Technescan HDP 3.15 mg/1
Technetium Tc 99m Oxidronate · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Curium US LLC
Technescan HDP is a injection, powder, lyophilized, for solution containing technetium tc 99m oxidronate at 3.15 mg/1, taken intravenous. Manufactured by Curium US LLC.
Key Facts
- Brand Name
- Technescan HDP
- Generic Name
- Technetium Tc 99m Oxidronate
- NDC Code (Product)
69945-091- Manufacturer
- Curium US LLC
- Strength
- 3.15 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA018321
- Marketing Start
- 10/13/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in adult and pediatric patients.
Dosage & Administration
DOSAGE AND ADMINISTRATION Radiation Safety – Drug Handling After radiolabeling of Technescan HDP, the reaction vial contains Technetium Tc 99m Oxidronate Injection. Handle Technetium Tc 99m Oxidronate Injection with appropriate safety measures to minimize radiation exposure. (See PRECAUTIONS, General .) Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Oxidronate Injection. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Recommended Dosage Adults The recommended amount of radioactivity of Technetium Tc 99m Oxidronate Injection in adults is 555 MBq (15 mCi) with a range of 370 MBq to 740 MBq (10 mCi to 20 mCi). The maximum dose of oxidronate sodium in adults is 2 mg. Pediatric Patients The recommended amount of radioactivity of Technetium Tc 99m Oxidronate Injection in pediatric patients is 7.4 MBq/kg to 13 MBq/kg (0.20 mCi/…
Warnings
WARNINGS Technetium Tc 99m oxidronate may cause life-threatening hypersensitivity reactions. Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. (See ADVERSE REACTION S .) Technetium Tc 99m oxidronate is known to complex cations such as calcium. Particular caution should be used with patients who have or who may be predisposed to hypocalcemia. The biodistribution of technetium Tc 99m oxidronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions .)
Contraindications
CONTRAINDICATIONS None known.
Drug Interactions
Drug Interactions The biodistribution of technetium Tc 99m oxidronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. In patients with high levels of these cations caused by concomitant medications, particularly patients receiving iron infusions, consider performing an imaging study with technetium Tc 99m oxidronate injection once the cation levels have normalized (e.g., after 3 to 5 half-lives of the cation). (See WARNINGS .) 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 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. All radiopharmaceuticals, including Tehnescan HDP, have the potential to cause fetal harm depe…
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions associated with the use of Technescan HDP have been reported: hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting, and injection site reactions.
Frequently Asked Questions
What is Technescan HDP used for?
Technescan HDP contains Technetium Tc 99m Oxidronate. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Technescan HDP a controlled substance?
Technescan HDP is not classified as a controlled substance by the DEA.
What is the generic name for Technescan HDP?
The generic name for Technescan HDP is Technetium Tc 99m Oxidronate. There are no other listed brand versions of Technetium Tc 99m Oxidronate.
What is the NDC code for Technescan HDP 3.15 mg/1?
The NDC (National Drug Code) for Technescan HDP 3.15 mg/1 is 69945-091, listed by Curium US LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)