Sodium Pertechnetate Tc 99m (Mucosal-Local)


VA CLASSIFICATION
Primary: DX201


Note: For information on sodium pertechnetate Tc 99m injection for intravenous administration, see Sodium Pertechnetate Tc 99m (Systemic) .
For information on sodium pertechnetate Tc 99m injection for ophthalmic administration, see Sodium Pertechnetate Tc 99m (Ophthalmic) .



Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (urinary bladder disorders)—

Indications

Accepted

Urinary bladder imaging, radionuclide—Sodium pertechnetate Tc 99m is indicated in direct isotopic cystography for the detection of vesico-ureteral reflux. {01} {02} {04} {09} {11} {13}


Physical Properties

Nuclear data:



Radionuclide
(half-life)
Decay
constant
Mode
of
decay
Principal
photon
emissions
(keV)
Mean
number of
emissions/
disintegration
(³0.01)
Tc 99m
(6.0 hr)
0.1151 hr -1
Isomeric transition to Tc 99
Gamma
(18)
0.062
Gamma
(140.5)
0.891


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Urinary bladder imaging—Sodium pertechnetate Tc 99m is confined within the urinary tract after direct instillation via catheter into the bladder. The dynamic sequence of filling and voiding is recorded on film and/or digital device; reflux activity into the ureters and/or renal collecting system during filling and voiding can thus be detected. {10}

Elimination:
    Direct intraurethral instillation—Almost total with normal micturition. {04} {05}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Although systemic absorption of sodium pertechnetate is minimal with intraurethral administration, fetal exposure to radiation may result from radioactivity localized in the bladder. {12} Adequate and well-controlled studies with sodium pertechnetate Tc 99m have not been done in humans. The possibility of pregnancy should be assessed in women of child-bearing potential. Clinical situations exist in which the benefit to the patient and fetus derived from information from radiopharmaceutical use outweighs the risks from fetal exposure to radiation. In these situations, the physician should use discretion and reduce the administered activity of the radiopharmaceutical to the lowest possible amount. {06} {12}

Studies have not been done in animals.

FDA Pregnancy Category C. {08} {13}

Breast-feeding

Although Tc 99m is known to be distributed into breast milk, discontinuation of breast-feeding is generally not required because systemic absorption of sodium pertechnetate Tc 99m after intraurethral administration is minimal. Also, the activity administered for this procedure is much less than that used for other procedures. {12}

Pediatrics

Diagnostic studies performed to date using sodium pertechnetate Tc 99m have not demonstrated pediatrics-specific problems that would limit its usefulness in children. Risk of radiation exposure as opposed to benefit derived from use should be considered. {12}


Geriatrics


Although appropriate studies on the relationship of age to the effects of sodium pertechnetate Tc 99m have not been performed in the geriatric population, no geriatrics-specific problems have been documented to date.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:
» Obstruction to urethral catheterization, such as in extensive urinary tuberculosis, bladder tumors, urethral obstructions, and prostate enlargement
» Urinary tract infection, upper, acute    (procedure may increase risk of complications)



Side/Adverse Effects
There are no known side/adverse effects associated with the intraurethral use of sodium pertechnetate Tc 99m as a diagnostic aid. {04}



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopharmaceuticals (Diagnostic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use

Actions in the body
Direct instillation into bladder allows recording of dynamic sequence of filling and voiding to detect vesico-ureteral reflux

Small amounts of radioactivity used in diagnosis; radiation exposure is low and considered safe

Before having this test
»   Conditions affecting use, especially:

Pregnancy—Risk to fetus from radiation exposure as opposed to benefit derived from use should be considered





Use in children—Risk of radiation exposure as opposed to benefit derived from use should be considered

Other medical problems, especially obstruction or acute upper urinary tract infection

Preparation for this test
Special preparatory instructions may be given; patient should inquire in advance


General Dosing Information
Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials and who are authorized by the Nuclear Regulatory Commission (NRC) or the appropriate Agreement State agency or, outside the U.S., the appropriate authority. {07} {12}

Manufacturer's package insert or other appropriate literature should be consulted for optimal times when imaging should be performed.

Safety considerations for handling this medication
Improper handling of this radiopharmaceutical may cause radioactive contamination. Guidelines for handling radioactive material have been prepared by scientific, professional, state, federal, and international bodies and are available to the specially qualified and authorized users who have access to radiopharmaceuticals.


Mucosal-Local Dosage Forms

SODIUM PERTECHNETATE Tc 99m INJECTION USP

Usual adult and adolescent administered activity
Urinary bladder imaging
Intraurethral instillation via catheter, 18.5 to 37 megabecquerels (0.5 to 1 millicurie). {03} {04}


Usual pediatric administered activity
See Usual adult and adolescent administered activity. {04} {09}

Usual geriatric administered activity
See Usual adult and adolescent administered activity .

Strength(s) usually available
U.S.—
740 megabecquerels to 3.7 gigabecquerels (20 to 100 millicuries) per mL at time of calibration.

Note: Sodium pertechnetate Tc 99m injection is supplied as a molybdenum Mo 99/technetium Tc 99m generator in sizes of Mo 99 ranging from 30.7 to 614.2 gigabecquerels (830 to 16,600 millicuries); 9.25 to 111 gigabecquerels (250 to 3000 millicuries) [ Ultra-TechneKow FM]; or 8.3 to 100 gigabecquerels (225 to 2700 millicuries) [ TechneLite]. Each eluate of the generator should not contain more than the USP limit of 0.15 kilobecquerel of molybdenum Mo 99 per megabecquerel of technetium Tc 99m (0.15 microcurie Mo 99 per millicurie Tc 99m) per administered activity at the time of administration.


Canada—
Sodium pertechnetate Tc 99m injection is supplied as a molybdenum Mo 99/technetium Tc 99m generator in sizes of Mo 99 ranging from 8.3 to 100 gigabecquerels (225 to 2700 millicuries). Each eluate of the generator should not contain more than the Canadian Regulatory limit of 1.1 kilobecquerels of molybdenum Mo 99 per 37 megabecquerels of technetium Tc 99m (0.03 microcurie Mo 99 per millicurie Tc 99m) per administered activity at the time of administration. {05}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Stability:
Generator eluate does not contain an antimicrobial agent, and thus should be used within 12 hours from the time of generator elution. {03} {04}

Note: Caution—Radioactive material.




Developed: 08/30/1994



References
  1. Minitec package insert (Squibb—US), Rev 9/88.
  1. Sodium Pertechnetate Tc 99m package insert (Medi-Physics—US), Rev 3/88.
  1. Sodium Pertechnetate Tc 99m package insert (Medi-Physics—US), Rev 4/91.
  1. Ultra-TechneKow package insert (Mallinckrodt—US), Rev 4/85.
  1. Lathrop KA, Harper PV. Biologic behavior of Tc 99m for Tc 99m pertechnetate ion. Progr Nucl Med 1972; 1: 145-62.
  1. Radiopharmaceuticals Advisory Panel Meeting, 5/91.
  1. Radiopharmaceuticals Advisory Panel meeting, 8/4/92.
  1. Ultra-TechneKow FM package insert (Mallinckrodt—US), Rev 8/90.
  1. Van den Abbeele AD, Treves ST, Lebowitz RL, et al. Vesicoureteral reflux in asymptomatic siblings of patients with known reflux: radionuclide cystography. Pediatrics 1987; 79: 147-53.
  1. Weiss S, Conway JJ. The technique of direct radionuclide cystography. Appl Radiol 1975 May/June.
  1. TechneLite package insert (Du Pont—US), Rev 11/92.
  1. Reviewers' comments per 3/14/94 monograph revision.
  1. Ultra-TechneKow FM package insert (Mallinckrodt—US), Rev 6/93.
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