Nitrous oxide

Description

Nitrous Oxide USP is a colorless, non-flammable gas with a slightly sweet odor and taste. Its chemical name is nitrous oxide, and it has a CAS number of 10024-97-2.

Uses and Indications

Nitrous Oxide is indicated for use only by or under the supervision of a licensed practitioner who is experienced in its use and administration.

This product can expose individuals to chemicals, including Nitrous Oxide, which is known to the State of California to cause birth defects or other reproductive harm.

No specific nonteratogenic effects are mentioned in the available data.

Dosage and Administration

For respiratory administration via inhalation, this medication is to be utilized exclusively by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrous Oxide. It is imperative that the practitioner is well-versed in the indications, effects, dosages, methods, and frequency and duration of administration associated with this treatment.

Healthcare professionals should ensure that they are familiar with the appropriate dosing ranges and intervals specific to the patient's needs. Proper preparation and administration techniques must be adhered to in order to optimize therapeutic outcomes and minimize potential risks.

Contraindications

Use of this product is contraindicated in the following situations:

Handling of the product should not occur until all safety precautions have been thoroughly read and understood to prevent potential hazards. The valve must not be opened until it is securely connected to the appropriate equipment prepared for use, as improper handling may lead to malfunction or safety risks. Additionally, connections should not be changed or forced to fit, as this may compromise the integrity of the system. It is also contraindicated to walk on or roll equipment over spills, as this could result in accidents or further contamination.

Warnings and Precautions

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

Hazards and Risks Nitrous Oxide is classified as an oxidizer and may cause or intensify fire. It is stored under pressure and poses an explosion risk if subjected to heat. Users should be aware that exposure may lead to drowsiness or dizziness, and the gas can displace oxygen, resulting in rapid suffocation. Additionally, contact with the gas may cause frostbite.

Chemical Exposure Warning This product contains Nitrous Oxide, which is recognized by the State of California as a chemical that may cause birth defects or other reproductive harm.

General Precautions Prior to handling Nitrous Oxide, all safety precautions must be thoroughly read and understood. It is essential to store the gas away from clothing and other combustible materials, ensuring that valves and fittings remain free from grease and oil. Users should avoid inhaling the gas and prevent contact with eyes, skin, or clothing. Nitrous Oxide should only be used and stored outdoors or in well-ventilated areas. Protective gloves, clothing, and either eye or face protection are recommended during use.

In the event of a fire, efforts should be made to stop the leak if it is safe to do so. The gas should be stored securely and locked up when not in use. Disposal of the contents and container must adhere to the instructions provided by the container supplier or owner. A backflow preventive device should be utilized in the piping, and the valve should be closed after each use and when the cylinder is empty. Equipment used must be rated for cylinder pressure and compatible with the materials of construction. The valve should only be opened slowly and should not be opened until connected to equipment prepared for use. Equipment must be cleaned for oxygen service, and the gas should be protected from sunlight when ambient temperatures exceed 52°C (125°F). It is crucial to read and follow the Matheson Tri-Gas Safety Data Sheet (SDS) prior to use.

Emergency Medical Help Instructions In the event of inhalation, the affected individual should be removed to fresh air and kept comfortable for breathing. If the person feels unwell, it is essential to contact a poison center or a physician immediately.

Instructions for Skin Contact If Nitrous Oxide comes into contact with the skin, affected areas should be thawed with lukewarm water without rubbing. Immediate medical advice or attention should be sought.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious and common effects.

Serious adverse reactions may include cryogenic burns or injury, which can occur due to improper handling or exposure to extreme cold. Additionally, the product may displace oxygen in the environment, leading to rapid suffocation, a critical safety concern that necessitates careful monitoring of the surrounding atmosphere during use.

Common adverse reactions reported by participants include drowsiness and dizziness. These effects may impair the ability to perform tasks that require full alertness and coordination.

It is important to note that this product can expose users to chemicals such as Nitrous Oxide, which is recognized by the State of California as a substance that may cause birth defects or other reproductive harm. Users should take appropriate precautions to mitigate these risks.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Nitrous Oxide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Administration of Nitrous Oxide in pediatric patients may pose hazards and is contraindicated in certain situations. It should only be used by or under the supervision of a licensed practitioner experienced in its administration. This practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Healthcare professionals should be aware that exposure to Nitrous Oxide can lead to potential reproductive harm, including birth defects, as recognized by the State of California. Caution is advised when considering the use of this product in pediatric populations.

Geriatric Use

There is no specific information regarding the use of Nitrous Oxide in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this agent to elderly patients, as individual responses may vary. Monitoring for potential adverse effects is advisable, given the lack of targeted data for this population.

Pregnancy

This product can expose pregnant patients to chemicals, including Nitrous Oxide, which is known to the State of California to cause birth defects or other reproductive harm. Healthcare professionals should advise women of childbearing potential to consider the potential risks associated with exposure to this product during pregnancy. It is essential to weigh the benefits against the risks when prescribing this product to pregnant patients. For further information regarding the specific risks and safety measures, healthcare providers are encouraged to refer to the California Proposition 65 website at www.P65Warnings.ca.gov.

Lactation

Lactating mothers should be aware that this product can expose them to chemicals, including Nitrous Oxide, which is known to the State of California to cause birth defects or other reproductive harm. The potential risks associated with exposure to these chemicals during lactation should be considered when making decisions about the use of this product.

Healthcare professionals are advised to counsel lactating mothers on the importance of weighing the benefits and risks of using this product while breastfeeding. Further information can be found at www.P65Warnings.ca.gov.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert for Nitrous Oxide. Healthcare professionals should exercise caution and consider the lack of data when treating patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of Nitrous Oxide. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for this patient population. It is recommended that healthcare providers exercise clinical judgment when considering the use of Nitrous Oxide in patients with compromised liver function, given the absence of specific data.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

This product can expose individuals to chemicals, including Nitrous Oxide, which is recognized by the State of California as a substance that may cause birth defects or other reproductive harm. For further information, individuals are encouraged to visit www.P65Warnings.ca.gov.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are currently no additional adverse events or rare case reports available for review.

Patient Counseling

Healthcare providers should advise patients that the administration of Nitrous Oxide may pose hazards or be contraindicated. It is essential that this substance 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 must be instructed not to handle Nitrous Oxide until they have read and understood all safety precautions. It is crucial to keep and store the gas away from clothing and other combustible materials, ensuring that valves and fittings remain free from grease and oil. Patients should be cautioned to avoid breathing the gas and to prevent contact with eyes, skin, or clothing.

The use and storage of Nitrous Oxide should occur only outdoors or in a well-ventilated area. Protective gloves, clothing, and either eye or face protection should be worn during handling. In the event of a fire, patients should be advised to stop the leak if it is safe to do so and to store the gas in a locked location. Proper disposal of the contents and container should be conducted in accordance with the instructions provided by the container supplier or owner.

Patients should be informed about the importance of using a backflow preventive device in the piping and to close the valve after each use and when the cylinder is empty. They should only use equipment rated for cylinder pressure and ensure that the valve is not opened until it is connected to equipment prepared for use. It is also important to use equipment made of compatible materials of construction and to open the valve slowly. Equipment must be cleaned for oxygen service, and the gas should be protected from sunlight when the ambient temperature exceeds 52°C (125°F).

Patients should read and follow the Matheson Tri-Gas Safety Data Sheet (SDS) prior to use. In case of inhalation, they should be instructed to remove themselves to fresh air and remain comfortable for breathing, seeking medical attention if they feel unwell. If Nitrous Oxide comes into contact with the skin, patients should thaw any frosted areas with lukewarm water without rubbing the affected area and seek immediate medical advice or attention.

Finally, it is important to communicate the warning that this product can expose individuals to chemicals, including Nitrous Oxide, which is known to the State of California to cause birth defects or other reproductive harm. For further information, patients should be directed to visit www.P65Warnings.ca.gov.

Storage and Handling

The product is supplied in a secure manner and must be stored in a locked location, away from clothing and other combustible materials. It is essential to keep valves and fittings free from grease and oil to ensure safe handling. The product should only be used and stored outdoors or in a well-ventilated area to minimize risks associated with gas accumulation.

Protective gloves, clothing, and either eye or face protection must be worn during handling. It is crucial to dispose of the contents and container in accordance with the instructions provided by the container supplier or owner. A backflow preventive device should be utilized in the piping to prevent any potential hazards.

After each use and when the container is empty, the valve must be closed. The valve should not be opened until it is connected to equipment that is prepared for use. Only equipment rated for cylinder pressure should be employed, and the valve should be opened slowly to avoid sudden pressure release. Additionally, only equipment that has been cleaned for oxygen service should be used with this product.

When ambient temperatures exceed 52°C (125°F), the container must be protected from sunlight. It is imperative to always keep the container in an upright position and to avoid changing or forcing connections. Spills should be avoided, and personnel should not walk on or roll equipment over any spills that may occur.

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. Clinicians should counsel patients that the administration of Nitrous Oxide may pose hazards or be contraindicated. It is essential that this medication is used only by or under the supervision of a licensed practitioner who is experienced in its use. This practitioner should be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrous Oxide as submitted by Matheson Tri-Gas, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)