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ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ARGININE, and HISTIDINE

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Overview

What is Aminosyn RF?

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-RF 5.2% is oxygen sensitive. The solution contains the following crystalline amino acids:

*Amount cited is for Lysine alone and does not include the acetate salt.

**The minimum daily quantities needed to maintain nitrogen balance in the healthy adult. (Rose, W.C., The Sequence of Events Leading to the Establishment of the Amino Acid Needs of Man, Am J. Public Health, 58:2020, 1968.)

***Histidine is considered essential for patients in renal failure.

Electrolytes and Product Characteristics

a

b

Each 500 mL represents three Rose Units of essential amino acids plus arginine and histidine.

The formulas for the individual amino acids present in Aminosyn-RF 5.2% are as follows:

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

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.



What does Aminosyn RF look like?



What are the available doses of Aminosyn RF?

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What should I talk to my health care provider before I take Aminosyn RF?

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How should I use Aminosyn RF?

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is indicated only as an adjunct to management of patients with potentially reversible acute renal failure who are unable to eat. When infused with hypertonic dextrose as a source of calories and with added appropriate electrolytes and vitamins, Aminosyn-RF 5.2% is suitable as an intravenous source of protein in a parenteral nutritional regimen for such patients.

Dosage

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free TPN.

Adults:

A dosage of 2.4 to 4.7 grams of nitrogen per day (from essential amino acids) with adequate calories will maintain nitrogen equilibrium in patients with uremia. If more nitrogen and calories are required in severely stressed patients in acute renal failure who cannot eat, higher dosages may be administered provided great care is taken to avoid exceeding limits of fluid intake or glucose tolerance.

In general, dosage should be guided by fluid, glucose and nitrogen tolerances, as well as the metabolic and clinical response. The rate of rise in BUN generally diminishes with infusion of essential amino acids. However, excessive intake of protein or increased protein catabolism may alter this response.

The usual daily dose ranges from 300 to 600 mL of Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) equivalent to 2.4 to 4.7 grams of nitrogen in 15.7 to 31 grams of essential amino acids. Adequate calories should be administered simultaneously. Each 500 mL of Aminosyn-RF 5.2% mixed under sterile conditions with 832 mL of Dextrose 70% will provide a solution of 1.95% of Aminosyn-RF 5.2% in 44% dextrose. This mixture provides a calorie-to-nitrogen ratio of 504:1.

Electrolyte supplementation may be required.

Elevated phosphorus, potassium and magnesium levels generally decrease during treatment with Aminosyn-RF 5.2%. Particular care should be taken in the presence of cardiac arrhythmias or digitalis toxicity to assure that sufficient quantities of these electrolytes are provided when necessary.

Compatibility of electrolyte additives to the mixtures of Aminosyn-RF 5.2% and hypertonic dextrose must be considered and potentially incompatible ions (calcium, phosphate) may be added to alternate infusion bottles to avoid precipitation.

Administration

Aminosyn-RF 5.2% admixed with sufficient dextrose to provide caloric energy requirements may be safely administered via a central venous catheter with the tip located in the vena cava.

Initial infusion rates should be slow, generally 20 to 30 mL/hour for the first 6 to 8 hours. Increments of 10 mL/hour for each hour are suggested up to a maximum rate of 60 to 100 mL/hour. If administration rates fall behind the scheduled 24 hour dosage, no attempt should be made to catch up to the planned intake. The patient’s fluid, nitrogen and glucose tolerance should be the governing factor of the rate of administration. Uremic patients are frequently glucose intolerant especially in association with peritoneal dialysis; insulin may be required to prevent hyperglycemia. When hypertonic dextrose infusion is abruptly discontinued, rebound hypoglycemia may be prevented by administering 5% dextrose.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. COLOR VARIATION FROM PALE YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY.

WARNING:


What interacts with Aminosyn RF?


  • Severe uncorrected electrolyte or acid-base imbalance.

  • Hyperammonemia.

  • Decreased circulating blood volume.



What are the warnings of Aminosyn RF?

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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 or nitrogen content reduced if BUN levels continue to rise inappropriately.

Administration of nitrogen in any form to patients with marked hepatic insufficiency may result in serum amino acid imbalances or CNS complications. Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula), therefore, should be used with caution in such patients.

Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis.

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.

Aminosyn-RF 5.2% does not replace dialysis and conventional supportive therapy in patients with renal failure.

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 are the precautions of Aminosyn RF?

CLINICAL EVALUATIONS AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE ATTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING ADMINISTRATION. Blood studies should include glucose, urea nitrogen, serum electrolytes, acid-base balance, blood ammonia levels, serum proteins, kidney and liver function tests, serum osmolality and hemogram. Circulating blood volume should be determined if indicated. If sepsis is suspected, blood cultures should be taken.

Clinically significant hypocalcemia, hypophosphatemia or hypomagnesemia may occur as a result of therapy with Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) and hypertonic dextrose; electrolyte replacement may become necessary.

In order to promote urea nitrogen reutilization in patients with renal failure, it is essential to provide adequate calories with minimal amounts of the essential amino acids and to restrict the intake of nonessential nitrogen. Hypertonic dextrose solutions are a convenient and metabolically effective source of concentrated calories. Special care must be taken when giving hypertonic glucose to provide calories in diabetic or prediabetic patients. Hypertonic solutions should be administered through an indwelling catheter with the tip located in the superior vena cava. When abrupt cessation of hypertonic dextrose is required, monitoring for rebound hypoglycemia should be instituted. Essential fatty acid deficiency (EFAD) is becoming increasingly recognized in patients on long term TPN (more than 5 days). The use of fat emulsion to provide 4−10% of total caloric intake as linoleic acid may prevent EFAD.

Fluid balance should be carefully monitored in patients with renal failure to avoid excessive fluid overload, especially in relation to cardiac insufficiency.

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Central vein infusion (with added carbohydrate solutions) of amino acid solutions requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of complications. Attention must be given to solution preparation, administration and patient monitoring. IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL PRACTICES, BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.

SUMMARY HIGHLIGHTS OF COMPLICATIONS

(Also see Current Medical Literature)

Pregnancy Category C

Animal reproduction studies have not been conducted with Aminosyn-RF 5.2%. It is also not known whether Aminosyn-RF 5.2% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn-RF 5.2% should be given to a pregnant woman only if clearly needed.

Geriatric Use

Clinical studies of Aminosyn-RF have not been performed to determine whether patients over 65 years respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal functions.

Aminosyn 5.2% contains no more than 25 mcg/L of aluminum.

SPECIAL PRECAUTIONS IN PATIENTS WITH RENAL INSUFFICIENCY

Frequent laboratory studies are necessary in patients with renal insufficiency. In renal failure hyperglycemia may not be reflected by glycosuria. Blood glucose must be determined frequently, often every six hours to guide dosage of dextrose, and insulin should be given, if required.

SPECIAL PRECAUTIONS IN PEDIATRIC PATIENTS

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) should be used with special caution in pediatric patients with acute renal failure, especially low birth weight infants. Laboratory and clinical monitoring of pediatric patients, especially those who are nutritionally depleted, must be extensive and frequent. See section under for additional information.

Frequent monitoring of blood glucose is required in low birth weight or septic infants as hypertonic dextrose infusion involves a greater risk of hyperglycemia in such patients.


What are the side effects of Aminosyn RF?

Adverse effects include metabolic, fluid, electrolyte and acid-base imbalances unless appropriate monitoring and corrective management are accomplished during Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) therapy.


What should I look out for while using Aminosyn RF?

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 or nitrogen content reduced if BUN levels continue to rise inappropriately.

Administration of nitrogen in any form to patients with marked hepatic insufficiency may result in serum amino acid imbalances or CNS complications. Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula), therefore, should be used with caution in such patients.

Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis.

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.

Aminosyn-RF 5.2% does not replace dialysis and conventional supportive therapy in patients with renal failure.

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 Aminosyn RF?

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See and .


How should I store and handle Aminosyn RF?

LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayAminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is supplied in 500 mL single-dose containers (NDC No. 0409–4166–03).Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Hospira, Inc., Lake Forest, IL 60045 USAAminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is supplied in 500 mL single-dose containers (NDC No. 0409–4166–03).Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Hospira, Inc., Lake Forest, IL 60045 USAAminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is supplied in 500 mL single-dose containers (NDC No. 0409–4166–03).Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Hospira, Inc., Lake Forest, IL 60045 USA


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection— renal formula) is a mixture of amino acids specifically designed for patients with acute renal failure who are unable to eat. The use of these essential amino acids in the management of the uremic patient is based on the minimal requirements for each of the eight amino acids essential in adult nutrition established by Rose. In renal failure nonspecific nitrogen such as urea, glycine, or ammonium chloride, are broken down in the intestine. The ammonia formed is absorbed into the portal system and incorporated by the liver into nonessential amino acids, provided requirements for essential amino acids are being met. By this metabolic route, urea nitrogen contributes to protein synthesis when the proper combination of essential amino acids, sufficient calories and other required nutrients are administered.

Thus, the administration of essential amino acids to uremic patients, particularly those who are protein-deficient, results in the utilization of retained urea in protein synthesis, and may be followed by a drop in BUN and resolution of many of the symptoms associated with azotemia.

Aminosyn-RF 5.2% contains histidine, an amino acid considered essential for infant growth, and identified as an essential amino acid for uremic patients.

In patients with potentially reversible acute renal failure who cannot eat, maintenance of adequate nutrition may assist in reducing morbidity.

Non-Clinical Toxicology
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 or nitrogen content reduced if BUN levels continue to rise inappropriately.

Administration of nitrogen in any form to patients with marked hepatic insufficiency may result in serum amino acid imbalances or CNS complications. Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula), therefore, should be used with caution in such patients.

Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis.

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.

Aminosyn-RF 5.2% does not replace dialysis and conventional supportive therapy in patients with renal failure.

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.

Aminoglutethimide:

Amphotericin B injection and potassium-depleting agents:

Antibiotics:

Anticholinesterases:

Anticoagulants, oral:

Antidiabetics:

Antitubercular drugs:

Cholestyramine:

Cyclosporine:

Digitalis glycosides:

Estrogens, including oral contraceptives:

Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin):

Ketoconazole:

Nonsteroidal anti-inflammatory drugs (NSAIDs):

Skin tests:





CLINICAL EVALUATIONS AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE ATTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING ADMINISTRATION. Blood studies should include glucose, urea nitrogen, serum electrolytes, acid-base balance, blood ammonia levels, serum proteins, kidney and liver function tests, serum osmolality and hemogram. Circulating blood volume should be determined if indicated. If sepsis is suspected, blood cultures should be taken.

Clinically significant hypocalcemia, hypophosphatemia or hypomagnesemia may occur as a result of therapy with Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) and hypertonic dextrose; electrolyte replacement may become necessary.

In order to promote urea nitrogen reutilization in patients with renal failure, it is essential to provide adequate calories with minimal amounts of the essential amino acids and to restrict the intake of nonessential nitrogen. Hypertonic dextrose solutions are a convenient and metabolically effective source of concentrated calories. Special care must be taken when giving hypertonic glucose to provide calories in diabetic or prediabetic patients. Hypertonic solutions should be administered through an indwelling catheter with the tip located in the superior vena cava. When abrupt cessation of hypertonic dextrose is required, monitoring for rebound hypoglycemia should be instituted. Essential fatty acid deficiency (EFAD) is becoming increasingly recognized in patients on long term TPN (more than 5 days). The use of fat emulsion to provide 4−10% of total caloric intake as linoleic acid may prevent EFAD.

Fluid balance should be carefully monitored in patients with renal failure to avoid excessive fluid overload, especially in relation to cardiac insufficiency.

Adverse effects include metabolic, fluid, electrolyte and acid-base imbalances unless appropriate monitoring and corrective management are accomplished during Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) therapy.

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).