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Nitrogen

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Active ingredient
Nitrogen 990 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
Marketed in the U.S.
Since 2018
Label revision date
October 30, 2025
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
Marketed in the U.S.
Since 2018
Label revision date
October 30, 2025
Manufacturer
Raimy Corporation
Registration number
NDA205866
NDC root
10942-2011

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Drug Overview

Nitrogen is a colorless, odorless gas that is commonly used in its refrigerated liquid form. It is primarily utilized in various industrial applications, including cryogenics, where its extremely cold temperature is beneficial for preserving biological samples or in processes that require rapid cooling.

As a gas under pressure, nitrogen can be hazardous if not handled properly, and it should only be administered by or under the supervision of a licensed practitioner experienced in its use. Due to its properties, nitrogen can cause rapid suffocation and severe frostbite, so it is important to follow safety guidelines when using it.

Uses

You should know that the administration of Nitrogen can be risky and is not suitable for everyone. It is important that this treatment is only given by a licensed healthcare professional who has experience with Nitrogen. They will understand the proper dosages, methods, and frequency of administration, as well as any potential hazards or side effects.

Additionally, there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with Nitrogen. However, always consult with your healthcare provider for personalized advice and information regarding your specific situation.

Dosage and Administration

Using Nitrogen requires careful handling and should only be done by a licensed practitioner who is experienced in its use. This is important because the administration of Nitrogen can be hazardous or not recommended in certain situations. Your healthcare provider will be familiar with the specific indications (reasons for use), effects, dosages, methods, frequency, and duration of administration.

Nitrogen is administered through inhalation, meaning you will breathe it in. It’s crucial to use equipment that can handle the pressure of the gas cylinder safely. Additionally, a backflow preventive device should be included in the piping to avoid any potential issues. Make sure that the cylinder is kept at a temperature that does not exceed 52°C (125°F). After each use, remember to close the valve, especially when the cylinder is empty, to ensure safety.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it’s important to follow your healthcare provider's guidance and discuss any questions or concerns you may have about this medication. Always prioritize your health and safety by staying informed.

Side Effects

Using this medication can lead to serious adverse reactions. One significant warning is that it can create pressure gas, which may cause rapid suffocation. If you or someone else inhales it, it's crucial to move to fresh air immediately. If breathing stops, perform artificial respiration, and if breathing becomes difficult, provide oxygen. Always seek medical help right away in such situations.

Warnings and Precautions

Using Nitrogen can be risky and should only be done by a trained professional who understands how to handle it safely. This substance is extremely cold and can cause serious injuries, such as rapid suffocation or severe frostbite. Always ensure that you are in a well-ventilated area when using Nitrogen, and avoid contact with your skin, eyes, or clothing. If you need to handle liquid Nitrogen, make sure to wear protective gear like gloves and a face shield.

In case of an emergency, if you inhale Nitrogen, move to fresh air immediately. If someone is not breathing, perform artificial respiration, and if breathing is difficult, provide oxygen. It's crucial to seek medical help right away if frostbite occurs. Always remember to close the valve after use and follow safety guidelines to prevent accidents.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

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.

If you are pregnant or planning to become pregnant, please consult your healthcare provider before considering any treatment involving Nitrogen. They can help you understand the potential risks and ensure that you receive the safest care possible.

Lactation Use

When it comes to breastfeeding, it's important to be aware that the information provided does not include specific guidelines or considerations for nursing mothers or lactation (the process of producing milk). This means that there are no detailed recommendations or warnings regarding the use of this medication while breastfeeding.

If you are breastfeeding or planning to breastfeed, it's always a good idea to consult with your healthcare provider about any medications you may be taking. They can provide personalized advice and help ensure the safety of both you and your baby.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that there are no recommended ages, dosage adjustments, or safety guidelines specifically for pediatric patients (children). If you are considering this medication for a child, it is essential to consult with a healthcare professional to ensure it is safe and appropriate for their individual needs. Always prioritize your child's health and well-being by seeking expert advice.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure safe storage and handling of the product, always keep the container in an upright position and store it in a well-ventilated area. When using the product, avoid contact with your eyes, skin, or clothing. If you need to withdraw liquid, make sure to wear a face shield and gloves for protection.

Be cautious not to drop the container; instead, use a hand truck for moving it. After each use, remember to close the valve, especially when the container is empty. It's important to keep the cylinder temperature below 52°C (125°F) and to use equipment that is rated for the cylinder's pressure. Additionally, ensure that a backflow preventive device is installed in the piping to maintain safety.

Additional Information

You will use this medication through inhalation, which means you will breathe it in to receive the treatment. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information. If you have any questions about how to use this medication or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is Nitrogen?

Nitrogen is a refrigerated liquid used under pressure, classified as UN1977.

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 risks associated with Nitrogen?

Nitrogen can cause rapid suffocation and severe frostbite due to its extremely cold temperature.

What precautions should I take when using Nitrogen?

Store and use Nitrogen with adequate ventilation, avoid contact with skin and eyes, and wear a face shield and gloves during liquid withdrawal.

What should I do in case of inhalation of Nitrogen?

If inhaled, remove the person to fresh air, provide artificial respiration if not breathing, and call a physician.

What should I do if I experience frostbite from Nitrogen?

Obtain medical treatment immediately if frostbite occurs.

How should Nitrogen be stored?

Always keep the container in an upright position and ensure it is stored with adequate ventilation.

What is the route of administration for Nitrogen?

Nitrogen is administered via respiratory inhalation.

What temperature should the Nitrogen cylinder not exceed?

The cylinder temperature should not exceed 52°C (125°F).

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

No specific information regarding the use of Nitrogen during pregnancy or lactation is provided.

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

No description information is available for the specified drug.

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 reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Administration of Nitrogen is associated with potential hazards and contraindications. It is intended for use solely by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrogen, as well as familiarity with its indications, effects, dosages, methods, frequency, and duration of administration.

The route of administration is via respiratory inhalation. Practitioners must utilize equipment that is rated for cylinder pressure to ensure safety and efficacy. It is essential to incorporate a backflow preventive device in the piping to prevent contamination and ensure proper delivery of the gas.

The temperature of the cylinder must not exceed 52°C (125°F) to maintain the integrity of the Nitrogen. After each use, and when the cylinder is empty, the valve should be closed to prevent any unintended release of gas.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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, and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Nitrogen is classified as an extremely cold liquid and gas under pressure. Exposure to this substance can lead to rapid suffocation and severe frostbite. Therefore, it is crucial to adhere to the following general precautions to ensure safe handling and use:

Adequate ventilation must be maintained during storage and use of Nitrogen. Direct contact with the liquid should be avoided; it is essential to prevent any liquid from coming into contact with the eyes, skin, or clothing. When withdrawing liquid Nitrogen, appropriate personal protective equipment, including a face shield and gloves, should be worn to mitigate the risk of injury. Containers should not be dropped; instead, a hand truck should be utilized for movement. After each use and when the container is empty, the valve must be closed to prevent accidental release. All handling and usage should comply with the guidelines outlined in the Material Safety Data Sheet (MSDS).

In the event of an emergency, immediate action is required. If Nitrogen is inhaled, the individual should be removed to fresh air. If breathing has ceased, artificial respiration should be administered. If breathing is difficult, supplemental oxygen should be provided, and a physician should be contacted without delay. In cases of frostbite, it is critical to seek medical treatment immediately to address the injury effectively.

Side Effects

Patients may experience serious adverse reactions associated with the use of this product. Notably, there is a warning regarding the potential for pressure gas, which can lead to rapid suffocation.

In the event of inhalation, it is critical to remove the affected individual to fresh air immediately. If the patient is not breathing, artificial respiration should be administered. Should breathing difficulties arise, supplemental oxygen must be provided. It is essential to contact a physician for further evaluation and management.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted 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

There is no specific pediatric use information available for this medication, including recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant data.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for 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 associated fetal outcomes or necessary dosage modifications. Therefore, it is essential that Nitrogen be used only by or under the supervision of a licensed practitioner who is experienced in its administration. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of Nitrogen during pregnancy.

Lactation

There are no specific statements or considerations regarding nursing mothers or lactation in the provided text. Therefore, the effects of this medication on breastfed infants and its excretion in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks and 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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients that the administration of Nitrogen 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 who possesses experience in its use and administration. Patients should be informed that the practitioner must 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 that Nitrogen is an extremely cold liquid and gas under pressure, which can lead to rapid suffocation and severe frostbite. It is crucial to store and use Nitrogen in an area with adequate ventilation to minimize risks. Patients must be cautioned against allowing the liquid to come into contact with their eyes, skin, or clothing. When withdrawing liquid Nitrogen, it is recommended that patients wear a face shield and gloves to protect themselves.

Healthcare providers should instruct patients not to drop containers of Nitrogen and to utilize a hand truck for safe movement. It is important to close the valve after each use and when the container is empty. Patients should be encouraged to follow the guidelines outlined in the Material Safety Data Sheet (MSDS) for safe handling and product information.

In the event of inhalation, patients should be advised to move to fresh air immediately. If breathing has ceased, artificial respiration should be administered, and if breathing is difficult, supplemental oxygen should be provided. Patients should be instructed to seek medical attention promptly. In cases of frostbite, immediate medical treatment is necessary. Providers should remind patients to refer to the Material Safety Data Sheet for comprehensive safety and product information.

Storage and Handling

The product is supplied in a container that must always be kept in an upright position. It is essential to store and use the product in an area with adequate ventilation to ensure safety. Care should be taken to avoid contact with eyes, skin, or clothing, and during liquid withdrawal, appropriate personal protective equipment, including a face shield and gloves, should be worn.

To prevent accidents, the container should not be dropped; instead, a hand truck should be utilized for movement. After each use and when the container is empty, the valve must be closed to maintain safety. The temperature of the cylinder should not exceed 52°C (125°F). It is important to use equipment that is rated for the cylinder pressure and to incorporate a backflow preventive device in the piping to ensure proper handling and safety.

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by Raimy Corporation. 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 (NDA205866) 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.