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 associated with this product include Praxair, the flowing airstream design, and Medipure, all of which are owned by Praxair Technology, Inc. The copyright for this product is held by Praxair Technology, Inc. for the years 2002, 2005, and 2007.

Uses and Indications

This drug is indicated for the administration of nitrogen under specific conditions. The use of nitrogen 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 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 absence of documented teratogenic or nonteratogenic effects, indicating that no specific risks in these categories have been identified.

Dosage and Administration

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

The route of administration for nitrogen is via respiratory inhalation. The active ingredient is nitrogen, with a concentration of 990 mL in 1 L. It is imperative that practitioners adhere to established guidelines and protocols when administering nitrogen to ensure patient safety and efficacy of treatment.

Contraindications

Administration of nitrogen is contraindicated in patients who are not under the supervision of a licensed practitioner experienced in its use. The use of nitrogen may pose hazards, and it is essential that practitioners are familiar with its indications, effects, dosages, methods, frequency, duration of administration, and associated risks.

Additionally, nitrogen should not come into contact with eyes, skin, or clothing. It is also contraindicated to drop the container or to alter or force-fit connections.

Warnings and Precautions

Administration of nitrogen may pose significant hazards 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 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.

High-pressure gas presents a serious risk, as it can lead to rapid suffocation. Users should be aware that exposure may result in dizziness and drowsiness. Additionally, nitrogen exists as an extremely cold liquid and gas under pressure, which can also cause rapid suffocation and severe frostbite. Symptoms such as dizziness and drowsiness may occur upon exposure.

In the event of inhalation, immediate action is required. The individual should be removed to fresh air. If the person is not breathing, artificial respiration should be administered. If breathing difficulties arise, qualified personnel may provide supplemental oxygen. It is crucial to contact a physician for further evaluation and treatment.

In cases of frostbite, prompt medical treatment is essential. Emergency assistance can be reached by calling 1-800-645-4633.

To ensure safety, it is important to close the valve after each use and to keep it closed even when the container is empty. Additionally, containers should always be secured to prevent them from being knocked over.

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 liquid and gas under pressure, 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 oxygen. Prompt medical attention is essential in all 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 take appropriate precautions to ensure patient safety.

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 hazards involved, careful consideration and monitoring are essential when administering nitrogen. Practitioners should ensure that they are familiar with the specific clinical context and patient conditions that may affect the safe use of nitrogen.

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 in pediatric patients may pose hazards or be contraindicated. It is essential that this treatment is conducted 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, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions. Careful consideration and adherence to these guidelines are critical to ensure the safety and efficacy of nitrogen administration in children.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for nitrogen gas. As there is no available information regarding the use of this drug in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in response to treatment, given the general considerations for pharmacotherapy in this age group.

Pregnancy

The administration of nitrogen during pregnancy may pose potential risks and is generally 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.

Given the lack of specific data regarding the effects of nitrogen on fetal outcomes, healthcare professionals are advised to carefully weigh the potential benefits against the risks when considering nitrogen administration in pregnant patients. It is essential to ensure that any treatment involving nitrogen is conducted with caution and under appropriate medical supervision.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information 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 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

Administration of nitrogen carries significant risks and should only be conducted by or under the supervision of a licensed practitioner experienced in its use. 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.

High-pressure gas poses a serious risk of rapid suffocation. Symptoms of overdosage may include dizziness and drowsiness, which can escalate quickly in severity. Additionally, the extremely cold nature of liquid nitrogen, combined with its pressurized state, can lead to severe frostbite and further complications related to suffocation.

In the event of an overdosage, immediate first aid measures are crucial. If nitrogen is inhaled, the individual should be removed to fresh air promptly. If the person is not breathing, artificial respiration should be administered. Should breathing difficulties arise, qualified personnel may provide supplemental oxygen. It is imperative to contact a physician for further evaluation and treatment. In cases of frostbite, immediate medical attention is essential to mitigate potential long-term damage.

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 limits the understanding of the compound's potential effects in these areas.

Postmarketing Experience

Administration of nitrogen has been associated with potential hazards and contraindications. Reports indicate that its use should be restricted to licensed practitioners who possess experience in the administration of nitrogen. These practitioners 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.

Patient Counseling

Healthcare providers should advise patients of the potential hazards associated with high-pressure gas, including the risk of rapid suffocation, dizziness, and drowsiness. It is crucial to emphasize the importance of using equipment that is rated for cylinder pressure and to utilize a backflow prevention device in any piping systems. Patients should be instructed to close the valve after each use and to keep it closed even when empty. Additionally, they should always secure the cylinder and install the cap, if provided, when not in use.

Patients must be informed to follow the guidelines outlined in the Praxair Material Safety Data Sheet (MSDS) form P-4631 and the safe practices booklets P-3499 and P-14-153, which can be obtained from their local supplier.

In the event of inhalation, patients should be instructed to move to fresh air immediately. If the patient is not breathing, they should receive artificial respiration, and if breathing is difficult, qualified personnel may administer oxygen. It is essential to call a physician for further evaluation. In cases of frostbite, patients should seek medical treatment without delay.

Healthcare providers should also caution patients that the administration of nitrogen may be hazardous or contraindicated. It is recommended that nitrogen be 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.

Patients should be reminded to store and use nitrogen with adequate ventilation and to avoid contact with eyes, skin, or clothing. When withdrawing liquid nitrogen, they should wear a face shield and gloves, and they should not drop the container. A suitable hand truck should be used for moving containers. It is important to ensure that the piping and equipment are adequately designed to withstand the pressures encountered, and that the container temperature does not exceed 125°F (52°C).

In case of an emergency, patients should be instructed to call 1-800-645-4633 for immediate assistance.

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. When withdrawing liquid, personnel are required to wear a face shield and gloves to protect against exposure. Care should be taken to avoid contact with eyes, skin, or clothing.

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

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 counsel patients that the administration of nitrogen 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 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 Westair Gas & Equipment, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)