Nitrogen

Description

Nitrogen, compressed, is classified under NF UN 1066 and is intended for prescription use only. The chemical substance is identified by the CAS number 7727-37-9. It is a non-flammable gas, categorized as 2 AS-10. The product is supplied by Air Source Industries, Inc., located at 3976 Cherry Ave., Long Beach, CA 90807. For inquiries within California, the contact numbers are (800) 295-4271 and (562) 426-4017.

Uses and Indications

This drug is indicated for use in specific medical situations where the administration of Nitrogen is deemed necessary. It is essential that this drug be administered only by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrogen. The 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.

Limitations of use include the potential hazards associated with Nitrogen administration, which necessitate careful consideration and oversight by qualified healthcare professionals. There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Administration of Nitrogen may pose hazards or contraindications. It is intended for use solely by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrogen. This practitioner should be well-versed in the indications, effects, dosages, methods, and frequency and duration of administration.

The route of administration for Nitrogen is via respiratory inhalation. Practitioners must ensure that the administration technique is appropriate and that the patient is monitored closely throughout the process.

Contraindications

Administration of Nitrogen is contraindicated in situations where safety precautions have not been fully understood or implemented. It is essential that Nitrogen is used only by or under the supervision of a licensed practitioner experienced in its administration, who is knowledgeable about its indications, effects, dosages, methods, frequency, duration, hazards, contraindications, side effects, and necessary precautions.

Additionally, Nitrogen should not be handled until all safety precautions have been read and understood. It must be used and stored exclusively outdoors or in a well-ventilated area. Connections should not be changed or forced, and the valve must be closed after each use and when empty. Protection from sunlight is required when ambient temperatures exceed 52°C (125°F). In case of skin contact, thaw any frosted areas with lukewarm water without rubbing the affected area.

Warnings and Precautions

Administration of Nitrogen may pose significant hazards and is contraindicated in certain situations. It is imperative to recognize that this product contains gas under pressure, which may explode if heated. Additionally, it can displace oxygen, leading to rapid suffocation. Therefore, it is crucial that all safety precautions are thoroughly read and understood prior to handling.

Furthermore, Nitrogen is classified as a refrigerated gas, which can cause cryogenic burns or injuries. Similar to the previous warning, it may also displace oxygen and result in rapid suffocation. Handling should only occur after a comprehensive review of all safety precautions.

For safe administration, Nitrogen 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 well-versed in the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

General precautions include the following:

• Nitrogen must be used and stored exclusively outdoors or in a well-ventilated area.

• A backflow preventive device should be utilized in the piping to prevent contamination.

• Equipment used must be rated for cylinder pressure to ensure safety.

• The valve should be closed after each use and when the cylinder is empty.

• Containers should be protected from sunlight when ambient temperatures exceed 52°C (125°F).

• It is essential to read and follow the Safety Data Sheet (SDS) prior to use.

• Personal protective equipment, including cold insulating gloves, a face shield, and eye protection, should be worn at all times.

• Connections should not be changed or forced to fit.

• Containers must always be kept in an upright position.

While no specific laboratory tests are recommended for the safe use of Nitrogen, it is critical to be prepared for emergencies. In the event of inhalation, the affected individual should be removed to fresh air and kept comfortable for breathing. Medical advice or attention should be sought immediately. If Nitrogen comes into contact with the skin, thaw any frosted areas with lukewarm water without rubbing the affected area, and seek immediate medical advice or attention.

There are no specific instructions provided for discontinuing use or contacting a doctor. However, practitioners should remain vigilant and responsive to any adverse effects or complications that may arise during the administration of Nitrogen.

Side Effects

Administration of Nitrogen may pose significant hazards, and its use is contraindicated in certain situations. Notably, it contains gas under pressure, which may lead to explosive reactions if heated. Additionally, Nitrogen can displace oxygen, resulting in rapid suffocation, a serious risk that must be considered during its handling and administration.

The refrigerated nature of Nitrogen also presents risks, including the potential for cryogenic burns or injuries. Similar to the aforementioned risks, the displacement of oxygen can lead to rapid suffocation, necessitating caution in environments where Nitrogen is utilized.

In the event of exposure, specific first aid measures should be followed. If Nitrogen is inhaled, it is crucial to remove the affected individual to fresh air and ensure they are comfortable for breathing. Medical advice or attention should be sought immediately. For skin exposure, it is recommended to thaw any frosted areas with lukewarm water without rubbing the affected skin. Immediate medical advice or attention is also necessary in such cases.

Drug Interactions

The administration of Nitrogen may pose significant risks and is contraindicated in certain situations. It is essential that Nitrogen is used exclusively by or under the supervision of a licensed practitioner who possesses experience in its use and administration.

Due to the potential hazards associated with Nitrogen, careful consideration and monitoring are advised when determining its use in clinical settings. Practitioners should ensure that they are adequately trained and familiar with the specific protocols related to Nitrogen administration to mitigate any adverse effects.

Packaging & NDC

The table below lists all NDC Code configurations of Nitrogen, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Administration of Nitrogen may pose hazards or be contraindicated in pediatric patients. It is essential that Nitrogen is used only by or under the supervision of a licensed practitioner who has experience in its use and administration, particularly with regard to pediatric considerations. Caution is advised when considering the use of Nitrogen in children, infants, and adolescents due to the potential risks associated with its administration.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The administration of Nitrogen during pregnancy may pose significant risks and is generally considered hazardous or contraindicated. It is essential that Nitrogen is used only by or under the supervision of a licensed practitioner who has experience in its use and administration.

Healthcare professionals should be aware of the potential dangers associated with Nitrogen, including the risk of explosion if heated, as it contains gas under pressure. Additionally, Nitrogen may displace oxygen, leading to rapid suffocation, which is a critical concern for both the pregnant patient and the fetus.

Furthermore, the refrigerated nature of Nitrogen poses a risk of cryogenic burns or injury, further complicating its use in pregnant patients. Given these risks, careful consideration and precaution are advised when evaluating the use of Nitrogen in this population.

Lactation

There are no specific warnings or recommendations regarding the use of Nitrogen in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of Nitrogen in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 defined in the available information.

Overdosage

The administration of Nitrogen can pose significant risks and may be contraindicated in certain situations. Healthcare professionals should be aware of the potential hazards associated with its use.

Risks of Overdosage

Nitrogen has the potential to displace oxygen in the environment, which can lead to rapid suffocation. This risk necessitates caution during administration, particularly in enclosed or poorly ventilated spaces.

Symptoms of Overdosage

In cases of overexposure, individuals may experience symptoms related to oxygen deprivation. It is crucial to monitor for signs of respiratory distress or loss of consciousness.

First Aid Measures

In the event of inhalation, immediate action is required. The affected individual should be removed to fresh air and positioned comfortably to facilitate breathing. It is imperative to seek medical advice or attention promptly to ensure appropriate care is provided.

Additional Warnings

Healthcare professionals should also be aware that Nitrogen can cause cryogenic burns or injuries. Proper handling and protective measures are essential to prevent such injuries during administration.

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 safety profile in nonclinical settings.

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 Nitrogen may pose hazards or be contraindicated. It is essential that Nitrogen 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 associated hazards, contraindications, side effects, and necessary precautions.

Providers must emphasize the importance of safety, including the warning that Nitrogen contains gas under pressure, which may explode if heated. Patients should be informed that Nitrogen can displace oxygen and cause rapid suffocation, and they should not handle it until all safety precautions have been read and understood. It is crucial to use and store Nitrogen only outdoors or in a well-ventilated area.

Patients should be instructed to use a backflow preventive device in the piping and to utilize equipment rated for cylinder pressure. They must close the valve after each use and when the cylinder is empty. Additionally, they should protect the cylinder from sunlight when the ambient temperature exceeds 52°C (125°F) and read and follow the Safety Data Sheet (SDS) prior to use.

In the event of inhalation, patients should be advised to remove themselves to fresh air and maintain comfort for breathing, seeking medical advice or attention as necessary. Providers should also warn that Nitrogen contains refrigerated gas, which may cause cryogenic burns or injury, and can similarly displace oxygen, leading to rapid suffocation. Patients must not handle the gas until all safety precautions have been thoroughly understood.

It is important to recommend that patients wear cold insulating gloves, a face shield, and eye protection when handling Nitrogen. They should be cautioned against changing or forcing connections and should always keep the container in an upright position. In case of inhalation, patients should again be advised to move to fresh air and remain comfortable for breathing. If skin contact occurs, they should thaw any frosted areas with lukewarm water without rubbing the affected area and seek immediate medical advice or attention.

Storage and Handling

The product is supplied in containers that must be used and stored exclusively outdoors or in a well-ventilated area. It is essential to protect the product from sunlight when the ambient temperature exceeds 52°C (125°F). After each use and when the container is empty, the valve should be closed to ensure safety.

Containers must always be maintained in an upright position to prevent leaks or spills. When handling the product, personnel are required to wear cold insulating gloves, a face shield, and eye protection to minimize risk. Additionally, a backflow preventive device should be utilized in the piping to ensure safe operation.

Before handling the product, it is crucial to read and understand all safety precautions. Connections should not be changed or forced to fit, as this may compromise safety and functionality.

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. It is crucial that the administration of Nitrogen is conducted only by or under the supervision of a licensed practitioner who possesses experience in its use. Clinicians must be familiar with 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 Nitrogen as submitted by Air Source Industries Inc. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)