Overview
11 DESCRIPTION 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 Table 8 .
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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. 12.3 Pharmacokinetics The disposition of infused amino acids, dextrose, and electrolytes are essentially the same as those absorbed from ordinary food.
Indications
- 1 INDICATIONS AND USAGE 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. 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. ( 1 )
Common Doses
- 0.8 g
- 1 g
- 1.2 g
- 2.5 g
Dosage
2 DOSAGE AND ADMINISTRATION See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in adults and pediatrics, and dosage modifications in patients with kidney disease. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) 2.1 Preparation Prior to Administration • CLINIMIX E is available in a three port container configuration and a two port container configuration. • Three Port Container: the ports consist of one medication port, one additive port and one outlet port.
Contraindications
- 4 CONTRAINDICATIONS The use of CLINIMIX E is contraindicated in: 1. Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . 2. Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.3) ] . 3.
Side Effects
- 6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Death in neonates due to calcium-ceftriaxone precipitates [see Warnings and Precautions (5.2) ] • Hypersensitivity reactions [see Warnings and Precautions (5.3) ] • Risk of Infections [see Warnings and Precautions (5.4) ] • Refeeding syndrome [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS 7.1 Drugs that Can Cause Hyperkalemia Because of its potassium content, CLINIMIX E should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.