Ulspira
Generic Name: ulspira
Brand Names:
Ulspira
11 DESCRIPTION ULSPIRA (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in ULSPIRA, is a pulmonary vasodilator. ULSPIRA is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). ULSPIRA is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]). The structural formula of nitric oxide (NO) is shown below: NO pic
Overview
11 DESCRIPTION ULSPIRA (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in ULSPIRA, is a pulmonary vasodilator. ULSPIRA is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). ULSPIRA is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]). The structural formula of nitric oxide (NO) is shown below: NO pic
Uses
1 INDICATIONS AND USAGE ULSPIRA™ is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. ULSPIRA is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near- term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Dosage
2 DOSAGE AND ADMINISTRATION 2.1 Dosage Term and near-term neonates with hypoxic respiratory failure The recommended dose of ULSPIRA is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from ULSPIRA therapy. Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2)] . 2.2 Administration Nitric Oxide Delivery Systems ULSPIRA must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System (NODS). There are various FDA-cleared NODS; refer to the NODS labeling to determine which NODS to use with this drug product and for needed information on training and technical support for users of this drug product with the NODS.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the label; Hypoxemia [see Warnings and Precautions (5.2)] Worsening Heart Failure [see Warnings and Precautions (5.4)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Controlled studies have included 325 patients on nitric oxide doses of 5 to 80 ppm and 251 patients on placebo.
Interactions
7 DRUG INTERACTIONS 7.1 Nitric Oxide Donor Agents Nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia. Nitric oxide donor compounds may increase the risk of developing methemoglobinemia (7).
Warnings
5 WARNINGS AND PRECAUTIONS 5.1 Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation Wean from ULSPIRA [see Dosage and Administration (2.2)]. Abrupt discontinuation of ULSPIRA may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate ULSPIRA therapy immediately. 5.2 Hypoxemia from Methemoglobinemia Nitric oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. 4 CONTRAINDICATIONS ULSPIRA is contraindicated in neonates dependent on right-to-left shunting of blood. Neonates dependent on right-to-left shunting of blood (4).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Size D Portable aluminum cylinders containing 362 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 350 liters) (NDC 82605-006-02) Size 88 Aluminum cylinders containing 2138 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 2083 liters) (NDC 82605-006-01) Distributed by Airgas Therape...
Frequently Asked Questions
What is Ulspira used for?▼
1 INDICATIONS AND USAGE ULSPIRA™ is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. ULSPIRA is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near- term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
What are the side effects of Ulspira?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the label; Hypoxemia [see Warnings and Precautions (5.2)] Worsening Heart Failure [see Warnings and Precautions (5.4)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Controlled studies have included 325 patients on nitric oxide doses of 5 to 80 ppm and 251 patients on placebo.
What are the important warnings for Ulspira?▼
5 WARNINGS AND PRECAUTIONS 5.1 Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation Wean from ULSPIRA [see Dosage and Administration (2.2)]. Abrupt discontinuation of ULSPIRA may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate ULSPIRA therapy immediately. 5.2 Hypoxemia from Methemoglobinemia Nitric oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. 4 CONTRAINDICATIONS ULSPIRA is contraindicated in neonates dependent on right-to-left shunting of blood. Neonates dependent on right-to-left shunting of blood (4).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.