Nitrous oxide

Description

Nitrous oxide, refrigerated liquid USP, is a non-flammable gas with the CAS number 10024-97-2. It is classified as an oxidizer with a designation of 5.1.

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 contain a chemical that the state of California recognizes as capable of causing birth defects or other reproductive harm. Therefore, practitioners should exercise caution and consider the potential teratogenic effects when administering Nitrous Oxide, particularly in pregnant patients or those planning to become pregnant.

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

Dosage and Administration

Administration of Nitrous Oxide is intended for respiratory inhalation only. It is crucial that this agent is administered exclusively 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.

Due to the potential hazards and contraindications associated with Nitrous Oxide, careful consideration must be given to the patient's condition and the clinical context prior to administration. Practitioners should ensure that they are familiar with the appropriate protocols and safety measures involved in the use of this anesthetic agent.

Contraindications

Administration of Nitrous Oxide is contraindicated in patients who are not under the supervision of a licensed practitioner experienced in its use. This is due to the potential hazards associated with its administration, including the need for familiarity with indications, effects, dosages, and precautions.

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

Inhalation of the gas is contraindicated; patients should not breathe the gas. Additionally, contact with eyes, skin, or clothing is contraindicated, and handling of the product should only occur after all safety precautions have been read and understood. Rubbing the affected area, if the product comes into contact with the skin, is also contraindicated.

Warnings and Precautions

Administration of Nitrous Oxide may pose significant risks and is contraindicated in certain situations. It is imperative that this product be used solely by or under the supervision of a licensed practitioner who possesses expertise in the use and administration of Nitrous Oxide. 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.

This product contains a chemical recognized by the state of California as capable of causing birth defects or other reproductive harm.

General Precautions DANGER: This product contains gas under pressure, which may explode if heated. It has the potential to displace oxygen, leading to rapid suffocation, and may cause or intensify fire as it acts as an oxidizer. Users should be aware that exposure may result in frostbite, drowsiness, or dizziness.

To ensure safe handling, it is crucial to avoid inhalation of the gas and to prevent contact with eyes, skin, or clothing. Valves and fittings must be kept free from grease and oil. Nitrous Oxide should only be used and stored outdoors or in a well-ventilated area, and it should be protected from sunlight when ambient temperatures exceed 52°C (125°F). Users should open the valve slowly and ensure it is closed after each use and when empty. A backflow preventive device should be utilized in the piping, and handling should not commence until all safety precautions have been thoroughly read and understood. Equipment used must be compatible with the materials of construction and rated for cylinder pressure, and it should be cleaned for oxygen service. Additionally, storage should be away from clothing and other combustible materials. In the event of a fire, efforts should be made to stop the leak if it is safe to do so. The product should be stored securely and locked up. It is essential to read and follow the Safety Data Sheet (SDS) prior to use.

Emergency Medical Help Instructions In the event of inhalation, the individual should be removed to fresh air and kept comfortable for breathing. Medical advice or attention should be sought immediately, and a poison center or physician should be contacted if the individual feels unwell.

Instructions for Skin Exposure If the product comes into contact with the skin, affected areas should be thawed with lukewarm water without rubbing. Immediate medical advice or attention is necessary in such cases.

Side Effects

Administration of Nitrous Oxide may be hazardous or contraindicated. It is intended for use only by or under the supervision of a licensed practitioner who is experienced in its use and administration. This practitioner should 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 may experience common adverse reactions such as drowsiness and dizziness. Additionally, there are important safety considerations associated with the use of Nitrous Oxide. The gas may cause frostbite if improperly handled. It has the potential to displace oxygen, leading to rapid suffocation, and it is also known to be an oxidizer that may intensify fire or explode if heated. Furthermore, it is important to note that this product contains a chemical known to the state of California to cause birth defects or other reproductive harm.

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

The administration of Nitrous Oxide in pediatric patients may pose hazards or be contraindicated. It is essential that Nitrous Oxide is used 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.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 informed of the potential risks associated with exposure to this product. Healthcare professionals are advised to weigh the benefits against the risks when considering the use of this product in women of childbearing potential. It is recommended that alternative therapies be considered for pregnant patients or those planning to become pregnant. Close monitoring and counseling regarding the potential fetal impacts should be provided to ensure informed decision-making.

Lactation

Lactating mothers should be aware that this product contains a chemical known to the state of California to cause birth defects or other reproductive harm. Due to the potential risks associated with this chemical, caution is advised when considering the use of this product during breastfeeding.

There is currently no available data on the excretion of this product in human breast milk or its effects on breastfed infants. Healthcare professionals should weigh the potential benefits against the risks when advising lactating mothers regarding the use of this product.

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 this medication. Consequently, there are no established 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. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not outlined in the prescribing information.

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 significantly 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 toxicology expert may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions thoroughly, as this information may be vital for ongoing patient management and for any necessary reporting to regulatory authorities.

Nonclinical Toxicology

This product contains a chemical known to the state of California to cause birth defects or other reproductive harm.

Postmarketing Experience

Administration of Nitrous Oxide may pose hazards or be contraindicated. It is recommended for use solely by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrous Oxide. Such practitioners 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.

Additionally, it is important to note that this product contains a chemical recognized by the state of California as a potential cause of birth defects or other reproductive harm.

Patient Counseling

Healthcare providers should advise patients to avoid inhaling gas and to prevent contact with eyes, skin, or clothing. It is essential to keep valves and fittings free from grease and oil. Patients should be instructed to use and store the product only outdoors or in a well-ventilated area, and to avoid spills. They should not walk or roll equipment over any spills that may occur.

Patients must be informed to open the valve slowly and to close it after each use and when the container is empty. The use of a backflow preventive device in the piping is recommended. It is crucial that patients do not handle the product until they have read and understood all safety precautions. They should wear appropriate protective gear, including cold insulating gloves, a face shield, and eye protection.

Patients should be cautioned against dropping the container and should use a suitable hand truck for moving it. The container should always be kept in an upright position, and patients must not change or force fit connections. They should only use the product with equipment that has been cleaned for oxygen service and should store it away from clothing and other combustible materials.

In the event of a fire, patients should be instructed to stop the leak if it is safe to do so. The product should be stored in a locked area. Patients must read and follow the Safety Data Sheet (SDS) before use.

In terms of first aid, if the gas is inhaled, patients should be removed to fresh air and kept comfortable for breathing, and they should seek medical advice or attention. If the product comes into contact with skin, patients should thaw any frosted areas with lukewarm water without rubbing the affected area and should call a poison center or physician if they feel unwell.

Healthcare providers should emphasize that the administration of Nitrous Oxide may be hazardous or contraindicated and is to be used only by or under the supervision of a licensed practitioner experienced in its use. They should also 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 use and store the product exclusively outdoors or in a well-ventilated area. The container must be protected from sunlight when the ambient temperature exceeds 52°C (125°F).

Users should open the valve slowly and ensure it is closed after each use and when empty. A backflow preventive device must be utilized in the piping to maintain safety. Prior to handling, all safety precautions must be read and understood. The product should only be used with equipment made of compatible materials of construction and rated for cylinder pressure, as well as equipment that has been cleaned for oxygen service.

It is critical to keep the product away from clothing and other combustible materials, and it should be stored in a locked location. The container must always be kept in an upright position and should not be dropped. For movement, a suitable hand truck should be employed to prevent damage. Users are advised to read and follow the Safety Data Sheet (SDS) before use to ensure comprehensive understanding of safety measures.

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. Clinicians should be aware 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 has experience with Nitrous Oxide. 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.

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 AIRGAS USA, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)