Technetium Tc-99m Pentetate Kit is a medicine sold in the U.S. under 3 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Draximage Dtpa (application NDA018511). Other technetium tc-99m pentetate kit products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
During preparation and handling, use water proof gloves and effective shielding, to minimize radiation exposure ( 2.1 , 5.3 ). See the Full Prescribing Information for detailed information regarding recommended Dosage and Image Acquisition Instructions ( 2.2 ) and Instructions for Drug Preparation ( 2.4 ). Do not administer more than one dose ( 2.2 ). 2.1 Radiation Safety – Drug Handling Tc 99m labeled DRAXIMAGE ® DTPA injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and healthcare worker. During preparation and handling, use water proof gloves and effective shielding, including syringe shields [see Warnings and Precautions ( 5.3 )] . 2.2 Recommended Dosage and Image Acquisition Instructions The recommended dose ranges for intravenous or inhalation administration of DRAXIMAGE® DTPA, after reconstitution, are presented in Table 1 through Table 3. Do not administer more than one dose. Table 1 Tc 99m Labeled DRAXIMAGE ® DTPA Injection – Intravenous Administration, Adults Indication Route of Administration Dose Image Acquisition Brain Imaging Intravenous Injection 370 MBq to 740 MBq (10 mCi to 20 mCi) Immediate dynamic imaging. Obtain at least one blood-pool image in same position as flow. Delayed images can be obtained 1 hour later. Renal Visualization and Perfusion Assessment Intravenous…
The following adverse reactions have been identified post-approval. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their exact frequency or establish a causal relationship to Technetium Tc 99m pentetate exposure. Adverse reactions are presented in decreasing order of reported frequency: Immune system disorders: allergic reaction, anaphylactic reaction, angioedema. Skin and subcutaneous tissue disorders: rash, itching, hives, erythema. Respiratory, thoracic and mediastinal disorders: throat irritation, wheezing. Vascular disorders: hypotension, hypertension. Nervous system disorders: headache, fainting, dizziness. General disorders and administration site conditions: chills. Gastrointestinal disorders: nausea, vomiting. Cardiac disorders: cyanosis, tachycardia. Most common adverse reactions reported with Technetium Tc 99m pentetate injection include allergic reactions, rash, itching ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | — | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | — | — | View → |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Hypersensitivity to the active ingredient or to any component of the product [see Warnings and Precautions ( 5.1 )]. Hypersensitivity to the active ingredient or any component of this product ( 4 ).
| 3 | Not yet rated | Prescription | Injectable | — | — | View → |