Compounding Sterile Preparations Third Edition

Compounding Sterile Preparations Third Edition' title='Compounding Sterile Preparations Third Edition' />Learn about the potential side effects of clindamycin. Includes common and rare side effects information for consumers and healthcare professionals. More than 500 important terms and definitions in the field of good manufacturing practices in the GMP glossary from Maas Peither GMP Publishing. Hyperlyte CR FDA prescribing information, side effects and uses. Generic Name multi electrolyte. Dosage Form injection, solution, concentrate. Disclaimer This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Hyperlyte CRHyperlyte CRMulti Electrolyte Concentrate 2. LdosePHARMACY BULK PACKAGENOT FOR DIRECT INFUSIONFOR INTRAVENOUS INFUSION ONLY. MUST BE DILUTED PRIOR TO INJECTION. Contains no phosphate. Hyperlyte CR Description. 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 service and are restricted to the preparation of admixtures for intravenous infusion. Hyperlyte CR Multi Electrolyte Concentrate is a sterile, nonpyrogenic, concentrated solution of intra and extracellular electrolytes, excluding phosphate. No bacteriostatic or antimicrobial agent has been added. Each 2. 0 m. L contains Potassium Acetate USP 1. Definition of practice of pharmacy. The practice of the profession of pharmacy is defined as the administering, preparing, compounding. Water is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical. Hyperlyte CR official prescribing information for healthcare professionals. Includes indications, dosage, adverse reactions, pharmacology and more. Sodium Chloride USP 1. Sodium Acetate Trihydrate USP 0. Magnesium Chloride Hexahydrate USP 0. Calcium Chloride Dihydrate USP 0. Water for Injection USP qsp. H adjusted with Glacial Acetic Acid USP as neededp. H 5. 2 5. 0 5. Calculated Osmolarity 5. Osmolliter. Concentration of Electrolytes m. E2%80%93+USP+%3C797%3E+Standards+%E2%80%93+Pharmaceutical+Compounding+Sterile+Preparations.jpg' alt='Compounding Sterile Preparations Third Edition' title='Compounding Sterile Preparations Third Edition' />Eq2. L dose Sodium 2. Potassium 2. Calcium 5 Magnesium 5 Chloride 3. Acetate 3. 0The formulas of the active ingredients are. Molecular Formula. Molecular Weight. Potassium Acetate USP. Sodium Chloride USP. Sodium Acetate Trihydrate USP. Vodafone Hsdpa Usb Modem Software Download here. Magnesium Chloride Hexahydrate USP. Calcium Chloride Dihydrate USP. Hyperlyte CR Clinical Pharmacology. Hyperlyte CR provides a source of intra and extracellular electrolytes in suitable amounts, to help maintain normal cellular metabolism during total parenteral nutrition TPN and other parenteral therapy in adults. Use of properly diluted Hyperlyte CR meets most adult daily electrolyte requirements and provides adjunctive therapy for replenishment of depleted electrolyte stores. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid base equilibrium of body fluid. Potassium is the chief cation of body cells 1. Eqliter of intracellular water and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid base balance of the body are reflected by changes in the chloride concentration. Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability. Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular irritability. Acetate is an organic ion which is a hydrogen ion acceptor, contributes bicarbonate during its metabolism to carbon dioxide and water, and serves as an alkalinizing agent. Indications and Usage for Hyperlyte CRHyperlyte CR is indicated for use as a supplement to parenteral nutritional solutions containing amino acids, dextrose andor other calorie sources delivered by central venous or peripheral infusion, to facilitate amino acid utilization and maintain electrolyte balance in adults. Hyperlyte CR Multi Electrolyte Concentrate is also indicated as a source of replacement electrolytes for the depleted adult patient during parenteral therapy. Contraindications. Hyperlyte CR is contraindicated in clinical conditions where the administration of potassium, sodium, calcium, magnesium, or chloride could be clinically detrimental. Hyperlyte CR is not intended for pediatric use. Warnings. Strongly hypertonic solution. Must be properly diluted and thoroughly mixed before injection. 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 mcgkgday accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Contains no phosphate. Patients receiving TPN solutions containing concentrated dextrose may also require phosphate in addition to Hyperlyte CR. Each 2. 0 m. L dose contains 2. Eq of potassium. Patient requirements should be carefully evaluated prior to the addition of any potassium salt to a solution containing Hyperlyte CR. Solutions containing sodium ions 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 is sodium retention with edema. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation. Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate should be done with great care in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency. Precautions. General. Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte free dextrose solutions to which individualized electrolyte supplements may be added. This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Blood levels of sodium, potassium, calcium, magnesium, phosphorus and chloride should be monitored frequently during parenteral nutrition or intravenous therapy, and the daily dosage of electrolytes may require tailoring to meet individual needs. In tissue electrolyte depletion, addition of certain electrolytes may be required to meet individual patient needs.