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Nitrogen

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This product has been discontinued

Active ingredient
Nitrogen 990 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 21, 2021
FDA Insert
Prescribing information, PDF file
Active ingredient
Nitrogen 990 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 21, 2021
Manufacturer
Toll Company
Registration number
NDA205850
NDC root
82457-002
FDA Insert
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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Drug Overview

Nitrogen is a compressed gas that is commonly used in various industrial and medical applications. It is a non-flammable gas that can be utilized under the supervision of a licensed practitioner who is experienced in its administration. Due to its properties, nitrogen can displace oxygen in the air, which may lead to rapid suffocation if not handled properly.

When using nitrogen, it is essential to be aware of safety precautions, as it is stored under pressure and can pose hazards if not managed correctly. Always ensure that it is used in well-ventilated areas and with appropriate equipment to prevent accidents.

Uses

You may be prescribed Nitrogen for specific medical uses, but it's important to know that its administration can be risky. This treatment should only be given by a licensed healthcare professional who has experience with Nitrogen. They will understand how to use it safely, including the correct dosages and methods, as well as the potential hazards and side effects.

While there are no specific teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects noted, it's crucial to follow your healthcare provider's guidance closely to ensure your safety during treatment. Always discuss any concerns or questions you have with your practitioner.

Dosage and Administration

Using Nitrogen requires careful handling, as it can be hazardous or not recommended for everyone. It’s important that this substance is administered only by a licensed healthcare professional who has experience with Nitrogen. This ensures that they are knowledgeable about its uses, effects, proper dosages, and how often it should be given.

Nitrogen is typically administered through the respiratory system, which means you will inhale it. The healthcare provider will guide you on the specific method and frequency of use, ensuring that you receive the right amount safely. Always follow their instructions closely to ensure your safety and the effectiveness of the treatment.

What to Avoid

It’s important to be cautious when using Nitrogen. You should only use it under the supervision of a licensed practitioner who is experienced with its administration. This ensures that you are aware of the potential hazards and side effects associated with its use.

To ensure your safety, do not handle Nitrogen until you have read and understood all safety precautions. Always use and store it outdoors or in a well-ventilated area. Avoid changing or forcing any connections, and make sure to keep the container in an upright position at all times.

Side Effects

Using nitrogen can come with some serious risks. It is important to know that nitrogen is a gas under pressure, which means it can explode if heated. Additionally, it can displace oxygen in the air, leading to rapid suffocation, so proper ventilation is crucial. If you come into contact with refrigerated nitrogen, it can cause cryogenic burns, which are severe injuries from extreme cold.

If you accidentally inhale nitrogen, move to fresh air immediately and seek medical help. For skin contact, gently thaw any frostbite with lukewarm water without rubbing the area, and get medical attention right away. Always prioritize safety when handling nitrogen.

Warnings and Precautions

Using Nitrogen can be risky, so it’s important to only use it under the guidance of a qualified healthcare professional who understands how to handle it safely. Be aware that Nitrogen is stored under pressure and can explode if heated. It can also displace oxygen, leading to rapid suffocation, and may cause cryogenic burns if it comes into contact with your skin.

To ensure your safety, always read and understand the safety precautions before handling Nitrogen. Use it outdoors or in a well-ventilated area, and make sure to use equipment that can handle the pressure. Keep the container upright, close the valve after each use, and protect it from sunlight in high temperatures. Wear protective gear, including cold insulating gloves and eye protection.

If you inhale Nitrogen, move to fresh air immediately and seek medical help. If it comes into contact with your skin, gently thaw the affected area with lukewarm water—do not rub it—and get medical attention right away.

Overdose

Using nitrogen can be risky, as it may cause serious health issues. If you inhale nitrogen, it can displace oxygen in the air, leading to rapid suffocation. Signs of an overdose may include difficulty breathing or feeling faint. If this happens, it’s crucial to move to fresh air immediately and stay calm while seeking medical help.

If nitrogen comes into contact with your skin, it can cause cryogenic burns (injuries from extreme cold). In this case, gently thaw the affected area with lukewarm water—do not rub it—and seek immediate medical attention. Always remember that nitrogen is stored under pressure and can explode if heated, so handle it with care.

Pregnancy Use

Using Nitrogen during pregnancy can be risky, and it is important to approach its use with caution. You should only consider this treatment under the guidance of a licensed healthcare professional who has experience with Nitrogen. This expert will be knowledgeable about the appropriate dosages, methods of administration, and potential side effects, as well as the specific risks and contraindications associated with its use during pregnancy.

If you are pregnant or planning to become pregnant, it is crucial to discuss any potential treatments with your healthcare provider to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Nitrogen for nursing mothers. This means that, based on the available information, it is considered safe to use during lactation (the period when you are breastfeeding). Always consult with your healthcare provider if you have any concerns or questions about medications while nursing.

Pediatric Use

Using Nitrogen in children can be risky and should only be done under the guidance of a qualified healthcare professional. This means that a doctor or other licensed practitioner who has experience with Nitrogen must oversee its use. They will know the right dosages, how often it should be given, and the potential side effects or risks involved.

It's important to ensure that any treatment involving Nitrogen is carefully monitored, especially in younger patients. Always consult with your child's healthcare provider to discuss the specific needs and safety precautions related to this treatment.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While the information provided does not list any specific drug interactions or laboratory test interactions, your healthcare provider can help ensure that your treatment plan is safe and effective. Always share your complete list of medications and any recent lab tests to avoid potential issues and to receive the best care tailored to your needs.

Storage and Handling

To ensure safe use and storage of the product, always keep it outdoors or in a well-ventilated area. When temperatures rise above 52°C (125°F), make sure to protect the product from direct sunlight. After each use, close the valve and keep the container upright at all times. Avoid changing or forcing any connections, as this can lead to safety issues.

When handling the product, it’s important to wear cold insulating gloves, a face shield, and eye protection to protect yourself from potential hazards. Before using the product, please read and follow the Safety Data Sheet (SDS), which provides essential safety information.

Additional Information

When using Nitrogen, it's important to know that it should only be administered by a licensed practitioner who is experienced in its use. This is because improper use can be hazardous. Nitrogen is delivered through inhalation, and you should be aware that it contains gas under pressure, which can explode if heated. It may also displace oxygen, leading to rapid suffocation. Always read and understand all safety precautions before handling it, and ensure you use it outdoors or in a well-ventilated area.

If you accidentally inhale Nitrogen, move to fresh air immediately and seek medical attention if needed. Remember to close the valve after each use and protect the cylinder from sunlight, especially in high temperatures. Always consult the Safety Data Sheet (SDS) for detailed safety information before use.

FAQ

What is Nitrogen?

Nitrogen is a compressed non-flammable gas used under the supervision of a licensed practitioner experienced in its administration.

What are the hazards associated with Nitrogen?

Nitrogen may displace oxygen, causing rapid suffocation, and contains gas under pressure, which may explode if heated.

How should Nitrogen be stored?

Nitrogen should be stored outdoors or in a well-ventilated place, protected from sunlight when temperatures exceed 52°C (125°F).

What should I do if Nitrogen is inhaled?

If inhaled, remove the person to fresh air and keep them comfortable for breathing; seek medical advice or attention.

What precautions should I take when handling Nitrogen?

Read and understand all safety precautions before handling Nitrogen, use a back flow preventive device, and always keep the container in an upright position.

Is there any specific information regarding the use of Nitrogen during pregnancy or lactation?

No specific teratogenic or nonteratogenic effects, or recommendations for use during pregnancy or lactation, are mentioned.

What is the route of administration for Nitrogen?

The route of administration for Nitrogen is respiratory, specifically through inhalation.

What should I do if Nitrogen comes into contact with skin?

If Nitrogen contacts the skin, thaw frosted parts with lukewarm water without rubbing the area, and seek immediate medical advice or attention.

Packaging Info

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.

Packaging configurations for Nitrogen.
Details

FDA Insert (PDF)

This is the full prescribing document for Nitrogen, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Nitrogen is a compressed gas classified under NF standards, with the chemical formula N₂ and a CAS number of 7727-37-9. It is a non-flammable gas, designated as UN1066. This product is intended for use only by or under the supervision of a licensed practitioner experienced in the administration of nitrogen. The administration of nitrogen may pose hazards or contraindications, and practitioners must be familiar with its indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Nitrogen is stored under pressure and may explode if heated. It can displace oxygen, leading to rapid suffocation. Therefore, it is imperative to read and understand all safety precautions before handling. The gas should be used and stored outdoors or in well-ventilated areas, and a backflow preventive device must be employed in the piping. Equipment used must be rated for cylinder pressure, and the valve should be closed after each use and when empty. Protection from sunlight is required when ambient temperatures exceed 52°C (125°F). For first aid, if inhaled, the affected individual should be moved to fresh air and kept comfortable for breathing, with medical advice sought as necessary.

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 expertise 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 contraindicate its use in certain patients or conditions. There are no specific teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Administration of Nitrogen may pose hazards or be contraindicated. It is essential that Nitrogen is used solely by or under the supervision of a licensed practitioner who possesses experience in its use and administration. This practitioner must be well-versed in the indications, effects, dosages, methods, and frequency and duration of administration.

The route of administration for Nitrogen is via respiratory inhalation. Healthcare professionals should ensure that the administration technique is appropriate and that the patient is monitored closely throughout the process.

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 hazardous and should only be conducted by professionals familiar with its indications, effects, dosages, methods, frequency, duration of administration, and associated hazards.

Additionally, handling of Nitrogen should not occur until all safety precautions have been thoroughly read and understood. It is imperative to use and store Nitrogen exclusively outdoors or in a well-ventilated area. Connections must not be altered or forced, and the container should always be maintained in an upright position to prevent accidents.

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 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.

Warnings

Nitrogen is classified as a gas under pressure, which presents a risk of explosion if subjected to heat. Additionally, it may displace oxygen in the environment, leading to rapid suffocation. The product also contains refrigerated gas, which can cause cryogenic burns or injuries. Care must be taken to avoid situations that may lead to oxygen displacement and suffocation.

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. A backflow preventive device should be employed in the piping to mitigate risks. Equipment used must be rated for cylinder pressure, and the valve should be closed after each use and when the cylinder is empty. Containers must be protected from sunlight, particularly when ambient temperatures exceed 52°C (125°F). Personal protective equipment, including cold insulating gloves, a face shield, and eye protection, should be worn at all times. Containers should always be maintained in an upright position, and the Safety Data Sheet (SDS) must be read and followed 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.

Stop Taking and Call Your Doctor Instructions

If Nitrogen comes into contact with the skin, it is crucial to thaw any frosted areas with lukewarm water without rubbing the affected area. Immediate medical advice or attention should be obtained.

Side Effects

Administration of Nitrogen may pose significant hazards, and its use is contraindicated in certain situations. Notably, it contains gas under pressure, which may lead to explosive reactions if heated. Additionally, Nitrogen can displace oxygen, resulting in rapid suffocation, a serious risk that must be considered during its handling and administration.

In terms of safety precautions, it is crucial to be aware of the potential for cryogenic burns or injuries due to its refrigerated gas state. This characteristic also contributes to the risk of oxygen displacement, further heightening the danger of suffocation.

In the event of exposure, specific first aid measures should be taken. If Nitrogen is inhaled, it is essential to remove the affected individual to fresh air and ensure they are comfortable for breathing. Medical advice or attention should be sought immediately. For skin exposure, any frosted areas should be thawed with lukewarm water, and it is important not to rub the affected area. Immediate medical advice or attention is also recommended in this scenario.

These warnings and first aid recommendations underscore the importance of handling Nitrogen with caution to mitigate the risks associated with its use.

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.

Packaging configurations for Nitrogen.
Details

Pediatric Use

The 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 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. Careful consideration and adherence to these guidelines are crucial to ensure the safety and efficacy of Nitrogen in pediatric populations.

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 considered hazardous or contraindicated. Pregnant patients should only receive Nitrogen under the supervision of a licensed practitioner who is experienced 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.

Due to the lack of comprehensive data on the effects of Nitrogen on fetal outcomes, healthcare professionals are advised to carefully weigh the potential benefits against the risks when considering its use in pregnant patients. It is essential to ensure that any administration is conducted with the utmost caution and under appropriate medical supervision.

Lactation

There are no specific warnings or recommendations regarding the use of Nitrogen in lactating mothers. Additionally, there are no specific warnings or recommendations concerning the use of Nitrogen during lactation. Therefore, healthcare professionals may consider the use of Nitrogen in nursing mothers without specific contraindications noted in the available data.

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 can pose significant risks, and its use may be hazardous or contraindicated in certain situations. Healthcare professionals should be aware of the potential dangers associated with nitrogen exposure, particularly in the context of overdosage.

Warnings

Nitrogen is classified as a gas under pressure, which presents a risk of explosion if subjected to heat. Additionally, it may displace oxygen in the environment, leading to rapid suffocation. This risk is compounded by the fact that nitrogen is often stored as a refrigerated gas, which can cause cryogenic burns or injuries upon contact with skin.

Symptoms of Overdosage

In cases of nitrogen overdosage, symptoms may include respiratory distress due to oxygen displacement, as well as potential cryogenic injuries if the gas comes into contact with skin.

Management Procedures

In the event of inhalation, it is crucial to remove the affected individual to an area with fresh air and ensure they are comfortable while breathing. Immediate medical advice or attention should be sought to address any respiratory complications.

If nitrogen comes into contact with the skin, the affected areas should be thawed gently using lukewarm water. It is important to avoid rubbing the area, as this may exacerbate the injury. Prompt medical advice or attention is essential to manage any potential cryogenic burns effectively.

Healthcare professionals must remain vigilant regarding the risks associated with nitrogen and be prepared to implement appropriate first aid measures in the event of overdosage.

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

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, 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 gas under pressure, which may explode if heated. Additionally, it may displace oxygen and cause rapid suffocation. Therefore, patients must not handle Nitrogen until they have read and understood all safety precautions. It is crucial to use and store Nitrogen only outdoors or in a well-ventilated area.

Healthcare providers should instruct patients to use a backflow preventive device in the piping and to utilize only equipment rated for cylinder pressure. Patients should be reminded to close the valve after each use and when the cylinder is empty. Furthermore, they should protect the Nitrogen container from sunlight when the ambient temperature exceeds 52°C (125°F) and to read and follow the Safety Data Sheet (SDS) before use.

In the event of inhalation, patients should be advised to remove themselves to fresh air and keep comfortable for breathing, while seeking medical advice or attention. Providers should also inform patients of the warning regarding the refrigerated gas, which may cause cryogenic burns or injury and can displace oxygen, leading to rapid suffocation.

Patients should wear cold insulating gloves, a face shield, and eye protection when handling Nitrogen. They must be cautioned against changing or forcing fit connections and should always keep the container in an upright position. In case of skin contact, patients should thaw frosted areas with lukewarm water without rubbing the affected area and seek immediate medical advice or attention.

Storage and Handling

This product is supplied in containers that must be used and stored exclusively outdoors or in a well-ventilated area. It is essential to protect the product from sunlight when the ambient temperature exceeds 52°C (125°F).

Users are advised to close the valve after each use and when the container is empty. The container should always be maintained in an upright position to ensure safety and integrity. It is critical not to change or force fit any connections during handling.

When handling this product, personnel must wear cold insulating gloves, a face shield, and eye protection to ensure safety. Prior to use, it is imperative to read and follow the Safety Data Sheet (SDS) for comprehensive safety information and guidelines.

Additional Clinical Information

The route of administration for the product is via respiratory inhalation. It is crucial that the administration of Nitrogen is conducted only by or under the supervision of a licensed practitioner experienced in its use. Clinicians 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.

Patients should be made aware of the potential hazards associated with Nitrogen, including the risk of explosion if heated and the possibility of oxygen displacement leading to rapid suffocation. It is essential to read and understand all safety precautions before handling the gas. The product should be used and stored outdoors or in well-ventilated areas, and a backflow preventive device must be utilized in the piping. After each use, the valve should be closed, and the product should be protected from sunlight when temperatures exceed 52°C (125°F). In case of inhalation, individuals should be moved to fresh air and kept comfortable for breathing, and medical advice should be sought.

FDA Insert (PDF)

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

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Nitrogen, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (NDA205850) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.