Kit for the Preparation of Technetium Tc 99M Medronate 20 mg/10mL
TC 99M MEDRONATE · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Sun Pharmaceutical Industries, Inc.
Technetium Tc 99M Medronate is a radioactive diagnostic agent given by injection that helps doctors visualize bone and skeletal system imaging to detect abnormalities, infections, or injuries. This medication is prepared from a kit that combines medronate with radioactive technetium and is used only for diagnostic imaging purposes.
Key Facts
- Brand Name
- Kit for the Preparation of Technetium Tc 99M Medronate
- Generic Name
- TC 99M MEDRONATE
- NDC Code (Product)
45567-0040- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 20 mg/10mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA018124
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 08/29/1979
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.
Dosage & Administration
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-…
Warnings
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 .)
Contraindications
CONTRAINDICATIONS None known.
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 .)
Adverse Reactions
ADVERSE REACTIONS 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.
Frequently Asked Questions
What is Kit for the Preparation of Technetium Tc 99M Medronate used for?
Technetium Tc 99M Medronate is a radioactive diagnostic agent given by injection that helps doctors visualize bone and skeletal system imaging to detect abnormalities, infections, or injuries. This medication is prepared from a kit that combines medronate with radioactive technetium and is used only for diagnostic imaging purposes.
Is Kit for the Preparation of Technetium Tc 99M Medronate a controlled substance?
Kit for the Preparation of Technetium Tc 99M Medronate is not classified as a controlled substance by the DEA.
What is the generic name for Kit for the Preparation of Technetium Tc 99M Medronate?
The generic name for Kit for the Preparation of Technetium Tc 99M Medronate is TC 99M MEDRONATE. There are no other listed brand versions of TC 99M MEDRONATE.
What is the NDC code for Kit for the Preparation of Technetium Tc 99M Medronate 20 mg/10mL?
The NDC (National Drug Code) for Kit for the Preparation of Technetium Tc 99M Medronate 20 mg/10mL is 45567-0040, listed by Sun Pharmaceutical Industries, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)