Technetium Tc 99m Medronate

Generic Name: technetium tc 99m medronate

Radioactive Diagnostic Agent [EPC]Over-the-Counter (OTC)

Brand Names:

Kit For The Preparation Of Technetium Tc 99m Medronate

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.

Overview

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.

Uses

INDICATIONS AND USAGE Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.

Dosage

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.

Side Effects

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.

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 .)

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). CONTRAINDICATIONS None known.

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.

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.

Frequently Asked Questions

What is Technetium Tc 99m Medronate used for?

INDICATIONS AND USAGE Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.

What are the side effects of Technetium Tc 99m Medronate?

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.

Can I take Technetium Tc 99m Medronate during 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.

What are the important warnings for Technetium Tc 99m Medronate?

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). CONTRAINDICATIONS None known.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.