Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/392
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Physiolyte (Injection)
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| dailymed-instance:dosage |
As required for irrigation. The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the directions of the additive's manufacturer should be followed. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
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| dailymed-instance:descripti... |
Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes. Each 100 mL contains:Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium ChlorideUSP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 gWater for Injection USP qsGlacial Acetic Acid USP has been added to adjust the pH pH: 6.8 (6.3���7.3)Calculated Osmolarity: The solution is isotonic (295 mOsmol/liter) Concentration of Electrolytes (mEq/liter): Sodium 140Potassium 5; Magnesium 3; Chloride 98; Acetate (CHCOO) 27Gluconate (HOCH(CHOH)COO) 23 It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are: The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap tomaintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
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| dailymed-instance:clinicalP... |
Physiolyte exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations. Physiolyte provides an isotonic calcium-free balanced electrolyte irrigation with the same ionic composition as Isolyte S (Multi-Electrolyte Solution) a multiple electrolyte solution for IV replacement of acute extracellular fluid losses. Physiological irrigation solutions are considered generally compatible with living tissues and organs. 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, the principal cation of intracellular fluid, 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. 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 and cardiac conduction and irritability. Gluconate and acetate are organic ions which are hydrogen ion acceptors and contribute bicarbonate during their metabolism to carbon dioxide and water, and serve as alkalinizing agents. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na) plays a major role in maintaining physiologic equilibrium.
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| dailymed-instance:contraind... |
Physiolyte is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
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| dailymed-instance:supply |
Physiolyte (A Physiological Irrigating Solution) is supplied sterile and nonpyrogenic in 1000 mL PIC���(Plastic Irrigation Containers) packaged 16 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25��C); however, brief exposure up to 40��C does not adversely affect the product. Do not warm above 150��F (66��C). Rx only Issued: July 2003Physiolyte and Isolyte S are registered trademarks and PIC is a trademark of B. Braun Medical Inc.Made in USA
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| dailymed-instance:activeMoi... | |
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| dailymed-instance:overdosag... |
In the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
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| dailymed-instance:genericMe... |
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride
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| dailymed-instance:fullName |
Physiolyte (Injection)
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| dailymed-instance:adverseRe... |
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
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| dailymed-instance:indicatio... |
Physiolyte (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
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| dailymed-instance:name |
Physiolyte
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