Ammonia N-13
Dosage form: injection, solution
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- References
- How Supplied/Storage and Handling
- Patient Counseling Information
INDICATIONS AND USAGE
Ammonia N 13 Injection USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
DOSAGE AND ADMINISTRATION
2.1 Rest Imaging Study
- Aseptically withdraw Ammonia N 13 Injection USP from its container and administer 0.368-0.736 GBq (10-20 mCi) as a bolus through a catheter inserted into a large peripheral vein.
- Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes.
2.2 Stress Imaging Study
- If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N 13 Injection USP to allow sufficient isotope decay.
- Administer a pharmacologic stress-inducing drug in accordance with its labeling.
- Aseptically withdraw Ammonia N 13 Injection USP from its container and administer 0.368-0.736 GBq (10-20 mCi) of Ammonia N 13 Injection USP as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug. Start imaging 3 minutes after the Ammonia N 13 Injection USP and acquire images for a total of 10-20 minutes.
2.3 Patient Preparation
To increase renal clearance of radioactivity and to minimize radiation dose to the bladder, ensure that the patient is well hydrated before the procedure and encourage voiding as soon as a study is completed and as often as possible thereafter for at least one hour.
2.4 Radiation Dosimetry
The converted radiation absorbed doses in rem/mCi are shown in Table 1. These estimates are calculated from the Task Group of Committee 2 of the International Commission on Radiation Protection. 1
