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CLINIMIX E
Overview
What is CLINIMIX E?
CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container.
The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in
The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl•2HO. Dextrose, USP, is chemically designated D-glucose, monohydrate (CHO • HO) and has the following structure:
Dextrose is derived from corn.
See for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product
The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic).
CLINIMIX E contains no more than 25 mcg/L of aluminum.
What does CLINIMIX E look like?
What are the available doses of CLINIMIX E?
CLINIMIX E injection is available in multiple strengths. See full prescribing information for detailed description of each formulation. (, )
What should I talk to my health care provider before I take CLINIMIX E?
How should I use CLINIMIX E?
CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.
What interacts with CLINIMIX E?
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What are the warnings of CLINIMIX E?
Sorry No Records found
What are the precautions of CLINIMIX E?
Sorry No Records found
What are the side effects of CLINIMIX E?
Sorry No records found
What should I look out for while using CLINIMIX E?
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What might happen if I take too much CLINIMIX E?
An increased infusion rate of CLINIMIX E can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance
Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal.
Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems
For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or .
How should I store and handle CLINIMIX E?
Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See ).Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective foil overwrap has been opened.Do not use if the protective foil overwrap has been previously opened or damaged.For storage of admixed solutions see.CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See ).Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective foil overwrap has been opened.Do not use if the protective foil overwrap has been previously opened or damaged.For storage of admixed solutions see.CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See ).Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective foil overwrap has been opened.Do not use if the protective foil overwrap has been previously opened or damaged.For storage of admixed solutions see.CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See ).Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective foil overwrap has been opened.Do not use if the protective foil overwrap has been previously opened or damaged.For storage of admixed solutions see.CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See ).Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective foil overwrap has been opened.Do not use if the protective foil overwrap has been previously opened or damaged.For storage of admixed solutions see.CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See ).Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective foil overwrap has been opened.Do not use if the protective foil overwrap has been previously opened or damaged.For storage of admixed solutions see.CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See ).Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective foil overwrap has been opened.Do not use if the protective foil overwrap has been previously opened or damaged.For storage of admixed solutions see.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CLINIMIX E is used as a supplement of nutrition in patients, providing macronutrients (amino acids and dextrose) and micronutrients (electrolytes) parenterally.
The amino acids provide the structural units that make up proteins and are used to synthesize proteins and other biomolecules or are oxidized to urea and carbon dioxide as a source of energy.
The administered dextrose is oxidized to carbon dioxide and water, yielding energy.
Non-Clinical Toxicology
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Drug Interactions:
It has been reported that ZYLOPRIM prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when ZYLOPRIM is given to patients already on dicumarol therapy.
Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and ZYLOPRIM has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with ZYLOPRIM alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on ZYLOPRIM alone or in combination with uricosuric agents, the possibility should be kept in mind.
The reports that the concomitant use of ZYLOPRIM and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of ZYLOPRIM was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and ZYLOPRIM even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with ZYLOPRIM compared to patients who are not receiving both drugs. The cause of the reported association has not been established.
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of ZYLOPRIM. However, in a well-controlled study of patients with lymphoma on combination therapy, ZYLOPRIM did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.
Tolbutamide's conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of these observations is unknown.
Chlorpropamide's plasma half-life may be prolonged by ZYLOPRIM, since ZYLOPRIM and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if ZYLOPRIM and chlorpropamide are given concomitantly in the presence of renal insufficiency.
Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with ZYLOPRIM. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.
Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes due to pulmonary embolism have occurred. Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. In addition to inspection of the solution , the infusion set and catheter should also periodically be checked for precipitates.
The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.
The following adverse reactions from voluntary reports or clinical studies have been reported with CLINIMIX E. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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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