Product image of Iasophyr (Nitric Oxide) supplied by GNH India

Iasophyr

Active Ingredient:
Nitric Oxide
Origin:
EU

Iasophyr (Nitric Oxide)

Nitric Oxide, the active ingredient in Iasophyr, is a medical gas presented as an inhalation gas for inhalation use. It is employed to manage pulmonary hypertension and neonatal respiratory distress syndrome by dilating the pulmonary vasculature in affected patients.

GNH India supplies Iasophyr as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, and specialty clinics worldwide. The product complies with European Union regulatory standards and is distributed under strict quality‑assured conditions. GNH India's global network ensures reliable logistics and regulatory support for cross‑border procurement.

Manufacturer / TM Owner

Sol Spa

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Indications & Clinical Uses

  • Iasophyr is used as an inhaled pulmonary vasodilator to treat conditions characterized by elevated pulmonary vascular resistance.
  • Pulmonary hypertension: reduces pulmonary arterial pressure and improves exercise capacity.
  • Neonatal respiratory distress syndrome: improves oxygenation by decreasing pulmonary vascular tone in newborns.

How It Works

  • Nitric oxide delivered by Iasophyr diffuses into the pulmonary arterial smooth‑muscle cells where it activates soluble guanylate cyclase. This enzyme catalyzes the conversion of GTP to cyclic GMP, raising intracellular cGMP levels. Elevated cGMP leads to relaxation of smooth‑muscle fibers, producing selective vasodilation of the pulmonary circulation without systemic hypotension. The localized effect helps improve ventilation‑perfusion matching and reduces right‑ventricular afterload.

Side Effects

Iasophyr may be associated with a range of adverse reactions following inhalation.

Common Side Effects

  • Headache: mild to moderate headache reported during therapy.
  • Flushing: transient skin flushing.
  • Hypotension: mild systemic blood pressure drop.
  • Methemoglobinemia: dose‑related increase in methemoglobin levels.
  • Bronchospasm: transient narrowing of airways in susceptible patients.

Serious or Rare Side Effects

  • Severe hypotension: marked drop in systemic blood pressure requiring intervention.
  • Rebound pulmonary hypertension: rapid increase in pulmonary pressure after abrupt discontinuation.
  • Significant methemoglobinemia: levels >10% causing cyanosis.
  • Bleeding complications: rare hemorrhagic events in coagulopathic patients.

Precautions & Warnings

When prescribing Iasophyr, clinicians should observe several safety considerations.

  • Patient selection: confirm diagnosis of pulmonary hypertension or neonatal distress before use.
  • Monitoring: regularly assess pulmonary artery pressure and methemoglobin levels during therapy.
  • Dose titration: adjust inhaled concentration based on clinical response and tolerance.
  • Contraindications: avoid in patients with known hypersensitivity to nitric oxide or severe left‑heart disease.
  • Store at ambient temperature: keep cylinder in a cool, dry place, protected from direct sunlight and secure from damage.

Avoid Interactions

Iasophyr can interact with other agents that affect vascular tone or hemoglobin metabolism.

Major Interactions (Avoid)

  • Phosphodiesterase‑5 inhibitors (e.g., sildenafil): additive pulmonary vasodilation may cause severe hypotension.
  • Nitroglycerin or other nitric oxide donors: risk of excessive systemic vasodilation.
  • Methylene blue: impairs nitric oxide signaling and may reduce efficacy.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., heparin): increased risk of bleeding when combined with severe hypotension.
  • Inhaled anesthetics (e.g., sevoflurane): may potentiate vasodilatory effects.
  • Drugs causing oxidative stress (e.g., high‑dose vitamin C): may influence methemoglobin formation.

Frequently Asked Questions

Iasophyr is an inhaled medical gas indicated for the management of pulmonary hypertension in adults and for improving oxygenation in newborns with neonatal respiratory distress syndrome. By delivering nitric oxide directly to the lungs, it selectively dilates pulmonary vessels, lowering pulmonary arterial pressure and enhancing gas exchange.

Nitric oxide released from Iasophyr activates soluble guanylate cyclase in pulmonary smooth‑muscle cells, increasing cyclic GMP levels. The rise in cyclic GMP causes smooth‑muscle relaxation, leading to selective vasodilation of the pulmonary circulation. This mechanism reduces pulmonary vascular resistance without causing significant systemic blood pressure changes.

The dose of Iasophyr is individualized and set by the prescribing clinician based on the patient’s condition, severity of pulmonary hypertension or neonatal distress, and response to therapy. Dosing regimens are adjusted according to clinical monitoring of pulmonary pressures, oxygenation, and safety parameters such as methemoglobin levels.

The safety of Iasophyr (nitric oxide) in pregnancy and lactation has not been definitively established. Current labeling classifies the pregnancy category as unknown, and it should only be used if the potential benefit justifies any potential risk to the fetus or infant. Consultation with a specialist is recommended.

To order Iasophyr, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Iasophyr delivers nitric oxide directly to the lungs, offering rapid and selective pulmonary vasodilation. Compared with systemic agents such as phosphodiesterase‑5 inhibitors, it provides targeted action with minimal systemic hypotension. Unlike prostacyclin analogues, it does not require continuous infusion pumps, but it does require specialized inhalation equipment and monitoring.

Store Iasophyr cylinders at ambient temperature, ideally below 25 °C, in a cool, dry location away from direct sunlight. Keep the cylinders upright, protect the regulator from damage, and ensure the gas container remains sealed when not in use. Follow all local regulations for medical gas storage.

Iasophyr is administered via a calibrated inhalation system that delivers a controlled concentration of nitric oxide gas to the patient’s airway. The gas is mixed with the patient’s inspiratory flow, and the delivery device monitors concentration, flow rate, and methemoglobin levels throughout the treatment session.

Serious risks include severe systemic hypotension, rebound pulmonary hypertension after abrupt discontinuation, significant methemoglobinemia (levels >10 %), and rare bleeding complications in patients with coagulopathy. Continuous hemodynamic and methemoglobin monitoring is essential to detect and manage these events promptly.

Iasophyr should be avoided in patients with known hypersensitivity to nitric oxide, severe left‑heart disease, or uncontrolled systemic hypotension. It is also contraindicated in individuals with methemoglobin reductase deficiency or those receiving other potent nitric oxide donors without careful supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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