Nitrogen

Description

Nitrogen, Refrigerated Liquid, is a cryogenic liquid with the National Formulary (NF) designation UN1977. It has a Chemical Abstracts Service (CAS) registry number of 7727-37-9. This product is supplied by Airgas Puritan Medical, a division of Airgas NCN, Inc., located in Sacramento, California.

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 necessitate careful consideration and oversight by qualified healthcare professionals. There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Administration of Nitrogen is intended for respiratory inhalation only. The active ingredient is provided in a strength of 992 mL per 1 L.

Due to the potential hazards associated with the use of Nitrogen, it is imperative that administration is conducted exclusively by or under the supervision of a licensed practitioner. This practitioner must possess experience in the use and administration of Nitrogen and be well-versed in its indications, effects, dosages, methods, and the appropriate frequency and duration of administration.

Healthcare professionals are advised to ensure that all safety protocols are followed during the administration process to mitigate any risks associated with the use of this agent.

Contraindications

Administration of Nitrogen is contraindicated in the following situations:

• Use is restricted to licensed practitioners experienced in the administration of Nitrogen, who are knowledgeable about its indications, effects, dosages, methods, frequency, duration, hazards, contraindications, side effects, and necessary precautions.

• Direct contact with liquid Nitrogen should be avoided; it must not come into contact with eyes, skin, or clothing due to the risk of severe injury.

• The container should not be dropped, and appropriate equipment, such as a suitable hand truck, must be used for movement to prevent accidents.

Warnings and Precautions

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 must 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.

The handling of Nitrogen requires strict adherence to safety protocols due to its extremely cold liquid state and gas under pressure, which can lead to rapid suffocation and severe frostbite. Adequate ventilation is essential during storage and use. It is critical to avoid contact with the liquid form of Nitrogen, as it can cause serious injury to the eyes, skin, and clothing. When withdrawing liquid Nitrogen, appropriate personal protective equipment, including a face shield and gloves, must be worn. Containers should not be dropped, and a suitable hand truck should be utilized for movement. The temperature of the cylinder must not exceed 52°C (125°F), and the valve should be closed after each use and when the cylinder is empty. All handling and usage should comply with the guidelines outlined in the Material Safety Data Sheets (MSDS).

General precautions must also be observed, as Nitrogen is a high-pressure gas that can lead to rapid suffocation. It is essential to store and use Nitrogen in well-ventilated areas and to employ equipment rated for cylinder pressure. A backflow preventive device should be installed in the piping to mitigate risks. As previously mentioned, the cylinder temperature must not exceed 52°C (125°F), and the valve should be closed after each use and when empty, in accordance with the MSDS.

In the event of inhalation, immediate action is required. The individual should be removed to fresh air, and if breathing has ceased, artificial respiration should be administered. If breathing difficulties arise, oxygen should be provided, and a physician must be contacted without delay. In cases of frostbite, it is crucial to seek medical treatment immediately.

Currently, there are no specific laboratory tests recommended for the safe use of Nitrogen.

Side Effects

Administration of Nitrogen may pose significant risks 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 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.

Serious adverse reactions associated with Nitrogen include the potential for rapid suffocation due to the extremely cold liquid and gas under pressure. Additionally, exposure to Nitrogen can lead to severe frostbite, necessitating immediate medical attention.

In the event of inhalation, it is critical to remove the affected individual to fresh air. If the individual is not breathing, artificial respiration should be administered, and if breathing difficulties arise, oxygen should be provided. Prompt consultation with a physician is advised in such cases.

In instances of frostbite, immediate medical treatment is essential to mitigate potential complications.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

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

The administration of Nitrogen in pediatric patients may pose significant hazards and is contraindicated unless performed by or under the supervision of a licensed practitioner experienced in its use. Due to the extremely cold nature of Nitrogen, both in liquid and gas forms, there is a risk of rapid suffocation and severe frostbite.

In the event of inhalation, it is critical to remove the patient to fresh air immediately. If the patient is not breathing, artificial respiration should be administered, and if breathing difficulties arise, supplemental oxygen must be provided. Prompt medical attention is essential in cases of frostbite.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including recommended age considerations, dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful monitoring and individualized assessment of treatment risks and benefits in this population.

Pregnancy

The safety and efficacy of this drug during pregnancy have not been established, as it has not been approved by the FDA. The administration of Nitrogen may pose significant risks, including potential hazards or contraindications for pregnant patients. Due to the nature of this product as an unapproved medical gas, healthcare professionals should exercise caution when considering its use in women of childbearing potential.

The administration of Nitrogen involves the handling of extremely cold liquid and gas under pressure, which can lead to rapid suffocation. Therefore, it is imperative that this drug is used only by or under the supervision of a licensed practitioner who is experienced in its use and administration. Given the potential for serious adverse effects, including those related to high-pressure gas, healthcare providers should carefully evaluate the risks versus benefits before considering Nitrogen for use in pregnant patients.

Lactation

The safety and efficacy of this drug have not been established by the FDA, and the labeling has not received FDA approval. The administration of Nitrogen may pose hazards or be contraindicated. Therefore, it is recommended that this drug be used only by or under the supervision of a licensed practitioner experienced in its use and administration.

There are no specific statements or data available regarding the excretion of this drug in breast milk, its effects on breastfed infants, or any lactation considerations. Lactating mothers should consult with their healthcare provider for guidance on the use of this drug while breastfeeding.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for Nitrogen. Healthcare professionals should exercise caution and consider individual patient factors when prescribing this medication to patients with renal impairment.

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 carries inherent risks, and its use is strictly limited to licensed practitioners who possess the requisite experience in its administration. These practitioners must 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.

In the event of overdosage, it is crucial to recognize the potential hazards associated with Nitrogen. The substance is classified as an extremely cold liquid and gas under pressure, which poses a significant risk of rapid suffocation and severe frostbite.

First Aid Measures If Nitrogen is inhaled, immediate action is required. The affected individual should be removed to an area with fresh air. If the individual is not breathing, artificial respiration should be administered. In cases where breathing is difficult, supplemental oxygen should be provided. It is imperative to contact a physician without delay for further evaluation and management.

Management of Frostbite In instances of frostbite, prompt medical treatment is essential. Healthcare professionals should ensure that the affected individual receives appropriate care as soon as possible to mitigate the risks of long-term damage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has revealed that the administration of Nitrogen may pose hazards or be contraindicated. It is recommended that this drug be 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.

Reports indicate that exposure to extremely cold liquid and gas under pressure can lead to rapid suffocation and may cause severe frostbite. In instances of frostbite, immediate medical treatment is advised. It is important to note that the FDA has not determined this drug to be safe and effective, and the labeling has not received FDA approval.

Patient Counseling

Healthcare providers should advise patients to always keep the container in an upright position to ensure safe handling and usage. It is crucial to communicate that the administration of Nitrogen may pose hazards or be contraindicated, and it should only be used by or under the supervision of a licensed practitioner who is experienced in its use. 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.

Providers must emphasize the extreme cold nature of the liquid and gas under pressure, which can lead to rapid suffocation and severe frostbite. Patients should be instructed to store and use Nitrogen in well-ventilated areas and to avoid contact with eyes, skin, and clothing. When withdrawing liquid, it is essential to wear a face shield and gloves to prevent injury. Patients should be cautioned against dropping the container and should use a suitable hand truck for movement. Additionally, the cylinder temperature must not exceed 52°C (125°F), and the valve should be closed after each use and when the container is empty. Patients should be encouraged to follow the guidelines outlined in the Material Safety Data Sheets (MSDS).

In the event of inhalation, patients should be instructed to seek fresh air immediately. If breathing has ceased, they should perform artificial respiration, and if breathing is difficult, they should administer oxygen and contact a physician. In cases of frostbite, it is imperative to obtain medical treatment without delay.

Storage and Handling

The product is supplied in a container that must always be kept in an upright position. It is essential to ensure that the cylinder temperature does not exceed 52°C (125°F) during storage and use. Adequate ventilation is required in the area where the product is stored and utilized.

When withdrawing the liquid, it is imperative to wear a face shield and gloves to protect against potential exposure. Care should be taken to avoid contact with eyes, skin, and clothing. The container should not be dropped; instead, a suitable hand truck should be used for movement to prevent damage.

After each use and when the container is empty, the valve must be closed to maintain safety. All handling and usage should be conducted in accordance with the Material Safety Data Sheets (MSDS) to ensure proper safety protocols are followed.

Additional Clinical Information

The route of administration for the product is via respiratory inhalation. Clinicians should be aware that the administration of Nitrogen may pose hazards or be contraindicated. It is intended for use only by or under the supervision of a licensed practitioner experienced in its use, who understands the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Patients should be counseled on the importance of adequate ventilation during storage and use. It is crucial to avoid contact with eyes, skin, and clothing, and to wear a face shield and gloves during liquid withdrawal. Containers should not be dropped, and a suitable hand truck should be used for movement. The cylinder temperature must not exceed 52°C (125°F), and the valve should be closed after each use and when empty. Usage should comply with the Material Safety Data Sheets (MSDS).

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by Airgas Northern California and Nevada, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)