CYSTEINE HYDROCHLORIDE
Generic: CYSTEINE HYDROCHLORIDE
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
cbf70fc3-14b3-4c17-8de8-acba1e12ac95
Indications & Usage
1 INDICATIONS AND USAGE 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.
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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 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Vein damage and thrombosis [see Warnings and Precautions (5.2) ] • Increased BUN [see Warnings and Precautions (5.3) ] • Acid-base imbalance [see Warnings and Precautions (5.4) ] • Hepatobiliary disorders [see Warning and Precautions (5.5) ] • Aluminum toxicity [see Warnings and Precautions (5.6) ] Adverse reactions with the use of cysteine hydrochloride injection were identified in clinical studies or postmarketing reports.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
• Metabolic acidosis • Local infusion site reactions, including a warm sensation, erythema, phlebitis, and thrombosis at the infusion site • Generalized flushing, fever, and nausea Most common adverse reactions are local reactions (warm sensation, erythema, phlebitis, and thrombosis at the infusion site), generalized flushing, fever, nausea, and metabolic acidosis.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
• Metabolic acidosis • Local infusion site reactions, including a warm sensation, erythema, phlebitis, and thrombosis at the infusion site • Generalized flushing, fever, and nausea Most common adverse reactions are local reactions (warm sensation, erythema, phlebitis, and thrombosis at the infusion site), generalized flushing, fever, nausea, and metabolic acidosis.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.