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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
10942-2010

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Drug Overview

Nitrogen is a refrigerated liquid that exists in a gaseous state under pressure. It is primarily used in various industrial applications, including cryogenic processes, where its extremely cold properties are beneficial. However, it is important to note that the administration of nitrogen should only be performed by a licensed practitioner who is experienced in its use, as it can pose hazards such as rapid suffocation and severe frostbite if not handled properly.

Due to its unique characteristics, nitrogen requires careful handling and storage, including adequate ventilation to ensure safety during use. Always follow safety guidelines and protocols when working with nitrogen to minimize risks.

Uses

You should be aware that the administration of Nitrogen can be risky and is only recommended when supervised by a qualified healthcare professional. This practitioner should have experience with Nitrogen, including its uses, effects, dosages, methods of administration, and any potential hazards or side effects.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with Nitrogen. Always consult with your healthcare provider for more information and guidance regarding its use.

Dosage and Administration

Using Nitrogen requires careful handling and should only be done by a licensed healthcare professional who is experienced in its use. This is important because Nitrogen can be hazardous, and the practitioner will know the right dosages, methods, and precautions to ensure your safety.

Nitrogen is administered through inhalation (breathing it in), which means it goes directly into your respiratory system. The healthcare provider will determine how often and for how long you should receive this treatment based on your specific needs. Always follow their guidance closely to ensure the best outcomes.

What to Avoid

It's important to follow specific guidelines when using this product. First and foremost, you should not remove the product label. This label contains essential information that can help ensure your safety and the proper use of the product.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always use it as directed and consult with a healthcare professional if you have any questions or concerns.

Side Effects

Using this medication comes with important safety information. It can cause rapid suffocation, which is a serious concern. If you or someone else inhales it and experiences difficulty breathing, it's crucial to act quickly. Move the person to fresh air immediately. If they are not breathing, perform artificial respiration, and if breathing is difficult, provide oxygen. Be sure to call a physician for further assistance.

Warnings and Precautions

Using Nitrogen can be risky and should only be done under the supervision of a qualified healthcare professional who understands its proper use and potential dangers. It is extremely cold and can cause rapid suffocation or severe frostbite if not handled correctly. Always ensure you have good ventilation when using it, and avoid contact with your eyes, skin, or clothing. When withdrawing liquid Nitrogen, wear protective gear like a face shield and gloves, and never drop the container—use a hand truck instead.

If you experience frostbite, seek medical attention right away. It's also important to call your doctor if you have any concerns or questions about using Nitrogen. Remember to close the valve after each use and store the cylinder properly, ensuring it does not exceed a temperature of 52°C (125°F). Always follow safety guidelines and use equipment designed for high-pressure gas.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. If you suspect an overdose, it’s important to stay calm and take immediate action. Look for any unusual symptoms, which may include extreme drowsiness, confusion, or difficulty breathing.

If you notice any signs of overdose, seek medical help right away. You can contact your healthcare provider or go to the nearest emergency room. Always keep the medication packaging handy, as it can provide important information to the medical team. Remember, it’s better to be safe and get checked 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 are no specific guidelines or safety information regarding its use in pregnant individuals, which means that the potential effects on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it is crucial to consult with a licensed healthcare provider who has experience in administering Nitrogen. They can provide guidance tailored to your situation and help ensure the safety of both you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

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 any potential side effects or precautions to consider.

It's important to ensure that you are following the advice of a healthcare provider who understands the specific needs and safety measures for children when it comes to administering Nitrogen. Always consult with your child's doctor before proceeding with any treatment involving this substance.

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 considering this medication, it’s important to consult with a healthcare provider. 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can help determine the best approach based on your kidney function and overall health.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

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 withdrawing liquid, it’s important to wear a face shield and gloves for your protection. Avoid dropping the container; instead, use a hand truck for safe movement. After each use, make sure to close the valve, especially when the container is empty.

Be mindful that the cylinder temperature should not exceed 52°C (125°F), and always use equipment that is rated for the cylinder's pressure. Additionally, incorporate a backflow preventive device in the piping to enhance safety. For detailed safety information, refer to the Material Safety Data Sheet (MSDS).

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, patient counseling, or postmarketing experiences related to this medication.

FAQ

What is Nitrogen?

Nitrogen is a refrigerated liquid classified as NF (National Formulary) and is stored under pressure.

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 hazards associated with Nitrogen?

Nitrogen can cause rapid suffocation and severe frostbite. It is extremely cold and should be handled with care.

What precautions should I take when using Nitrogen?

Always store and use Nitrogen with adequate ventilation, keep the container upright, and wear protective gear when handling.

What should I do if I inhale Nitrogen?

If inhaled, move to fresh air immediately. If not breathing, provide artificial respiration and call a physician.

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

The provided text does not mention any specific safety concerns or precautions regarding the use of Nitrogen during pregnancy.

What should I do in case of frostbite from Nitrogen?

Obtain medical treatment immediately if frostbite occurs.

Are there any contraindications for using Nitrogen?

No specific contraindications are mentioned in the provided text, but administration may be hazardous.

What is the route of administration for Nitrogen?

Nitrogen is administered via respiratory inhalation.

What should I do after using Nitrogen?

Close the valve after each use and when the container is empty, and follow the guidelines in the Material Safety Data Sheet (MSDS).

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 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 necessitate careful consideration and oversight by qualified healthcare professionals. There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Administration of Nitrogen is to be conducted exclusively 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.

The route of administration for Nitrogen is via respiratory inhalation. It is imperative that healthcare professionals adhere to established protocols and guidelines when administering this substance to ensure patient safety and efficacy.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the instruction to not remove the product label, as it contains critical information for safe use.

Warnings and Precautions

Administration of Nitrogen may pose significant hazards and is contraindicated in certain situations. It is imperative that this substance is used solely by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrogen. This practitioner must be well-versed in the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

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 usage:

  • Store and utilize Nitrogen in areas with adequate ventilation to prevent the accumulation of gas.

  • Avoid contact of the liquid with eyes, skin, or clothing to prevent injury.

  • When withdrawing liquid Nitrogen, it is essential to wear appropriate personal protective equipment, including a face shield and gloves.

  • Handle containers with care; do not drop them. Utilize a hand truck for safe movement of containers.

  • Always close the valve after each use and when the container is empty to prevent accidental release.

  • Follow the guidelines outlined in the Material Safety Data Sheet (MSDS) for safe handling practices.

  • Be aware that Nitrogen is a high-pressure gas that can cause rapid suffocation if not managed properly.

  • Use equipment that is rated for the cylinder pressure to avoid accidents.

  • Implement a backflow preventive device in the piping to ensure safety.

  • Ensure that the cylinder temperature does not exceed 52°C (125°F) to maintain integrity.

In the event of frostbite, immediate medical treatment is necessary. Healthcare professionals should instruct patients to stop using Nitrogen and seek medical assistance without delay. For any emergencies or adverse reactions, contacting a physician is strongly advised. No specific laboratory tests are required for monitoring the use of Nitrogen; however, practitioners should remain vigilant and prepared to respond to any complications that may arise during its administration.

Side Effects

Patients should be aware that the use of this product can lead to serious adverse reactions, including the potential for rapid suffocation. In the event of inhalation, it is critical to remove the 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, and a physician should be contacted without delay.

It is essential for healthcare providers to monitor patients closely for these serious reactions and to be prepared to implement appropriate first aid measures.

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

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

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 may pose potential risks during pregnancy, and its use is contraindicated or hazardous in this population. There are no specific data available regarding the safety of Nitrogen in pregnant patients, nor are there any documented dosage modifications or special precautions for its use during pregnancy. Therefore, it is essential that Nitrogen be administered only by or under the supervision of a licensed practitioner who is experienced in its use and administration. Healthcare professionals should carefully consider the potential risks and benefits before recommending Nitrogen to women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers. Additionally, there is no available data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

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. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, prompt recognition and appropriate management of overdose symptoms are critical in ensuring patient safety.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported. 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 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. Therefore, it is crucial to store and use Nitrogen in an area with adequate ventilation. 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, they should perform artificial respiration, and if breathing is difficult, they should administer oxygen. Patients must be instructed to seek medical attention by calling a physician. In cases of frostbite, immediate medical treatment is necessary. Patients should be reminded 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. For liquid withdrawal, personnel are required to wear a face shield and gloves to protect against potential exposure.

Care should be taken to avoid dropping the container; a hand truck should be utilized for any movement of the cylinder. After each use and when the container is empty, the valve must be closed to prevent any leaks. The cylinder temperature must not exceed 52°C (125°F) to maintain product integrity.

It is important to use equipment that is rated for the cylinder pressure and to incorporate a backflow preventive device in the piping system. All handling and usage should be conducted in accordance with the Material Safety Data Sheet (MSDS) to ensure compliance with safety protocols.

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

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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.