aminosyn ii 10% in plastic container
Aminosyn II 10% in Plastic Container (Amino Acids) is a medication supplied as an injection, solution.
Amino Acids · by Otsuka Icu Medcl
Key facts
- Active ingredient
- Amino Acids
- Form
- Injectable
- Strength
- Amino Acids 10% (10GM/100ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Otsuka Icu Medcl
- FDA application
- NDA020015
- FDA boxed warning
- Yes — see the boxed warning
What is Aminosyn II 10% in Plastic Container?
From the FDA label:Aminosyn ™ II, Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulations are described below: Essential Amino Acids (mg/100 mL) Aminosyn II 10% 15% Isoleucine 660 990 Leucine 1000 1500 Lysine (acetate)* 1050 1575 Methionine 172 258 Phenylalanine 298 447 Threonine 400 600 Tryptophan 200 300 Valine 500 750 *Amount cited is for lysine alone and does not include the acetate. Nonessential Amino Acids (mg/100 mL) Alanine 993 1490 Arginine 1018 1527 L-Aspartic Acid 700 1050 L-Glutamic Acid 738 1107 Histidine 300 450 Proline 722 1083 Serine 530 795 N-Acetyl-L-Tyrosine 270 405 Glycine 500 750 Other Characteristics Protein Equivalent (approx. grams/liter) 100 150 Total Nitrogen (grams/liter) 15.3 23.0 Osmolarity (mOsmol/liter, actual) 840 1270 pH a 5.8 (5.0 – 6.5) 5.8 (5.0 – 6.5) Specific Gravity 1.03 1.05 Electrolytes (mEq/L) Sodium (Na + ) b 38 50 Acetate (C 2 H 3 O 2 - ) c 71.8 107.6 a Solution contains sodium hydroxide for pH adjustment. b Figure includes Na + from the pH adjustor. c Includes acetate from lysine acetate. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the…
How to use
Each 100 mL of Aminosyn II contains: Amino Acids Nitrogen Aminosyn II 10% 10 g 1.53 g Aminosyn II 15% 15 g 2.30 g The total daily dose of the solution depends on the daily protein requirements and on the patient’s metabolic and clinical response. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued. 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. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Aminosyn II in the 2000 mL flexible Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated gravimetric compounding devices for preparing intravenous nutritional admixtures. Admixtures must be stored under refrigeration and used within 24 hours of admixing. Peripheral Vein Nutritional Maintenance A mixture of Aminosyn II and dextrose…
Side effects
Peripheral Infusions A 3.5% to 5% solution of amino acids (without additives) is slightly hypertonic. 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 infused at another venous site. Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Pharmacy Bulk Package – Not For Direct Infusion.
Warnings
Important safety information
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. 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 even at lower rates of administration.
Who should not take Aminosyn II 10% in Plastic Container
This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.
Overdose — what happens if you take too much
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS .)
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential effects of amino acids infused with dextrose as part of a parenteral feeding regimen.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- Is there a coupon or discount for Aminosyn II 10% in Plastic Container?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Aminosyn II 10% in Plastic Container. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Aminosyn II 10% in Plastic Container?
- Aminosyn II 10% in Plastic Container is marketed by Otsuka Icu Medcl. You can see Otsuka Icu Medcl's full profile, rating, and other products on pharmaranks.
- Is Aminosyn II 10% in Plastic Container a brand-name or generic drug?
- Aminosyn II 10% in Plastic Container is a brand-name product with the active ingredient Amino Acids.
- Is Aminosyn II 10% in Plastic Container available over the counter?
- No. Aminosyn II 10% in Plastic Container is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Aminosyn II 10% in Plastic Container come in?
- Aminosyn II 10% in Plastic Container is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Aminosyn II 10% in Plastic Container FDA-registered?
- Aminosyn II 10% in Plastic Container is on record with the U.S. FDA under application number NDA020015. You can verify this on its official FDA label.
- Is Aminosyn II 10% in Plastic Container safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Aminosyn II 10% in Plastic Container. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Aminosyn II 10% in Plastic Container?
- Aminosyn II 10% in Plastic Container's side effects are taken directly from its FDA label. From the label: Peripheral Infusions A 3.5% to 5% solution of amino acids (without additives) is slightly hypertonic. 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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