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L-Cysteine Hydrochloride
Overview
What is L-Cysteine Hydrochloride?
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, is a sterile, nonpyrogenic solution. Each mL contains: 50 mg of L-Cysteine Hydrochloride Monohydrate USP; Water for Injection, USP q.s.; Air replaced with Nitrogen. pH 1.0-2.5
L-Cysteine is a sulfur-containing amino acid. In premixed solutions of crystalline amino acids, cysteine is relatively unstable over time, eventually converting to insoluble cystine. To avoid such precipitation, L-Cysteine Hydrochloride Injection USP is intended to be used as an additive with Crystalline Amino Acid Injections immediately prior to administration to the patient.
The structural formula of Cysteine Hydrochloride Monohydrate USP is:
What does L-Cysteine Hydrochloride look like?
What are the available doses of L-Cysteine Hydrochloride?
Sorry No records found.
What should I talk to my health care provider before I take L-Cysteine Hydrochloride?
Sorry No records found
How should I use L-Cysteine Hydrochloride?
L-Cysteine Hydrochloride Injection, USP is intended for use only after dilution as an additive to Crystalline Amino Acid Injections to meet the intravenous amino acid nutritional requirements of infants receiving total parenteral nutrition.
L-Cysteine Hydrochloride Injection USP is intended for use only after dilution in Crystalline Amino Acid Injection. Each 0.5 gram of L-Cysteine Hydrochloride Monohydrate should be combined aseptically with 12.5 grams of Crystalline Amino Acid Injection, such as that present in 250 mL of 5% Crystalline Amino Acid Injection. The admixture is then diluted with 250 mL of dextrose 50% or such lesser volume as indicated. Equal volumes of 5% Crystalline Amino Acid Injection and dextrose 50% produce a final solution which contains Crystalline Amino Acid Injection 2.5% in dextrose 25%, which is suitable for administration by central venous infusion. Administration of the final admixture should begin within one hour of mixing. Otherwise, the admixture should be refrigerated immediately and used within 24 hours of the time of mixing. For the recommended rate of administration, see the Crystalline Amino Acid Injection package insert.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
What interacts with L-Cysteine Hydrochloride?
This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.
What are the warnings of L-Cysteine Hydrochloride?
Withdrawal symptoms may occur if tramadol hydrochloride and acetaminophen tablets is discontinued abruptly (see also ). Reported symptoms have included anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been reported less frequently with tramadol hydrochloride and acetaminophen tablets discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering tramadol hydrochloride and acetaminophen tablets at the time of discontinuation.
Peripheral intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN) especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.
Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.
Solutions containing sodium ion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
Solutions which contain potassium ion should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.
Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion such as severe hepatic insufficiency.
Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore it is essential that blood ammonia levels be measured frequently in infants.
Instances of asymptomatic hyperammonemia have been reported in patients without overt liver dysfunction. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function.
Frequent Clinical Evaluation and Laboratory Determinations are Necessary for Proper Monitoring During Administration.
Safe use during pregnancy has not been established, therefore, infusion of amino acids should be undertaken during pregnancy only when this is deemed essential to the patients' welfare, as judged by the physician.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration
What are the precautions of L-Cysteine Hydrochloride?
Special care must be taken when administering hypertonic glucose to provide calories in diabetic or prediabetic patients.
Because of its antianabolic activity, concurrent administration of tetracycline may reduce the nitrogen sparing effects of infused amino acids.
Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as interference with estimations of nitrogen containing substances may occur.
Intravenous feeding regimens which include amino acids should be used with caution in patients with a history of renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid accumulation.
The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is not known at this time.
Nitrogen intake should be carefully monitored in patients with impaired renal function. For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate exogenous calories concurrently with the amino acids. Concentrated dextrose solutions are an effective source of such calories. Such strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.
What are the side effects of L-Cysteine Hydrochloride?
Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids, particularly if the other substances, such as antibiotics, are also administered through the same site. In such cases the infusion site should be changed promptly to another vein. Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce the incidence of local venous irritation. Electrolyte additives should be spread throughout the day. Irritating additive medications may need to be injected at another venous site.
Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.
What should I look out for while using L-Cysteine Hydrochloride?
This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.
Peripheral intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN) especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.
Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.
Solutions containing sodium ion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
Solutions which contain potassium ion should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.
Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion such as severe hepatic insufficiency.
Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore it is essential that blood ammonia levels be measured frequently in infants.
Instances of asymptomatic hyperammonemia have been reported in patients without overt liver dysfunction. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function.
Frequent Clinical Evaluation and Laboratory Determinations are Necessary for Proper Monitoring During Administration.
Safe use during pregnancy has not been established, therefore, infusion of amino acids should be undertaken during pregnancy only when this is deemed essential to the patients' welfare, as judged by the physician.
WARNING:
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration
What might happen if I take too much L-Cysteine Hydrochloride?
Sorry No Records found
How should I store and handle L-Cysteine Hydrochloride?
L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows:Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.For Sandoz Inc. Customer Service, call 1-800-525-8747.Rx onlyManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540Product of JapanRevised: June 2015D46164097
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
L-Cysteine is synthesized from methionine via the trans-sulfuration pathway in the adult, but newborn infants lack the enzyme necessary to effect this conversion. Therefore, L-Cysteine is generally considered to be an essential amino acid in infants.
Non-Clinical Toxicology
This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.Peripheral intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN) especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.
Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.
Solutions containing sodium ion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
Solutions which contain potassium ion should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.
Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion such as severe hepatic insufficiency.
Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore it is essential that blood ammonia levels be measured frequently in infants.
Instances of asymptomatic hyperammonemia have been reported in patients without overt liver dysfunction. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function.
Frequent Clinical Evaluation and Laboratory Determinations are Necessary for Proper Monitoring During Administration.
Safe use during pregnancy has not been established, therefore, infusion of amino acids should be undertaken during pregnancy only when this is deemed essential to the patients' welfare, as judged by the physician.
WARNING:
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration
Cyclobenzaprine HCl may have life-threatening interactions with MAO inhibitors (see ). Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).
Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.
____________________________________________________________________ ULTRAM (tramadol HCl tablets, Ortho-McNeil Pharmaceutical) ULTRACET (tramadol HCl and acetaminophen tablets, Ortho-McNeil Pharmaceutical) _____________________________________________________________________
Special care must be taken when administering hypertonic glucose to provide calories in diabetic or prediabetic patients.
Because of its antianabolic activity, concurrent administration of tetracycline may reduce the nitrogen sparing effects of infused amino acids.
Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as interference with estimations of nitrogen containing substances may occur.
Intravenous feeding regimens which include amino acids should be used with caution in patients with a history of renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid accumulation.
The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is not known at this time.
Nitrogen intake should be carefully monitored in patients with impaired renal function. For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate exogenous calories concurrently with the amino acids. Concentrated dextrose solutions are an effective source of such calories. Such strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.
Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids, particularly if the other substances, such as antibiotics, are also administered through the same site. In such cases the infusion site should be changed promptly to another vein. Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce the incidence of local venous irritation. Electrolyte additives should be spread throughout the day. Irritating additive medications may need to be injected at another venous site.
Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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