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Technetium Tc 99m Oxidronate
Overview
What is Technescan HDP?
Technescan™ HDP is supplied as a lyophilized powder, packaged under nitrogen in vials for intravenous administration after reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO as active ingredients. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. The pH of the reconstituted drug is between 4.0 and 5.5. The contents of the vial are sterile and non-pyrogenic.
The chemical structure of oxidronate sodium is:
This radiopharmaceutical diagnostic agent, when reconstituted with ADDITIVE-FREE sodium pertechnetate Tc 99m forms a complex of unknown structure.
What does Technescan HDP look like?
What are the available doses of Technescan HDP?
Sorry No records found.
What should I talk to my health care provider before I take Technescan HDP?
Sorry No records found
How should I use Technescan HDP?
Technescan HDP Tc 99m is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.
What interacts with Technescan HDP?
None known.
What are the warnings of Technescan HDP?
Use of Chloroquine Phosphate Tablets in patients with psoriasis may precipitate a severe attack of psoriasis. When used in patients with porphyria the condition may be exacerbated. The drug should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the potential risks.
Technetium Tc 99m Oxidronate may cause life-threatening hypersensitivity reactions. Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.
This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to hypocalcemia (i.e., alkalosis).
What are the precautions of Technescan HDP?
General
The components of the kit are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. Sodium pertechnetate Tc 99m solutions which contain an oxidizing agent or saline solutions containing preservatives are not suitable for use in the preparation of Technescan HDP Tc 99m.
Contents of the vial are intended only for use in the preparation of Technetium Tc 99m Oxidronate and are NOT to be administered directly to the patient. Technetium Tc 99m Oxidronate should be formulated within eight (8) hours prior to clinical use. Optimal imaging results are obtained one to four hours after administration. Technetium Tc 99m Oxidronate as well as other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients consistent with proper patient management and to ensure minimum radiation exposure to occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. To minimize radiation dose to the bladder, the patients should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next four to six hours.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether Technetium Tc 99m Oxidronate affects fertility in males and females.
Pregnancy Category C
Animal reproduction studies have not been conducted with Technetium Tc 99m Oxidronate. It is also not known whether Technetium Tc 99m Oxidronate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc 99m Oxidronate should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
Nursing Mothers
Technetium Tc 99m is excreted in human milk during lactation, therefore formula feedings should be substituted for breast feedings.
Overdose
In the event of the administration of an overdose with Technescan HDP, encourage patients to drink fluids and void frequently to reduce the radiation dose to the patient.
What are the side effects of Technescan HDP?
Hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting and injection site reactions, have been infrequently reported with Technetium Tc 99m Oxidronate use.
What should I look out for while using Technescan HDP?
None known.
Technetium Tc 99m Oxidronate may cause life-threatening hypersensitivity reactions. Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.
This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to hypocalcemia (i.e., alkalosis).
What might happen if I take too much Technescan HDP?
Sorry No Records found
How should I store and handle Technescan HDP?
Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl•2HO), 0.297 mg, theoretical, stannous chloride (SnCl•2HO) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl•2HO. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by: Mallinckrodt Nuclear Medicine LLC2703 Wagner PlaceMaryland Heights, MO 63043Made in USAA091I0Rev 03/2017Mallinckrodt™
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
During the 24 hours following injection, Technetium Tc 99m-labeled Technescan HDP is rapidly cleared from blood and other non-osseous tissues and accumulates in the skeleton and urine in humans. Blood levels are about 10% of the injected dose at one hour post-injection and continue to fall to about 6%, 4% and 3% at 2, 3 and 4 hours, respectively. When measured at 24 hours following its administration, skeletal retention is approximately 50% of the injected dose. Technescan HDP exhibits its greatest affinity for areas of altered osteogenesis and actively metabolizing bone.
Non-Clinical Toxicology
None known.Technetium Tc 99m Oxidronate may cause life-threatening hypersensitivity reactions. Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.
This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to hypocalcemia (i.e., alkalosis).
(See and .) Fluconazole is a potent inhibitor of cytochrome P450 (CYP) isoenzyme 2C9 and 2C19, and a moderate inhibitor of CYP3A4. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19 and CYP3A4 coadministered with fluconazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of fluconazole persists 4–5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed. These are described in greater detail below:
Oral hypoglycemics Coumarin-type anticoagulants Phenytoin Cyclosporine Rifampin Theophylline Terfenadine Cisapride Astemizole Rifabutin Voriconazole Tacrolimus Short-acting benzodiazepines Tofacitinib Triazolam Oral Contraceptives Pimozide Quinidine Hydrochlorothiazide Alfentanil Amitriptyline, nortriptyline Amphotericin B Azithromycin Carbamazepine Calcium Channel Blockers Celecoxib Cyclophosphamide Fentanyl Halofantrine HMG-CoA reductase inhibitors Losartan Methadone Non-steroidal anti-inflammatory drugs Prednisone Saquinavir Sirolimus Vinca Alkaloids Vitamin A Zidovudine
The components of the kit are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. Sodium pertechnetate Tc 99m solutions which contain an oxidizing agent or saline solutions containing preservatives are not suitable for use in the preparation of Technescan HDP Tc 99m.
Contents of the vial are intended only for use in the preparation of Technetium Tc 99m Oxidronate and are NOT to be administered directly to the patient. Technetium Tc 99m Oxidronate should be formulated within eight (8) hours prior to clinical use. Optimal imaging results are obtained one to four hours after administration. Technetium Tc 99m Oxidronate as well as other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients consistent with proper patient management and to ensure minimum radiation exposure to occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. To minimize radiation dose to the bladder, the patients should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next four to six hours.
Hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting and injection site reactions, have been infrequently reported with Technetium Tc 99m Oxidronate use.
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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