Nouress

Cysteine hydrochloride injection, USP is indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. Cysteine hydrochloride injection, USP is a sulfur-containing amino acid indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition.

( 1 )

Cysteine hydrochloride injection, USP is contraindicated in:

• Patients with known hypersensitivity to one or more amino acids.
• Patients with inborn errors of amino acid metabolism due to risk of severe metabolic or neurologic complications.
• Patients with pulmonary edema or acidosis due to low cardiac output.
• Hypersensitivity to one or more amino acids ( 4 )
• Inborn errors of amino acid metabolism ( 4 )
• Pulmonary edema or acidosis due to low cardiac output ( 4 )

• Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 )
• Vein Damage and Thrombosis : Solutions with osmolarity of 900 mOsm/L or more must be infused through a central catheter ( 2.1 , 5.2 )
• Increased Blood Urea Nitrogen (BUN) : Monitor laboratory parameters and discontinue if BUN exceeds normal postprandial limits and continues to increase. ( 5.3 )
• Acid-Base Imbalance : Monitor laboratory parameters and supplement with electrolytes as needed. ( 5.4 )
• Hepatobiliary Disorders : Neurocognitive delay possible in infants; monitor liver function parameters and ammonia levels. ( 5.5 , 8.4 )
• Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants. ( 5.6 , 8.4 )
• Monitoring and Laboratory Tests : Monitor fluid and electrolytes, serum osmolarity, blood glucose, kidney and liver function, blood count, and coagulation parameters throughout treatment. ( 5.7 )

5.1Pulmonary

Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some fatal cases, pulmonary embolism occurred as a result of calcium phosphate precipitates. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported.