Kit for the Preparation of Technetium Tc 99m Medronate
technetium tc 99m medronate · Injection, Powder, Lyophilized, For Solution · Intravenous
Uses
Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.
Dosage and administration
After preparation with oxidant-free sodium pertechnetate Tc 99m injection the suggested dose range of technetium Tc 99m medronate injection in the average patient (70 kg) is 370 MBq to 740 MBq (10 mCi to 20 mCi) given intravenously. Imaging post injection is optimal at 1 to 4 hours. 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. Shielding should be utilized when preparing the technetium Tc 99m medronate injection. Radiation Dosimetry The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average patient (70 kg) from an intravenous injection of a maximum dose of 740 MBq (20 mCi) of technetium Tc 99m medronate are shown in Table 4 . Table 4 Absorbed Radiation Dose Organ mGy/740 MBq rads/20 mCi Total Body 1.3 0.13 Bone Total 7.0 0.70 Red Marrow 5.6 0.56 Kidneys 8.0 0.80 Liver 0.6 0.06 Bladder Wall 2-hr. void 26.0 2.60 4.8-hr. void 62.0 6.20 Ovaries 2-hr. void 2.4 0.24 4.8-hr. void 3.4 0.34 Testes 2-hr. void 1.6 0.16 4.8-hr. void 2.2 0.22 Method of Calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975
Contraindications
None known.
Warnings
This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have or who may be predisposed to hypocalcemia (i.e., alkalosis). Preliminary reports indicate interference with brain scans using sodium pertechnetate Tc 99m injection which have been preceded by a bone scan using an agent containing stannous ions. This interference may result in false-positive or false-negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions .)
Precautions
General The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc 99m injection is added, adequate shielding of the final preparation must be maintained. Contents of the reaction vial are intended only for use in the preparation of technetium Tc 99m medronate and are NOT to be administered directly to the patient. Technetium Tc 99m medronate as well as other radioactive drugs, must be handled with care. Once sodium pertechnetate Tc 99m is added to the vial, appropriate safety measures should be used to minimize external radiation to clinical occupational personnel. Care should also be taken to minimize radiation exposure to patients in a manner consistent with proper patient management. To minimize the radiation dose to the bladder, the patient should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next four to six hours. Technetium Tc 99m medronate should be formulated within six (6) hours prior to clinical use. Optimal imaging results are obtained one to four hours after administration. Technetium Tc 99m medronate injection should be discarded six hours after reconstitution. The solution should not be used if cloudy. The components of the kit are sterile and pyrogen-free. It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation. The technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state. Any oxidant present in the sodium pertechnetate Tc 99m supply may, thus, adversely affect the quality of the radiopharmaceutical. Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides. Drug Interactions The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. In patients with high levels of these cations caused by concomitant medications, particularly patients receiving iron infusions, consider performing an imaging study with technetium Tc 99m medronate injection once the cation levels have normalized (e.g., after 3 to 5 half-lives of the cation). (See WARNINGS .) Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential or whether technetium Tc 99m medronate affects fertility in males or females. Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m medronate. It is also not known whether technetium Tc 99m medronate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m medronate should be given to a pregnant woman only if clearly needed. Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation; therefore, formula-feedings should be substituted for breast-feedings. Pediatric Use Safety and effectiveness in children have not been established.
Side effects
Several adverse reactions due to technetium Tc 99m medronate have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea and vomiting. There have also been rare cases of dizziness and asthenia associated with the use of technetium Tc 99m medronate.
Drug interactions
Drug Interactions The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. In patients with high levels of these cations caused by concomitant medications, particularly patients receiving iron infusions, consider performing an imaging study with technetium Tc 99m medronate injection once the cation levels have normalized (e.g., after 3 to 5 half-lives of the cation). (See WARNINGS .)
Pregnancy
Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m medronate. It is also not known whether technetium Tc 99m medronate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m medronate should be given to a pregnant woman only if clearly needed.
Pediatric use
Pediatric Use Safety and effectiveness in children have not been established.
Description
Each reaction vial contains a sterile, nonpyrogenic, nonradioactive lyophilized mixture of 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride, SnF 2 and 0.38 mg total tin, maximum (as stannous fluoride, SnF 2 ). The pH is adjusted with sodium hydroxide or hydrochloric acid to 6.5 (6.3 to 6.7) prior to lyophilization. The vial does not contain a preservative. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 5.4 to 6.8. The structure of medronic acid is given below: The precise structure of technetium Tc 99m medronate is unknown at this time. When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent technetium Tc 99m medronate is formed for administration by intravenous injection. Structure of Medronic Acid
How supplied
Kit for the Preparation of Technetium Tc 99m Medronate is supplied as kits of 10 reaction vials (NDC 65857-505-10). Each reaction vial contains a sterile, nonpyrogenic, nonradioactive lyophilized mixture of 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride, SnF 2 and 0.38 mg total tin, maximum (as stannous fluoride, SnF 2 ). The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The vial does not contain a preservative. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 5.4 to 6.8. Kit Contents 10 sterile reaction vials 20 pressure-sensitive labels for technetium Tc 99m medronate 1 package insert Storage Store the product as supplied at 20° to 25°C (68° to 77°F). After reconstitution store refrigerated at 2° to 8°C (36° to 46°F). Do not use and discard radiolabeled technetium Tc 99m medronate 6 hours after reconstitution.
Storage
Storage Store the product as supplied at 20° to 25°C (68° to 77°F). After reconstitution store refrigerated at 2° to 8°C (36° to 46°F). Do not use and discard radiolabeled technetium Tc 99m medronate 6 hours after reconstitution.
Label text from the FDA structured product label by Cardinal Health 414, LLC (revised Sep 8, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Technetium Tc-99m Medronate in 2 products
Kit for the Preparation of Technetium Tc 99m Medronate NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 65857-505 | Technetium Tc-99m Medronate 20 mg/1 Injection, Powder, Lyophilized, For Solution | Cardinal Health 414, LLC | NDA |
| 45567-0040 | Technetium Tc-99m Medronate 20 mg/10mL Injection, Powder, Lyophilized, For Solution | Sun Pharmaceutical Industries, Inc. | NDA |
Kit for the Preparation of Technetium Tc 99m Medronate recalls
- D-1040-2018 Aug 15, 2018 · Class II · Terminated
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Frequently asked questions
What is Kit for the Preparation of Technetium Tc 99m Medronate used for?
Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.
What are the side effects of Kit for the Preparation of Technetium Tc 99m Medronate?
Several adverse reactions due to technetium Tc 99m medronate have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea and vomiting. There have also been rare cases of dizziness and asthenia associated with the use of technetium Tc 99m medronate. See the full label for the complete list.
Who makes Kit for the Preparation of Technetium Tc 99m Medronate?
Kit for the Preparation of Technetium Tc 99m Medronate is listed by 2 labelers in the FDA NDC directory, including Cardinal Health 414, LLC, Sun Pharmaceutical Industries, Inc..
Has Kit for the Preparation of Technetium Tc 99m Medronate been recalled?
The FDA enforcement database lists 1 recall for Kit for the Preparation of Technetium Tc 99m Medronate, most recently D-1040-2018 (class ii): Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.