pharmacopeia

Cobaltous Chloride

US-FDASourced from openFDA
GET
/api/v1/drug/cobaltous-chloride

Mechanism of action

Sourced from openFDA

General When technetium Tc 99m pertechnetate is added to exametazime in the presence of stannous reductant, a lipophilic technetium Tc 99m complex is formed. This lipophilic complex is the active moiety and is able to cross the blood-brain barrier as well as penetrate cell membranes to label leukocytes.

Indications

Sourced from openFDA
  • Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ( 1.1 ) Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke.ICD-10: I63.9

Contraindications

Sourced from openFDA
  • None None.contraindicated

Dosage & administration

Sourced from openFDA

Do not use cobalt stabilizer solution for leukocyte labeled scintigraphy. ( 2.1 ) Use appropriate radiation safety measures and aseptic technique during preparation and handling. ( 2.1 ) Leukocyte Labeled Scintigraphy - The recommended adult dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer as soon as possible after labeling, preferably within 20 minutes but no later than 1 hour. ( 2.2 ) Cerebral Scintigraphy - The recommended adult dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection. ( 2.2 ) See full prescribing information for preparation and administration, interpretation of chromatograms and radiation dosimetry. ( 2 ) 2.1 Important Preparation and Radiation Safety Instructions The Ceretec kit includes a cobalt stabilizer solution, which is optional for cerebral scintigraphy. DO NOT USE COBALT STABILIZER SOLUTION FOR LEUKOCYTE LABELED Scintigraphy [see Dosage and Administration (2.4 , 2.6) ] . Technetium Tc 99m exametazime injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.3) ] . Use waterproof gloves and effective shielding, including syringe shields, when preparing and administering technetium Tc 99m exametazime injection. 2.2 Recommended Dosing and Imaging Procedures Leukocyte Labeled Scintigraphy Dosing Adults: The recommended dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection.

Warnings & precautions

Sourced from openFDA

Hypersensitivity reactions: Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions have been reported following the administration of Tc 99m exametazime injection and Tc 99m exametazime labeled leukocytes including serious signs and symptoms of anaphylaxis following administration [see Adverse Reactions (6) ] . Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. 5.2 Risk for Image Interpretation Errors The interpretation of images for leukocyte labeled imaging can be affected by the presence of other pathophysiological processes such as: tumor, infarction, trauma, and inflammatory conditions. 5.3 Radiation Exposure Risk Technetium Tc 99m contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Encourage patients to drink fluids and instruct patients to void when the examination is completed and as often thereafter as frequently as possible after administration [see Dosage and Administration (2.1 , 2.3) ] . Radiation risks associated with the use of Tc 99m exametazime injection and Tc 99m exametazime labeled leukocytes are greater in pediatric patients than in adults due to greater radiosensitivity and longer life expectancy.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]. The following adverse reactions associated with the use of Ceretec were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders: Reversible increase in blood pressure, flushing Gastrointestinal disorders: Nausea, vomiting General disorders and administration site conditions: Malaise, fatigue, fever Immune system disorders: Hypersensitivity reactions: anaphylactic reactions including shock, facial edema, rash, pruritus or erythema Nervous system disorders: Headache, dizziness, paresthesia Most common adverse reactions include a reversible increase in blood pressure . ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Use in specific populations

Sourced from openFDA

Pregnancy - Advise the pregnant woman of the potential risk to the fetus based on the radiation dose from the Technetium Tc 99m exametazime injection and the gestational timing of exposure. ( 8.1 ) Lactation – Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Technetium Tc 99m Exametazime labeled leukocyte administration. ( 8.2 ) 8.1 Pregnancy Risk Summary Limited available data with technetium Tc 99m exametazime use in pregnant women are insufficient to inform any drug associated risks for major birth defects and miscarriage. Technetium Tc 99m exametazime is transferred across the placenta [see Data ]. Animal reproduction studies with technetium Tc 99m exametazime have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering technetium Tc 99m exametazime administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m exametazime and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Pharmacokinetics

Sourced from openFDA
Metabolism
Distribution Leukocytes Labeled with Tc 99m Exametazime During the first hour following injection of Tc 99m labeled leukocytes, activity is seen in the lungs, liver, spleen, blood pool, bone marrow, kidneys, gall bladder, and urinary bladder. At 4 hours following injection, lung radioactivity was decreased and bone marrow radioactivity was increased.

Approval history

Sourced from openFDA
  • Dec 30, 1988NDANDA019829Ge Healthcare

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
37 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1No Adverse Event1335%
  2. 2Drug Ineffective822%
  3. 3Radioisotope Scan Abnormal719%
  4. 4Rash411%
  5. 5Chills38.1%
  6. 6Headache38.1%
  7. 7Condition Aggravated25.4%
  8. 8Dyspnoea25.4%
  9. 9Malaise25.4%
  10. 10Unresponsive To Stimuli25.4%
  11. 11Vasospasm25.4%
  12. 12Abdominal Discomfort12.7%
  13. 13Anaphylactic Reaction12.7%
  14. 14Autoimmune Thyroiditis12.7%
  15. 15Blood Creatinine Increased12.7%

Literature

View JSON

Recent PubMed references pinned to Cobaltous Chloride as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Frequently asked questions

How does Cobaltous Chloride work?
General When technetium Tc 99m pertechnetate is added to exametazime in the presence of stannous reductant, a lipophilic technetium Tc 99m complex is formed. This lipophilic complex is the active moiety and is able to cross the blood-brain barrier as well as penetrate cell membranes to label leukocytes.
What is Cobaltous Chloride used for?
According to FDA labeling, Cobaltous Chloride carries indications including: Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ( 1.1 ) Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the contraindications for Cobaltous Chloride?
Cobaltous Chloride labeling lists contraindications including: None None.. Always consult the full prescribing information and a clinician.
Note. Data for cobaltous-chloride is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients