Thallous Chloride, Tl 201
Generic Name: thallous chloride, tl 201
Brand Names:
Thallous Chloride Tl 201
11 DESCRIPTION 11.1 Drug Characteristics Thallous Chloride Tl 201 Injection is a sterile, radioactive diagnostic drug for intravenous use. Each mL contains 37 MBq (1 mCi) thallous chloride Tl 201 at calibration time and the following inactive ingredients: 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium-201 is cyclotron produced.
Overview
11 DESCRIPTION 11.1 Drug Characteristics Thallous Chloride Tl 201 Injection is a sterile, radioactive diagnostic drug for intravenous use. Each mL contains 37 MBq (1 mCi) thallous chloride Tl 201 at calibration time and the following inactive ingredients: 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium-201 is cyclotron produced.
Uses
1 INDICATIONS AND USAGE Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels Thallous Chloride Tl 201 Injection is a radioactive diagnostic drug indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for: Myocardial perfusion imaging in adults...
Dosage
2 DOSAGE AND ADMINISTRATION • For myocardial perfusion imaging: Planar 37 MBq to 74 MBq (1 mCi to 2 mCi) ( 2.2 ) SPECT 74 MBq to 111 MBq (2 mCi to 3 mCi) ( 2.2 ) For localization of parathyroid hyperactivity, planar or SPECT: 75 MBq to 130 MBq (2 mCi to 3.5 mCi) Administer by intravenous injection. ( 2.2 ) See full prescribing information for administration and imaging instructions and radiation dosimetry information. ( 2.3 , 2.4 ) 2.1 Radiation Safety – Drug Handling Handle Thallous Chloride Tl 201 Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.3 )] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Thallous Chloride Tl 201 Injection.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Risk Associated with Stress Testing [see Warnings and Precautions ( 5.2 )] Injection Site Reactions and Tissue Damage [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of Thallous Chloride Tl 201 Injection were identified in clinical studies or postmarketing reports.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Anaphylactic reactions characterized by cardiovascular, respiratory, and cutaneous symptoms may occur. Have resuscitation equipment and trained staff readily available. ( 5.1 ) Risk Associated with Stress Testing: Induction of cardiovascular stress may be associated with serious adverse reactions. Perform stress testing in a setting where cardiac resuscitation equipment and trained staff are readily available. ( 5.2 ) Radiation Risk: Ensure safe handling to minimize radiation exposure to patients and health care providers. ( 2.1 , 5.3 ) 5.1 Hypersensitivity Reactions Thallous Chloride Tl 201 Injection may cause anaphylactic reactions characterized by cardiovascular, respiratory, and cutaneous symptoms [see Adverse Reactions ( 6 )] . 4 CONTRAINDICATIONS None. None
Pregnancy
8.1 Pregnancy Risk Summary There are no data on Thallous Chloride Tl 201 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies using human placentas demonstrate that thallous chloride Tl 201 crosses the placenta. No animal reproductive studies have been conducted. All radiopharmaceuticals, including Thallous Chloride Tl 201 Injection 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 How Supplied Thallous Chloride Tl 201 Injection is supplied as a clear, colorless solution in the following strength at calibration time: 207.2 MBq (5.6 mCi) per 5.6 mL (37 MBq (1 mCi) per mL) in a multiple-dose vial (NDC 69945-120-56) Storage and Handling Store Thallous Chloride Tl 201 Injection in the original container with radiation shielding at 20°C to 25°...
Frequently Asked Questions
What is Thallous Chloride, Tl 201 used for?▼
1 INDICATIONS AND USAGE Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels Thallous Chloride Tl 201 Injection is a radioactive diagnostic drug indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for: Myocardial perfusion imaging in adults...
What are the side effects of Thallous Chloride, Tl 201?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Risk Associated with Stress Testing [see Warnings and Precautions ( 5.2 )] Injection Site Reactions and Tissue Damage [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of Thallous Chloride Tl 201 Injection were identified in clinical studies or postmarketing reports.
Can I take Thallous Chloride, Tl 201 during pregnancy?▼
8.1 Pregnancy Risk Summary There are no data on Thallous Chloride Tl 201 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies using human placentas demonstrate that thallous chloride Tl 201 crosses the placenta. No animal reproductive studies have been conducted. All radiopharmaceuticals, including Thallous Chloride Tl 201 Injection 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 Thallous Chloride, Tl 201?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Anaphylactic reactions characterized by cardiovascular, respiratory, and cutaneous symptoms may occur. Have resuscitation equipment and trained staff readily available. ( 5.1 ) Risk Associated with Stress Testing: Induction of cardiovascular stress may be associated with serious adverse reactions. Perform stress testing in a setting where cardiac resuscitation equipment and trained staff are readily available. ( 5.2 ) Radiation Risk: Ensure safe handling to minimize radiation exposure to patients and health care providers. ( 2.1 , 5.3 ) 5.1 Hypersensitivity Reactions Thallous Chloride Tl 201 Injection may cause anaphylactic reactions characterized by cardiovascular, respiratory, and cutaneous symptoms [see Adverse Reactions ( 6 )] . 4 CONTRAINDICATIONS None. None
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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.