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 in medical settings under the supervision of a licensed practitioner experienced in its administration.

This product contains a chemical known to the state of California to cause birth defects or other reproductive harm. Therefore, caution is advised when considering its use in pregnant individuals or those planning to become pregnant.

No specific nonteratogenic effects have been identified in the available data.

Dosage and Administration

Administration of Nitrous Oxide should be conducted exclusively by or under the supervision of a licensed practitioner who possesses experience in its use and administration. Practitioners must be well-versed in the indications, effects, dosages, methods, frequency, and duration of administration to ensure safe and effective use.

Nitrous Oxide is administered via the respiratory route through inhalation. The active ingredient is contained in a concentration of 990 mL per 1 L. It is available in a variety of cylinder sizes to accommodate different clinical needs, including but not limited to:

• 29.03 L

• 3.04 L

• 185 L

• 370 L

• 940 L

• 1225 L

• 1590 L

• 2466 L

• 4930 L

• 7570 L

• 8524 L

• 12300 L

• 13800 L

• 15800 L

• 18578 L

• 95155 L

Healthcare professionals must ensure that they are familiar with the specific cylinder size being utilized, as well as the appropriate techniques for administration to optimize patient safety and therapeutic outcomes.

Contraindications

Administration of Nitrous Oxide is contraindicated in the following situations:

• Use is restricted to licensed practitioners experienced in its administration, who are knowledgeable about its indications, effects, dosages, methods, frequency, duration, hazards, contraindications, side effects, and necessary precautions.

• Handling of Nitrous Oxide should not occur until all safety precautions have been thoroughly read and understood.

• Direct contact with eyes, skin, or clothing must be avoided.

• The valve should not be opened until it is securely connected to the appropriate equipment prepared for use.

Warnings and Precautions

This product contains a chemical recognized by the state of California as a potential cause of birth defects or other reproductive harm. The administration of Nitrous Oxide may pose hazards or be contraindicated; therefore, it should only be used 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, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Hazardous Properties Nitrous Oxide is classified as a DANGER due to its potential to cause or intensify fire, as it is an oxidizer. It contains gas under pressure, which may lead to explosion if heated. Users should be aware that exposure may result in drowsiness or dizziness, and the gas can displace oxygen, leading to rapid suffocation. Additionally, contact with the gas may cause frostbite.

General Precautions Prior to handling this product, it is imperative that all safety precautions are thoroughly read and understood. The product should be stored away from clothing and other combustible materials, and valves and fittings must be kept 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 the product only outdoors or in a well-ventilated area. Protective gloves, clothing, and either eye or face protection should be worn at all times.

In the event of a fire, efforts should be made to stop the leak if it is safe to do so. The product must be stored securely and locked up when not in use. Disposal of the contents or container should be conducted in accordance with 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 rated for cylinder pressure must be used, and the valve should not be opened until it is connected to the appropriate equipment. Only equipment made from compatible materials of construction should be employed, and the valve should be opened slowly. Equipment must be cleaned for oxygen service, and the product should be protected from sunlight when ambient temperatures exceed 52°C (125°F). Users are advised to read and follow the Safety Data Sheet (SDS) prior to use.

Emergency Medical Help In case of feeling unwell, it is crucial to contact a POISON CENTER or a physician immediately.

Medical Attention Instructions If the product comes into contact with skin, immediate medical advice should be sought. Affected areas should be thawed with lukewarm water, and rubbing the area should be avoided.

Side Effects

Administration of Nitrous Oxide may be hazardous or contraindicated and should only be performed by or under the supervision of a licensed practitioner experienced in its use. This 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.

Common adverse reactions observed in patients include drowsiness and dizziness, which may occur following administration. Additionally, there is a risk of oxygen displacement, potentially leading to rapid suffocation. Patients may also experience frostbite due to the properties of the gas.

It is important to note that Nitrous Oxide contains a chemical recognized by the state of California as capable of causing birth defects or other reproductive harm. Therefore, caution is advised in populations that may be affected by these risks.

Furthermore, it is critical to acknowledge that Nitrous Oxide is an oxidizer and may cause or intensify fire. The gas is stored under pressure and poses an explosion risk if heated.

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 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 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

This product contains a chemical known to the state of California to cause birth defects or other reproductive harm. Pregnant patients should be made aware of the potential risks associated with exposure to this product. Additionally, this product can expose individuals to chemicals, including Nitrous Oxide, which is also recognized by the state of California as a substance that may cause birth defects or other reproductive harm.

Healthcare professionals are advised to counsel women of childbearing potential regarding these risks and to consider alternative therapies when appropriate. It is essential to weigh the benefits against the potential risks when prescribing this product to pregnant patients or those planning to become pregnant.

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 carefully considered. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Therefore, healthcare professionals are advised to weigh the benefits of treatment against the potential risks when considering the use of this product in 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 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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate any necessary follow-up.

Nonclinical Toxicology

This product contains a chemical known to the state of California to cause birth defects or other reproductive harm. Additionally, it can expose individuals to chemicals such as Nitrous Oxide, which is also recognized by the state of California as a substance that may lead to birth defects or other reproductive harm.

Postmarketing Experience

The product has been associated with warnings regarding potential reproductive harm. Specifically, it contains a chemical recognized by the state of California as capable of causing birth defects or other reproductive harm. Additionally, exposure to Nitrous Oxide, also identified by the state of California, may pose similar risks. For further information, individuals are directed to visit www.p65Warnings.ca.gov.

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 the risk of drowsiness or dizziness, the possibility of oxygen displacement leading to rapid suffocation, and the risk of frostbite. It is crucial that patients do not handle Nitrous Oxide until they have read and understood all safety precautions.

Providers should instruct patients to keep and store Nitrous Oxide 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. It is recommended that Nitrous Oxide be used and stored 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. Nitrous Oxide should be stored securely and disposed of in accordance with the instructions provided by the container supplier or owner. A backflow preventive device should be used in the piping, and the valve should be closed after each use and when empty. Patients should only use equipment rated for cylinder pressure and should not open the valve until it is connected to the prepared equipment. It is important to use equipment made of compatible materials and to open the valve slowly. Equipment must be cleaned for oxygen service, and Nitrous Oxide should be protected from sunlight when the ambient temperature exceeds 52°C (125°F).

Patients should be encouraged to read and follow the Safety Data Sheet (SDS) before 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 the affected area with lukewarm water without rubbing and seek immediate medical advice or attention.

Finally, healthcare providers should inform patients that this product contains a chemical known to the state of California to cause birth defects or other reproductive harm.

Storage and Handling

The product is supplied in a manner that ensures safe handling and storage. It is essential to keep the product away from clothing and other combustible materials. Valves and fittings must be maintained free from grease and oil to prevent any hazards. The product should only be used and stored outdoors or in a well-ventilated area to minimize risks associated with gas accumulation.

For safety, the product must be stored in a locked location. Disposal of the contents and container should be conducted in accordance with the instructions provided by the container supplier or owner. When ambient temperatures exceed 52°C (125°F), it is crucial to protect the product from direct sunlight to prevent degradation or potential hazards.

After each use and when the product is empty, the valve should be closed to ensure safety. The valve must not be opened until it is connected to equipment that is prepared for use. It is important to use the product only with equipment that is rated for cylinder pressure and constructed from compatible materials. When opening the valve, it should be done slowly to avoid sudden release of gas. Additionally, the product should only be used with equipment that has been cleaned for oxygen service to ensure safe operation.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

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

View full prescribing information (PDF)