Cardiolite

DRUG DESCRIPTION

Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of:

  • Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1.0 mg
  • Sodium Citrate Dihydrate - 2.6 mg
  • L-Cysteine Hydrochloride Monohydrate -1.0 mg
  • Mannitol - 20 mg
  • Stannous Chloride, Dihydrate, minimum (SnCl22H20) - 0.025 mg
  • Stannous Chloride, Dihydrate, (SnCl22H20) - 0.075 mg
  • Tin Chloride (stannous and stannic) Dihydrate, maximum
  • (as SnCl22H20) - 0.086 mg

Prior to lyophilization the pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen.

This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The pH of the reconstituted product is 5.5 (5.0 - 6.0). No bacteriostatic preservative is present.

The precise structure of the technetium complex is Tc99m[MIBI]6+ where MIBI is 2-methoxy isobutyl isonitrile.

Physical Characteristics

Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours1. Photons that are useful for detection and imaging studies are listed below in Table 4.

Table 4.0 - Principal Radiation Emission Data

Radiation Mean %/Disintegration Mean Energy (KeV)
Gamma-2 89.07 140.5
1Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108 (1981).

External Radiation

The specific gamma ray constant for Tc99m is 5.4 micro coulombs/Kg-MBq-hr (0.78R/mCi-hr) at 1 cm. The first half value layer is 0.017 cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radio nuclide that results from interposition of various thicknesses of Pb is shown in Table 5.0. To facilitate control of the radiation exposure from Megabequerel (millicurie) amounts of this radio nuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of 1,000.

Table 5.0 - Radiation Attenuation by Lead Shielding

Shield Thickness (Pb) cm Coefficient of Attenuation
0.017 0.5
0.08 10-1
0.16 10-2
0.25 10-3
0.33 10-4

To correct for physical decay of this radio nuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 6.0.

Table 6.0 - Physical Decay Chart; Tc99m Half-Life 6.02 Hours

Hours Fraction Remaining Hours Fraction Remaining
0* 1.000 8 .398
1 .891 9 .355
2 .794 10 .316
3 .708 11 .282
4 .631 12 .251
5 .562
6 .501
7 .447
* Calibration Time

What are the precautions when taking prep kit for technetium tc99 sestamibi for injection (Cardiolite)?

Before taking diltiazem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as sick sinus syndrome/atrioventricular block unless you have a pacemaker).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart failure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires...

Read All Potential Precautions of Cardiolite


Cardiolite Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, weakness, nausea, flushing, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, slow/irregular/pounding/fast heartbeat, swelling ankles/feet, shortness of breath, unusual tiredness, unexplained/sudden weight gain, mental/mood changes (such as depression, agitation), unusual dreams.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, dark urine, persistent nausea/vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking diltiazem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as sick sinus syndrome/atrioventricular block unless you have a pacemaker).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart failure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.



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