Medronic acid
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
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Preparation and administration
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DOSAGE AND ADMINISTRATION 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 vials are sealed under an atmosphere of nitrogen. Radioassay information labels with radiation warning symbol and a package insert are supplied in each box. STORAGE Store the unreconstituted reaction vials at 25ºC (77ºF); excursions permitted between 15° and 30ºC (59° to 86ºF). After labeling with Technetium Tc-99m, the reconstituted product should be stored at 25ºC (77ºF) in the original vial, and be placed in a suitable lead shield.
Excursions permitted between 15° and 30ºC (59° to 86ºF). Discard the reconstituted solution after 12 hours. DIRECTIONS NOTE: Use aseptic procedures throughout and take precautions to minimize radiation exposure by use of suitable shielding. Use waterproof gloves during the following preparation procedure. MDP-25 reaction vials are intended for the preparation of multiple doses of technetium Tc-99m medronate and the entire contents of the vial should not be used as a single dose.
Before reconstituting a vial, it should be inspected for cracks and/or a melted plug or any other indication that the integrity of the vacuum seal has been compromised. To prepare Technetium Tc 99m Medronate: Remove the central metal disc from a reaction vial and swab the closure with either an alcohol swab or a suitable bacteriostatic agent.
Sufficient sodium pertechnetate is to be used for the reconstitution of a reaction vial to ensure that the dose of medronate administered does not exceed 10 mg. Sodium pertechnetate Tc-99m solutions containing an oxidizing agent are not suitable for use. Using a shielded syringe, add the sodium pertechnetate Tc-99m solution to the reaction vial aseptically.
Place the lead cap on the reaction vial shield and agitate the shielded reaction vial until the contents are completely dissolved. The solution must be clear and free of particulate matter before proceeding. Assay the product in a suitable calibrator, record the radioassay information on the label with radiation warning symbol, and apply it to the reaction vial.
Withdrawals for administration must be made aseptically using a shielded sterile syringe and needle. Since the reaction vials contain nitrogen to prevent oxidation of the complex, they should not be vented. If repeated withdrawals are made, minimize the replacement of contents with room air. The following steps should be followed to ensure that each reconstituted of Technetium Tc 99m Medronate contains between 1 and 10 mg of medronic acid.
Where: Vr = Final volume of in the vial in mL after reconstitution. C = Concentration of Medronic Acid in mg/mL. Max. V = Maximum volume to be used for one dose in mL. Min. V = Minimum volume to be used for one dose in mL. a) Prior to reconstitution, determine the radioactive concentration of the sodium pertechnetate Tc-99m. b) Note the volume and activity added to the vial.
It should be between 1.85 – 37.0 GBq (50 – 1000 mCi) in 1 to 10 mL. c) Calculate the concentration (C) of Medronic acid in the vial after reconstitution. C (mg/mL) = 25 mg ÷ Vr (mL) d)To ensure that the dose contains a maximum of 10 mg, the following formula should be used to calculate the maximum volume (Max. V) to be dispensed as one dose.
| The following steps should be followed to ensure that each reconstituted of Technetium Tc 99m Medronate contains between 1 and 10 mg of medronic acid. Where: Vr = Final volume of in the vial in mL after reconstitution. C = Concentration of Medronic Acid in mg/mL. Max. V = Maximum volume to be used for one dose in mL. Min. V = Minimum volume to be used for one dose in mL. a) Prior to reconstitution, determine the radioactive concentration of the sodium pertechnetate Tc-99m. b) Note the volume and activity added to the vial. It should be between 1.85 – 37.0 GBq (50 – 1000 mCi) in 1 to 10 mL. c) Calculate the concentration (C) of Medronic acid in the vial after reconstitution. C (mg/mL) = 25 mg ÷ Vr (mL) d)To ensure that the dose contains a maximum of 10 mg, the following formula should be used to calculate the maximum volume (Max. V) to be dispensed as one dose. Max. V (mL) = 10 mg ÷ C (mg/mL) e) To ensure that a minimum dose of 1 mg is dispensed, the following formula should be used to calculate the minimum volume (Min. V) to be dispensed as one dose Min. V = 1mg ÷ C(mg/mL) |
Drug interactions
Check medronic acid against a medication listLabel text (1 paragraph)
Drug Interactions 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. 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 medronate injection once the cation levels have normalized (e.g., after 3 to 5 half-lives of the cation). (See WARNINGS .)
Contraindications
None known.
Pregnancy and lactation
Pregnancy
Pregnancy Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Medronate. It is also not known whether Technetium Tc 99m Medronate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. There have been no studies in pregnant women. Technetium Tc-99m 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.
Lactation
Nursing Mothers Technetium Tc-99m is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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