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warnings
WARNINGS Anaphylactic/anaphylactoid reactions that may be life-threatening have occurred with the use of technetium Tc99m medronate. Manifestations include: shock, hypotension, loss of consciousness, dyspnea, cyanosis, wheezing, generalized rash, and pruritus. Advanced life support equipment and trained personnel should be readily available. This class of compound 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 clinical significance of this information is unknown as no cases of hypocalcemia have been reported. Reports indicate impairment of brain scans using sodium pertechnetate Tc99m injection which have been preceded by a bone scan using an agent containing stannous ions. This impairment may result in false-positive or false-negative brain scans. It is recommended that brain scans precede bone imaging procedures. Alternately, a brain-imaging agent such as technetium Tc99m pentetate injection may be employed.
ADVERSE REACTIONS Several adverse reactions due to technetium Tc99m 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 Tc99m medronate. Postmarketing Experience The following adverse reactions associated with the use of technetium Tc99m medronate have been identified during post-approval use: Anaphylactic/anaphylactoid reactions that may be life-threatening and include shock, hypotension, loss of consciousness, dyspnea, cyanosis, and wheezing. Advanced life support equipment and trained personnel should be readily available. Local or generalized rash with itching and dermal irritation, headache, malaise, edema of the extremities, and arthralgia have also been reported. The time to onset of these symptoms may occur within minutes or be delayed by several hours post-administration of technetium Tc99m medronate. Users are requested to report to GE Healthcare any instances of suspected adverse drug reactions associated with the use of technetium Tc99m medronate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.