Nitrogen

Description

Nitrogen Compressed NF is a non-flammable gas classified under UN 1066 and is available by prescription only (Rx Only M41-2). It is produced through air liquefaction and is characterized as a high-pressure gas. Caution is advised due to the potential for rapid suffocation and death without warning. It is imperative to avoid the use of oil on valves or connections, and transfilling of this gas is strictly prohibited.

Uses and Indications

This drug is indicated for use in specific medical situations where the administration of Nitrogen is deemed necessary. It is essential that this drug be administered only by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrogen. The practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Limitations of use include the potential hazards associated with Nitrogen administration, which may render it contraindicated in certain circumstances. There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Administration of Nitrogen is to be conducted only by or under the supervision of a licensed practitioner experienced in its use. The practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

The route of administration is via respiratory inhalation. It is imperative to adhere to the guidelines outlined in the Material Safety Data Sheet during administration. When withdrawing the liquid form of Nitrogen, appropriate personal protective equipment, including a face shield and gloves, must be worn to ensure safety.

Contraindications

Administration of Nitrogen is contraindicated in individuals who are not under the supervision of a licensed practitioner experienced in its use. The handling of Nitrogen cylinders and the use of their contents should only occur after thorough understanding of the Material Safety Data Sheet, and appropriate training in cylinder operation and emergency procedures has been completed.

It is prohibited to use oil on valves or connections, and the transfilling of this gas is not allowed. Additionally, it is contraindicated to carry liquid Nitrogen Dewars in the passenger compartment or trunk of an automobile, or in vans without a sealed bulkhead separating the cargo area from the driver compartment.

Federal law mandates that Nitrogen can only be dispensed with a prescription.

Warnings and Precautions

Healthcare professionals are advised to adhere to the following warnings and precautions when handling and administering Nitrogen.

Warnings

It is imperative that individuals do not handle the cylinder or utilize its contents until they have thoroughly read and understood the Material Safety Data Sheet (MSDS) for this product. For additional copies of the MSDS, contact 1-800-231-1366. Furthermore, individuals must be adequately trained in the use of the cylinder and its contents, including emergency procedures.

Caution is warranted due to the high-pressure nature of the gas, which can lead to rapid suffocation and death without warning. The administration of Nitrogen may pose hazards or be contraindicated; therefore, it should only be performed by or under the supervision of a licensed practitioner experienced in its use. This practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Containers must always be maintained in an upright position. The extremely cold liquid and gas under pressure can cause rapid suffocation and death without warning, as well as severe frostbite. It is unsafe to transport liquid Nitrogen Dewars in the passenger compartment or trunk of an automobile, or in vans lacking a sealed bulkhead separating the cargo area from the driver compartment. Dewars may tip during transit, leading to spills that can release large volumes of vapor, obscuring vision and causing rapid suffocation. Nitrogen is not life-supporting and can displace oxygen, resulting in asphyxiation and death without warning. Additionally, contact with cold Nitrogen gas or liquid can cause cryogenic burns and freeze body tissue. Liquid Nitrogen spills can compromise the integrity of a vehicle's metal components, as materials become brittle at the temperatures associated with liquid Nitrogen.

General Precautions

Cylinders should be secured and stored in well-ventilated areas. Use only equipment rated for cylinder pressure, and ensure that the cylinder temperature does not exceed 125°F (52°C). The valve should be closed after each use and when the cylinder is empty. A backflow preventive device should be utilized in the piping, and cylinders should be returned with a minimum pressure of 25 PSIG. All handling and usage must comply with the guidelines outlined in the Material Safety Data Sheet.

Adequate ventilation is essential during storage and use. Avoid contact with liquid Nitrogen in the eyes, on the skin, or on clothing. When withdrawing liquid, it is necessary to wear a face shield and gloves. Containers should not be dropped or handled roughly; instead, a suitable hand truck should be employed for movement. The use of oil on valves or connections is strictly prohibited, and transfilling of this gas is not allowed.

Emergency Medical Help Instructions

In the event of inhalation, the affected individual should be removed to fresh air. If breathing has ceased, artificial respiration should be administered. If breathing is difficult, oxygen should be provided, and a physician should be contacted immediately. In cases of frostbite, prompt medical treatment is essential.

No specific instructions are provided regarding the cessation of use or when to contact a physician.

Side Effects

Administration of Nitrogen may pose significant hazards and is contraindicated in certain situations. It is essential that Nitrogen is used only by or under the supervision of a licensed practitioner who possesses experience in its use and administration. This includes familiarity with the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Patients exposed to Nitrogen may experience serious adverse reactions due to its properties as a high-pressure gas. Notably, Nitrogen can cause rapid suffocation and death without warning, as it is not life-supporting and can displace oxygen necessary for survival. Additionally, exposure to extremely cold liquid or gas under pressure can lead to severe frostbite and also poses a risk of rapid suffocation.

In the event of inhalation, it is critical to remove the affected individual to fresh air immediately. If the individual is not breathing, artificial respiration should be administered, and if breathing is difficult, supplemental oxygen should be provided. Medical assistance should be sought promptly. In cases of frostbite resulting from contact with cold Nitrogen gas or liquid, immediate medical treatment is necessary.

Furthermore, it is important to note that liquid Nitrogen spills can compromise the structural integrity of vehicles and equipment, as materials such as steel may become brittle at the low temperatures associated with liquid Nitrogen. This can lead to unexpected failures of metal parts, including floors, bulkheads, and supports.

Drug Interactions

Administration of Nitrogen may pose significant risks and is contraindicated in certain situations. It is imperative that Nitrogen is used exclusively by or under the supervision of a licensed practitioner who possesses expertise in its use and administration. This practitioner should be well-versed in the indications, effects, dosages, methods, frequency, and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Due to the potential for adverse effects, careful monitoring and adherence to established guidelines are essential when considering the use of Nitrogen. Practitioners should ensure that they are fully informed about the specific circumstances under which Nitrogen may be administered, as well as the potential interactions with other medications or conditions that may exacerbate its risks.

Packaging & NDC

The table below lists all NDC Code configurations of Nitrogen, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Administration of Nitrogen in pediatric patients may pose hazards or be contraindicated. It is essential that Nitrogen is used only by or under the supervision of a licensed practitioner who has experience in its use and administration. This practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions. Careful consideration and adherence to these guidelines are critical to ensure the safety and efficacy of Nitrogen in children.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The administration of Nitrogen during pregnancy may pose potential risks and is contraindicated unless under the supervision of a licensed practitioner experienced in its use. Pregnant patients should be closely monitored due to the potential hazards associated with Nitrogen administration. The effects on fetal outcomes are not well established, and caution is advised when considering the use of this agent in women of childbearing potential. It is essential that healthcare providers weigh the benefits against the risks and ensure that appropriate precautions are taken to mitigate any potential adverse effects on both the mother and the fetus.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Administration of Nitrogen may pose significant hazards and is contraindicated in certain situations. It is imperative that Nitrogen is used solely by or under the supervision of a licensed practitioner who possesses experience in its administration. This practitioner should be well-versed in the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Hazards of Nitrogen Overdosage

Caution must be exercised as Nitrogen is a high-pressure gas that can lead to rapid suffocation and death without warning. The risk of asphyxiation arises from Nitrogen's non-life-supporting nature, as it can displace oxygen in the environment, leading to potentially fatal outcomes.

First Aid Measures

In the event of inhalation, immediate action is required. The affected individual should be removed to fresh air. If the individual is not breathing, artificial respiration should be administered. Should breathing difficulties arise, supplemental oxygen must be provided, and a physician should be contacted without delay.

Frostbite and Cryogenic Burns

Exposure to cold Nitrogen gas or liquid can result in cryogenic burns and tissue freezing. In cases of frostbite, it is crucial to seek medical treatment immediately to mitigate potential damage.

Healthcare professionals must remain vigilant regarding the risks associated with Nitrogen overdosage and ensure that appropriate safety measures and emergency protocols are in place.

Nonclinical Toxicology

Administration of Nitrogen may pose hazards or contraindications. It is recommended for use only by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrogen. This practitioner should be knowledgeable about the indications, effects, dosages, methods, frequency and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

No information is available regarding teratogenic effects, non-teratogenic effects, or specific animal pharmacology and toxicology studies.

Postmarketing Experience

Administration of Nitrogen has been associated with various safety concerns based on postmarketing experience. Reports indicate that the use of Nitrogen should be conducted only by or under the supervision of a licensed practitioner who possesses expertise in its administration. Practitioners must be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Additionally, it has been noted that transporting liquid Nitrogen Dewars in passenger compartments or trunks of vehicles, or in vans without a sealed bulkhead separating the cargo area from the driver compartment, poses significant risks. Incidents have been reported where Dewars may tip during transit, leading to spills that can release large volumes of vapor. Such vapor can obscure vision and create an environment that may result in rapid suffocation, as Nitrogen is not life-supporting and can displace oxygen necessary for survival.

Furthermore, exposure to cold Nitrogen gas or liquid has been documented to cause cryogenic burns and freeze body tissue. There are also concerns regarding the structural integrity of vehicles, as liquid Nitrogen spills can lead to the failure of metal components, such as floors and bulkheads, due to the embrittlement of materials at the low temperatures associated with liquid Nitrogen.

Patient Counseling

Healthcare providers should advise patients to read and understand the Material Safety Data Sheet (MSDS) for this product before handling the cylinder or using its contents. Patients should be informed that they can obtain additional copies of the MSDS by calling 1-800-231-1366. It is crucial that patients are trained in the proper use of the cylinder and its contents, including emergency procedures.

Patients must be cautioned that the gas is under high pressure, which can lead to rapid suffocation and death without warning. They should be instructed to secure the cylinder and ensure adequate ventilation during storage and use. It is important to use the cylinder only with equipment rated for its pressure and to maintain the cylinder temperature below 125°F (52°C). Patients should be reminded to close the valve after each use and when the cylinder is empty, and to return the cylinder with at least 25 PSIG pressure.

Patients should be made aware that the administration of Nitrogen may be hazardous or contraindicated and should only be performed by or under the supervision of a licensed practitioner experienced in its use. This practitioner should be familiar with the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

It is essential to inform patients that federal law prohibits dispensing this product without a prescription. They should also be cautioned against using oil on the valve or connections, as well as against transfilling the gas, which is prohibited.

Patients must be warned to always keep the container in an upright position, as it contains extremely cold liquid and gas under pressure, which can cause rapid suffocation and death without warning, as well as severe frostbite. They should be instructed to store and use the product with adequate ventilation and to avoid contact with liquid nitrogen in the eyes, on the skin, or on clothing. When withdrawing liquid, patients should wear a face shield and gloves, and they should avoid dropping or handling the container roughly, using a suitable hand truck for movement.

In the event of inhalation, patients should be advised to remove themselves to fresh air immediately. If not breathing, they should be instructed to give artificial respiration, and if breathing is difficult, to provide oxygen and call a physician. In case of frostbite, patients should seek medical treatment immediately.

Finally, patients should be warned against carrying liquid Nitrogen Dewars in the passenger compartment or trunk of an automobile or in vans without a sealed bulkhead separating the cargo area from the driver compartment. They should be informed that Dewars can tip during transit, leading to spills that release large quantities of vapor, which can obscure vision and cause rapid suffocation. Nitrogen is not life-supporting and can displace oxygen, leading to asphyxiation and death without warning. Contact with cold Nitrogen gas or liquid can cause cryogenic burns and freeze body tissue, and spills can compromise the integrity of a vehicle's metal parts due to the extreme cold.

Storage and Handling

The product is supplied in secure cylinders that must be stored and used with adequate ventilation. It is essential to utilize equipment rated for the cylinder pressure. The temperature of the cylinder should not exceed 125°F (52°C). After each use and when the cylinder is empty, the valve should be closed. Cylinders must be returned with a minimum pressure of 25 PSIG and always maintained in an upright position.

For safe handling, it is crucial to avoid contact with liquid, which should not come into contact with eyes, skin, or clothing. When withdrawing liquid, appropriate personal protective equipment, including a face shield and gloves, must be worn. Containers should not be dropped or handled roughly; instead, a suitable hand truck should be used for movement.

To prevent contamination, the Dewar closure device should be replaced after use. All handling and usage must comply with the Material Safety Data Sheet. It is important to refrain from using oil on the valve or connections, and the transfilling of this gas or liquid is strictly prohibited.

Additional Clinical Information

Patients should be aware that the product is administered via respiratory inhalation. Clinicians must ensure that patients are properly trained in the use of the cylinder and its contents, including emergency procedures, before handling. It is crucial for patients to read and understand the Material Safety Data Sheet for this product, which can be obtained by calling 1-800-231-1366.

In case of inhalation, patients should be moved to fresh air immediately. If breathing has ceased, artificial respiration should be provided, and if breathing is difficult, oxygen should be administered. A physician should be contacted for further assistance. Additionally, the administration of Nitrogen may pose hazards or contraindications and should only be conducted by or under the supervision of a licensed practitioner experienced in its use, who is knowledgeable about its indications, effects, dosages, and potential risks.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by Air Liquide America L. P.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)