cysteine hydrochloride - Medications

Cysteine hydrochloride injection, USP (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous use supplied as 500 mg/10 mL cysteine hydrochloride, USP in a single-dose vial. Each mL of cysteine hydrochloride injection, USP contains 50 mg of cysteine hydrochloride, (equivalent to 34.5 mg of cysteine), and 0.006 mL of hydrochloric acid (6M) in water for injection. Sodium hydroxide and/or hydrochloric acid are used as needed to adjust the pH. The pH range of cysteine hydrochloride injection, USP is 1.0 to 1.5. The active ingredient is cysteine hydrochloride. The chemical name of cysteine hydrochloride is L-cysteine hydrochloride monohydrate. Its molecular formula is C 3 H 7 NO 2 S • HCI • H 2 O and molecular weight is 175.63. The chemical structure of L-cysteine hydrochloride monohydrate is depicted below: Cysteine hydrochloride is a white crystalline powder soluble in water. Cysteine is a sulfur-containing amino acid and is prone to oxidation when exposed to air in aqueous solution, which may convert cysteine to insoluble cystine resulting in precipitation over time. Cysteine hydrochloride injection, USP contains no more than 145 mcg/L of aluminum. Structural Formula

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. The chemical name of cysteine hydrochloride is L-cysteine hydrochloride monohydrate and is chemically designated as C 3 H 7 NO 2 S • HCI • H 2 O having a molecular weight of 175.63. Cysteine hydrochloride is a white crystalline powder soluble in water. Cysteine aqueous solution is prone to oxidation when exposed to air, and when mixed with amino acids solutions, cysteine may convert to insoluble cystine which leads to precipitation over time. It has the following structural formula: ELCYS ® contains no more than 80 mcg/L of aluminum. Structure

ELCYS (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous use. Each 10 mL of ELCYS contains 500 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. The chemical name of cysteine hydrochloride is L-cysteine hydrochloride monohydrate and is chemically designated as C3H7NO2S • HCI • H2O having a molecular weight of 175.63. Cysteine hydrochloride is a white crystalline powder soluble in water. Cysteine aqueous solution is prone to oxidation when exposed to air, and when mixed with amino acids solutions, cysteine may convert to insoluble cystine which leads to precipitation over time. It has the following structural formula: ELCYS contains no more than 80 mcg/L of aluminum. Structure

PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride ( PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains: Essential Amino Acids 10% Leucine - (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH 1.4 g Isoleucine - CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH 0.82 g Lysine (added as Lysine Acetate) - H 2 N (CH 2 ) 4 CH (NH 2 ) COOH 0.82 g Valine - (CH 3 ) 2 CHCH (NH 2 ) COOH 0.78 g Histidine Holt LE, Snyderman SE: The amino acid requirements of infants. JAMA 1961; 175(2):124-127. - (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH 0.48 g Phenylalanine - (C 6 H 5 ) CH 2 CH (NH 2 ) COOH 0.48 g Threonine - CH3CH (OH) CH (NH 2 ) COOH 0.42 g Methionine - CH 3 S (CH 2 ) 2 CH (NH 2 ) COOH 0.34 g Tyrosine (added as Tyrosine and N-Acetyl-L-Tyrosine) - [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH 0.24 g Tryptophan - (C 8 H 6 N) CH 2 CH (NH 2 ) COOH 0.20 g Cysteine (added as Cysteine HCl·H 2 O) - SHCH 2 CHNH 2 COOH <0.016 g Nonessential Amino Acids Arginine - H 2 NC (NH) NH (CH 2 ) 3 CH (NH 2 ) COOH 1.2 g Proline – [(CH 2 ) 3 NHCH] COOH 0.68 g Alanine – CH 3 CH (NH 2 ) COOH 0.54 g Glutamic Acid – HOOC (CH 2 ) 2 CH (NH 2 ) COOH 0.50 g Serine - HOCH 2 CH (NH 2 ) COOH 0.38 g Glycine - H 2 NCH 2 COOH 0.36 g Aspartic Acid – HOOC CH 2 CH (NH 2 ) COOH 0.32 g Taurine Rigo J, Senterre J: Is taurine essential for the neonates? Biol Neonate 1977; 32:73-76. Gaull G, Sturman JA, Raiha NCR: Development of mammalian sulfur metabolism: Absence of cystothionase in human fetal tissues. Pediatr Res 1972: 6:538-547. - H 2 NCH 2 CH 2 SO 3 H 0.025 g pH adjusted with glacial acetic acid pH: 5.5 (5.0-6.0) Osmolarity (mOsmol/L) (Calc.) 865 Total Amino Acids (grams/100 mL) (Calc.) 10 Total Nitrogen (grams/100 mL) (Calc.) 1.55 Acetate * - (CH 3 COO-) 94 mEq/L Chloride (Calc.) <3 mEq/L *Provided as acetic acid and lysine acetate. All amino acids are added as the “L”-isomer with the exception of Glycine and Taurine, which do not have isomers.

TrophAmine® (10% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. All amino acids designated USP are the “L”-isomer with the exception of Glycine USP, which does not have an isomer. Each 100 mL contains: Essential Amino Acids 10% Isoleucine USP 0.82 g Leucine USP 1.4 g Lysine 0.82 g (added as Lysine Acetate USP 1.2 g) Methionine USP 0.34 g Phenylalanine USP 0.48 g Threonine USP 0.42 g Tryptophan USP 0.2 g Valine USP 0.78 g Cysteine <0.016 g (as Cysteine HCl∙H 2 O USP <0.024 g) Histidine USP Holt LE, Snyderman SE: The amino acid requirements of infants. JAMA 1961; 175(2):124–127. 0.48 g Tyrosine 0.24 g (added as Tyrosine USP 0.044 g and N-Acetyl-L-Tyrosine 0.24 g) Nonessential Amino Acids Alanine USP 0.54 g Arginine USP 1.2 g Proline USP 0.68 g Serine USP 0.38 g Glycine USP 0.36 g L-Aspartic Acid 0.32 g L-Glutamic Acid 0.5 g Taurine Rigo J, Senterre J: Is taurine essential for the neonates? Biol Neonate 1977; 32:73–76. Gaull G, Sturman JA, Räihä NCR: Development of mammalian sulfur metabolism: Absence of cystothionase in human fetal tissues. Pediatr Res 1972; 6:538–547. 0.025 g Water for Injection USP qs pH adjusted with Glacial Acetic Acid USP pH: 5.5 (5.0–6.0) Calc. Osmolarity (mOsmol/liter) 866 Total Amino Acids (grams/liter) 100 Total Nitrogen (grams/liter) 15.5 Protein Equivalent (grams/liter) 97 Electrolytes (mEq/liter) Provided as acetic acid and lysine acetate. Acetate (CH 3 COO – ) 96.2 Chloride <3