Premasol

PremaSol is a brand name medication included in the following groups of medications: Other antidepressants, Other irrigating solutions, Amino acids, Antidotes. For more information about PremaSol see its generics Glycine, Lysine, Methionine, Tryptophan

6% and 10% Premasol - sulfite-free (Amino Acid) Injections are 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:

* Holt LE, Snyderman SE: The amino acid requirements of infants. JAMA 1961; 175(2):124-127. † 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.
Essential Amino Acids	6%	10%
Leucine - (CH3)2 CHCH2CH (NH2) COOH	0.84 g	1.4 g
Isoleucine - CH3CH2CH (CH3) CH (NH2) COOH	0.49 g	0.82 g
Lysine (added as Lysine Acetate) - H2N (CH2)4 CH (NH2) COOH	0.49 g	0.82 g
Valine - (CH3)2 CHCH (NH2) COOH	0.47 g	0.78 g
Histidine* - (C3H3N2) CH2CH (NH2) COOH	0.29 g	0.48 g
Phenylalanine - (C6H5) CH2 CH (NH2) COOH	0.29 g	0.48 g
Threonine - CH3CH (OH) CH (NH2) COOH	0.25 g	0.42 g
Methionine - CH3S (CH2)2 CH (NH2) COOH	0.20 g	0.34 g
Tyrosine* (added as Tyrosine and N-Acetyl-L-Tyrosine) - [C6H4 (OH)] CH2CH (NH2) COOH	0.14 g	0.24 g
Tryptophan - (C8H6N) CH2CH (NH2) COOH	0.12 g	0.20 g
Cysteine (added as Cysteine HCl·H2O) - SHCH2 CHNH2 COOH	<0.014 g	<0.016 g
Nonessential Amino Acids
Arginine - H2NC (NH) NH (CH2)3 CH (NH2) COOH	0.73 g	1.2 g
Proline – [(CH2)3NHCH] COOH	0.41 g	0.68 g
Alanine – CH3CH (NH2) COOH	0.32 g	0.54 g
Glutamic Acid – HOOC (CH2)2 CH (NH2) COOH	0.30 g	0.50 g
Serine - HOCH2 CH (NH2) COOH	0.23 g	0.38 g
Glycine - H2NCH2COOH	0.22 g	0.36 g
Aspartic Acid – HOOC CH2 CH (NH2) COOH	0.19 g	0.32 g
Taurine†‡- H2NCH2CH2SO3H	0.015 g	0.025 g
pH adjusted with glacial acetic acid
pH: 5.5 (5.0-6.0)
Osmolarity (mOsmol/L) (Calc.)	520	865
Total Amino Acids (grams/100 mL) (Calc.)	6	10
Total Nitrogen (grams/100 mL) (Calc.)	0.93	1.55
Acetate* - (CH3COO-)	57 mEq/L	94 mEq/L
Chloride (Calc.)	<3 mEq/L	<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.

See WARNINGS and Special Precautions for Central Venous Nutrition.

Reactions reported in clinical studies as a result of infusion of the parenteral fluid were water weight gain, edema, increase in BUN, and mild acidosis.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Local reaction at the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis, have been reported with peripheral amino acid infusions, especially if other substances are also administered through the same site.

If electrolyte supplementation is required during peripheral infusion, it is recommended that additives be administered throughout the day in order to avoid possible venous irritation. Irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

The objective of nutritional management of infants and young children is the provision of sufficient amino acid and caloric support for protein synthesis and growth.

The total daily dose of 6% and 10% Premasol - sulfite-free (Amino Acid) Injections depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response.

Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of protein per kilogram of body weight per day (2.0 to 4.0 g/kg/day)1. The recommended dosage of Premasol - sulfite-free (Amino Acid) Injections is 2.0 to 2.5 grams of amino acids per kilogram of body weight per day (2.0 to 2.5 g/kg/day) for infants up to 10 kilograms. For infants and young children larger than 10 kilograms, the total dosage of amino acids should include the 20 to 25 grams/day for the first 10 kg of body weight plus 1.0 to 1.25 g/day for each kg of body weight over 10 kilograms.

Typically, Premasol - sulfite-free (Amino Acid) Injections are admixed with 50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24 hour period.

Total daily fluid intake should be appropriate for the patient's age and size. A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance.

Cysteine is considered to be an essential amino acid in infants and young children. An admixture of cysteine hydrochloride to the TPN solution is therefore recommended. Based on clinical studies, the recommended dosage is 1.0 mmole of L-cysteine hydrochloride monohydrate per kilogram of body weight per day.

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 solutions are abruptly discontinued.

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.

The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of 6% and 10% Premasol - sulfite-free (Amino Acid) Injections must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.

Appropriate vitamins, minerals and trace elements should also be provided.

1 Suskind RM: Textbook of Pediatric Nutrition, Raven Press, New York, 1981.

Central Venous Nutrition.

Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60-125 mL per kilogram of body weight per day. If administration rate should fall behind schedule, no attempt to “catch up” to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine.

Peripheral Parenteral Nutrition.

For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, Premasol - sulfite-free (Amino Acid) Injections may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution with Sterile Water for Injection or 5% -10% Dextrose Injection to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is essential that peripheral infusion be accompanied by adequate caloric intake.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

A slight yellow color does not alter the quality and efficacy of the product.

Premasol - sulfite-free (Amino Acid) Injections may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, in order to avoid precipitation.

Care must be taken to avoid incompatible admixtures. Consult with pharmacist.

Parenteral nutrition solutions should be used promptly after mixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.

Directions for use of VIAFLEX plastic Pharmacy Bulk Package container

To Open

Tear overpouch across top at slit and remove solution container. Discard overpouch and sachet. Visually inspect the container.  If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

For compounding only, not for direct infusion.

Preparation for Admixing 1. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). 2. Suspend container from eyelet support. 3. Remove plastic protector from outlet port at bottom of container. 4. Attach solution transfer set. Refer to complete directions accompanying set. Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. 5. VIAFLEX containers should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry. 6. Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25°C/77°F) and dispense within 4 hours.

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.

6% and 10% Premasol - sulfite-free (Amino Acid) Injections are supplied in VIAFLEX plastic Pharmacy Bulk Package containers in the following sizes and concentrations:

	500 mL	1000 mL	2000 mL
6%	2B0011
	NDC 0338-1131-03
10%	2B0012	2B0009	2B0010
	NDC 0338-1130-03	NDC 0338-1130-04	NDC 0338-1130-06

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25°C/77°F). Brief exposure up to 40°C/104°F does not adversely affect the product.

Protect from light until immediately prior to use.

Do not remove container from overpouch until ready to use.

Do not use if overpouch has been previously opened or damaged.

Baxter Healthcare Corporation
Clintec Nutrition Division
Deerfield, IL 60015 USA

Printed in USA

BAXTER, Premasol, PL 146, and VIAFLEX are trademarks of Baxter International Inc.

07-19-72-999

Rev. April 2014

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of PremaSol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.