Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/579
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Phosphotec (Injection, Powder, Lyophilized, For Solution)
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Each reaction vial contains 40 mg sodium pyrophosphate (equivalent to 23.9 mg anhydrous sodium pyrophosphate) and 0.4 mg stannous fluoride (minimum) and 0.9 mg total tin (maximum) as stannous fluoride; the product does not contain a preservative. The pH of the product is
adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. At the time of manufacture, the air in the vial is replaced with a nitrogen gas atmosphere. The pH of the reconstituted product is 5.5 to 6.9. When sterile, nonpyrogenic sodium pertechnetate Tc 99m solution is added to the vial, a diagnostic agent, technetium Tc 99m pyrophosphate, is formed for intravenous administration; the structure of this radiolabeled complex is unknown. The product as supplied is sterile and nonpyrogenic.
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| dailymed-instance:clinicalP... |
Bone and Cardiac Imaging: Following intravenous administration of the technetium Tc 99m
pyrophosphate skeletal uptake occurs as a function of blood flow to bone and bone efficiency in extracting the complex. Bone mineral
crystals are generally considered to be hydroxyapatite, and the complex appears to have an affinity for the hydroxyapatite crystals in bone. It is
theorized that the complex also reacts with the mitochondrial calcium crystals, produced within infarcted myocardial cells which are believed
to be hydroxyapatite; this phenomenon usually does not persist beyond six days after the occurrence of an infarction. Clearance of the radioactivity from the blood is quite rapid with skeletal uptake and urinary excretion being the principal mechanisms of clearance. At two hours following intravenous injection, approximately 55 percent of the injected dose has localized in bone; at four hours
approximately 10 percent of the dose remains in the vascular system, decreasing to about 7 percent at 24 hours. The average urinary
excretion was observed to be about 38 percent of the administered dose after eight hours increasing to an average of about 44 percent at 24
hours. A minimum amount of uptake has been observed in soft-tissue organs, most notably the kidneys.<br/>Blood Pool Imaging: The in vivo tagging of Phosphotec results in the radiolabelling of red blood cells. Approximately 76 percent of the injected activity remains in the blood pool between 30 and 60 minutes after injection of sodium pertechnetate Tc 99m, thereby permitting excellent images of the cardiac chambers. Maximum blood radioactivity levels occur in about 30 minutes; the initial biological half-life is approximately 18 hours. There is virtually no biological elimination of the agent after approximately six hours.
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None known.
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Phosphotec (Kit for the Preparation of Technetium Tc 99m Pyrophosphate) is supplied in a kit containing 10 reaction vials (5 mL
size), 10 pressure-sensitive labels, and 1 package insert.<br/>Storage: Store the Phosphotec (Kit for the Preparation of Technetium Tc 99m Pyrophosphate) refrigerated at 2��-8��C (36��-46��F). The reconstituted preparation should be refrigerated since the product does not contain a preservative. When reconstituted with sodium pertechnetate Tc 99m, Phosphotec must be used within 6 hours. When reconstituted with Sodium Chloride Injection USP for blood pool imaging, use the solution within 30 minutes.
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General: The lyophilized contents of the Phosphotec reaction vial are to be administered to the patient only as an intravenous solution . Any sodium pertechnetate Tc 99m solution which contains an oxidizing agent is not suitable for use with Phosphotec (Kit for the
Preparation of Technetium Tc 99m Pyrophosphate). When reconstituted with sodium pertechnetate Tc 99m, Phosphotec must be used within 6 hours. When reconstituted with Sodium Chloride Injection USP for blood pool imaging, use the solution within 30 minutes. The imaging of gastrointestinal bleeding is dependent on such factors as the region of imaging, rate and volume of the bleed, efficacy of labeling of the red blood cells and timeliness of imaging. Due to these factors, images should be taken sequentially over a period of time until
a positive image is obtained or clinical conditions warrant the discontinuance of the procedure. The period of time for collecting the images may range up to thirty-six hours. Technetium Tc 99m pyrophosphate as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patient and occupational workers 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.<br/>Bone Imaging: Both prior to and following administration of the technetium Tc 99m pyrophosphate, the patient should be encouraged to drink fluids and to void as often as possible thereafter to minimize radiation exposure to the bladder and background interference during imaging.<br/>Cardiac Imaging: The patient's cardiac condition should be stable before beginning the cardiac imaging procedure. If not contraindicated by the patient's cardiac status, patients should be encouraged to drink fluids and to void as often as possible in order to reduce unnecessary radiation exposure to the bladder. Interference from chest wall lesions such as breast tumors and healing rib fractures can be minimized by employing the three
recommended projections . False-positive and false-negative myocardial scans may occur;
therefore, the diagnosis of acute myocardial infarctiondepends on the overall assessment of laboratory and clinical findings.<br/>Blood Pool Imaging: The reconstituted agent should be injected by direct venipuncture. Heparinized catheter systems should be avoided, as interference with red blood cell tagging will result.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been performed to determine any carcinogenic potential or impairment of fertility in males or females.<br/>Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with technetium Tc 99m pyrophosphate. It is also not known whether technetium Tc 99m pyrophosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc 99m
pyrophosphate should be administered to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.<br/>Nursing Mothers: Caution should be exercised when technetium Tc 99m pyrophosphate is administered to a nursing woman. Technetium Tc 99m is excreted in human milk during lactation; therefore, formula-feedings should be substituted for breast-feedings.<br/>Pediatric Use: Safety and effectiveness in children have not been established.
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| dailymed-instance:genericMe... |
sodium pyrophosphate and stannous fluoride
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| dailymed-instance:fullName |
Phosphotec (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:adverseRe... |
Several adverse reactions due to Phosphotec have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, fever, chills, nausea, vomiting and dizziness.
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Preliminary reports indicate impairment of brain scans using sodium pertechnetate Tc 99m injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain scans. It is recommended,
where feasible, that brain scans precede bone imaging procedures. Alternatively, a brain-imaging agent such as technetium Tc 99m pentetate may be employed.
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Bone Imaging: Phosphotec (Kit for the Preparation of Technetium Tc 99m Pyrophosphate) may be used as a bone imaging agent to delineate
areas of altered osteogenesis.<br/>Cardiac Imaging: Phosphotec is a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. The infarction is best visualized one to six days after onset of symptoms. False-negative images can occur if imaging is done too early in the evolutionary phase of the infarct or too late in the resolution phase. The incidence of false-positives may range from 5 to 9 percent and of false-negatives from 6 to 9 percent but may vary
even more depending on selection criteria of patient populations.<br/>Blood Pool Imaging: Phosphotec is also a blood pool imaging agent which may be used for gated cardiac blood pool imaging and for the detection of sites of gastrointestinal bleeding. When administered intravenously 15 to 60 minutes prior to intravenous administration of sodium pertechnetate Tc 99m, approximately 75% of the injected activity remains in the blood pool.
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Phosphotec
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