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Nitrous oxide

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This product has been discontinued

Active ingredient
Nitrous Oxide 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 2017
Label revision date
November 9, 2021
FDA Insert
Prescribing information, PDF file
Active ingredient
Nitrous Oxide 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 2017
Label revision date
November 9, 2021
Manufacturer
Praxair Mexico, S. de R. L. de C. V
Registration number
NDA210235
NDC root
72223-001
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

Nitrous Oxide USP Medical Gas is a medicinal gas that is primarily used for its anesthetic and analgesic (pain-relieving) properties. It is commonly utilized in medical settings to help manage pain and anxiety during procedures. This gas meets strict purity standards, ensuring that it contains at least 99.0% nitrous oxide, making it safe and effective for medical use.

While the specific mechanism of action is not detailed, nitrous oxide is known to work by affecting the central nervous system, providing sedation and pain relief. It is important to use this gas under the supervision of a qualified healthcare professional to ensure safety and effectiveness during medical procedures.

Uses

Nitrous Oxide USP Medical Gas is primarily used as a medicinal gas. This means it can be utilized in various medical settings to help with procedures or treatments. It's important to note that there are no specific teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects mentioned, indicating that it has not been associated with these types of risks in the available information. Always consult with your healthcare provider for more details on how this gas may be used in your specific situation.

Dosage and Administration

When using this medication, you will be inhaling nitrous oxide gas, which is a common method for delivering this treatment. The nitrous oxide comes in a strength of 990 mL in a 1-liter container, ensuring you receive the correct dosage.

To use it, simply inhale the gas as directed by your healthcare provider. This method allows the medication to work quickly and effectively. Make sure to follow your provider's instructions on how often to use it to ensure the best results for your health.

What to Avoid

It seems that the information regarding what to avoid while using this medication is not specified in the provided text. Therefore, I recommend consulting your healthcare provider or the medication's official guidelines for detailed information on contraindications, controlled substance classification, risks of abuse or misuse, dependence concerns, and specific instructions on when not to take or use the medication. Your safety and well-being are important, so please ensure you have all the necessary information before proceeding.

Side Effects

You may experience some common side effects, including dizziness, nausea, vomiting, headache, and fatigue. While these are generally mild, it's important to be aware of more serious reactions that can occur, such as hypoxia (low oxygen levels), respiratory depression (slowed breathing), cardiac arrest, and neurological effects like peripheral neuropathy (nerve damage).

There is also a risk of severe allergic reactions, including anaphylaxis (a life-threatening allergic response), angioedema (swelling beneath the skin), and urticaria (hives). Additionally, reports have indicated potential issues like abuse and dependence, increased intracranial pressure, spontaneous abortion, and malignant hyperthermia (a severe reaction to certain drugs). If you have a history of substance abuse, use this medication with caution, and be sure to monitor for any signs of respiratory depression or hypoxia during use. Long-term exposure may lead to vitamin B12 deficiency, which can also cause neurological effects.

Warnings and Precautions

While there are no specific warnings or precautions associated with this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or have concerns while using this medication, it's a good idea to consult your doctor for guidance.

Currently, there are no laboratory tests required for safe use of this medication, which simplifies your experience. However, if you ever feel uncertain or have questions about your treatment, don't hesitate to reach out to your healthcare provider for support.

Overdose

Using nitrous oxide in excessive amounts can lead to a serious condition called hypoxia, which means your body isn't getting enough oxygen. This can result in unconsciousness or even death. If you experience symptoms like dizziness, lightheadedness, or loss of coordination after using nitrous oxide, it’s important to seek immediate medical help.

In the case of an overdose, medical professionals will provide supportive care and monitor your vital signs to ensure your safety. Always remember that if you suspect an overdose, getting help right away is crucial.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that nitrous oxide is not recommended for use during this time. This is because there is a potential risk to the fetus (the developing baby) associated with its use. To ensure the safety of both you and your baby, it's best to avoid nitrous oxide while pregnant. Always consult with your healthcare provider for guidance on safe options for pain management or any medical procedures during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's reassuring to know that there are no specific warnings or considerations regarding the use of Nitrous Oxide for nursing mothers in the available information. This means that, based on current guidelines, you can use this medication without special precautions related to breastfeeding.

However, it's always a good idea to discuss any medications with your healthcare provider to ensure they are safe for you and your baby.

Pediatric Use

Currently, there is no specific information available regarding the use of Nitrous Oxide in children. This means that there are no recommended ages, dosage differences, or safety concerns outlined for pediatric use. If you are considering this treatment for a child, it is important to consult with a healthcare professional to discuss any potential risks and to ensure the best care for your child.

Geriatric Use

When it comes to using this medication in older adults, the information provided does not specifically address any unique considerations. This means there are no recommended age-related guidelines, dosage adjustments, or safety precautions outlined for elderly patients.

If you are caring for an older adult, it’s important to consult with a healthcare professional for personalized advice, as they can provide guidance tailored to individual health needs and circumstances. Always prioritize open communication with your healthcare provider to ensure safe and effective use of any medication.

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 is no specific information available regarding dosage adjustments, special monitoring, or precautions for using Nitrous Oxide. This means that the drug insert does not provide guidelines tailored for individuals with hepatic impairment (liver issues).

Before using Nitrous Oxide, you should discuss your liver condition with your healthcare provider to ensure it is safe for you. They can help determine the best approach based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions to be concerned about. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place away from direct light. It's important to keep the container upright and avoid freezing, as extreme temperatures can affect its effectiveness. By following these simple storage guidelines, you can help maintain the quality and safety of the product for your use.

Additional Information

The laboratory tests for this product confirm its high purity and safety. The nitrous oxide purity is at 99.84%, well above the minimum requirement of 99.0%. Other gases, such as carbon monoxide, carbon dioxide, nitric oxide, nitrogen dioxide, ammonia, and halogens, were all found to be below their maximum allowable levels, ensuring the product is safe for use. Additionally, moisture levels were also within safe limits.

This product is administered through inhalation, meaning you will breathe it in. If you have any questions about its use or safety, be sure to consult with your healthcare provider.

FAQ

What is Nitrous Oxide USP Medical Gas?

Nitrous Oxide USP Medical Gas is a medicinal gas used for various medical purposes.

What is the purity of Nitrous Oxide?

The purity of Nitrous Oxide is a minimum of 99.0 cmol/mol, with test results showing 99.84 cmol/mol.

How is Nitrous Oxide administered?

Nitrous Oxide is administered via respiratory inhalation.

What are common adverse reactions to Nitrous Oxide?

Common adverse reactions include dizziness, nausea, vomiting, headache, and fatigue.

What serious adverse reactions can occur with Nitrous Oxide?

Serious adverse reactions may include hypoxia, respiratory depression, cardiac arrest, and neurological effects.

Is Nitrous Oxide safe to use during pregnancy?

Nitrous Oxide is contraindicated in pregnancy due to potential risks to the fetus.

What should I do if I experience an allergic reaction to Nitrous Oxide?

Seek immediate medical attention if you experience symptoms of an allergic reaction, such as anaphylaxis, angioedema, or urticaria.

How should Nitrous Oxide be stored?

Store Nitrous Oxide in a cool, dry place, protect it from light, do not freeze, and keep the container upright.

Are there any contraindications for using Nitrous Oxide?

Specific contraindications are not mentioned in the provided text.

What is the expiration date for Nitrous Oxide?

The expiration date for Nitrous Oxide is March 23, 2020.

Packaging Info

The table below lists all NDC Code configurations of Nitrous Oxide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nitrous Oxide.
Details

FDA Insert (PDF)

This is the full prescribing document for Nitrous Oxide, 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

Nitrous Oxide USP Medical Gas is a medicinal gas with a minimum purity of 99.0 cmol/mol. The product is compliant with the standards set forth in the United States Pharmacopeia 39th edition (2016) and the Mexican United States Pharmacopeia 11th edition (2014), as well as the specifications of Praxair Mexico, S. de R.L. de C.V. and Praxair Distribution, Inc.

The expiration date for this product is March 23, 2020, and it is identified by the DUNS number 8129539029 and the FDA Establishment Identifier 3012518051. The batch number is TCM-N20-MED-002-18.

Component specifications include the following results from various test procedures: Nitrous Oxide purity was measured at 99.84 cmol/mol using gas chromatography. Carbon Monoxide levels were found to be less than 5 µmol/mol, Carbon Dioxide levels were less than 300 µmol/mol, and Nitric Oxide levels were less than 1.0 µmol/mol, all determined by detector tube methods. Nitrogen Dioxide and Ammonia levels were also below their respective maximums of 1.0 µmol/mol and 25.0 µmol/mol. Halogens, specifically Chlorine, were measured at less than 1.0 µmol/mol, and moisture content was found to be less than 100 ppm. Air contamination was measured at 0.16 cmol/mol, and the identity of the gas was confirmed as positive through gas chromatography.

Uses and Indications

Nitrous Oxide USP Medical Gas is indicated for use as a medicinal gas in various medical settings.

There are no specific teratogenic or nonteratogenic effects associated with the use of this gas.

Dosage and Administration

Nitrous oxide is administered via inhalation as a respiratory route. The active ingredient is provided in a concentration of 990 mL per 1 L.

Healthcare professionals should ensure that the nitrous oxide is delivered using appropriate inhalation techniques to achieve the desired therapeutic effect. The administration should be performed in a controlled environment, with monitoring of the patient’s response throughout the procedure.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment when considering its use in patients with specific health conditions or circumstances that may not be explicitly outlined.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals should be aware that no laboratory tests are required or suggested for safe use. Additionally, there are no instructions regarding the need for emergency medical assistance or recommendations to discontinue use and consult a physician. It is essential for healthcare providers to remain vigilant and monitor patients for any unforeseen reactions or complications, even in the absence of documented warnings or precautions.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Common adverse reactions reported include dizziness, nausea, vomiting, headache, and fatigue. These reactions are generally mild and may resolve with continued use or upon discontinuation of the medication.

Serious adverse reactions, although less common, can occur and include hypoxia, respiratory depression, cardiac arrest, and neurological effects such as peripheral neuropathy. It is crucial for healthcare providers to monitor patients for signs of respiratory depression and hypoxia during administration, particularly in those with a history of substance abuse, as there is a risk of hypoxia if the medication is used inappropriately.

Allergic reactions have also been documented, with rare cases of severe reactions such as anaphylaxis, angioedema, and urticaria. Patients should be advised to seek immediate medical attention if they experience symptoms indicative of an allergic reaction.

Postmarketing experience has revealed additional concerns, including reports of abuse and dependence, increased intracranial pressure, spontaneous abortion, and malignant hyperthermia. Long-term exposure to the medication may lead to vitamin B12 deficiency and associated neurological effects, necessitating careful monitoring of patients over extended treatment periods.

Given the potential for serious adverse reactions and the risk of abuse and dependence, it is recommended that this medication be used with caution, particularly in patients with a history of substance abuse.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no 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 Nitrous Oxide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nitrous Oxide.
Details

Pediatric Use

Pediatric use of Nitrous Oxide has not been specifically addressed in the available data. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for children provided in the prescribing information. Therefore, healthcare professionals should exercise caution when considering the use of Nitrous Oxide in pediatric patients, as the efficacy and safety profile in this population remain undefined.

Geriatric Use

Geriatric patients have not been specifically addressed in the provided text. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as their response to treatment may differ from that of younger populations. Monitoring for efficacy and safety is advised in this demographic.

Pregnancy

Nitrous oxide is contraindicated in pregnancy due to the potential risk to the fetus associated with its use. Healthcare professionals should be aware that administering nitrous oxide to pregnant patients may pose significant risks, and alternative analgesic options should be considered to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or considerations regarding the use of Nitrous Oxide in lactating mothers or its effects on breastfed infants. Current data does not indicate any known risks associated with the excretion of Nitrous Oxide in breast milk. Therefore, healthcare professionals may consider the use of Nitrous Oxide in lactating mothers without additional precautions.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of Nitrous Oxide. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for this patient population. It is recommended that healthcare providers exercise caution and consider the overall clinical context when administering Nitrous Oxide to patients with compromised liver function.

Overdosage

Overdosage of nitrous oxide can lead to significant health risks, primarily hypoxia, which may result in unconsciousness or even death. Healthcare professionals should be vigilant in recognizing the symptoms associated with overdosage, which may manifest as dizziness, lightheadedness, and loss of coordination.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Prompt intervention is crucial to mitigate the potential consequences of hypoxia.

Management of nitrous oxide overdosage should focus on supportive measures. Continuous monitoring of vital signs is essential to assess the patient's condition and guide further treatment. Ensuring adequate oxygenation and addressing any respiratory distress are key components of effective management in these cases.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, adverse developmental outcomes were not noted in these studies.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should inform patients that the information provided has been prepared by expert personnel of Praxair Mexico for orientation purposes. It is essential to emphasize that while the suggested analytic techniques have demonstrated high dependability in their results, the responsibility for the use of this information lies solely with the patient.

Providers should also advise patients that this report is proprietary and cannot be reproduced without prior authorization from the Laboratory of Control of Quality of Product of Praxair Mexico, S. de R.L. de C.V., located in Toluca Plants. It is important for patients to understand the implications of this restriction and to seek guidance if they have any questions regarding the use of the information provided.

Storage and Handling

The product is supplied in a container that must be kept upright to ensure integrity. It should be stored in a cool, dry place, away from direct light exposure. Freezing is not permitted, as it may compromise the product's quality. Proper handling and storage conditions are essential to maintain the efficacy and safety of the product.

Additional Clinical Information

Laboratory tests for the product indicate that nitrous oxide purity is a minimum of 99.0 cmol/mol, with a test result of 99.84 cmol/mol obtained via gas chromatography. Other measured gases include carbon monoxide (max. 5.0 µmol/mol, result < 5 µmol/mol), carbon dioxide (max. 300.0 µmol/mol, result < 300 µmol/mol), nitric oxide (max. 1.0 µmol/mol, result < 1 µmol/mol), nitrogen dioxide (max. 1.0 µmol/mol, result < 1 µmol/mol), ammonia (max. 25.0 µmol/mol, result < 25 µmol/mol), and halogens (chlorine, max. 1.0 µmol/mol, result < 1 µmol/mol). Moisture levels are capped at 100.0 ppm, with results showing < 100 ppm. Capacitance air is measured with a maximum of 1.0 cmol/mol, yielding a result of 0.16 cmol/mol. The identity of the substance is confirmed as positive through gas chromatography.

The product is administered via respiratory inhalation. There is no additional information available regarding abuse potential, patient counseling, or postmarketing experience.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrous Oxide as submitted by Praxair Mexico, S. de R. L. de C. V. 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 Nitrous Oxide, 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 (NDA210235) 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.