CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose 584 mg/100mL; 448 mg/100mL; 464 mg/100mL; 320 mg/100mL; 480 mg/100mL; 464 mg/100mL; 384 mg/100mL; 336 mg/100mL; 144 mg/100mL; 1656 mg/100mL; 824 mg/10 Injection
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Clinimix is used when eating or tube feeding isn't safe, isn't working well enough, or isn't possible for you right now. It delivers the protein and calories your body needs direct...
- Why am I being given Clinimix instead of regular food or a feeding tube?
- No — it's quite different. Standard IV fluids mostly provide water and electrolytes. Clinimix actually provides nutrition: a full set of amino acids (the building blocks of protein...
- Is Clinimix the same as regular IV fluids like saline?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII N762921K75
A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.1298 | $0.52 / 4 bags |
| Medicare drug plans payPart D · Q2 2026 | $0.0446 | $0.18 / 4 bags |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clinimix 584 mg/100mL; 448 mg/100mL; 464 mg/100mL; 320 mg/100mL; 480 mg/100mL; 464 mg/100mL; 384 mg/100mL; 336 mg/100mL; 144 mg/100mL; 1656 mg/100mL; 824 mg/10 00338-0180-06 | Baxter | 1000 ml | — | — | FDA listed | — |
| Clinimix 584 mg/100mL; 448 mg/100mL; 464 mg/100mL; 320 mg/100mL; 480 mg/100mL; 464 mg/100mL; 384 mg/100mL; 336 mg/100mL; 144 mg/100mL; 1656 mg/100mL; 824 mg/10this 00338-0194-04 | Baxter | 2000 ml | — | — | FDA listed | — |
| Clinimix 584 mg/100mL; 448 mg/100mL; 464 mg/100mL; 320 mg/100mL; 480 mg/100mL; 464 mg/100mL; 384 mg/100mL; 336 mg/100mL; 144 mg/100mL; 1656 mg/100mL; 824 mg/10 00338-0184-04 | Baxter | 2000 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-0194-04 You're viewing this | 4 BAG in 1 CARTON (0338-0194-04) / 2000 mL in 1 BAG (0338-0194-01) | 2020-09-21 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
CLINIMIX may be used to treat negative nitrogen balance in patients. ( 1 )
⏱️ Dosage and Administration ▾
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 )
2.1Preparation Prior to Administration • CLINIMIX is available in a three port container configuration and a two port container configuration. o Three Port Container : the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container. o Two Port Container : the ports consist of one medication port and one outlet port. Additives, including lipids, can be introduced to the container through the medication port on the two port container. • Tear protective overwrap at slit and remove solution container.
Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks. • Inspect the container prior to activation.
Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
Evaluate the following: o If the outlet or additive port protectors are damaged, detached, or not present, discard container as solution path sterility may be impaired. o Check to ensure seal between chambers is intact, solutions are contained in separate chambers, and the content of the individual chambers is clear, colorless or slightly yellow. Discard if the seal is broken or if the solution is bright yellow or yellowish brown. o Check for minute leaks by separately squeezing each chamber. If external leaks or leakage between the chambers are found, discard solution as sterility or stability may be impaired. • Lipids and/or additives can be introduced to the container after opening seal between chambers.
Because additives may be incompatible, evaluate all additions to the plastic container for compatibility. Activate chambers of container prior to introduction of additives. Mix thoroughly when additives have been introduced.
Supplemental medication may be added with a 19 to 22 gauge needle through the medication port. • Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1) ] . • Inspect the container to ensure precipitates have not formed during the mixing or addition of additives. A slight yellow color does not alter the quality and efficacy of this product.
If lipid has been added, ensure the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion. Discard the admixture if any of the above are observed.
2.2Important Administration Instructions • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism. • CLINIMIX is for intravenous infusion only into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see Warnings and Precautions (5.6) ] . o For central vein infusion only: CLINIMIX 4.25/10, 5/15, 5/20, 8/10, 8/14 o For central or peripheral vein infusion: CLINIMIX 4.25/5, 6/5 • The solution should be inspected for precipitates before admixing, after admix…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS CLINIMIX injection is available in 1000 mL and 2000 mL dual chamber containers. The individual chambers contain essential and nonessential amino acids and dextrose. Table 7 describes the individual components of CLINIMIX.
Table 7: INGREDIENTS PER 100mL OF CLINIMIX Strength of CLINIMIX CLINIMIX 4.25/5 sulfite‑free (4.25% Amino Acid in 5% Dextrose) Injection CLINIMIX4.25/10 sulfite‑free (4.25% Amino Acid in 10% Dextrose) Injection CLINIMIX 5/15 sulfite‑free (5% Amino Acid in 15% Dextrose) Injection CLINIMIX 5/20 sulfite‑free (5% Amino Acid in 20% Dextrose) Injection CLINIMIX 6/5 sulfite‑free (6% Amino Acid in 5% Dextrose) Injection CLINIMIX 8/10 sulfite‑free (8% Amino Acid in 10% Dextrose) Injection CLINIMIX 8/14 sulfite‑free (8% Amino Acid in 14% Dextrose) Injection Dextrose Hydrous, USP (g/100 mL) 5 10 15 20 5 10 14 Amino Acids (g/100 mL) 4.25 4.25 5 5 6 8 8 Total Nitrogen (mg/100 mL) 702 702 826 826 990 1320 1320 Essential Amino Acids (mg/100 mL) Leucine 311 311 365 365 438 584 584 Isoleucine 255 255 300 300 360 480 480 Valine 247 247 290 290 348 464 464 Lysine (added as the hydrochloride salt) 247 247 290 290 348 464 464 Phenylalanine 238 238 280 280 336 448 448 Histidine 204 204 240 240 288 384 384 Threonine 179 179 210 210 252 336 336 Methionine 170 170 200 200 240 320 320 Tryptophan 77 77 90 90 108 144 144 Nonessential Amino Acids (mg/100 mL) Alanine 880 880 1035 1035 1242 1656 1656 Arginine 489 489 575 575 690 920 920 Glycine 438 438 515 515 618 824 824 Proline 289 289 340 340 408 544 544 Serine 213 213 250 250 300 400 400 Tyrosine 17 17 20 20 24 32 32 Anion Profile (mEq/L) Balanced by ions from amino acids.
Acetate Derived from glacial acetic acid (for pH adjustment). 37 37 42 42 53 71 71 Chloride Contributed by lysine hydrochloride and hydrochloric acid (for pH adjustment). 17 17 20 20 24 32 32 pH pH of sulfite-free amino acid injection in the outlet port chamber may be adjusted with glacial acetic acid and pH of dextrose injection port chamber may be adjusted with hydrochloric acid.
(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) 6.0 (4.5 to 7.0) 6.0 (4.5 to 7.0) Osmolarity (mOsmol/L) (calc) 675 930 1255 1505 850 1308 1520 Caloric Content (kcal/L) From Dextrose 170 340 510 680 170 343 477 From Amino Acids 170 170 200 200 240 320 320 TOTAL (Dextrose and Amino Acids) 340 510 710 880 410 663 797 CLINIMIX injection is available in multiple strengths. See full prescribing information for detailed description of each formulation. ( 3 , 11 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of CLINIMIX is contraindicated in: • Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.2) ] . • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications. • Patients with pulmonary edema or acidosis due to low cardiac output. • Known hypersensitivity to one or more amino acids or dextrose. ( 4) • Inborn errors of amino acid metabolism. ( 4 ) • Patients with pulmonary edema or acidosis due to low cardiac output.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates : if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.2 ) • Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State : monitor for signs and symptoms; monitor laboratory parameters.
( 5.3 , 5.4 , 5.5 ) • Vein Damage and Thrombosis : solutions with osmolarity of ≥ 900 mOsm/L must be infused through a central catheter. ( 2.2 , 5.6 ) • Hepatobiliary Disorders : monitor liver function parameters and ammonia levels. ( 5.7 ) • Aluminum Toxicity : increased risk in patients with impaired kidney function, including preterm infants.
( 5.8 , 8.4 ) • Parenteral Nutrition Associated Liver Disease : increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. ( 5.9 , 8.4 ) • Electrolyte Imbalance and Fluid Overload : patients with cardiac insufficiency or kidney disease may require adjustment of fluid, protein and electrolyte content. ( 5.10 , 8.4 )
5.1Pulmonary Embolism due to Pulmonary Vascular Precipitates 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. CLINIMIX contains no added phosphorus.
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 [see Dosage and Administration (2.1 , 2.2 , 2.3 , 2.4 )] , the infusion set and catheter should also periodically be checked for precipitates.
5.2Hypersensitivity Reactions Hypersensitivity/infusion reactions including anaphylaxis have been reported with CLINIMIX. Stop infusion immediately and treat patient accordingly if any signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: hypotension, hypertension, peripheral cyanosis, tachycardia, dyspnea, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, pyrexia, and chills.
5.3Risk of Infections Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. Infection and sepsis may also occur as a result of the use of intravenous catheters to administer parenteral nutrition. The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).
To decrease the risk of infection, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.
5.4 Refeeding Syndrome Refeeding severely undernouri…
🤒 Adverse Reactions ▾
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) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of Infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10) ] The following adverse reactions from voluntary reports or clinical studies have been reported with CLINIMIX.
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 Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use : increased risk of hypoglycemia/hyperglycemia: monitor serum glucose concentrations. ( 8.4 )
8.1Pregnancy Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX can cause fetal harm when administered to a pregnant woman.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality.
8.2Lactation Risk Summary It is not known whether CLINIMIX is present in human milk. There are no data on the effects of CLINIMIX on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLINIMIX and any potential adverse effects on the breastfed child from CLINIMIX or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness of CLINIMIX in pediatric patients have not been established by adequate and well-controlled studies. Use of dextrose, amino acid infusions and electrolytes in pediatric patients is based on clinical practice [see Dosage and Administration (2.8) ] . Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects.
Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.
Because of immature renal function, preterm infants receiving prolonged treatment with CLINIMIX may be at risk of aluminum toxicity [see Warnings and Precautions (5.8) ] . Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9) ] . Hyperammonemia is of special significance in infants (birth to two years).
This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants [ see Warnings and Precautions (5.7) ] .
8.5Geriatric Use Clinical studies of CLINIMIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX can cause fetal harm when administered to a pregnant woman.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of CLINIMIX in pediatric patients have not been established by adequate and well-controlled studies. Use of dextrose, amino acid infusions and electrolytes in pediatric patients is based on clinical practice [see Dosage and Administration (2.8) ] . Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects.
Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.
Because of immature renal function, preterm infants receiving prolonged treatment with CLINIMIX may be at risk of aluminum toxicity [see Warnings and Precautions (5.8) ] . Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9) ] . Hyperammonemia is of special significance in infants (birth to two years).
This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants [ see Warnings and Precautions (5.7) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of CLINIMIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE An increased infusion rate of CLINIMIX cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.5 , 5.10) ]. 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 ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action CLINIMIX is used as a supplement of nutrition in patients, providing macronutrients (amino acids and dextrose) 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.
12.3Pharmacokinetics The disposition of infused amino acids and dextrose, are essentially the same as those absorbed from ordinary food.
🧬 Mechanism of Action ▾
12.1Mechanism of Action CLINIMIX is used as a supplement of nutrition in patients, providing macronutrients (amino acids and dextrose) 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING CLINIMIX (amino acids in dextrose) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9 ). Table 9: CLINIMIX Formulations (per 07-19-00-3604 and BE-30-03-648) After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number CLINIMIX 4.25/5 sulfite‑free (4.25% Amino Acid in 5% Dextrose) Injection Code 2B7726 NDC 0338‑1133‑03 Code 2B7704 NDC 0338‑1089‑04 CLINIMIX 4.25/10 sulfite‑free (4.25% Amino Acid in 10% Dextrose) Injection Code 2B7727 NDC 0338‑1134‑03 Code 2B7705 NDC 0338‑1091‑04 CLINIMIX 5/15 sulfite‑free (5% Amino Acid in 15% Dextrose) Injection Code 2B7730 NDC 0338‑1137‑03 Code 2B7709 NDC 0338‑1099‑04 CLINIMIX 5/20 sulfite‑free (5% Amino Acid in 20% Dextrose) Injection Code 2B7731 NDC 0338‑1138‑03 Code 2B7710 NDC 0338‑1101‑04 CLINIMIX 6/5 sulfite‑free (6% Amino Acid in 5% Dextrose) Injection Code EADB9913 NDC 0338‑0198-06 _____ CLINIMIX 8/10 sulfite‑free (8% Amino Acid in 10% Dextrose) Injection Code EADB9933 NDC 0338‑0188-06 Code EADB9935 NDC 0338‑0194-04 CLINIMIX 8/14 sulfite‑free (8% Amino Acid in 14% Dextrose) Injection Code EADB9953 NDC 0338‑0180-06 Code EADB9955 NDC 0338‑0184-04 Table 9: CLINIMIX Formulations (per BE-30-04-047) After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number CLINIMIX 4.25/5 sulfite‑free (4.25% Amino Acid in 5% Dextrose) Injection Code 2B7726L NDC 0338‑7001-01 Code 2B7704L NDC 0338‑7003-01 CLINIMIX 4.25/10 sulfite‑free (4.25% Amino Acid in 10% Dextrose) Injection Code 2B7727L NDC 0338‑7005-01 Code 2B7705L NDC 0338‑7007-01 CLINIMIX 5/15 sulfite‑free (5% Amino Acid in 15% Dextrose) Injection Code 2B7730L NDC 0338‑7009-01 Code 2B7709L NDC 0338‑7011-01 CLINIMIX 5/20 sulfite‑free (5% Amino Acid in 20% Dextrose) Injection Code 2B7731L NDC 0338‑7013-01 Code 2B7710L NDC 0338‑7015-01 CLINIMIX 6/5 sulfite‑free (6% Amino Acid in 5% Dextrose) Injection Code EADB9913 NDC 0338‑0198-06 _____ CLINIMIX 8/10 sulfite‑free (8% Amino Acid in 10% Dextrose) Injection Code EADB9933 NDC 0338‑0188-06 Code EADB9935 NDC 0338‑0194-04 CLINIMIX 8/14 sulfite‑free (8% Amino Acid in 14% Dextrose) Injection Code EADB9953 NDC 0338‑0180-06 Code EADB9955 NDC 0338‑0184-04 Minimize exposure of CLINIMIX to heat and avoid excessive heat.
Protect from freezing. Store CLINIMIX 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 overwrap has been opened.
Do not use if the protective overwrap has been previously opened or damaged. For storage of admixed solutions see Dosage and Administration (2.3 , 2.4 ) .
📋 Description ▾
11 DESCRIPTION CLINIMIX sulfite-free (amino acids in dextrose) 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. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8 .
Table 8: Formulas for Amino Acids Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH The injection port chamber contains dextrose.
Dextrose, USP, is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O) and has the following structure: Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [ see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic).
CLINIMIX contains no more than 25 mcg/L of aluminum. Structural Formula Dexrose Hydrous, USP
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of CLINIMIX: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of Infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.8) ] • Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10) ]