देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
Nitric Oxide
BIOMEDICAL STRATEGY CONSULTANTS PTE LTD
R07AX01
800ppm
GAS
RESPIRATORY (INHALATION)
Prescription Only
INO Therapeutics
2007-09-20
Page 1 of 9 INOMAX® (NITRIC OXIDE) FOR INHALATION 800 PPM (PARTS PER MILLION) DESCRIPTION_ _ INOMAX (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in INOmax, is a pulmonary vasodilator. INOmax is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). INOmax 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: N O CLINICAL PHARMACOLOGY_ _ Nitric oxide is a compound produced by many cells of the body. It relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3’,5’-monophosphate, which then leads to vasodilation. When inhaled, nitric oxide produces pulmonary vasodilation. INOmax appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios. EFFECTS ON PULMONARY VASCULAR TONE IN PPHN: Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia. In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to- left shunting of blood through the patent ductus arteriosus and foramen ovale. In neonates with PPHN, INOmax improves oxygenation (as indicated by significant increases in PaO2). PHARMACOKINETICS The pharmacokinetics of nitric oxide has been studied in adults._ _ UPTAKE AND DISTRIBU पूरा दस्तावेज़ पढ़ें