Indium DTPA In 111

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Overview

What is Indium DTPA In 111?

GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111 is a diagnostic drug for intrathecal use. It is available as a sterile, pyrogen-free, isotonic, aqueous solution, buffered to pH 7 to 8. At calibration time, each milliliter contains 37 MBq, 1 mCi of Pentetate Indium Disodium In 111 (no-carrier-added), 20 to 50 g of pentetic acid, and sodium bicarbonate for pH adjustment. Radionuclidic purity at calibration time is at least 99.88% with less than 0.06% Indium In 114m and 0.06% Zinc Zn 65. The concentration of each radionuclidic contaminant changes with time. Graph 1 shows maximum concentration of each radionuclidic impurity as a function of time.

Graph 1 - Radionuclidic Impurities

The chemical names are 1. Indate(2-)- -[-bis[2-[bis-(carboxymethyl)amino]ethyl]glycinato(5-)]-disodium; and 2. Disodium [-bis[2-(carboxymethyl)amino]glycinato(5-)]-indate (2-)In.

Molecular formula: CHON In Na

Molecular weight: 545.29

Structural formula:

What does Indium DTPA In 111 look like?

What are the available doses of Indium DTPA In 111?

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What should I talk to my health care provider before I take Indium DTPA In 111?

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How should I use Indium DTPA In 111?

Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.

Extreme care must be exercised to assure aseptic conditions in intrathecal injections.

The maximum recommended intrathecal dose in the average patient (70 kg) is 18.5 MBq, 500 Ci. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

What interacts with Indium DTPA In 111?

None known.

What are the warnings of Indium DTPA In 111?

Physicians should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension. Higher rates of anaphylactic-like reactions have been reported in children who received infusions at concentrations higher than those recommended. The role that concentration of infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is uncertain. (See .) Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician. For parenteral administration, etoposide Injection USP should be given only by slow intravenous infusion (usually over a 30- to 60-minute period), since hypotension has been reported as a possible side effect of rapid intravenous injection.

The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times.

Since the drug is excreted by the kidneys, caution should be exercised in patients with severely impaired renal function.

What are the precautions of Indium DTPA In 111?

General

Pentetate Indium Disodium In 111, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize external radiation exposure to clinical personnel, and to minimize radiation exposure to patients consistent with proper patient management.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Do not use after the expiration time and date (7 days after calibration time and date stated on the label).

Discard vial after a single use. Do not use if contents are turbid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether Pentetate lndium Disodium In 111 affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111. Also, it is not known whether Pentetate Indium Disodium In 111 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentetate Indium Disodium In 111 should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, formula feedings should be substituted for breast feedings when Pentetate Indium Disodium In 111 is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric use

Clinical studies of Indium DTPA In 111 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

What are the side effects of Indium DTPA In 111?

Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111.

One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported. There have also been reports of skin reactions and vomiting following administration of Pentetate lndium Disodium In 111. Relationship of the drug to these latter occurrences has not been established.

What should I look out for while using Indium DTPA In 111?

None known.

The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times.

Since the drug is excreted by the kidneys, caution should be exercised in patients with severely impaired renal function.

What might happen if I take too much Indium DTPA In 111?

Sorry No Records found

How should I store and handle Indium DTPA In 111?

Store vial in its lead shield at a temperature of 5°-30°C, 41°-86°F. Do not freeze.Pentetate Indium Disodium In 111 (no-carrier-added) is supplied in single-dose glass vials, each containing 1.5 mL of solution with a concentration of 37 MBq, 1 mCi per mL and a total activity of 55.5 MBq, 1.5 mCi per vial at calibration time. Vials are packaged in individual lead shields with plastic outer containers.NDC 17156-251-08Pentetate Indium Disodium In 111 (no-carrier-added) is supplied in single-dose glass vials, each containing 1.5 mL of solution with a concentration of 37 MBq, 1 mCi per mL and a total activity of 55.5 MBq, 1.5 mCi per vial at calibration time. Vials are packaged in individual lead shields with plastic outer containers.NDC 17156-251-08

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

After intrathecal administration, the radiopharmaceutical is absorbed from the subarachnoid space as described below, and the remainder flows superiorly to the basal cisterns within 2 to 4 hours and subsequently will be apparent in the Sylvian cisterns, the interhemispheric cisterns, and over the cerebral convexities. In normal individuals, the radiopharmaceutical will have ascended to the parasagittal region within 24 hours with simultaneous partial or complete clearance of activity from the basal cisterns and Sylvian regions. In contrast to air, the radiopharmaceutical does not normally enter the cerebral ventricles.

Although the primary absorption of cerebrospinal fluid (CSF) into the blood stream occurs at the arachnoid villi, there is some evidence that a significant fraction of CSF is also absorbed across both the cerebral and spinal leptomeninges. Lesser quantities may also be absorbed across the ventricular ependyma. It is also generally held that these alternate routes of CSF absorption may assume primary importance when the major routes of the flow are pathologically obstructed. Approximately 65% of the administered dose is excreted by the kidneys within 24 hours and this increases to 85% in 72 hours.

Non-Clinical Toxicology

None known.

The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times.

Since the drug is excreted by the kidneys, caution should be exercised in patients with severely impaired renal function.

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta-adrenergic blocking agents. When such drugs are administered to a patient receiving glyburide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glyburide, the patient should be observed closely for loss of control.

An increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore concomitant administration of glyburide tablets (micronized) and bosentan is contraindicated.

Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glyburide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glyburide, the patient should be observed closely for hypoglycemia.

A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been reported, resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism of action for this interaction is not known.

A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical or vaginal preparations of miconazole is not known.

Pentetate Indium Disodium In 111, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize external radiation exposure to clinical personnel, and to minimize radiation exposure to patients consistent with proper patient management.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Do not use after the expiration time and date (7 days after calibration time and date stated on the label).

Discard vial after a single use. Do not use if contents are turbid.

Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111.

One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported. There have also been reports of skin reactions and vomiting following administration of Pentetate lndium Disodium In 111. Relationship of the drug to these latter occurrences has not been established.

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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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