Clinimix E 5/25 (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 recent surgery. It may also be used to treat negative nitrogen balance in the blood.

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

It is very important that your doctor checks 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, trouble 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 itchy 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 must consider the risks against the benefits. The following points should be taken into account:

Allergies

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

Pediatric

To date, appropriate studies have not shown any pediatric-specific problems that would limit the usefulness of amino acids with electrolytes in dextrose with calcium injection for children. However, infants and children receiving this medicine may experience serious side effects, including low or high blood sugar, aluminum toxicity, liver issues, or excess ammonia in the blood. Safety and effectiveness have not been confirmed.

Geriatric

Current studies have not found any geriatric-specific problems that would limit the usefulness of amino acids in dextrose injection for older adults. However, elderly patients are more likely to have age-related liver, kidney, or heart issues, which may require caution and a dose adjustment for patients receiving this medicine.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the risks before taking this medicine while nursing.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if they might interact. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions are highlighted based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of 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 may increase the risk of certain side effects, but using both drugs may be the best treatment option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Acidosis (too much acid in the blood) or
• Errors in amino acid metabolism, inborn or
• Pulmonary edema (fluid in the lungs)—This medicine should not be used in patients with these conditions.

• Diabetes or
• Heart disease or
• Kidney disease—Use with caution. May worsen these conditions.

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

• Hyperglycemia (high blood sugar) worsened by dextrose or
• A weak immune system due to poor nutrition or other medicines—This may increase 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 intended effects, this 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 mentioned may also occur in some patients. If you notice any other effects, consult 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.