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Nitrogen

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Active ingredient
Nitrogen 99 L/100 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 2017
Label revision date
October 27, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Nitrogen 99 L/100 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 2017
Label revision date
October 27, 2024
Manufacturer
Ineos Pigments ASU LLC
Registration number
NDA211737
NDC root
71408-003
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 is a colorless, odorless gas that is essential for various applications, including medical and industrial uses. It is known for its high purity, with a post-fill purity level of 99.99%, making it suitable for environments where contamination must be minimized. Nitrogen is often used in laboratories and medical settings to create inert atmospheres, preserve samples, and support various processes that require a stable, non-reactive environment.

In terms of its properties, nitrogen is tested to ensure it meets strict specifications, including low levels of oxygen, carbon monoxide, and water vapor, which helps guarantee its quality and safety for use.

Uses

It appears that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, please consult your healthcare provider for personalized advice.

Dosage and Administration

When using this medication, you will be administering it through your respiratory system, which means you will inhale it. The active ingredient in this medication is nitrogen, making up 99% of the mixture you will be using.

It's important to follow the instructions provided by your healthcare provider regarding how to properly inhale the medication to ensure you receive the correct dosage. Always make sure to use the medication as directed for the best results.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or risks when using it. Always remember to follow your healthcare provider's guidance for the best outcomes.

Side Effects

There are no known side effects or adverse reactions associated with nitrogen gas. The information available does not indicate any risks or negative effects related to its use. If you have any concerns or experience unusual symptoms, it's always best to consult with a healthcare professional for guidance.

Warnings and Precautions

You can feel reassured that there are no specific warnings or precautions associated with this medication. It is also important to note that no laboratory tests are required for safe use, which simplifies your experience.

If you ever feel uncertain or have questions about your health while using this medication, it’s always a good idea to reach out to your healthcare provider for guidance. Your well-being is important, and they can provide the support you need.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel concerned, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the situation, including what substance was taken and how much. Remember, acting quickly can make a significant difference in ensuring your safety and well-being.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits of using this medication while pregnant are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for your health and the health of 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 gas while nursing. Additionally, there are no particular considerations or precautions related to lactation mentioned. This means that, based on the available information, you can use nitrogen gas without concern for its effects on your milk production or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that the safety and effectiveness of the drug for pediatric patients (children and adolescents) have not been established. If you are considering this medication for a child, it is important to consult with a healthcare professional to discuss any potential risks and to explore alternative options that may be more suitable for younger patients. Always prioritize your child's health and well-being by seeking expert advice.

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.

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 need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or share concerns during your appointments.

Storage and Handling

To ensure the safety and effectiveness of the product, store it in a well-ventilated area and keep the container tightly closed to prevent contamination. It's important to protect the container from physical damage and avoid exposing it to heat, flames, or sparks, as these can compromise the product's integrity.

When handling the product, always use appropriate safety equipment to protect yourself. Additionally, make sure to dispose of any unused or expired materials according to your local regulations to ensure safe and responsible waste management.

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 experiences reported after the medication has been on the market.

FAQ

What is the active ingredient in Nitrogen?

The active ingredient in Nitrogen is 99% Nitrogen in a 100 L container.

How is Nitrogen administered?

Nitrogen is administered via respiratory inhalation.

What are the purity levels of Nitrogen?

The purity post-fill of Nitrogen is 99.99%, with O2 levels at <=2.0 ppm/V, CO at <=5.0 ppm/V, and H2O at <=2.0 ppm/V.

Are there any contraindications for using Nitrogen?

No contraindications are listed for the use of Nitrogen.

What precautions should I take when handling Nitrogen?

Store Nitrogen in a well-ventilated area, keep the container tightly closed, protect it from physical damage, and avoid exposure to heat, flames, or sparks.

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

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

What should I do in case of an emergency while using Nitrogen?

No specific instructions for emergency medical help are provided in the text.

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 gaseous product produced by Air Liquefaction, identified by lot number 4004N17360050000. The substance exhibits a high purity level, with a post-fill purity of 99.99%. The concentration of oxygen (O2) is maintained at or below 2.0 parts per million (ppm), while carbon monoxide (CO) and water (H2O) levels are kept at or below 5.0 ppm and 2.0 ppm, respectively. Nitrogen is characterized by the absence of odor.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the overall clinical context when prescribing this medication.

Dosage and Administration

The active ingredient, nitrogen, is administered via the respiratory route through inhalation. The concentration of nitrogen is 99 liters in a total volume of 100 liters.

Healthcare professionals should ensure that the inhalation device is properly prepared and functioning before administration. The dosage may vary based on the specific clinical scenario and patient needs. It is essential to monitor the patient’s response to the treatment and adjust the dosage accordingly, adhering to established clinical guidelines and protocols.

Inhalation should be performed in a controlled environment, ensuring that the patient is comfortable and able to follow the inhalation technique as instructed. Regular assessment of the patient's respiratory status is recommended to evaluate the effectiveness of the therapy and to make any necessary adjustments to the administration regimen.

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

There are currently no specific warnings or general precautions associated with the use of this medication. Additionally, no laboratory tests are required or suggested for safe use. Healthcare professionals should remain vigilant and monitor patients as necessary, although no specific monitoring parameters have been outlined.

In the absence of detailed instructions regarding emergency medical assistance or recommendations to discontinue use and consult a physician, it is advisable for healthcare providers to exercise clinical judgment and consider individual patient circumstances when prescribing this medication.

Side Effects

The evaluation of nitrogen gas in clinical settings has not identified any adverse reactions associated with its use. Clinical trials and postmarketing experiences have not reported any side effects or adverse reactions related to nitrogen gas. As such, patients and healthcare providers can consider the absence of documented adverse reactions when assessing the safety profile of nitrogen gas.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the provided data. Therefore, no specific recommendations for dosage adjustments or monitoring 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

No pediatric use information is provided in the insert. Therefore, the safety and efficacy of this medication in pediatric patients have not been established. Healthcare professionals should exercise caution when considering this treatment for children, infants, or adolescents, as there are no available data to guide dosing or therapeutic outcomes in these populations.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There are no specific warnings or recommendations regarding the use of nitrogen gas in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of nitrogen gas in nursing mothers without specific concerns for breastfed infants.

Renal Impairment

There is no specific information 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 is no information available regarding 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.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures based on the clinical presentation of the patient.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Patients should be informed that nitrogen is a colorless, odorless gas utilized for respiratory inhalation. Healthcare providers should emphasize the importance of having the North American Emergency Response Guide or a Material Safety Data Sheet (MSDS) readily available when receiving this product, as it contains critical safety information.

It is essential for patients to understand the proper administration route, which is through inhalation. Providers should ensure that patients are aware of the product's purity and specifications, confirming that it meets the required standards for safety and efficacy. This understanding is crucial for the safe and effective use of nitrogen in their treatment.

Storage and Handling

The product is supplied in a well-ventilated area, ensuring that the container remains tightly closed to maintain integrity. It is essential to protect the product from physical damage and to avoid exposure to heat, flames, or sparks during storage and handling. Appropriate safety equipment should be utilized when handling the product to ensure safety. Disposal must be conducted in accordance with local regulations to comply with environmental standards.

Additional Clinical Information

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

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by Ineos Pigments ASU LLC. 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 (NDA211737) 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.