Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate
Generic Name: tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate
Brand Names:
Cardiolite
11. 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 (SnCl 2 ∙2H 2 O) - 0.025 mg Stannous Chloride, Dihydrate, (SnCl 2 ∙2H 2 O) - 0.075 mg Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 2 ∙2H 2 O) - 0.086 mg Prior to lyophilization...
Overview
11. 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 (SnCl 2 ∙2H 2 O) - 0.025 mg Stannous Chloride, Dihydrate, (SnCl 2 ∙2H 2 O) - 0.075 mg Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 2 ∙2H 2 O) - 0.086 mg Prior to lyophilization...
Uses
1. INDICATIONS AND USAGE CARDIOLITE® is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions 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.
Dosage
2. DOSAGE AND ADMINISTRATION 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). For Breast Imaging: The recommended dose range for I.V. administration of MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi). 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). For Breast Imaging: The recommended dose range for I.V. administration of MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi).
Side Effects
6. ADVERSE REACTIONS 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 Section 5 ). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table: Table 2.0 Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc99m Sestamibi in Either Breast or Cardiac Clinical Studies Excludes the 22 patients whose gender was not recorded.
Interactions
7. DRUG INTERACTIONS Specific drug-drug interactions have not been studied. Specific drug-drug interactions have not been studied.
Warnings
5. WARNINGS AND PRECAUTIONS Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events. CARDIOLITE® 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. Caution should be exercised and emergency equipment should be available when administering CARDIOLITE®. Before administering CARDIOLITE® patients should be asked about the possibility of allergic reactions to either drug. 4. CONTRAINDICATIONS None known. None known.
Pregnancy
8.1 Pregnancy Risk Summary Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
Storage
16. HOW SUPPLIED/STORAGE AND HANDLING 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.
Frequently Asked Questions
What is Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate used for?▼
1. INDICATIONS AND USAGE CARDIOLITE® is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions 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.
What are the side effects of Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate?▼
6. ADVERSE REACTIONS 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 Section 5 ). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table: Table 2.0 Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc99m Sestamibi in Either Breast or Cardiac Clinical Studies Excludes the 22 patients whose gender was not recorded.
Can I take Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate during pregnancy?▼
8.1 Pregnancy Risk Summary Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
What are the important warnings for Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate?▼
5. WARNINGS AND PRECAUTIONS Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events. CARDIOLITE® 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. Caution should be exercised and emergency equipment should be available when administering CARDIOLITE®. Before administering CARDIOLITE® patients should be asked about the possibility of allergic reactions to either drug. 4. CONTRAINDICATIONS None known. None known.
Related Medications
Deferiprone
deferiprone
Iron Chelator [EPC]
11 DESCRIPTION FERRIPROX Tablets (deferiprone) contain 1,000 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C 7 H 9 NO 2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula: Deferiprone is a white to pinkish-white powder. It is sparingly soluble in deionized water (14.3 mg/mL) and has a melting point range of 272 °C - 278 °C.
Dysphania Ambrosioides
dysphania ambrosioides
Headaches with dizziness*
Insulin Aspart-xjhz
insulin aspart-xjhz
Insulin Analog [EPC]
11 DESCRIPTION Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris . Insulin aspart-xjhz has the empirical formula C 256 H 381 N 65 O 79 S 6 and a molecular weight of 5825.8 Da. Figure 1. Structural formula of insulin aspart-xjhz.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.