Nitrous oxide

Description

Nitrous Oxide U.S.P. is classified as a non-flammable oxidizer (UN 1070) with a hazard classification of 5.1. The administration of nitrous oxide may pose risks and is contraindicated in certain situations. It is intended for use solely by or under the supervision of a licensed practitioner experienced in its administration, who is knowledgeable about its indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

This product is available by prescription only, and federal law prohibits dispensing without a valid prescription. The gross weight, tare weight, and net weight of the product are to be specified, along with the size and contents measured in liters. The product is identified by the code 7025R1, dated 5/04. An accompanying nitrous label is available in image/jpeg format.

Uses and Indications

This drug is indicated for use in medical settings where nitrous oxide is deemed appropriate for patient management. 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 use and administration of nitrous oxide. The practitioner must be familiar with the indications, effects, dosages, methods, and frequency and duration of administration.

Limitations of use include the necessity for oversight by qualified personnel to ensure safe and effective application. There are no specific teratogenic or nonteratogenic effects associated with this drug noted in the available data.

Dosage and Administration

Administration of nitrous oxide is to be conducted only by or under the supervision of a licensed practitioner experienced in its use and administration. It is essential that the practitioner is familiar with 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 nitrous oxide at a concentration of 99 L in 100 L. Prior to administration, practitioners must consult the Material Safety Data Sheet (MSDS) to understand the safety and handling requirements associated with nitrous oxide.

To prevent backflow during administration, it is mandatory to utilize a backflow preventative device in the piping system. This precaution is critical to ensure the safety of both the patient and the healthcare provider.

Contraindications

Administration of nitrous oxide is contraindicated in patients who are not under the supervision of a licensed practitioner experienced in its use. Due to the risk of rapid suffocation, breathing pure nitrous oxide is hazardous and may result in death.

Additionally, nitrous oxide should not be used if there is a risk of liquid exposure to the eyes, skin, or clothing. It is imperative to avoid breathing the gas directly. This product is classified as a controlled substance and is available by prescription only; federal law prohibits dispensing without a prescription. The product label must not be removed.

Warnings and Precautions

WARNING: Nitrous oxide is classified as a high-pressure oxidizing liquid and gas that vigorously accelerates combustion. It poses significant risks, including rapid suffocation, anesthetic effects, and potential frostbite. Healthcare professionals must ensure that patients avoid breathing the gas directly and that the substance is stored and utilized in environments with adequate ventilation. It is critical to keep oil and grease away from nitrous oxide and to use only equipment that has been cleaned and designated for nitrous oxide service, rated for cylinder pressure.

The cylinder temperature must not exceed 125°F (52°C). When handling the cylinder, the valve should be opened slowly, and it must be closed after each use and when empty. Users are required to secure the cylinder both during use and in storage, and it should always be maintained in an upright position. If the cylinder is equipped with a valve protection cap, it should remain in place when not in use. All handling must be conducted in accordance with the Material Safety Data Sheet (MSDS), and cylinders should be returned with a pressure of 25 psig.

Breathing pure nitrous oxide can lead to death by rapid suffocation, underscoring the importance of strict adherence to safety protocols.

CAUTION: This product is available by prescription only. Federal law prohibits dispensing without a valid prescription.

Laboratory precautions must be observed to prevent accidents. The risk of suck-back into the cylinder can lead to rupture; therefore, it is essential to always utilize a backflow preventative device in the piping system.

In the event of an emergency, immediate action is required. If nitrous oxide is inhaled, the individual should be removed to fresh air. If the person is not breathing, artificial respiration should be administered. If breathing is difficult, supplemental oxygen should be provided, and a physician should be contacted promptly. In cases of frostbite, immediate medical treatment is necessary.

Side Effects

Patients using nitrous oxide may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include the risk of rapid suffocation due to the inhalation of pure nitrous oxide, which can lead to death. Additionally, exposure to high-pressure oxidizing liquid and gas can vigorously accelerate combustion, posing significant safety hazards. Patients may also experience anesthetic effects, which can be profound and require careful monitoring. Frostbite is another serious concern, particularly if liquid nitrous oxide comes into contact with skin or mucous membranes.

Common adverse reactions associated with nitrous oxide use include respiratory difficulties, which may necessitate the administration of oxygen or artificial respiration. It is crucial for patients to be monitored for these effects, especially in settings where nitrous oxide is administered.

In clinical settings, it is imperative to adhere to safety precautions to mitigate these risks. Patients should be advised to avoid breathing the gas directly and to ensure adequate ventilation during use. Equipment must be specifically cleaned and designated for nitrous oxide service, and cylinders should be stored and used upright, with proper valve protection in place when not in use.

In the event of an adverse reaction, immediate first aid measures should be taken. If nitrous oxide is inhaled, the patient should be removed to fresh air, and if breathing is difficult, oxygen should be provided. In cases of frostbite, prompt medical treatment is essential.

Overall, the safe use of nitrous oxide requires awareness of these potential adverse reactions and adherence to established safety protocols.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 should only be used under the supervision of a licensed practitioner who is experienced in its use and administration. Special precautions are necessary when administering nitrous oxide to children, given the potential anesthetic effects and the risks associated with rapid suffocation. The safety and efficacy of nitrous oxide in this population have not been established.

Geriatric Use

Elderly patients may not have specific information regarding the use of Nitrous Oxide, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when administering this agent to geriatric patients.

Due to the lack of data, it is advisable for practitioners to closely monitor elderly patients for any potential adverse effects or complications that may arise during treatment. Individual patient assessment is essential to ensure safe and effective use in this population.

Pregnancy

The administration of nitrous oxide during pregnancy may pose potential risks and is generally considered hazardous or contraindicated. Pregnant patients should be aware that breathing pure nitrous oxide can lead to severe adverse outcomes, including death by rapid suffocation. Therefore, nitrous oxide should only be used under the supervision of a licensed practitioner who has experience in its use and administration.

Currently, there is no specific information available regarding the safety of nitrous oxide use during pregnancy, including any safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to exercise caution and consider the potential risks when discussing the use of nitrous oxide with women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of nitrous oxide in lactating mothers. Additionally, there is no information available concerning the potential for excretion of nitrous oxide in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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

In cases of overdosage, it is critical to recognize the severe risks associated with the inhalation of nitrous oxide. Breathing pure nitrous oxide poses a significant danger, as it can lead to death by rapid suffocation.

Healthcare professionals should be vigilant for symptoms indicative of nitrous oxide overexposure, which may include respiratory distress and loss of consciousness. Immediate intervention is essential in such scenarios.

Management of nitrous oxide overdosage involves ensuring the affected individual is removed from the source of exposure and provided with fresh air. If the individual is unresponsive or exhibiting severe respiratory symptoms, emergency medical services should be contacted without delay. Continuous monitoring of the patient's respiratory status and vital signs is crucial until professional medical assistance arrives.

It is imperative that healthcare providers remain aware of these risks and act swiftly to mitigate the potential consequences of nitrous oxide overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. 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 be hazardous or contraindicated. It is essential that nitrous oxide is used 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, duration of administration, as well as the hazards, contraindications, side effects, and necessary precautions.

Providers must emphasize that nitrous oxide is available by prescription only, and federal law prohibits dispensing it without a prescription. Patients should be warned that nitrous oxide is a high-pressure oxidizing liquid and gas that vigorously accelerates combustion, can cause rapid suffocation, and may induce anesthetic effects.

Patients should be informed about the risk of frostbite and the importance of avoiding breathing the gas directly. Adequate ventilation is crucial during use, and patients should be instructed to keep oil and grease away from the area where nitrous oxide is being used. It is imperative to use equipment that has been cleaned and designated for nitrous oxide service and is rated for cylinder pressure.

Healthcare providers should caution patients against allowing liquid nitrous oxide to come into contact with their eyes, skin, or clothing. The cylinder temperature should not exceed 125°F (52°C), and patients should be instructed to open the valve slowly and to close it after each use and when empty. It is important for patients to secure the cylinder both in use and during storage, and to use it in an upright position. If the cylinder is equipped with a valve protection cap, patients should be advised to keep it in place when not in use.

Patients should be made aware of the importance of using nitrous oxide in accordance with the Material Safety Data Sheet (MSDS) and to return the cylinder with a pressure of 25 PSIG. They should also be informed that suck-back into the cylinder may cause rupture, and a backflow preventative device should always be used in the piping.

Healthcare providers must stress that breathing pure nitrous oxide can lead to death by rapid suffocation. In the event of inhalation, patients should be removed to fresh air immediately. If the patient is not breathing, artificial respiration should be administered, and if breathing is difficult, oxygen should be provided. It is crucial to call a physician in such cases. Additionally, if frostbite occurs, patients should seek medical treatment immediately.

Storage and Handling

The product is supplied in cylinders that must be handled with care to ensure safety and efficacy. The temperature of the cylinder should not exceed 125°F (52°C). Users are advised to open the valve slowly and to close it after each use and when the cylinder is empty. It is essential to secure the cylinder both during use and while in storage, ensuring it remains in an upright position at all times.

When not in use, the valve protection cap should be kept in place if the cylinder is equipped with one. The equipment used must be specifically cleaned and designated for nitrous oxide service and rated for the cylinder pressure. Additionally, it is important to return the cylinder with a pressure of 25 PSIG. A backflow preventative device should always be utilized in the piping to prevent any potential hazards.

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 Compressed Gases Inc. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)