver and small intestine provide the major alternate route of excretion. In patients with severe renal impairment, the excretion of this contrast medium through the gallbladder and into the small intestine sharply increases.
Iothalamate salts cross the placental barrier in humans and are excreted unchanged in human milk.
Non-Clinical Toxicology
Conray 43 should not be used for myelography.Refer to , concerning hypersensitivity.
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.
Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided.
Diagnostic procedures which involve the use of iodinated intravascular contrast agents should be carried out under the direction of personnel skilled and experienced in the particular procedure to be performed. All procedures utilizing contrast media carry a definite risk of producing adverse reactions. While most reactions may be minor, life threatening and fatal reactions may occur without warning. The risk-benefit factor should always be carefully evaluated before such a procedure is undertaken. At all times a fully equipped emergency cart, or equivalent supplies and equipment, and personnel competent in recognizing and treating adverse reactions of all severity, or situations which may arise as a result of the procedure, should be immediately available. If a serious reaction should occur, immediately discontinue administration. Since severe delayed reactions have been known to occur, emergency facilities and competent personnel should be available for at least 30 to 60 minutes after administration ( ).
Preparatory dehydration is dangerous and may contribute to acute renal failure in infants, young children, the elderly, patients with pre-existing renal insufficiency, patients with advanced vascular disease and diabetic patients.
Severe reactions to contrast media often resemble allergic responses. This has prompted the use of several provocative pretesting methods, none of which can be relied on to predict severe reactions. No conclusive relationship between severe reactions and antigen-antibody reactions or other manifestations of allergy has been established. 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. Such a history, by suggesting histamine sensitivity and consequently proneness to reactions, may be more accurate than pre-testing in predicting the potential for reaction, although not necessarily the severity or type of reaction in the individual case. A positive history of this type does not arbitrarily contraindicate the use of a contrast agent, when a diagnostic procedure is thought essential, but does call for caution ( ).
Prophylactic therapy including corticosteroids and antihistamines should be considered for patients who present with a strong allergic history, a previous reaction to a contrast medium, or a positive pre-test since in these patients the incidence of reaction is two to three times that of the general population. Adequate doses of corticosteroids should be started early enough prior to contrast medium injection to be effective and should continue through the time of injection and for 24 hours after injection. Antihistamines should be administered within 30 minutes of the contrast medium injection. Recent reports indicate that such pre-treatment does not prevent life-threatening reactions, but may reduce both their incidence and severity. A separate syringe should be used for these injections.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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