Technetium Tc 99m Medronate 25 mg/1
Technetium Tc 99m Medronate · INJECTION, POWDER, FOR SOLUTION · Jubilant DraxImage Inc., dba Jubilant Radiopharma
Technetium Tc 99m Medronate is a injection, powder, for solution containing technetium tc 99m medronate at 25 mg/1, taken intravenous. Manufactured by Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Key Facts
- Brand Name
- Technetium Tc 99m Medronate
- Generic Name
- Technetium Tc 99m Medronate
- NDC Code (Product)
65174-660- Manufacturer
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Strength
- 25 mg/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA018035
- Marketing Start
- 02/27/2004
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 MDP-25 (Kit for the Preparation of Technetium Tc 99m Medronate) may be used as a bone imaging agent to delineate areas of altered osteogenesis.
Dosage & Administration
DOSAGE AND ADMINISTRATION The recommended adult dose, after reconstitution with oxidant-free sodium pertechnetate Tc-99m, is 370 to 740 megabecquerels (10 to 20 millicuries [200 µCi/kg]) by slow intravenous injection over a period of 30 seconds. Optimum scanning time is 1 to 4 hours post-injection. To minimize the contribution of the bladder content to the image, the patient should void immediately before imaging is started. 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. The solution should not be used if cloudy. RADIATION DOSIMETRY The estimated absorbed radiation 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. The effective half-life was assumed to be the physical half-life for all calculated values. Table 4 Radiation Doses 2 Tissue Absorbed Radiation Dose mGy/740 MBq rads/20 mCi Total Body Total Bone Red Marrow Kidneys Liver Bladder Wall 2 hr. void 4.8 hr. void Ov…
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). The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc-99m is added, adequate shielding of the final preparation must be maintained. Preliminary reports indicate impairment of brain images using Sodium Pertechnetate Tc 99m Injection which have been preceded by bone imaging using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain images. It is recommended, where feasible, that brain imaging using Sodium Pertechnetate Tc 99m Injection precede bone imaging procedures. Alternatively, a brain imaging agent such as technetium Tc-99m pentetate may be employed. 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 b…
Contraindications
CONTRAINDICATIONS None known.
Adverse Reactions
ADVERSE REACTIONS Several cases of allergic dermatological reactions have been reported in association with the use of Technetium Tc 99m Medronate. Several reactions have also been reported in association with other radiopharmaceuticals of the diphosphonate class, particularly Technetium Tc 99m Medronate. These are usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, fever, and vomiting. One death secondary to cardiac arrhythmia following the administration of Technetium Tc 99m Medronate has been reported. In addition, one case of cardiac arrest in a patient also undergoing pulmonary function testing one and one-half hours after the performance of a bone scan using Technetium Tc 99m Medronate has been reported.
Frequently Asked Questions
What is Technetium Tc 99m Medronate used for?
Technetium Tc 99m Medronate contains Technetium Tc 99m Medronate. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Technetium Tc 99m Medronate a controlled substance?
Technetium Tc 99m Medronate is not classified as a controlled substance by the DEA.
What is the generic name for Technetium Tc 99m Medronate?
The generic name for Technetium Tc 99m Medronate is Technetium Tc 99m Medronate. There are 1 other brand versions of Technetium Tc 99m Medronate.
What is the NDC code for Technetium Tc 99m Medronate 25 mg/1?
The NDC (National Drug Code) for Technetium Tc 99m Medronate 25 mg/1 is 65174-660, listed by Jubilant DraxImage Inc., dba Jubilant Radiopharma.