Nitrogen

Description

UN166 Nitrogen, compressed NF, is a pharmaceutical-grade gas with the chemical abstract service (CAS) number 7727-37-8. It is distributed by Praxair, Inc., located in Danbury. This product is intended for prescription use only. The trademarks "Praxair," "the flowing airstream design," and "Medipure" are owned by Praxair Technology, Inc.

Uses and Indications

This drug is indicated for the administration of nitrogen in clinical settings. The use of nitrogen may pose hazards or contraindications; therefore, it is essential that this drug is administered only by or under the supervision of a licensed practitioner. The practitioner must possess experience in the use and administration of nitrogen and be knowledgeable about its indications, effects, dosages, methods, frequency and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

There are no specific teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Administration of nitrogen is to be conducted only by or under the supervision of a licensed practitioner who possesses experience in the use and administration of nitrogen. 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.

The route of administration is via respiratory inhalation. The active ingredient is nitrogen, with a concentration of 990 mL in 1 L. It is imperative to refer to the Praxair Material Safety Data Sheet (MSDS) form P-4630 and the accompanying safety booklets P-3499 and P-14-153, which can be obtained from the local supplier, along with the manufacturer's instructions specific to this container.

Contraindications

Administration of nitrogen is contraindicated in the following situations:

• Use is restricted to licensed practitioners experienced in nitrogen administration. It should not be administered without appropriate supervision due to the potential hazards associated with its use.

• Direct contact with liquid nitrogen is contraindicated; it must not come into contact with eyes, skin, or clothing to prevent injury.

• The product should not be dropped or subjected to force, as this may compromise its integrity and safety.

• Connections should not be altered or forced, as improper handling may lead to hazardous situations.

Warnings and Precautions

Caution is advised when handling high-pressure gas, as it poses a risk of rapid suffocation. Users may experience dizziness and drowsiness. Additionally, the extremely cold liquid and gas under pressure can lead to severe frostbite and similar symptoms of dizziness and drowsiness. The administration of nitrogen is potentially hazardous or contraindicated; therefore, it should only be performed by or under the supervision of a licensed practitioner who possesses expertise in nitrogen use and administration. This includes knowledge of indications, effects, dosages, methods, frequency, duration of administration, as well as awareness of associated hazards, contraindications, side effects, and necessary precautions.

General precautions must be observed to ensure safe handling and usage. It is essential to store and use nitrogen in an area with adequate ventilation. Direct contact with the liquid should be avoided to prevent exposure to eyes, skin, or clothing. When withdrawing liquid nitrogen, appropriate personal protective equipment, including a face shield and gloves, should be worn. Containers must not be dropped, and a suitable hand truck should be utilized for movement. Piping and equipment must be designed to withstand the pressures encountered during use, and a backflow prevention device should be installed in any piping system. The container temperature must not exceed 125°F (52°C). After each use, the valve should be closed and kept closed even when the container is empty. It is crucial to secure the container to prevent it from being knocked over.

In case of an emergency, immediate medical assistance should be sought by calling 1-800-645-4633. If nitrogen is inhaled, the individual should be removed to fresh air. If breathing has ceased, artificial respiration should be administered. In instances of difficulty breathing, qualified personnel may provide oxygen. Medical treatment should be obtained immediately in cases of frostbite.

Side Effects

Administration of nitrogen may pose significant risks and should only be conducted by or under the supervision of a licensed practitioner experienced in its use. The following adverse reactions have been observed in patients:

Serious adverse reactions include the potential for rapid suffocation due to the high-pressure gas nature of nitrogen. This risk is compounded by the extremely cold temperature of the liquid and gas, which can also lead to severe frostbite. In the event of inhalation, it is critical to remove the patient to fresh air immediately. If the patient is not breathing, artificial respiration should be administered, and if breathing difficulties arise, qualified personnel may provide supplemental oxygen. Prompt medical attention is essential in cases of frostbite.

Common adverse reactions reported include dizziness and drowsiness, which may occur during or following administration. It is important for practitioners to monitor patients for these effects and to provide appropriate guidance and support as needed.

Drug Interactions

Administration of nitrogen may pose significant risks and is contraindicated in certain situations. It is imperative that nitrogen is used solely by or under the supervision of a licensed practitioner who possesses expertise in its use and administration. This practitioner should be well-versed in the indications, effects, dosages, methods, frequency, and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Due to the potential for adverse effects, careful monitoring and adherence to established guidelines are essential when considering the use of nitrogen in clinical practice.

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

The administration of nitrogen in pediatric patients may pose hazards or be contraindicated. It is essential that nitrogen is used only by or under the supervision of a licensed practitioner who possesses experience in its use and administration. This practitioner should be well-versed in 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 dosage adjustments, safety concerns, or special precautions outlined in the drug insert for nitrogen gas. As such, healthcare providers should exercise caution when administering this agent to geriatric patients, particularly those aged 65 and older.

Due to the absence of detailed information regarding geriatric use, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects or complications that may arise during treatment. Individual patient assessment and clinical judgment should guide the decision-making process in this population.

Pregnancy

The administration of nitrogen during pregnancy may pose potential risks and is considered hazardous or contraindicated. Pregnant patients should only receive nitrogen under the supervision of a licensed practitioner who is experienced 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.

Due to the lack of comprehensive data on the effects of nitrogen on fetal outcomes, healthcare professionals are advised to carefully evaluate the risks versus benefits before administering nitrogen to pregnant patients. It is essential to ensure that any treatment involving nitrogen is conducted with caution and under appropriate medical guidance.

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 for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 the event of overdosage, it is critical to recognize the potential hazards associated with high-pressure gas and extremely cold liquid nitrogen. Exposure to these substances can lead to rapid suffocation, dizziness, and drowsiness.

Symptoms of Overdosage

Healthcare professionals should be vigilant for symptoms such as dizziness and drowsiness, which may indicate an adverse reaction to nitrogen exposure. Additionally, severe frostbite can occur due to contact with the extremely cold liquid or gas under pressure.

Recommended Actions

In the case of inhalation, immediate action is required. The affected individual should be removed to fresh air. If the individual is not breathing, artificial respiration should be administered. If breathing difficulties persist, qualified personnel may provide supplemental oxygen. It is imperative to contact a physician for further evaluation and management.

Frostbite Management

Should frostbite occur, it is essential to seek medical treatment without delay. Prompt intervention is necessary to mitigate the effects of frostbite and prevent further complications.

Administration Precautions

The administration of nitrogen carries inherent risks and may be contraindicated in certain situations. It should only be performed by or under the supervision of a licensed practitioner who possesses expertise in the use and administration of nitrogen. This includes a thorough understanding of the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

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

The administration of nitrogen has been associated with potential hazards and contraindications. It is recommended that nitrogen be used solely by or under the supervision of a licensed practitioner who possesses experience in its use and administration. 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.

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 possesses experience in its use and administration. Patients should be informed that the practitioner 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.

In the event of inhalation, patients should be instructed to seek fresh air immediately. If the patient is not breathing, artificial respiration should be administered. If breathing difficulties arise, qualified personnel may provide oxygen, and a physician should be contacted without delay.

Patients should be made aware of the risk of frostbite and the importance of obtaining medical treatment immediately if such an incident occurs.

It is crucial to emphasize the importance of proper storage and usage conditions. Patients should be counseled to ensure adequate ventilation during use and to avoid contact with liquid nitrogen in the eyes, on the skin, or on clothing. When withdrawing liquid nitrogen, the use of a face shield and gloves is recommended. Patients should be advised against dropping containers and to utilize a suitable hand truck for movement. Additionally, they should be informed that piping and equipment must be designed to withstand the pressures encountered, and a backflow prevention device should be employed in any piping system.

Patients should be instructed to close the valve after each use and to keep it closed even when empty. It is important to secure containers to prevent them from being knocked over. Patients should refer to the Praxair MSDS form P-4630 and safety booklets P-3499 and P-14-153, which can be obtained from their local supplier, as well as the manufacturer's instructions for the container.

Storage and Handling

The container must always be maintained in an upright position to ensure safety and integrity. It should be stored and utilized in an area with adequate ventilation to prevent the accumulation of potentially harmful vapors. The temperature of the container must not exceed 125°F (52°C) to avoid compromising the contents.

After each use, the valve should be securely closed, and it is important to keep it closed even when the container is empty. To prevent accidental tipping, the container must be properly secured to avoid being knocked over. When withdrawing liquid, personnel are required to wear a face shield and gloves to protect against exposure. It is critical to avoid contact with the liquid to prevent it from getting into the eyes, on the skin, or on clothing.

For the movement of the container, a suitable hand truck should be employed to ensure safe transport. Additionally, all piping and equipment used must be adequately designed to withstand the pressures that may be encountered during use. A backflow prevention device should be installed in any piping to maintain safety standards.

For further guidance, refer to the Praxair MSDS form P-4630 and safety booklets P-3499 and P-14-153, which can be obtained from the local supplier, along with the manufacturer's instructions for this container.

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. Clinicians should be aware that the administration of nitrogen may pose hazards or be contraindicated. It is crucial that this medication is used only by or under the supervision of a licensed practitioner who is experienced in its use. 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 Nitrogen as submitted by Praxair Distribution Southeast LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)