Drugplain

CERETEC .5 mg/5mL

TECHNETIUM TC-99M EXAMETAZIME · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Medi-Physics Inc. dba GE Healthcare.

No Recall HistoryCurrently in Shortage
Plain English

CERETEC is a injection, powder, lyophilized, for solution containing technetium tc-99m exametazime at .5 mg/5mL, taken intravenous. Manufactured by Medi-Physics Inc. dba GE Healthcare..

Key Facts

Brand Name
CERETEC
Generic Name
TECHNETIUM TC-99M EXAMETAZIME
NDC Code (Product)
17156-022
Manufacturer
Medi-Physics Inc. dba GE Healthcare.
Strength
.5 mg/5mL
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA019829
Drug Class
Radioactive Diagnostic Agent [EPC]
Marketing Start
12/30/1988

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

no adverse event13 reports
drug ineffective8 reports
radioisotope scan abnormal7 reports
rash4 reports
chills3 reports
headache3 reports
condition aggravated2 reports
dyspnoea2 reports
malaise2 reports
unresponsive to stimuli2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.

Dosage & Administration

DOSAGE AND ADMINISTRATION Tc99m labeled leukocytes for adjunctive localization of intra-abdominal infection or inflammation. The normal adult (70 kg) dose is 0.259-0.925 GBq (7-25 mCi) as Tc99m labeled leukocytes by intravenous injection. Optimal planar imaging is between 2-4 hours. Cerebral Scintigraphy The recommended dose range for i.v. administration, of reconstituted sodium pertechnetate Tc99m exametazime in the average adult (70 kg) is 370-740 MBq (10-20 mCi). Dynamic imaging may be performed between 0 to 10 minutes following injection. Static imaging may be performed from 15 minutes up to 6 hours after injection.

Contraindications

CONTRAINDICATIONS None known.

Adverse Reactions

ADVERSE REACTIONS Rash with generalized erythema, facial edema and fever has been reported in less than 1% of patients. A transient increase in blood pressure was seen in 8% of patients.

Frequently Asked Questions

What is CERETEC used for?

CERETEC contains TECHNETIUM TC-99M EXAMETAZIME. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.

Is CERETEC a controlled substance?

CERETEC is not classified as a controlled substance by the DEA.

What is the generic name for CERETEC?

The generic name for CERETEC is TECHNETIUM TC-99M EXAMETAZIME. There are 1 other brand versions of TECHNETIUM TC-99M EXAMETAZIME.

What is the NDC code for CERETEC .5 mg/5mL?

The NDC (National Drug Code) for CERETEC .5 mg/5mL is 17156-022, listed by Medi-Physics Inc. dba GE Healthcare..

Product NDC

17156-022

Package NDC

17156-022-05

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)