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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 1997
Label revision date
November 7, 2024
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 1997
Label revision date
November 7, 2024
Manufacturer
Middlesex Gases and Technologies, Inc.
Registration number
NDA205850
NDC root
63961-200
FDA Insert
Prescribing information, PDF file
Packaging Info (12 NDCs)
Packaging & NDC Codes (12)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Nitrogen, compressed NF UN 1066, is a non-flammable gas commonly used in various industrial and medical applications. It is important to note that nitrogen is typically administered under the supervision of a licensed practitioner who is experienced in its use. This gas is often utilized for its ability to displace oxygen, which can be beneficial in certain controlled environments.

Due to its properties, nitrogen must be handled with care, as it is stored under pressure and can pose hazards if not managed properly. It is essential to follow safety precautions when using nitrogen to ensure safe handling and storage.

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 any potential side effects or precautions you need to be aware of.

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.

Dosage and Administration

It's important to know that this medication should only be used by you or under the supervision of a licensed healthcare professional who has experience with Nitrogen. This ensures that the medication is administered correctly and safely, taking into account its specific uses, effects, dosages, and how often it should be given.

You will receive this medication through your respiratory system, which means it is inhaled. This method allows the medication to work quickly and effectively. Always follow your healthcare provider's instructions regarding how often and for how long you should use this treatment.

What to Avoid

It’s important to be aware of certain precautions when using Nitrogen. First, do not handle it until you have read and understood all safety precautions. Avoid changing or forcing any connections, as this can lead to hazardous situations.

Be cautious, as Nitrogen is a gas under pressure and can explode if heated. Additionally, it may displace oxygen in the air, which can lead to rapid suffocation. Always prioritize your safety and the safety of those around you when using this substance.

Side Effects

Using Nitrogen can come with some serious risks. It is important to know that it may be hazardous or not suitable for everyone. The gas is under pressure, which means it can explode if heated, and it can also displace oxygen, leading to rapid suffocation.

If you happen to inhale Nitrogen, it's crucial to move to fresh air immediately and seek medical attention. If it comes into contact with your skin, gently thaw any frostbite with lukewarm water without rubbing the area, and get medical help right away. Always ensure that Nitrogen is administered by a qualified professional who understands its proper use and potential dangers.

Warnings and Precautions

Using Nitrogen can be risky, so it’s important to only use it under the guidance of a qualified professional who knows how to handle it safely. This gas is under pressure and can explode if heated, so always store it outdoors or in a well-ventilated area. Make sure to wear protective gear, such as cold insulating gloves and eye protection, and never change or force fit connections. Always keep the container upright and close the valve after each use.

If you accidentally inhale Nitrogen, move to fresh air immediately and seek medical help. If it comes into contact with your skin, gently thaw any frost with lukewarm water—do not rub the area—and get medical attention right away. Always read and understand the safety precautions before using Nitrogen to ensure your safety.

Overdose

Using Nitrogen can be risky, as it may not be safe for everyone. It's important to be aware that this gas is under pressure, which means it can explode if heated. Additionally, Nitrogen can displace oxygen in the air, leading to rapid suffocation, which is a serious concern.

If you or someone else has inhaled Nitrogen, the first step is to move to fresh air immediately and ensure that the person is comfortable while breathing. It's crucial to seek medical advice or attention right away, as inhaling this gas can lead to dangerous situations. Always prioritize safety and be aware of the risks associated with using Nitrogen.

Pregnancy Use

Using Nitrogen during pregnancy may pose risks, and it is important to approach its use with caution. There is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. Therefore, it is crucial that you only use Nitrogen under the guidance of a licensed healthcare professional who has experience with its administration.

Additionally, be aware that Nitrogen is stored under pressure, which means it can be hazardous if heated and may explode. It can also displace oxygen, leading to rapid suffocation. Always prioritize your safety and consult with your healthcare provider before considering any use of Nitrogen during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the use of Nitrogen in nursing mothers or its effects on lactation (the production of breast milk). Since the drug insert does not address this topic, it’s advisable to consult your healthcare provider for personalized guidance and to discuss any potential risks or concerns related to your situation. Always prioritize your health and the well-being of your baby when considering any medications.

Pediatric Use

When considering the use of this medication for your child, it's important to know that it should only be administered by a licensed healthcare professional who has experience with Nitrogen. This means that the practitioner should be well-versed in how to use this treatment safely, including understanding the correct dosages, methods of administration, and potential side effects.

Always ensure that the healthcare provider is aware of any specific precautions and contraindications (situations where the medication should not be used) related to your child's health. This careful oversight helps to ensure your child's safety and the effectiveness of the treatment.

Geriatric Use

When it comes to using Nitrogen, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult or are an older adult yourself, it's important to consult with a healthcare provider for personalized advice. They can help determine the best approach to using this medication based on individual health needs and circumstances. 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 the drug insert for Nitrogen does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Before starting any new medication, including Nitrogen, you should discuss your kidney health with your healthcare provider to ensure it is safe for you. They can provide personalized advice and monitor your condition appropriately.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert for Nitrogen does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication should be used in patients with liver impairment.

Before starting any new medication, including Nitrogen, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking or laboratory tests you may undergo. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you take works well together and that your health is monitored effectively. Always feel free to ask questions and share your complete list of medications and supplements to avoid any potential issues.

Storage and Handling

To ensure your safety and the proper use of the product, always store and use it outdoors or in a well-ventilated area. When temperatures rise above 52 degrees Celsius (125 degrees Fahrenheit), make sure to protect the product from direct sunlight. After each use, close the valve and keep the container upright at all times.

When handling the product, it’s important to wear cold insulating gloves, a face shield, and eye protection to safeguard against any potential hazards. Additionally, use a backflow preventive device in the piping to avoid any unwanted backflow. Before you begin handling the product, please read and understand all safety precautions, and remember not to change or force fit any connections.

Additional Information

When using Nitrogen, it's important to remember that it should only be administered by a licensed practitioner who is experienced in its use. This means you should not handle it yourself until you fully understand all safety precautions. Always use Nitrogen outdoors or in a well-ventilated area, and make sure to wear protective gear such as cold insulating gloves, a face shield, and eye protection. Before using, read the Safety Data Sheet (SDS) to familiarize yourself with the necessary safety information.

In case of an emergency, if Nitrogen is inhaled, move the person to fresh air and ensure they are comfortable while breathing. Seek medical advice immediately. If it comes into contact with skin, gently thaw any frostbite with lukewarm water—do not rub the area—and get medical attention right away.

FAQ

What is Nitrogen, and how is it classified?

Nitrogen is a non-flammable gas classified as compressed NF UN 1066.

Who should administer Nitrogen?

Nitrogen should only be administered by or under the supervision of a licensed practitioner experienced in its use.

What are the safety precautions for handling Nitrogen?

You must read and understand all safety precautions before handling Nitrogen, including using it outdoors or in a well-ventilated area.

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 are the risks associated with Nitrogen?

Nitrogen may displace oxygen and cause rapid suffocation; it is also under pressure and may explode if heated.

How should Nitrogen be stored?

Store Nitrogen outdoors or in a well-ventilated place, and protect it from sunlight when temperatures exceed 52 degrees C (125 degrees F).

What should I do after using Nitrogen?

Close the valve after each use and when the cylinder is empty.

Are there any specific teratogenic effects of Nitrogen?

No specific teratogenic effects are mentioned for Nitrogen.

What is the route of administration for Nitrogen?

The route of administration for Nitrogen is respiratory (inhalation).

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

If Nitrogen is on the skin, thaw frosted parts with lukewarm water and do not rub the affected area. Seek immediate medical advice.

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, compressed NF UN 1066, is a non-flammable gas classified as a prescription-only product. It is identified by the CAS number 7727-37-9. The gas is supplied under pressure and may pose hazards if not handled properly. Administration of Nitrogen 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, methods, frequency, duration of administration, and associated hazards, contraindications, side effects, and necessary precautions.

The product is stored in a pressurized cylinder, which 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. Nitrogen should be used and stored outdoors or in well-ventilated areas, and a backflow preventive device must be utilized in the piping. Equipment 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 degrees C (125 degrees F).

In case of inhalation, it is advised to remove the affected individual to fresh air and ensure comfort for breathing, followed by seeking medical advice or attention. For further information, refer to the Safety Data Sheet (SDS). The product is distributed by Middlesex Gases & Technologies, Inc., located at 292 2nd Street, Everett, MA 02149, with a contact number of 617-387-5050.

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 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 this medication is restricted to licensed practitioners who possess experience in the use and administration of Nitrogen. These practitioners must be well-versed in the indications, effects, dosages, methods, and frequency and duration of administration.

The medication is to be administered via the respiratory route, specifically through inhalation. It is imperative that healthcare professionals adhere to established protocols for inhalation techniques to ensure optimal delivery and efficacy of the treatment.

Contraindications

Administration of Nitrogen is contraindicated in situations where safety precautions have not been fully understood and implemented. Handling of Nitrogen should not occur until all safety measures have been reviewed. Additionally, altering or forcing connections is prohibited due to potential hazards.

Nitrogen is also contraindicated in environments where there is a risk of rapid suffocation, as it may displace oxygen. The product contains gas under pressure and poses a risk of explosion if subjected to heat.

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.

Nitrogen is contained under pressure and may explode if subjected to heat. Additionally, it has the potential to displace oxygen, leading to rapid suffocation. Therefore, it is crucial that all safety precautions are thoroughly read and understood prior to handling. Nitrogen should only be used and stored outdoors or in a well-ventilated area to mitigate risks.

Personal protective equipment is essential when handling Nitrogen. Users must wear cold insulating gloves, a face shield, and eye protection to prevent injury. A backflow preventive device should be utilized in the piping to ensure safety. Connections must not be changed or forced, and the valve should be closed after each use and when the container is empty. It is also important to maintain the container in an upright position at all times. Prior to use, the Safety Data Sheet (SDS) must be read and followed to ensure safe handling practices.

In the event of an emergency, immediate action is required. If Nitrogen is inhaled, the affected individual should be removed to fresh air and kept comfortable for breathing while seeking medical advice or attention. If Nitrogen comes into contact with the skin, the affected area should be thawed with lukewarm water without rubbing, and immediate medical advice or attention should be sought.

Side Effects

Administration of Nitrogen may pose significant risks, and its use is associated with several warnings and adverse reactions. It is crucial to note that Nitrogen is a gas under pressure, which may explode if heated. Additionally, it can displace oxygen in the environment, leading to rapid suffocation.

In the event of inhalation, it is imperative to remove the affected individual to fresh air and ensure they are comfortable for breathing. Medical advice or attention should be sought immediately. If Nitrogen comes into contact with the skin, it is advised to thaw any frosted areas with lukewarm water without rubbing the affected region, and to obtain immediate medical advice or attention.

Due to the potential hazards associated with Nitrogen, its administration should only be conducted by or under the supervision of a licensed practitioner who possesses experience in its use. 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.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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

Pediatric patients should receive this medication only under the supervision of a licensed practitioner experienced in the use and administration of Nitrogen. 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. It is essential to ensure that all safety measures are adhered to when treating pediatric populations.

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 is advisable in this population, given the lack of established guidelines for geriatric use.

Pregnancy

The administration of Nitrogen during pregnancy may pose potential risks, as it is contraindicated or hazardous. There is no specific information available regarding the safety of Nitrogen use in pregnant patients, including any known fetal impacts or necessary dosage modifications. Given the lack of data, healthcare professionals are advised to exercise caution when considering the use of Nitrogen in women of childbearing potential.

It is important to note that Nitrogen is to be used only by or under the supervision of a licensed practitioner experienced in its administration. Additionally, the product carries a warning indicating that it contains gas under pressure, which may explode if heated, and it may displace oxygen, leading to rapid suffocation. Therefore, appropriate precautions should be taken to ensure the safety of both the patient and the fetus.

Lactation

There is no information available regarding the use of Nitrogen in nursing mothers or its effects on lactation. Consequently, the safety and efficacy of this drug in lactating mothers and its potential impact on breastfed infants remain undetermined. Healthcare professionals should exercise caution and consider the 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 are no dosage adjustments, special monitoring requirements, or precautions outlined for this population in the prescribing information. 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 defined in the available information.

Overdosage

Administration of Nitrogen can pose significant risks and may be contraindicated in certain situations. Healthcare professionals should be aware of the potential hazards associated with its use.

Safety Warnings

It is critical to note that Nitrogen is classified as a gas under pressure, which presents a risk of explosion if subjected to heat. Additionally, Nitrogen can displace oxygen in the environment, leading to rapid suffocation. These factors necessitate caution when handling and administering this substance.

First Aid Measures

In the event of inhalation, immediate action is required. The affected individual should be removed to an area with fresh air and positioned comfortably to facilitate breathing. It is essential to seek medical advice or attention promptly to ensure appropriate care is provided.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 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.

Patients should be made aware of the warning that Nitrogen contains gas under pressure and may explode if heated. Additionally, it may displace oxygen, leading 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 also be informed about the necessity of using a backflow preventive device in the piping and to utilize equipment that is rated for cylinder pressure. Patients should be reminded to close the valve after each use and when the cylinder is empty, and to protect the cylinder from sunlight when the ambient temperature exceeds 52 degrees Celsius (125 degrees Fahrenheit).

Healthcare providers should encourage patients to read and follow the Safety Data Sheet (SDS) prior to use. In the event of an emergency, patients should be informed of the 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 the skin, patients should thaw any frosted areas with lukewarm water without rubbing the affected area and should seek immediate medical advice or attention.

Storage and Handling

The product is supplied in a manner that necessitates careful handling and storage to ensure safety and efficacy. It must be used and stored exclusively outdoors or in a well-ventilated area. When ambient temperatures exceed 52 degrees Celsius (125 degrees Fahrenheit), it is essential to protect the product from direct sunlight.

After each use and when the container is empty, the valve should be securely closed. The container must always be maintained in an upright position to prevent any potential hazards.

When handling the product, it is imperative to wear appropriate personal protective equipment, including cold insulating gloves, a face shield, and eye protection. Additionally, a backflow preventive device should be utilized in the piping to ensure safe operation.

Prior to handling, all safety precautions must be thoroughly read and understood. It is also critical to avoid changing or forcing any connections to maintain the integrity of the system.

Additional Clinical Information

The route of administration for Nitrogen is via respiratory inhalation. It is crucial that this substance is used only by or under the supervision of a licensed practitioner who is knowledgeable about its indications, effects, dosages, methods, and potential hazards. Clinicians should ensure that all safety precautions are thoroughly understood before handling Nitrogen. It should be used and stored outdoors or in well-ventilated areas, and appropriate personal protective equipment, including cold insulating gloves, face shields, and eye protection, must be worn.

In the event of exposure, first aid measures include removing the affected individual to fresh air and ensuring comfort for breathing. If Nitrogen comes into contact with skin, thaw any frostbite with lukewarm water without rubbing the area, and seek immediate medical attention. It is essential to read and follow the Safety Data Sheet (SDS) prior to use.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by Middlesex Gases and Technologies, Inc.. 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.