Nitrous oxide

Description

Nitrous Oxide USP is a colorless, non-flammable gas with a slightly sweet odor and taste, classified as an oxidizer (5.1). It is identified by the Chemical Abstracts Service (CAS) number 10024-97-2. This product is supplied in high-pressure cylinders and is intended for use only under the supervision of a licensed practitioner experienced in its administration.

The administration of Nitrous Oxide may pose hazards or contraindications, and it is essential that practitioners are familiar with its indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Caution is advised as Nitrous Oxide is a high-pressure oxidizing liquid and gas that vigorously accelerates combustion, can cause rapid suffocation, and may induce anesthetic effects. It can also lead to frostbite if mishandled. Proper ventilation is required during use, and it is critical to keep oil and grease away from the gas. Equipment must be cleaned for oxygen and rated for cylinder pressure. The cylinder temperature should not exceed 52°C (125°F), and valves should be opened slowly and closed after each use.

In case of inhalation, the individual should be removed to fresh air, and if not breathing, artificial respiration should be administered. If breathing is difficult, oxygen should be provided, and a physician should be contacted. In the event of frostbite, immediate medical treatment is necessary.

This product is labeled with a warning indicating that it contains a chemical known to the state of California to cause birth defects and other reproductive harm. The product is distributed by Airgas Puritan Medical, Airgas NCN, Inc., Sacramento, CA 95828.

Uses and Indications

This drug is indicated for use in medical settings where Nitrous Oxide is deemed appropriate for analgesia and sedation. Administration of Nitrous Oxide may be hazardous or contraindicated in certain situations. It is intended for use only by or under the supervision of a licensed practitioner who possesses experience in the administration of Nitrous Oxide. The 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.

Limitations of use include the acknowledgment that this product contains a chemical known to the state of California to cause birth defects and other reproductive harm. Therefore, practitioners should exercise caution and consider potential risks when administering this drug, particularly in pregnant individuals or those planning to become pregnant.

Dosage and Administration

Nitrous Oxide is administered via the respiratory route through inhalation. The active ingredient is provided in a concentration of 992 mL per 1 L.

Administration of Nitrous Oxide should only be conducted by or under the supervision of a licensed practitioner who possesses experience in its use. It is essential that the practitioner is knowledgeable about the indications, effects, dosages, methods, and frequency and duration of administration. Due to potential hazards or contraindications associated with its use, careful consideration and adherence to established protocols are imperative.

Contraindications

Administration of Nitrous Oxide is contraindicated in situations where its use may pose a hazard to the patient. It is essential that Nitrous Oxide is administered only by or under the supervision of a licensed practitioner who possesses experience 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.

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 experience in the administration of Nitrous Oxide. The 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.

Warnings

This product contains a chemical recognized by the state of California as a potential cause of birth defects and other reproductive harm.

General Precautions

Nitrous Oxide is classified as a high-pressure oxidizing liquid and gas, which vigorously accelerates combustion. It poses risks of rapid suffocation and can induce anesthetic effects. Additionally, exposure may lead to frostbite. Healthcare professionals are advised to avoid inhalation of the gas and ensure that the environment is adequately ventilated during use. It is crucial to keep oil and grease away from the gas and to utilize equipment that has been cleaned for oxygen and is rated for cylinder pressure. Care should be taken to prevent liquid from contacting the eyes, skin, or clothing. The temperature of the cylinder must not exceed 52°C (125°F). Valves should be opened slowly, closed after each use, and when the cylinder is empty. A backflow preventive device should be employed in the piping, and all usage should comply with the Material Safety Data Sheet (MSDS).

Emergency Medical Help Instructions

In the event of inhalation, the individual should be removed to fresh air immediately. If the person is not breathing, artificial respiration should be administered. If breathing difficulties arise, supplemental oxygen should be provided. It is essential to contact a physician without delay. In cases of frostbite, immediate medical treatment is required.

Stop Taking and Call Your Doctor Instructions

No specific instructions have been provided regarding the cessation of use or the need to contact a physician.

Side Effects

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

Serious adverse reactions include the potential for rapid suffocation, which underscores the necessity for careful administration under the supervision of a licensed practitioner experienced in the use of Nitrous Oxide. Additionally, the product carries warnings indicating that it may be hazardous or contraindicated in certain situations. Notably, it contains a chemical known to the state of California to cause birth defects and other reproductive harm.

Common adverse reactions associated with Nitrous Oxide include anesthetic effects, which may manifest during its use. Participants may also experience frostbite, particularly if the gas is not handled properly.

It is crucial for patients to avoid breathing the gas directly and to ensure that the administration occurs in an environment with adequate ventilation. Furthermore, precautions should be taken to keep oil and grease away from the gas, and care should be exercised to prevent liquid from coming into contact with the eyes, skin, or clothing.

Drug Interactions

Administration of Nitrous Oxide may pose significant risks and is contraindicated in patients receiving this product. Healthcare professionals should exercise caution and consider alternative anesthetic agents to avoid potential adverse effects.

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 and other reproductive harm. Clinicians should inform patients of this risk and consider appropriate counseling and monitoring for individuals who may be pregnant or planning to become pregnant.

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

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 pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution and consider the lack of specific pediatric information when evaluating the use of Nitrous Oxide in this population.

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 and other reproductive harm (CAS 10024-97-2). Pregnant patients should be made aware of this potential risk when considering the use of this product. Healthcare professionals are advised to weigh the benefits against the risks when prescribing this product to women of childbearing potential. It is recommended that appropriate precautions be taken to avoid exposure during pregnancy. Further studies may be necessary to fully understand the implications of this chemical on fetal outcomes.

Lactation

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

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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 defined in the available information.

Overdosage

Overdosage of nitrous oxide can lead to significant adverse effects, which may include respiratory depression, unconsciousness, and, in severe cases, death. Healthcare professionals should be vigilant for symptoms indicative of overdosage, such as dizziness, lightheadedness, and loss of coordination.

In the event of suspected overdosage, it is imperative that immediate medical attention is sought. Prompt intervention is crucial to mitigate potential complications associated with excessive exposure to nitrous oxide.

Management of overdosage should focus on symptomatic and supportive care. This may involve monitoring the patient's respiratory function and providing oxygen therapy as needed, along with other supportive measures tailored to the patient's clinical presentation.

Nonclinical Toxicology

This product contains a chemical known to the state of California to cause birth defects and other reproductive harm. The specific chemical identified is CAS 10024-97-2.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 administration and is knowledgeable about its indications, effects, dosages, methods, frequency, duration, hazards, contraindications, side effects, and necessary precautions.

Patients should be cautioned that Nitrous Oxide is a high-pressure oxidizing liquid and gas that vigorously accelerates combustion, which can lead to rapid suffocation and anesthetic effects. Additionally, exposure may result in frostbite. Therefore, it is crucial to avoid breathing the gas and to ensure adequate ventilation during use. Patients should be instructed to keep oil and grease away from the area of use and to utilize equipment that has been cleaned for oxygen and is rated for cylinder pressure. They should also be informed to avoid contact with liquid Nitrous Oxide in the eyes, on the skin, or on clothing. The cylinder temperature must not exceed 52°C (125°F), and the valve should be opened slowly and closed after each use and when empty. A backflow preventive device should be used in the piping, and all procedures should be conducted in accordance with the Material Safety Data Sheet (MSDS).

In the event of inhalation, patients should be instructed to seek fresh air immediately. If breathing has ceased, artificial respiration should be administered, and if breathing is difficult, oxygen should be provided. Patients must be advised to contact a physician promptly. In cases of frostbite, immediate medical treatment is necessary.

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

Storage and Handling

The product is supplied in a manner that ensures safe handling and effective use. It is essential to store and utilize the product in an environment with adequate ventilation to prevent the accumulation of harmful gases. Care should be taken to keep oil and grease away from the product to maintain its integrity and safety.

When using the product, it is crucial to employ equipment that has been thoroughly cleaned for oxygen use and is rated for cylinder pressure. The temperature of the cylinder must not exceed 52°C (125°F) to prevent any risk of degradation or failure.

Users should open the valve slowly to control the release of the product and ensure safety. After each use, and when the cylinder is empty, the valve should be closed to prevent any unintended release. Additionally, it is recommended to utilize a backflow preventive device in the piping to safeguard against any potential reverse flow that could compromise the system.

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

FDA Insert (PDF)

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

View full prescribing information (PDF)