TC 99M MEDRONATE

FDA Drug Profile — Kit for the Preparation of Technetium Tc 99M Medronate

Drug Details

Generic Name
TC 99M MEDRONATE
Brand Names
Kit for the Preparation of Technetium Tc 99M Medronate
Application Number
NDA018124
Sponsor
Sun Pharmaceutical Industries, Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
TECHNETIUM TC-99M MEDRONATE

Indications and 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.

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 by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions. )