Medronate

• MDP-25 (Kit for the Preparation of Technetium Tc 99m Medronate) may be used as a bone imaging agent to delineate areas of altered osteogenesis.

• None known.contraindicated

The recommended adult dose, after reconstitution with oxidant-free sodium pertechnetate Tc-99m, is 370 to 740 megabecquerels (10 to 20 millicuries [200 µCi/kg]) by slow intravenous injection over a period of 30 seconds. Optimum scanning time is 1 to 4 hours post-injection. To minimize the contribution of the bladder content to the image, the patient should void immediately before imaging is started. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The solution should not be used if cloudy. RADIATION DOSIMETRY The estimated absorbed radiation doses to an average patient (70 kg) from an intravenous injection of a maximum dose of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate are shown in Table 4. The effective half-life was assumed to be the physical half-life for all calculated values. Table 4 Radiation Doses 2 Tissue Absorbed Radiation Dose mGy/740 MBq rads/20 mCi Total Body Total Bone Red Marrow Kidneys Liver Bladder Wall 2 hr. void 4.8 hr. void Ovaries 2 hr. void 4.8 hr. void Testes 2 hr. void 4.8 hr. void 1.3 7.0 5.6 8.0 0.6 26.0 62.0 2.4 3.4 1.6 2.2 0.13 0.70 0.56 0.80 0.06 2.60 6.20 0.24 0.34 0.16 0.22 2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975 HOW SUPPLIED MDP-25, Kit for the Preparation of Technetium Tc 99m Medronate Injection Product No.

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). The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc-99m is added, adequate shielding of the final preparation must be maintained. Preliminary reports indicate impairment of brain images using Sodium Pertechnetate Tc 99m Injection which have been preceded by bone imaging using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain images. It is recommended, where feasible, that brain imaging using Sodium Pertechnetate Tc 99m Injection precede bone imaging procedures. Alternatively, a brain imaging agent such as technetium Tc-99m pentetate may be employed. The biodistribution of technetium Tc 99m medronate 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. )

Several cases of allergic dermatological reactions have been reported in association with the use of Technetium Tc 99m Medronate. Several reactions have also been reported in association with other radiopharmaceuticals of the diphosphonate class, particularly Technetium Tc 99m Medronate. These are usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, fever, and vomiting. One death secondary to cardiac arrhythmia following the administration of Technetium Tc 99m Medronate has been reported. In addition, one case of cardiac arrest in a patient also undergoing pulmonary function testing one and one-half hours after the performance of a bone scan using Technetium Tc 99m Medronate has been reported.

• Nov 28, 1978NDANDA018035Jubilant
• Aug 29, 1979NDANDA018124Sun Pharm Inds Inc
• Feb 17, 1981NDANDA018107Cardinal Health 414

1. 1Pruritus233%
2. 2Chills117%
3. 3Dysphagia117%
4. 4Erythema117%
5. 5Eye Oedema117%
6. 6Eye Pain117%
7. 7Hypersensitivity117%
8. 8Hypoaesthesia117%
9. 9Mucosal Inflammation117%
10. 10Palpitations117%
11. 11Rash117%
12. 12Stomatitis117%
13. 13Throat Tightness117%
14. 14Ulcer117%
15. 15Visual Impairment117%

The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Medronate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy of Ra-223 in PSMA PET Optimally Selected Patients
  Active not recruiting · Phase 2 · Interventional · 2 enrolled · University of California, San Francisco
  NCT05924672updated 2026-01-14
• Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
  Completed · Phase 2 · Interventional · 114 enrolled · Stanford University
  NCT00375830updated 2023-12-12
• Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations
  Completed · Phase 2 · Interventional · 40 enrolled · Kafrelsheikh University
  NCT05973292updated 2023-08-02
• Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
  Completed · Phase 3 · Interventional · 280 enrolled · HTA Co., Ltd.
  NCT05614518updated 2022-11-14
• Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies
  Unknown · Observational · 70 enrolled · Assiut University
  NCT05597215updated 2022-10-27
• 18F-NaF PET Imaging for Bone Scintigraphy
  Completed · Phase 3 · Interventional · 286 enrolled · British Columbia Cancer Agency
  NCT01930812updated 2019-04-25
• Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo
  Terminated · Phase 3 · Interventional · 4 enrolled · University of Manitoba
  NCT03002454updated 2017-10-03
• Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer
  Completed · Early phase 1 · Interventional · 50 enrolled · National Cancer Institute (NCI)
  NCT00956163updated 2014-07-02

Frequently asked questions

What is Medronate used for?

According to FDA labeling, Medronate carries indications including: MDP-25 (Kit for the Preparation of Technetium Tc 99m Medronate) may be used as a bone imaging agent to delineate areas of altered osteogenesis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Medronate?

Medronate labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.