FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Mdp-bracco Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.
History
There is currently no drug history available for this drug.
Other Information
Each reaction vial contains a sterile, nonpyrogenic, nonradioactive lyophilized mixture of 20 mg medronic acid, 11 mg sodium hydroxide, 1 mg ascorbic acid, 0.13 mg (minimum) stannous fluoride, SnF2 and 0.38 mg total tin, maximum (as stannous fluoride, SnF2).
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.
Sources
Mdp-bracco Manufacturers
-
Bracco Diagnostics Inc.
Mdp-bracco | Bracco Diagnostics Inc.
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 to 740 megabecquerels (10 to 20 millicuries) 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 DosimetryThe 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 megabecquerels (20 millicuries) 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 0.22Method of Calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MlRD Pamphlet No. 11, 1975
Login To Your Free Account