Cysteine Hydrochloride
Generic Name: cysteine hydrochloride
Brand Names:
Elcys
11 DESCRIPTION ELCYS ® (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous use. Each 50 mL of ELCYS ® contains 2500 mg of cysteine hydrochloride, USP (equivalent to 345 mg of cysteine) in water for injection. Sodium hydroxide and/or hydrochloric acid are used as needed to adjust the pH. The pH range is 1.0 to 2.5. The active ingredient is cysteine hydrochloride. Cysteine is a sulfur-containing amino acid.
Overview
11 DESCRIPTION ELCYS ® (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous use. Each 50 mL of ELCYS ® contains 2500 mg of cysteine hydrochloride, USP (equivalent to 345 mg of cysteine) in water for injection. Sodium hydroxide and/or hydrochloric acid are used as needed to adjust the pH. The pH range is 1.0 to 2.5. The active ingredient is cysteine hydrochloride. Cysteine is a sulfur-containing amino acid.
Uses
1 INDICATIONS AND USAGE ELCYS ® is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ELCYS ® is a sulfur-containing amino acid indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN.
Dosage
2 DOSAGE AND ADMINISTRATION • ELCYS ® is for admixing use only. Not for direct intravenous infusion . ( 2.1 ) • PHARMACY BULK PACKAGE: Dispense single-doses to many patients in a pharmacy admixture program. Use within 4 hours of puncture. ( 2.1 ) • See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in pediatric patients and adults. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ) 2.1 Important Administration Information Prior to administration, ELCYS® must be diluted and used as an admixture in PN solutions. ELCYS® is not for direct intravenous infusion. The resulting solution is for intravenous infusion into a central or peripheral vein.
Side Effects
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 Warnings and Precautions ( 5.5 )] • Hyperammonemia [see Warnings and Precautions ( 5.6 )] • Aluminum toxicity [see Warnings and Precautions ( 5.7 )] Adverse reactions with the use of cysteine hydrochloride injection were identified in clinical studies or postmarketing reports.
Warnings
5 WARNINGS AND PRECAUTIONS • 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 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: Monitor liver function parameters and ammonia levels. ( 5.5 ) • Hyperammonemia: Neurocognitive delay possible in infants; monitor blood ammonia levels. 4 CONTRAINDICATIONS ELCYS ® 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.
Pregnancy
8.1 Pregnancy Risk Summary Appropriate administration of ELCYS ® is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with cysteine hydrochloride. The estimated background risk for major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING ELCYS ® is supplied as follows: Pharmacy Bulk Package: 2,500 mg/50 mL (50 mg/mL) of cysteine hydrochloride, USP is a clear, colorless, sterile and nonpyrogenic solution in 50 mL vials packaged as 1 per carton (NDC 51754-1008-1), 25 cartons per case (NDC 51754-1008-4) Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Cysteine Hydrochloride used for?▼
1 INDICATIONS AND USAGE ELCYS ® is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ELCYS ® is a sulfur-containing amino acid indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN.
What are the side effects of Cysteine Hydrochloride?▼
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 Warnings and Precautions ( 5.5 )] • Hyperammonemia [see Warnings and Precautions ( 5.6 )] • Aluminum toxicity [see Warnings and Precautions ( 5.7 )] Adverse reactions with the use of cysteine hydrochloride injection were identified in clinical studies or postmarketing reports.
Can I take Cysteine Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary Appropriate administration of ELCYS ® is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with cysteine hydrochloride. The estimated background risk for major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S.
What are the important warnings for Cysteine Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS • 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 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: Monitor liver function parameters and ammonia levels. ( 5.5 ) • Hyperammonemia: Neurocognitive delay possible in infants; monitor blood ammonia levels. 4 CONTRAINDICATIONS ELCYS ® 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.
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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.