Nitrogen

Description

Nitrogen, compressed NF (CAS: 7727-37-9), is a non-flammable gas classified under UN1066. It is intended for use only by or under the supervision of a licensed practitioner experienced in its administration. The administration of Nitrogen may pose hazards or contraindications, necessitating familiarity with its indications, effects, dosages, methods, frequency, duration, and associated risks, including side effects and necessary precautions.

This high-pressure gas can cause rapid suffocation; therefore, it must be stored and utilized in well-ventilated areas. Equipment used should be rated for cylinder pressure, and a backflow preventive device should be installed in the piping. Cylinder temperatures must not exceed 52°C (125°F), and the valve should be closed after each use and when the cylinder is empty. Compliance with the Material Safety Data Sheet (MSDS) is required.

In case of inhalation, the individual should be removed to fresh air. If not breathing, artificial respiration should be administered, and if breathing is difficult, oxygen should be provided. A physician should be contacted immediately. Cylinders must be refilled by Encompass Medical and Specialty Gases, LTD., located at 4646 Linden Road, P.O. Box 5404, Rockford, IL 61109.

Uses and Indications

This drug is indicated for use in specific medical situations where the administration of Nitrogen is deemed necessary. The administration of Nitrogen may be hazardous or contraindicated, and therefore, it is essential that it be used only by or under the supervision of a licensed practitioner. This practitioner must possess experience in the use and administration of Nitrogen and be knowledgeable about its indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Limitations of Use: There are no specific teratogenic or nonteratogenic effects associated with this drug mentioned in the available data.

Dosage and Administration

Administration of Nitrogen may pose hazards or be contraindicated; therefore, it should only be utilized by or under the supervision of a licensed practitioner experienced in the use and administration of Nitrogen. This practitioner must be well-versed in the indications, effects, dosages, methods, and frequency and duration of administration.

When Nitrogen is employed as a diluent for oxygen to create respirable mixtures, it is imperative that the user ensures a sufficient oxygen concentration to sustain life.

The route of administration is via respiratory inhalation. Practitioners should open the valve slowly and ensure it is closed after each use. Additionally, it is essential to secure the cylinder in an upright position at all times to maintain safety during administration.

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; do not allow it to come into contact with eyes, skin, or clothing.

• The product must not be dropped or subjected to forceful connection alterations.

• Nitrogen should be kept away from heat sources, flames, or sparks.

• Striking an arc or directing a laser beam at the cylinder is prohibited.

Warnings and Precautions

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

Hazardous Properties

Nitrogen is classified as an extremely cold liquid and gas under pressure, which can lead to rapid suffocation and frostbite. Therefore, utmost caution is required when handling this substance.

General Precautions

The high-pressure nature of Nitrogen gas necessitates careful handling to prevent rapid suffocation and potential fatality. Practitioners should open the valve slowly and ensure it is closed after each use. It is crucial to keep Nitrogen away from heat sources, flames, or sparks, and to avoid striking an arc or laser beam on the cylinder. Adequate ventilation must be maintained during transport, storage, and use. Equipment rated for cylinder pressure should be utilized, and a backflow preventive device must be installed in the piping. Cylinder temperatures must not exceed 52°C (125°F), and cylinders should always be secured in an upright position. When returning cylinders, they should have a pressure of 25 psig and be returned with the cylinder cap secured, if applicable. Users are advised to follow the guidelines outlined in the Material Safety Data Sheet, which is accessible at www.us.lindegas.com.

Emergency Medical Assistance

In the event of inhalation, it is critical to remove the individual to fresh air immediately. If the individual is not breathing, 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, immediate medical treatment is essential.

No specific laboratory tests are recommended for the safe use of Nitrogen. However, practitioners should remain vigilant and prepared to respond to any adverse effects or emergencies that may arise during administration.

Side Effects

Administration of Nitrogen may pose significant risks and should only be conducted 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, and side effects.

Serious adverse reactions associated with Nitrogen include the potential for rapid suffocation and death due to high-pressure gas. The extremely cold nature of both the liquid and gas forms of Nitrogen can lead to frostbite, necessitating immediate medical treatment in such cases.

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 is difficult, oxygen should be provided. Prompt consultation with a physician is essential for further management.

Patients and participants should be made aware of these risks and the necessary precautions to mitigate them during the use of Nitrogen.

Drug Interactions

There are currently no specific drug interactions or drug and laboratory test interactions identified for the product. As such, no dosage adjustments or monitoring recommendations are necessary at this time. Healthcare professionals are advised to remain vigilant and consult relevant resources for any updates regarding potential interactions as new data becomes available.

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 and is contraindicated in certain situations. It is essential that Nitrogen is used only by or under the supervision of a licensed practitioner experienced in its administration. When utilized as a diluent for oxygen to create respirable mixtures, it is critical to ensure that the oxygen concentration is sufficient to sustain life.

In the event of inhalation, immediate action is required: the patient should be removed to fresh air, and if not breathing, artificial respiration should be provided. If breathing difficulties arise, supplemental oxygen should be administered, and a physician must be contacted promptly.

In cases of frostbite, immediate medical treatment is necessary to address potential complications.

Geriatric Use

There is no specific information regarding the use of Nitrogen in geriatric patients, including 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 consideration of individual patient factors and potential risks. Monitoring for any adverse effects or changes in response to treatment is advisable in this population.

Pregnancy

The administration of Nitrogen during pregnancy may pose potential risks and is considered hazardous or contraindicated. There is no specific information available regarding the safety of Nitrogen use in pregnant patients, including any associated fetal impacts, dosage modifications, or special precautions that should be taken. Therefore, 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. Healthcare professionals should carefully evaluate the risks and benefits before considering Nitrogen for use in pregnant patients.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Nitrogen. Therefore, the effects on breastfed infants and the excretion of Nitrogen in breast milk remain undetermined. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this medication.

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 Nitrogen. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for this population. It is recommended that healthcare providers exercise caution when prescribing Nitrogen to patients with compromised liver function, given the lack of data on its safety and efficacy in this group. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not outlined in the prescribing information.

Overdosage

Administration of nitrogen can pose significant hazards and may be contraindicated in certain situations. It is essential for healthcare professionals to exercise caution due to the high-pressure nature of this gas, which can lead to rapid suffocation and potentially fatal outcomes.

When nitrogen is utilized as a diluent for oxygen to create respirable mixtures, it is imperative to ensure that the oxygen concentration remains sufficient to sustain life. Failure to maintain appropriate oxygen levels can result in serious health risks.

The extremely cold nature of nitrogen, both in its liquid and gaseous forms, presents additional dangers. Exposure to nitrogen can lead to rapid suffocation and frostbite, necessitating immediate attention.

In the event of inhalation, the first aid response should involve removing the affected individual to fresh air. If the person 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.

In cases of frostbite, it is critical to seek medical treatment immediately to mitigate potential tissue damage and other complications. Prompt and appropriate management is essential to ensure patient safety and recovery.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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.

When Nitrogen is utilized as a diluent for oxygen to create respirable mixtures, it is critical for the user to ensure that the oxygen concentration is sufficient to sustain life. Providers should emphasize the importance of caution, as Nitrogen is a high-pressure gas that can lead to rapid suffocation and death. Patients should be instructed to open the valve slowly and to close it after each use. They must keep the gas away from heat, flames, or sparks, and should not strike an arc or laser beam on the cylinder. Adequate ventilation is necessary during transport, storage, and use. Equipment rated for cylinder pressure should be employed, and a backflow preventive device should be used in the piping. Additionally, cylinder temperatures must not exceed 52°C (125°F), and cylinders should always be secured in an upright position. Patients should return cylinders with a pressure of 25 psig and ensure that the cylinder cap is secured, if applicable. It is also important to use this product in accordance with the Material Safety Data Sheet available at www.us.lindegas.com.

In the event of inhalation, patients should be instructed to move to fresh air immediately. If the patient is not breathing, artificial respiration should be administered, and if breathing is difficult, oxygen should be provided. A physician should be contacted without delay.

Healthcare providers should also warn patients about the extremely cold nature of the liquid and gas under pressure, which can cause rapid suffocation and frostbite. Patients must be advised to store and use Nitrogen with adequate ventilation and to avoid contact with eyes, skin, or clothing. When withdrawing liquid, it is crucial to wear a face shield and gloves. Patients should be cautioned against dropping the cylinder and should use a suitable hand truck for container movement. The same temperature restrictions and safety measures regarding valve closure and backflow prevention apply as previously mentioned.

In cases of frostbite, patients should seek medical treatment immediately.

Storage and Handling

The product is supplied in cylinders that must be stored and handled with care to ensure safety and efficacy. It is essential to maintain adequate ventilation during storage and use. The temperature of the cylinders should not exceed 52°C (125°F).

Cylinders must always be secured in an upright position to prevent tipping or falling. After each use and when the cylinder is empty, the valve should be closed to maintain safety. Equipment used with the cylinders must be rated for the cylinder pressure to prevent accidents.

When withdrawing liquid from the cylinder, appropriate personal protective equipment, including a face shield and gloves, should be worn to protect against exposure. It is critical to avoid contact with the liquid, as it should not come into contact with eyes, skin, or clothing.

Cylinders should not be dropped; instead, a suitable hand truck should be utilized for safe movement. When returning the cylinder, it should have a pressure of 25 psig and the cylinder cap should be secured, if applicable.

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, and it should only be used 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.

When Nitrogen is utilized as a diluent for oxygen to create respirable mixtures, it is critical to ensure that the oxygen concentration is sufficient to sustain life. In the event of inhalation, first aid measures include removing the patient to fresh air, providing artificial respiration if not breathing, administering oxygen if breathing is difficult, and contacting a physician.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by Encompass Medical & Specialty Gases, Ltd.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)