Nitrous oxide

Description

NITROUS OXIDE USP is a medical gas classified under SPL Code UN1070 and identified by CAS Number 10024-97-2. It is available by prescription only and is intended for administration by or under the supervision of a licensed practitioner experienced in its use. The administration of Nitrous Oxide may pose hazards or contraindications, necessitating familiarity with its indications, effects, dosages, methods, frequency, duration, and associated risks, including contraindications and side effects.

Nitrous Oxide is classified as an oxidizer and may cause or intensify fire. It is stored under pressure and may explode if heated. The gas can induce drowsiness or dizziness, displace oxygen, and lead to rapid suffocation. Frostbite may occur upon contact with the gas. Safety precautions must be thoroughly understood before handling, including the necessity to keep the gas away from combustible materials, ensure valves and fittings are free from grease and oil, and avoid inhalation or contact with skin and eyes. It is recommended to use and store the gas outdoors or in well-ventilated areas. In the event of a fire, stopping the leak is advised if safe to do so, and a backflow preventive device should be utilized in the piping. Equipment must be compatible with the gas and rated for cylinder pressure, and only equipment cleaned for oxygen service should be used. Valves should be opened slowly and closed after each use and when empty. Protection from sunlight is required when ambient temperatures exceed 52°C (125°F). Users should read and follow the Safety Data Sheet (SDS) prior to use.

The product is distributed by Linde Gas North America LLC, located at 200 Somerset Corporate Blvd., Suite 7000, Bridgewater, NJ 08807, with a contact number of 866.543.3427. The gas is available in various cylinder sizes, including Type K (13810 Liters), Type M (7386 Liters), Type E (1726 Liters), and Type D (991 Liters).

Uses and Indications

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

This product is known to expose individuals to nitrous oxide, which is recognized by the State of California as a substance that may cause birth defects or other reproductive harm.

Limitations of use include the necessity for administration by qualified personnel, ensuring that all safety protocols and guidelines are strictly followed to mitigate risks associated with its use.

Dosage and Administration

Administration of Nitrous Oxide is associated with potential hazards and contraindications. It is imperative that this agent is utilized solely by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrous Oxide. The practitioner must be well-versed in the indications, effects, dosages, methods, and frequency and duration of administration.

Nitrous Oxide is administered via the respiratory route through inhalation. The specific dosing regimen should be determined by the supervising practitioner based on individual patient needs and clinical circumstances. Careful monitoring of the patient during administration is essential to ensure safety and efficacy.

Contraindications

Administration of Nitrous Oxide is contraindicated in situations where safety precautions have not been fully understood or implemented. It should only be administered by or under the supervision of a licensed practitioner experienced in its use, who is knowledgeable about its indications, effects, dosages, methods, frequency, duration of administration, and associated hazards.

The following specific contraindications apply:

• Do not handle Nitrous Oxide until all safety precautions have been read and understood.

• Avoid inhalation of the gas.

• Prevent contact with eyes, skin, or clothing.

• Use and store Nitrous Oxide exclusively outdoors or in a well-ventilated area to mitigate risks associated with exposure.

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 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.

Hazards and Risks Nitrous Oxide is classified as a dangerous oxidizer that may cause or intensify fire. It is stored under pressure and can explode 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. Notably, this product is known to the State of California to potentially cause birth defects or other reproductive harm.

General Precautions Prior to handling Nitrous Oxide, it is essential that all safety precautions are thoroughly read and understood. The gas should be stored away from clothing and other combustible materials, and care must be taken to keep valves and fittings free from grease and oil. Users should avoid inhaling the gas and prevent contact with eyes, skin, or clothing. It is recommended to use and store Nitrous Oxide outdoors or in a well-ventilated area. In the event of a fire, efforts should be made to stop the leak if it is safe to do so. A backflow preventive device should be utilized in the piping, and only equipment compatible with the materials of construction and rated for cylinder pressure should be employed. Equipment must be cleaned for oxygen service prior to use. Valves should be opened slowly, closed after each use, and when empty. Protection from sunlight is necessary when ambient temperatures exceed 52°C (125°F). Users must read and adhere to the Safety Data Sheet (SDS) before use.

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

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

Administration of Nitrous Oxide may be associated with several adverse reactions, which can vary in seriousness and frequency.

Warnings The use of Nitrous Oxide is contraindicated in certain situations and should only be administered by or under the supervision of a licensed practitioner experienced in its use. It is crucial for practitioners to be familiar with the indications, effects, dosages, methods, frequency, duration of administration, and the associated hazards, contraindications, and side effects.

Nitrous Oxide is classified as an oxidizer and may cause or intensify fire. It is stored under pressure and can explode if heated. Patients may experience drowsiness or dizziness following administration. Additionally, Nitrous Oxide can displace oxygen, leading to rapid suffocation, and may cause frostbite upon contact with skin.

First Aid In the event of inhalation, it is advised to remove the individual to fresh air and ensure they are comfortable for breathing. If the person feels unwell, contacting a poison center or physician is recommended. For skin exposure, thaw any frosted areas with lukewarm water without rubbing the affected area, and seek immediate medical advice or attention.

Additional Adverse Reactions It is important to note that exposure to Nitrous Oxide is known to the State of California to cause birth defects or other reproductive harm. For further information, individuals are encouraged to visit www.P65Warnings.ca.gov.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

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 or be contraindicated. It is essential that it be used only by or under the supervision of a licensed practitioner experienced in the use and administration of Nitrous Oxide.

Healthcare professionals should be aware that exposure to nitrous oxide is associated with potential risks, including the possibility of birth defects or other reproductive harm, as noted 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 recommended age considerations, 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 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 this risk when evaluating the use of this product during pregnancy. It is essential to weigh the potential benefits against the known risks to fetal outcomes. For further information, healthcare providers can refer to www.P65Warnings.ca.gov.

Lactation

Lactating mothers should be aware that this product can expose them to nitrous oxide, a substance known to the State of California to cause birth defects or other reproductive harm. Due to the potential risks associated with nitrous oxide exposure, healthcare professionals are advised to consider the benefits and risks of using this product in lactating individuals. There is no specific data available regarding the excretion of nitrous oxide in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this product to lactating mothers.

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 drug 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 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, necessitating prompt recognition and intervention.

Potential Symptoms Healthcare professionals should be vigilant for symptoms indicative of overdosage, which may include drowsiness, dizziness, unconsciousness, and respiratory depression. The displacement of oxygen caused by excessive Nitrous Oxide exposure can result in rapid suffocation, further complicating the clinical picture.

Recommended Actions In the event of suspected overdosage, immediate medical attention is imperative. Healthcare providers should ensure that the patient is in a safe environment and monitor vital signs closely. Supportive care, including the administration of oxygen and respiratory support, may be necessary to manage the effects of overdosage effectively.

Timely intervention is crucial to mitigate the risks associated with Nitrous Oxide overdosage and to ensure patient safety.

Nonclinical Toxicology

This product has been associated with exposure to nitrous oxide, a substance recognized by the State of California as a potential cause of birth defects or other reproductive harm. Individuals are advised to seek further information regarding this warning at www.P65Warnings.ca.gov.

Postmarketing Experience

Postmarketing experience has identified adverse reactions associated with the use of Nitrous Oxide. Notably, exposure to Nitrous Oxide has been recognized by the State of California as potentially leading to birth defects or other reproductive harm. This information has been reported voluntarily and through surveillance programs.

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 is experienced in its use and administration. Patients should be informed that the practitioner must be familiar with the indications, effects, dosages, methods, frequency and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Patients should be made aware of the potential dangers associated with Nitrous Oxide, including its ability to cause or intensify fire, as it is an oxidizer. They should be cautioned that it contains gas under pressure, which may explode if heated, and that it can cause drowsiness or dizziness. Additionally, patients should understand that Nitrous Oxide may displace oxygen, leading to rapid suffocation, and can cause frostbite.

It is crucial for patients to read and understand all safety precautions before handling Nitrous Oxide. They should be instructed 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 avoid breathing the gas and should take care to prevent contact with eyes, skin, or clothing. Furthermore, they should only use and store Nitrous Oxide outdoors or in a well-ventilated area.

In the event of a fire, patients should be advised to stop the leak if it is safe to do so. They should use a backflow preventive device in the piping and ensure that they are using equipment made of compatible materials that are rated for cylinder pressure. It is important to use only equipment that has been cleaned for oxygen service and to open the valve slowly. Patients should also be reminded to close the valve after each use and when the cylinder is empty, and to protect the gas from sunlight when the ambient temperature exceeds 52°C (125°F).

Patients should be encouraged to read and follow the 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, and to contact a poison center or physician 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.

Lastly, healthcare providers should inform patients that this product can expose them to nitrous oxide, which is known to the State of California to cause birth defects or other reproductive harm. For further information, patients can visit www.P65Warnings.ca.gov. It is imperative that patients understand not to remove the label from the product.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available upon request. It is essential to store the product away from clothing and other combustible materials to ensure safety. Valves and fittings must be kept free from grease and oil to maintain integrity and functionality.

Storage should be conducted exclusively outdoors or in a well-ventilated area. When the ambient temperature exceeds 52°C (125°F), the product must be protected from direct sunlight to prevent degradation. Users are advised to open the valve slowly and to close it securely after each use and when the cylinder is empty.

It is crucial to utilize the product only with equipment that is constructed from compatible materials and rated for cylinder pressure. Additionally, all equipment must be cleaned for oxygen service to ensure safe operation. Prior to use, it is imperative to read and follow the Safety Data Sheet (SDS) for comprehensive safety and handling instructions.

Additional Clinical Information

The product is administered via the respiratory route through inhalation. Clinicians should counsel patients regarding the potential exposure to nitrous oxide, which is recognized by the State of California as a substance that may cause birth defects or other reproductive harm. For further details, patients are advised to visit www.P65Warnings.ca.gov. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

FDA Insert (PDF)

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

View full prescribing information (PDF)