These highlights do not include all the information needed to use Ammonia N 13 Injection, USP safely and effectively. See full prescribing information for Ammonia N 13 Injection, USP. Ammonia N 13 Injection, USP for intravenous useInitial U.S. Approval | Ammonia N 13 [Biomedical Research Foundation of Northwest Louisiana] | BioPortfolio

12:50 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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.

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.

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.

Table 1: N 13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatric Groups.
Organ Age (years)
Adult 15 10 5 1
Adrenals 0.0085 0.0096 0.016 0.025 0.048
Bladder wall 0.030 0.037 0.056 0.089 0.17
Bone surfaces 0.0059 0.0070 0.011 0.019 0.037
Brain 0.016 0.016 0.017 0.019 0.027
Breast 0.0067 0.0067 0.010 0.017 0.033
Stomach wall 0.0063 0.0078 0.012 0.019 0.037
Small intestine 0.0067 0.0081 0.013 0.021 0.041
Upper large intestine,ULI 0.0067 0.0078 0.013 0.021 0.037
Lower large intestineLLI 0.0070 0.0078 0.013 0.020 0.037
Heart 0.0078 0.0096 0.015 0.023 0.041
Kidneys 0.017 0.021 0.031 0.048 0.089
Liver 0.015 0.018 0.029 0.044 0.085
Lungs 0.0093 0.011 0.018 0.029 0.056
Ovaries 0.0063 0.0085 0.014 0.021 0.041
Pancreas 0.0070 0.0085 0.014 0.021 0.041
Red marrow 0.0063 0.0078 0.012 0.020 0.037
Spleen 0.0093 0.011 0.019 0.030 0.056
Testes 0.0067 0.0070 0.011 0.018 0.035
Thyroid 0.0063 0.0081 0.013 0.021 0.041
Uterus 0.0070 0.0089 0.014 0.023 0.041
Other tissues 0.0059 0.0070 0.011 0.018 0.035

Glass vial (30 mL) containing 0.138 GBq -1.387 GBq (3.75 mCi/mL-37.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9% sodium chloride solution (approximately 13 mL volume) that is suitable for intravenous administration.


Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration(2.4) ].

No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.

The possibility of interactions of Ammonia N 13 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

Pregnancy Category C Animal reproduction studies have not been conducted with Ammonia N 13 Injection.  It is also not known whether Ammonia N 13 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Ammonia N 13 Injection should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from Ammonia N 13 Injection, use alternative infant nutrition sources (e.g. stored breast milk or infant formula) for 2 hours (>10 half-lives of radioactive decay for N 13 isotope) after administration of the drug or avoid use of the drug, taking into account the importance of the drug to the mother.

The safety and effectiveness of Ammonia N 13 Injection has been established in pediatric patients based on known metabolism of ammonia, radiation dosimetry in the pediatric population, and clinical studies in adults [see Dosage and Administration(2.4)].

Ammonia N 13 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [N] ammonia, has the molecular formula of NHwith a molecular weight of 16.02, and has the following chemical structure:

Ammonia N 13 Injection, USP is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride solution. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of ammonia.

Nitrogen N 13 decays by emitting positron to Carbon C13 (stable) and has a physical half-life of 9.96 minutes.  The principal photons useful for imaging are the dual 511 keV gamma photons that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron (Table 2).

The specific gamma ray constant (point source air kerma coefficient) for nitrogen N 13 is 5.9 R/hr/mCi (1.39 x 10 Gy/hr/kBq) at 1 cm.  The half-value layer (HVL) of lead (Pb) for 511 keV photons is 4 mm. Selected coefficients of attenuation are listed in Table 3 as a function of lead shield thickness. For example, the use of 39 mm thickness of lead will attenuate the external radiation by a factor of about 1000.

Table 4 lists fractions remaining at selected time intervals from the calibration time.  This information may be used to correct for physical decay of the radionuclide.

Table 2: Principal Radiation Emission Data for NitrogeN 13
Radiation/Emission %Per Disintegration Energy
Positron(β+) 100 1190 keV (Max.)
Gamma(±)Produced by positron annihilation 200 511 keV
Table 3: Radiation Attenuation of 511 keV Photons by lead (Pb) shielding
Shield Thickness (Pb) mm Coefficient of Attenuation
4 0.5
8 0.25
13 0.1
26 0.01
39 0.001
52 0.0001
Table 4: Physical Decay Chart for Nitrogen N 13
Minutes Fraction Remaining
0Calibration time 1.000
5 0.706
10 0.499
15 0.352
20 0.249
25 0.176
30 0.124

Ammonia N 13 Injection is a radiolabeled analog of ammonia that is distributed to all organs of the body after intravenous administration.  It is extracted from the blood in the coronary capillaries into the myocardial cells where it is metabolized to glutamine N 13 and retained in the cells.  The presence of ammonia N 13 and glutamine N 13 in the myocardium allows for PET imaging of the myocardium.

Following intravenous injection, ammonia N 13 enters the myocardium through the coronary arteries.  The PET technique measures myocardial blood flow based on the assumption of a three-compartmental disposition of intravenous ammonia N 13 in the myocardium.  In this model, the value of the rate constant, which represents the delivery of blood to myocardium, and the fraction of ammonia N 13 extracted into the myocardial cells, is a measure of myocardial blood flow. Optimal PET imaging of the myocardium is generally achieved between 10 to 20 minutes after administration.

Following intravenous injection, Ammonia N 13 Injection is cleared from the blood with a biologic half-life of about 2.84 minutes (effective half-life of about 2.21 minutes).  In the myocardium, its biologic half-life has been estimated to be less than 2 minutes (effective half-life less than 1.67 minutes).

The mass dose of Ammonia N 13 Injection is very small as compared to the normal range of ammonia in the blood (0.72-3.30 mg) in a healthy adult man [see Description(11.1)].

Plasma protein binding of ammonia N 13 or its N 13 metaboliteshas not been studied.

Ammonia N 13 undergoes a five-enzyme step metabolism in the liver to yield urea N 13 (the main circulating metabolite).  It is also metabolized to glutamine N 13 (the main metabolite in tissues) by glutamine synthesis in the skeletal muscles, liver, brain, myocardium, and other organs.  Other metabolites of ammonia N 13 include small amounts of N 13 amino acid anions (acidic amino acids) in the forms of glutamate N 13 or aspartate N 13.

Ammonia N 13 is eliminated from the body by urinary excretion mainly as urea N 13.

The pharmacokinetics of Ammonia N 13 Injection have not been studied in renally impaired, hepatically impaired, or pediatric patients.

Long term animal studies have not been performed to evaluate the carcinogenic potential of Ammonia N 13 Injection.  Genotoxicity assays and impairment of male and female fertility studies with Ammonia N 13 Injection have not been performed.

In a descriptive, prospective, blinded image interpretation study of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtained with Ammonia N 13 (N=111) or Rubidium 82 (N=82) were compared to changes in stenosis flow reserve (SFR) as determined by coronary angiography. The principal outcome of the study was the evaluation of PET defect severity relative to SFR.

PET perfusion defects at rest and stress for seven cardiac regions (anterior, apical, anteroseptal, posteroseptal, anterolateral, posterolateral, and inferior walls) were graded on a 0 to 5 scale defined as normal (0), possible (1), probable (2), mild (3), moderate (4), and severe (5) defects. Coronary angiograms were used to measure absolute and relative stenosis dimensions and to calculate stenosis flow reserve defined as the maximum value of flow at maximum coronary vasodilatation relative to rest flow under standardized hemodynamic conditions. SFR scores ranged from 0 (total occlusion) to 5 (normal)

With increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defect score of 2 or higher was positively correlated with flow reserve impairment (SFR<3).

Ammonia N 13 Injection, USP is packaged in 30 mL multiple dose glass vial containing between 1.80 GBq to 18.0 GBq (48.75 mCi to 487.5 mCi) of [N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 13 mL volume. The recommended dose of radioactivity (10 mCi-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of Ammonia.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP Controlled Room Temperature]. Use the solution within 60 minutes of the End of Synthesis (EOS) calibration.

Instruct patients to drink plenty of water or other fluids (as tolerated) in the 4 hours before their PET study.

Instruct patients to void after completion of each image acquisition session and as often as possible for one hour after the PET scan ends.

Instruct nursing patients to substitute stored breast milk or infant formula for breast milk for 2 hours after administration of Ammonia N 13 Injection.

Manufactured and Distributed by: Biomedical Research Foundation of Northwest Louisiana, Shreveport, LA 71103

Revised: May 2015


NDC#24562-004-30Multiple-Dose Vial

Ammonia N 13 Injection, USP 3.75 mCi/mL to 37.5 mCi/mL (@ EOS*)Activity @ EOS*: Total mCi Volume mLConcentration mCi/mL

Sterile, Non-pyrogenicCalibration (EOS*) TimeCalibration Date

Diagnostic - For Intravenous Use OnlyExp. Date/Time Lot#(Expires 60 minutes after EOS*)

Contains: 0.138 GBq to 1.387GBq (3.75 mCi to 37.5 mCi) ofAmmonia N 13 @ EOS* in 0.9% aqueous sodiumchloride per mL.

Store at 20° to 25°C (68° to 77°F);excursions permitted to 15-30°C(59-86°F) [See USP Controlled RoomTemperature]Store upright in a shielded container.Aseptically withdraw and handle doses.[N] Half-Life = 9.96 minutes

Calculate correct dosage from date andtime of calibration.

Do not use if cloudy or if it contains particulate matter.*EOS = End of Synthesis


Manufactured for:Biomedical Research Foundation of NorthwestLouisianaShreveport, LA 71103



Biomedical Research Foundation of Northwest Louisiana

Active Ingredients


Drugs and Medications [43 Associated Drugs and Medications listed on BioPortfolio]

Ammonia [kreitchman pet center]

These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for...

Ammonia inhalants [x-gen pharmaceuticals, inc.]


Ammonia inhalants [sina health inc]


Ammonia inhalants [a-s medication solutions]

Ammonia Inhalants

Ammonia n 13 [ncm usa bronx llc ]

These highlights do not include all the information needed to use Ammonia N 13 Injection, USP safely and effectively. See full prescribing information for Ammonia N 13 Injection, USP. Ammonia N 13 Inj...

Clinical Trials [36 Associated Clinical Trials listed on BioPortfolio]

Breath and Blood Ammonia Response to an Oral Protein Challenge

The investigators specific aim is to evaluate the changes in breath ammonia in comparison to blood ammonia and other physiologic markers after a moderate oral protein challenge in healthy ...

L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients

L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in corr...

PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact m...

Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects

The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.

PCORI Urea Cycle Disorder Study

Urea cycle disorders (UCD) are genetic disorders caused by the liver's inability to breakdown ammonia from proteins; ammonia then accumulates and is toxic to the brain. UCD cause brain dam...

PubMed Articles [423 Associated PubMed Articles listed on BioPortfolio]

Hydrogen enrichment as a bioaugmentation tool to alleviate ammonia inhibition on anaerobic digestion of phenol-containing wastewater.

Phenol and ammonia are prevalent toxic pollutants in various industrial wastewaters, but phenol degraders are frequently inhibited by high concentration of ammonia. Hydrogen enrichment was developed t...

Impacts of ammonia nitrogen on autothermal thermophilic micro-aerobic digestion for sewage sludge treatment.

The concentration of ammonia nitrogen is relatively high during autothermal thermophilic micro-aerobic digestion (ATMAD), which could significantly affect the sludge stabilization. This paper aims to ...

Incorporation of C-HCO by ammonia-oxidizing archaea and bacteria during ammonia oxidation of sludge from a municipal wastewater treatment plant.

Ammonia-oxidizing archaea (AOA) have recently been proposed as potential players for ammonia removal in wastewater treatment plants (WWTPs). However, there is little evidence directly showing the cont...

Impact of Mn and ammonia on nitrogen conversion in biofilter coupling nitrification and ANAMMOX that simultaneously removes Fe, Mn and ammonia.

One lab-scale biofilter coupling nitrification and anaerobic ammonium oxidation (ANAMMOX) that simultaneously removes Fe, Mn and ammonia from simulated groundwater was adopted to investigate the influ...

Prognostic Role of Ammonia in Cirrhotic Patients.

Ammonia is thought to be central to the pathogenesis of hepatic encephalopathy (HE), but its prognostic role in cirrhotic patients with acute decompensation (AD) is unknown. The aims of this study wer...

Quick Search


Relevant Topics

Mental Health
Adhd Anorexia Depression Dyslexia Mental Health Psychiatry Schizophrenia Stress Mental health, although not being as obvious as physical health, is very important, causing great unhappiness to those affected, causing add...

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Bladder Cancer
Non-invasive bladder cancer is a cancer that is only in the inner lining of the bladder. Invasive bladder cancer is cancer that has spread into the deeper walls of the bladder. When the cancer has spread outside the bladder to other parts of the body, th...

Drugs and Medication Quicklinks

Searches Linking to this Drug Record