Amino Acids with Electrolytes in Dextrose with Calcium Injection

Name: Amino Acids with Electrolytes in Dextrose with Calcium Injection

How supplied

Dosage Forms And Strengths

CLINIMIX E injection is available in 1000 mL and 2000 mL dual chamber containers. The individual chambers contain essential and nonessential amino acids with electrolytes and dextrose with calcium. Table 7 describes the individual components of CLINIMIX E.

TABLE 7 : INGREDIENTS PER 100mL OF CLINIMIX E Injection

Strength of CLINIMIX E CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid in 5% Dextrose) Injection CLINIMIX E 4.25/5 sulfite-free (4.25% Amino Acid in 5% Dextrose) Injection CLINIMIX E 4.25/10 sulfite-free (4.25% Amino Acid in 10% Dextrose) Injection CLINIMIX E 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection CLINIMIX E 5/20 sulfite-free (5% Amino Acid in 20% Dextrose) Injection
  Dextrose Hydrous, USP (g/100 mL) 5 5 10 15 20
Amino Acids (g/100 mL) 2.75 4.25 4.25 5 5
Total Nitrogen (mg/100 mL) 454 702 702 826 826
Essential Amino Acids (mg/100 mL) Leucine 201 311 311 365 365
Isoleucine 165 255 255 300 300
Valine 160 247 247 290 290
Lysine (added as the hydrochloride salt) 159 247 247 290 290
Phenylalanine 154 238 238 280 280
Histidine 132 204 204 240 240
Threonine 116 179 179 210 210
Methionine 110 170 170 200 200
Tryptophan 50 77 77 90 90
Nonessential Amino Acids (mg/100 mL) Alanine 570 880 880 1035 1035
Arginine 316 489 489 575 575
Glycine 283 438 438 515 515
Proline 187 289 289 340 340
Serine 138 213 213 250 250
Tyrosine 11 17 17 20 20
Electrolytes (mg/100 mL) Sodium Acetate Trihydrate, USP 217 297 297 340 340
Dibasic Potassium Phosphate, USP 261 261 261 261 261
Sodium Chloride, USP 112 77 77 59 59
Magnesium Chloride, USP 51 51 51 51 51
Calcium Chloride Dihydrate, USP 33 33 33 33 33
Electrolyte Profile (mEq/L)1 Sodium 35 35 35 35 35
Potassium 30 30 30 30 30
Magnesium 5 5 5 5 5
Calcium 4.5 (2.2 mmol/L) 4.5 (2.2 mmol/L) 4.5 (2.2 mmol/L) 4.5 (2.2 mmol/L) 4.5 (2.2 mmol/L)
Acetate2 51 70 70 80 80
Chloride3 39 39 39 39 39
Phosphate (as HPO4 =) 30 (15 mmol/L) 30 (15 mmol/L) 30 (15 mmol/L) 30 (15 mmol/L) 30 (15 mmol/L)
  pH4 (Range) 6.0 (4.5 to 7.0) 6.0 (4.5 to 7.0) 6.0 (4.5 to 7.0) 6.0 (4.5 to 7.0) 6.0 (4.5 to 7.0)
Osmolarity (mOsmol/L) (calc) 665 815 1070 1395 1650
Caloric Content (kcal/ L) From Dextrose 170 170 340 510 680
From Amino Acids 110 170 170 200 200
TOTAL (Dextrose and Amino Acids) 280 340 510 710 880
1. Balanced by ions from amino acids.
2. Derived from glacial acetic acid (for pH adjustment) and sodium acetate.
3. Contributed by calcium chloride, lysine hydrochloride, magnesium chloride, and sodium chloride.
4. pH of sulfite-free amino acid injection with electrolytes in the outlet port chamber was adjusted with glacial acetic acid.

Storage And Handling

CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9).

Table 9: CLINIMIX E Formulations

After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number
CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection Code 2B7735 NDC 0338-1142-03  
CLINIMIX E 4.25/5 sulfite-free (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection Code 2B7737 NDC 0338-1144-03 Code 2B7716 NDC 0338-1113-04
CLINIMIX E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection Code 2B7738 NDC 0338-1145-03 Code 2B7717 NDC 0338-1115-04
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection Code 2B7740 NDC 0338-1147-03 Code 2B7721 NDC 0338-1123-04
CLINIMIX E 5/20 sulfite-free (5% Amino Acid with Electrolytes in 20% Dextrose with Calcium) Injection Code 2B7741 NDC 0338-1148-03 Code 2B7722 NDC 0338-1125-04

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 clear overwrap has been opened.

Do not use if the protective clear overwrap has been previously opened or damaged.

For storage of admixed solutions see DOSAGE AND ADMINISTRATION.

REFERENCES

1. Ayers Phil, et al. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. 2014, pg. 123.

2. Mueller CM ed. The A.S.P.E.N. Nutrition Support Core Curriculum, 2nd ed. 2012. Chapter 29. Wolk R, Foulks C. Renal Disease, pg. 500.

Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Revised: Oct 2018

Overdose

An increased infusion rate of CLINIMIX E can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see WARNINGS AND PRECAUTIONS].

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 www.poison.org.

Clinical pharmacology

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.

Pharmacokinetics

The disposition of infused amino acids, dextrose, and electrolytes are essentially the same as those absorbed from food.

Patient information

Inform patients, caregivers, or home healthcare providers of the following risks of CLINIMIX E:

  • Pulmonary embolism due to pulmonary vascular precipitates [see WARNINGS AND PRECAUTIONS]
  • Death in neonates due to calcium-ceftriaxone precipitates [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Risk of Infections [see WARNINGS AND PRECAUTIONS]
  • Refeeding syndrome [see WARNINGS AND PRECAUTIONS]
  • Hyperglycemia or hyperosmolar hyperglycemic state [see WARNINGS AND PRECAUTIONS]
  • Vein damage and thrombosis [see WARNINGS AND PRECAUTIONS]
  • Hepatobiliary disorders [see WARNINGS AND PRECAUTIONS]
  • Aluminum toxicity [see WARNINGS AND PRECAUTIONS]
  • Parenteral Nutrition Associated Liver Disease (PNALD) [see WARNINGS AND PRECAUTIONS]
  • Electrolyte imbalance and fluid overload [see WARNINGS AND PRECAUTIONS]

Side effects

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]
  • Death in neonates due to calcium-ceftriaxone precipitates [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Risk of Infections [see WARNINGS AND PRECAUTIONS]
  • Refeeding syndrome [see WARNINGS AND PRECAUTIONS]
  • Hyperglycemia or hyperosmolar hyperglycemic state [see WARNINGS AND PRECAUTIONS]
  • Vein damage and thrombosis [see WARNINGS AND PRECAUTIONS]
  • Hepatobiliary disorders [see WARNINGS AND PRECAUTIONS]
  • Parenteral Nutrition Associated Liver Disease (PNALD) [see WARNINGS AND PRECAUTIONS]
  • Electrolyte imbalance and fluid overload [see WARNINGS AND PRECAUTIONS]

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.

  • Diuresis
  • Extravasation
  • Glycosuria
  • Hyperglycemia
  • Hyperosmolar coma

Read the entire FDA prescribing information for Clinimix E (Amino Acids with Electrolytes in Dextrose with Calcium Injection)

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