Clinimix E 4.25/10 (Intravenous)

Amino acids and electrolytes with calcium injection is used as a dietary supplement for patients who cannot get enough calories, proteins, and electrolytes from their diet, often due to specific illnesses or a recent surgery. It may also be used to treat negative nitrogen balance in the blood.

This medicine should be given only by or under the supervision of your doctor.

It is very important that your doctor check you or your child closely to ensure that this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.

Do not give this medicine together with ceftriaxone in children younger than 28 days of age (neonates).

This medicine may increase your risk for blood clots forming in the lungs or veins. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a cough, chest pain, fast heartbeat, troubled breathing, dizziness, lightheadedness, or fainting, or tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area.

Serious allergic reactions may occur while you are using this medicine. Tell your doctor right away if you have the following symptoms: rapid, shallow breathing, trouble breathing, fast heartbeat, lightheadedness, dizziness, or fainting, nausea or vomiting, rash or itching skin, or a fever or chills.

This medicine may increase your risk of developing infections. Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, talk with your doctor.

Call your doctor if you have redness, swelling, pain, or infection at the injection site.

This medicine may cause liver problems, including parenteral nutrition associated liver disease (PNALD). This usually occurs in patients who have been receiving parenteral nutrition for a long time, especially preterm infants. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin.

This medicine may also cause electrolyte imbalance, fluid overload, and aluminum toxicity (too much aluminum in the blood). Talk to your doctor if you have concerns.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits of the medicine. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Research has not shown any specific problems in children that would limit the use of amino acids with electrolytes in dextrose with calcium injection in young patients. However, infants and children using this medicine are at a higher risk for serious side effects (like low or high blood sugar, aluminum toxicity, liver issues, or excess ammonia in the blood). Safety and effectiveness have not been established.

Geriatric

Research has not shown any specific problems in older adults that would limit the usefulness of amino acids in dextrose injection in elderly patients. However, older patients are more likely to have liver, kidney, or heart issues related to aging, which may require careful monitoring and possible dose adjustments for those using this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a chance of interaction. In cases where both medicines are prescribed, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may change the dose or frequency for one or both medicines.

• Amiloride
• Azilsartan
• Azilsartan Medoxomil
• Baloxavir Marboxil
• Bictegravir
• Candesartan
• Canrenoate
• Canrenone
• Cilazapril
• Cyclosporine
• Digoxin
• Eltrombopag
• Enalapril
• Enalaprilat
• Eplerenone
• Eprosartan
• Erdafitinib
• Fosinopril
• Irbesartan
• Lisinopril
• Losartan
• Moexipril
• Olmesartan
• Perindopril
• Quinapril
• Raltegravir
• Ramipril
• Spirapril
• Spironolactone
• Tacrolimus
• Telmisartan
• Trandolapril
• Triamterene
• Valsartan
• Zofenopril

Using this medicine with any of the following medicines might increase the risk of certain side effects, but taking both medicines may be the best option for you. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both medicines.

• Chlorothiazide
• Delafloxacin
• Felodipine
• Isradipine
• Nicardipine
• Strontium Ranelate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may influence the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Acidosis (too much acid in the blood) or
• Inborn errors in amino acid metabolism, or
• Pulmonary edema (fluid in the lungs)—This medicine should not be used if you have these conditions.

• Diabetes or
• Heart disease or
• Kidney disease—Use with care. This may worsen these conditions.

• Severe electrolyte imbalance or
• Severe metabolic disorders—These should be corrected before using this medicine.

• Hyperglycemia (high blood sugar) worsened by dextrose or
• Weakened immune system due to poor nutrition or other medicines—This may raise the risk of infections.

• Severely undernourished patients—This may lead to refeeding syndrome. Monitor and gradually increase nutrient intake for these patients.

Along with its beneficial effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

Incidence not known

• Anxiety
• bloating
• blurred vision
• chest pain
• chills
• confusion
• cough or hoarseness
• dark urine
• decrease in the amount of urine
• dizziness or lightheadedness
• dry mouth
• extreme thirst
• fainting
• fast heartbeat
• fatigue
• fever
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• light-colored stools
• lower back or side pain
• nausea
• noisy, rattling breathing
• pain or redness at the injection site
• painful or difficult urination
• pale skin at the injection site
• seizure
• stomach pain
• sugar in the urine
• sweating
• swelling of the fingers, hands, feet, or lower legs
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• troubled breathing
• troubled breathing at rest
• unexplained weight loss
• urinating large amounts or very little
• vomiting
• weakness
• weight gain
• yellow eyes or skin

Other side effects not listed may also happen in some patients. If you notice any other effects, talk to your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Clinimix 5/20
• Clinimix E 2.75/10
• Clinimix E 2.75/5
• Clinimix E 4.25/10
• Clinimix E 4.25/25
• Clinimix E 4.25/5
• Clinimix E 5/15
• Clinimix E 5/25

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Amino Acids

Chemical Class: Amino Acid

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It is given through a needle placed into one of your veins.