Nitrogen

Description

Refrigerated liquid nitrogen is classified under the chemical name nitrogen, refrigerated liquid NF, with a CAS number of 7727-37-9. It is designated as a prescription-only product and is identified by the UN number 1977. This substance is utilized in various medical and industrial applications, requiring careful handling and storage due to its cryogenic properties.

Uses and Indications

Nitrogen is indicated for administration only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrogen.

There are no teratogenic effects associated with the use of this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For administration, Nitrogen is intended for use only by or under the supervision of a licensed practitioner experienced in its use and administration.

The route of administration is via respiratory inhalation. The active ingredient is Nitrogen, provided in a concentration of 990 mL within a 1 L container.

Healthcare professionals should ensure that the administration is conducted in a controlled environment, adhering to established safety protocols and guidelines for inhalation therapies.

Contraindications

Administration of Nitrogen is contraindicated in individuals who are not under the supervision of a licensed practitioner experienced in its use. The use of Nitrogen is restricted to those familiar with its indications, effects, dosages, methods, frequency, duration of administration, hazards, contraindications, side effects, and necessary precautions.

Additionally, handling of Nitrogen should not occur until all safety precautions have been thoroughly read and understood. It is essential to use and store Nitrogen only outdoors or in a well-ventilated area. The valve must not be opened until it is connected to the appropriate equipment prepared for use, and connections should not be changed or forced.

Warnings and Precautions

Administration of Nitrogen may pose significant hazards and is contraindicated in certain situations. It is imperative that this substance is used solely by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrogen. 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.

Hazard Warnings Nitrogen is classified as a refrigerated gas, which may lead to cryogenic burns or injuries upon contact. Additionally, it has the potential to displace oxygen in the environment, resulting in rapid suffocation. Furthermore, as a gas under pressure, Nitrogen may explode if subjected to heat. Therefore, it is crucial to handle this substance with extreme caution.

General Precautions Prior to handling Nitrogen, all safety precautions must be thoroughly read and understood. It is essential to use and store Nitrogen exclusively outdoors or in well-ventilated areas. Personal protective equipment, including cold insulating gloves, a face shield, and eye protection, should be worn at all times. A backflow preventive device must be utilized in the piping to prevent any hazardous situations.

After each use, the valve should be closed, and it should also be closed when the cylinder is empty. Equipment used with Nitrogen must be rated for cylinder pressure, and the valve should not be opened until it is securely connected to the prepared equipment. Only equipment made from compatible materials of construction should be employed. The container must always be kept in an upright position, and connections should never be changed or forced. It is also critical to read and follow the Safety Data Sheet (SDS) prior to use.

Emergency Medical Help Instructions In the event of inhalation, the affected individual should be removed to fresh air and kept comfortable for breathing. Immediate medical advice or attention should be sought. If Nitrogen comes into contact with the skin, any frosted areas should be thawed using lukewarm water, and the affected area should not be rubbed. Immediate medical advice or attention is also necessary in this case.

No specific laboratory tests are recommended for the safe use of Nitrogen, and there are no instructions provided regarding the cessation of use or the need to contact a physician.

Side Effects

Administration of Nitrogen may be associated with serious adverse reactions, necessitating careful oversight by a licensed practitioner experienced in its use. The use of Nitrogen is contraindicated in certain situations, and it is crucial that practitioners are familiar with the indications, effects, dosages, methods, and frequency and duration of administration, as well as the associated hazards, contraindications, and side effects.

Serious warnings include the potential for cryogenic burns or injury due to the refrigerated nature of the gas. Additionally, Nitrogen may displace oxygen, leading to rapid suffocation, which poses a significant risk in enclosed or poorly ventilated spaces. The gas is also stored under pressure, and improper handling may result in explosions if exposed to heat.

In the event of exposure, specific first aid measures should be taken. If Nitrogen is inhaled, it is imperative to remove the individual to fresh air and ensure they are comfortable for breathing while seeking medical advice or attention. For skin exposure, it is advised to thaw any frosted areas with lukewarm water without rubbing the affected skin, and immediate medical advice or attention should be sought.

These precautions and responses are critical to mitigate the risks associated with the use of Nitrogen.

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.

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

There is no specific pediatric use information available for this medication. The prescribing information does not include recommended ages, dosing differences, safety concerns, or special precautions for pediatric patients, including children and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the absence of relevant data.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The administration of Nitrogen during pregnancy may pose potential risks, and its use is contraindicated or hazardous. There is no specific information available regarding the safety of Nitrogen in pregnant patients, including any known fetal impacts or outcomes. Due to the lack of data on its use during pregnancy, healthcare professionals are advised to exercise caution. Nitrogen should only be administered by or under the supervision of a licensed practitioner who has experience in its use and administration. Given the absence of safety concerns, dosage modifications, or special precautions outlined in the prescribing information, healthcare providers should carefully consider the potential risks versus benefits when treating women of childbearing potential.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Nitrogen. Therefore, the effects on breastfed infants and the excretion of Nitrogen in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks versus benefits when prescribing this medication to lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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

Overdosage of nitrogen can result in serious health consequences, primarily due to the displacement of oxygen in the environment, which may lead to rapid suffocation. Healthcare professionals should be vigilant for signs of oxygen deprivation in affected individuals.

Symptoms associated with nitrogen overdosage may include cryogenic burns or injuries, particularly if there has been exposure to refrigerated liquid nitrogen. These injuries can manifest as severe tissue damage, necessitating prompt evaluation and treatment.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Rapid intervention is crucial to mitigate the risks associated with oxygen displacement and to address any potential cryogenic injuries effectively.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients that the administration of Nitrogen may pose hazards or be contraindicated. It is essential that Nitrogen is used only by or under the supervision of a licensed practitioner who is experienced in its use and administration. This practitioner should be familiar with the indications, effects, dosages, methods, frequency and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Patients should be made aware of the warning that Nitrogen contains refrigerated gas, which may cause cryogenic burns or injury. Additionally, it may displace oxygen and lead to rapid suffocation. Therefore, healthcare providers must emphasize the importance of not handling Nitrogen until all safety precautions have been thoroughly read and understood.

It is crucial to instruct patients to use and store Nitrogen only outdoors or in a well-ventilated area. They should be advised to wear appropriate protective gear, including cold insulating gloves, a face shield, and eye protection. The use of a backflow preventive device in the piping is also recommended.

Patients should be informed to close the valve after each use and when the cylinder is empty. They must use only equipment that is rated for cylinder pressure and should not open the valve until it is connected to equipment that is prepared for use. It is important to use only equipment made of compatible materials of construction and to always keep the container in an upright position. Patients should be cautioned against changing or forcing fit connections.

Healthcare providers should encourage patients to read and follow the Safety Data Sheet (SDS) before use. In the event of an emergency, patients should be instructed on first aid measures: if Nitrogen is inhaled, they should be removed to fresh air and kept comfortable for breathing, and medical advice or attention should be sought. If Nitrogen comes into contact with skin, patients should thaw any frosted areas with lukewarm water without rubbing the affected area and seek immediate medical advice or attention.

Storage and Handling

The product is supplied in a container that must be used and stored exclusively outdoors or in a well-ventilated area. It is essential to keep the container in an upright position at all times. After each use and when the container is empty, the valve should be securely closed. The valve must not be opened until it is connected to equipment that is prepared for use, and it should only be utilized with equipment that is rated for cylinder pressure.

To ensure safety, the container should be protected from sunlight when the ambient temperature exceeds 52°C (125°F). Additionally, a backflow preventive device must be employed in the piping to prevent any potential hazards. It is imperative to read and follow the Safety Data Sheet (SDS) prior to use to ensure proper handling and safety measures are observed.

Additional Clinical Information

Administration of Nitrogen is exclusively via the respiratory route (inhalation) and should only be conducted by or under the supervision of a licensed practitioner experienced in its use. Clinicians must be familiar with the indications, effects, dosages, methods, frequency, duration of administration, and the associated hazards, contraindications, side effects, and necessary precautions.

Patients should be warned that Nitrogen is a refrigerated gas that may cause cryogenic burns or injury and can displace oxygen, leading to rapid suffocation. It is crucial to read and understand all safety precautions before handling. Nitrogen should be used and stored outdoors or in well-ventilated areas, with appropriate protective gear such as cold insulating gloves, face shields, and eye protection. A backflow preventive device must be used in the piping, and the valve should be closed after each use. Containers must remain upright, and connections should not be altered or forced. In case of inhalation, individuals should be moved to fresh air and kept comfortable while seeking medical attention. For skin contact, affected areas should be thawed with lukewarm water without rubbing, and immediate medical advice should be sought.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by AMERICAN GASES CORPORATION. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)