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Cardiolite
Overview
What is Cardiolite?
Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of:
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]
where MIBI is 2-methoxy isobutyl isonitrile.
What does Cardiolite look like?
What are the available doses of Cardiolite?
CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial.
What should I talk to my health care provider before I take Cardiolite?
How should I use Cardiolite?
Myocardial Imaging: CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. CARDIOLITE evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling).
It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia.
For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE® in a single dose to be employed in the average patient (70 Kg) is 370 - 1110 MBq (10 - 30 mCi).
What interacts with Cardiolite?
Sorry No Records found
What are the warnings of Cardiolite?
Sorry No Records found
What are the precautions of Cardiolite?
Sorry No Records found
What are the side effects of Cardiolite?
Sorry No records found
What should I look out for while using Cardiolite?
None known.
What might happen if I take too much Cardiolite?
The clinical consequences of overdosing with CARDIOLITE® are not known.
How should I store and handle Cardiolite?
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC # 11994-001-55) and twenty (20) vials (NDC # 11994-001-20), sterile and non-pyrogenic.The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77° F) before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels.This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC # 11994-001-55) and twenty (20) vials (NDC # 11994-001-20), sterile and non-pyrogenic.The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77° F) before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels.This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC # 11994-001-55) and twenty (20) vials (NDC # 11994-001-20), sterile and non-pyrogenic.The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77° F) before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels.This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC # 11994-001-55) and twenty (20) vials (NDC # 11994-001-20), sterile and non-pyrogenic.The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77° F) before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels.This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC # 11994-001-55) and twenty (20) vials (NDC # 11994-001-20), sterile and non-pyrogenic.The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77° F) before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels.This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC # 11994-001-55) and twenty (20) vials (NDC # 11994-001-20), sterile and non-pyrogenic.The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77° F) before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels.This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Technetium Tc99m Sestamibi is a cationic Tc99m complex which has been found to accumulate in viable myocardial tissue in a manner analogous to that of thallous chloride Tl-201. Scintigraphic images obtained in humans after the intravenous administration of the drug have been comparable to those obtained with thallous chloride Tl-201 in normal and abnormal myocardial tissue.
Animal studies have shown that myocardial uptake is not blocked when the sodium pump mechanism is inhibited. Although studies of subcellular fractionation and electron micrographic analysis of heart cell aggregates suggest that Tc99m Sestamibi cellular retention occurs specifically within the mitochondria as a result of electrostatic interactions, the clinical relevance of these findings has not been determined.
The mechanism of Tc99m Sestamibi localization in various types of breast tissue (e.g., benign, inflammatory, malignant, fibrous) has not been established.
Non-Clinical Toxicology
None known.Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see and anaphylactoid reactions (see
Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin.
In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure. Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See ).
Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events. Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent's labeling.
Technetium Tc99m Sestamibi has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during CARDIOLITE® imaging. Patients who receive CARDIOLITE® or MIRALUMA® imaging are receiving the same drug. Caution should be exercised and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Also, before administering either CARDIOLITE® or MIRALUMA®, patients should be asked about the possibility of allergic reactions to either drug.
Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patient's genders were not recorded) were in cardiac clinical trials and 673 (100% women) in breast imaging trials. Cases of angina, chest pain, and death have occurred (see ). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table:
In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients. In 11 of these patients the pain appears to be associated with biopsy/surgical procedures.
The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis, angioedema, arrythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritis, rash, urticaria and fatigue have also been attributed to administration of the agent.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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