Kit for the Preparation of Technetium Tc99m Sestamibi

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Overview

What is Kit for the Preparation of Technetium Tc99m Sestamibi?

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 Tc 99m 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 Tc 99m[MIBI] where MIBI is 2-methoxy isobutyl isonitrile.

Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate has the following structural formula:

What does Kit for the Preparation of Technetium Tc99m Sestamibi look like?

What are the available doses of Kit for the Preparation of Technetium Tc99m Sestamibi?

Kit for Preparation of Technetium Tc 99m Sestamibi Injection is supplied as a 5 mL vial in kits of five (5) (NDC # 65857-500-05) and twenty (20) (NDC # 65857-500-20), sterile and non-pyrogenic.

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. Kit for Preparation of Technetium Tc 99m Sestamibi Injection 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 by the U.S. Nuclear Regulatory Commission to use byproduct material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State or Licensing State.

What should I talk to my health care provider before I take Kit for the Preparation of Technetium Tc99m Sestamibi?

How should I use Kit for the Preparation of Technetium Tc99m Sestamibi?

Myocardial Imaging: Technetium Tc 99m Sestamibi 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. Technetium Tc 99m Sestamibi 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.

Breast Imaging: Technetium Tc 99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.

Technetium Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

For Myocardial Imaging: The suggested dose range for I.V. administration of Technetium Tc 99m Sestamibi 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 Technetium Tc 99m Sestamibi is a single dose of 740–1110 MBq (20–30 mCi).

What interacts with Kit for the Preparation of Technetium Tc99m Sestamibi?

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What are the warnings of Kit for the Preparation of Technetium Tc99m Sestamibi?

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What are the precautions of Kit for the Preparation of Technetium Tc99m Sestamibi?

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What are the side effects of Kit for the Preparation of Technetium Tc99m Sestamibi?

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What should I look out for while using Kit for the Preparation of Technetium Tc99m Sestamibi?

None known.

What might happen if I take too much Kit for the Preparation of Technetium Tc99m Sestamibi?

The clinical consequences of overdosing with Technetium Tc 99m Sestamibi are not known.

How should I store and handle Kit for the Preparation of Technetium Tc99m Sestamibi?

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.Store at 15–25°C (59–77°F) before and after reconstitution.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.Store at 15–25°C (59–77°F) before and after reconstitution.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.Store at 15–25°C (59–77°F) before and after reconstitution.

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Pulmonary activity is negligible even immediately after injection. Blood clearance studies indicate that the fast clearing component clears with a t of 4.3 minutes at rest, and clears with a t of 1.6 minutes under exercise conditions. At five minutes post injection about 8% of the injected dose remains in circulation. There is less than 1% protein binding of technetium Tc 99m Sestamibi in plasma. The myocardial biological half-life is approximately six hours after a rest or exercise injection. The biological half-life for the liver is approximately 30 minutes after a rest or exercise injection. The effective half-life of clearance (which includes both the biological half-life and radionuclide decay) for the heart is approximately 3 hours, and for the liver is approximately 30 minutes, after a rest or exercise injection. The ideal imaging time reflects the best compromise between heart count rate and surrounding organ uptake.

Myocardial uptake which is coronary flow dependent is 1.2% of the injected dose at rest and 1.5% of the injected dose at exercise. illustrates the biological clearance as well as effective clearance (which includes biological clearance and radionuclide decay) of Tc 99m Sestamibi from the heart and liver.

[Organ concentrations expressed as percentage of injected dose; data based on an average of 5 subjects at rest and 5 subjects during exercise.]

A study in a dog myocardial ischemia model reported that Technetium Tc 99m Sestamibi undergoes myocardial distribution (redistribution), although more slowly and less completely than thallous chloride Tl-201. A study in a dog myocardial infarction model reported that the drug showed no redistribution of any consequence. Definitive human studies to demonstrate possible redistribution have not been reported. In patients with documented myocardial infarction, imaging revealed the infarct up to four hours post dose.

Non-Clinical Toxicology

None known.

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.

Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see ).

Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QTprolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established.

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 Tc 99m Sestamibi use and is usually associated with exercise stress testing [].

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 Tc 99m 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 Tc 99m Sestamibi imaging. Patients who receive Technetium Tc 99m Sestamibi for either myocardial or breast imaging are receiving the same drug. Caution should be exercised and emergency equipment should be available when administering Technetium Tc 99m Sestamibi. Also, before administering Technetium Tc 99m Sestamibi Injection, patients should be asked about the possibility of allergic reactions to the 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 patients’ 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 []. Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc 99m 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, arrhythmia, 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 Tc 99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritus, rash, urticaria and fatigue have also been attributed to administration of the agent.

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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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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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