Clinimix E 5/15 (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 be given only by or under the supervision of your doctor.

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

Do not give this medicine along with ceftriaxone to children younger than 28 days old (neonates).

This medicine may raise your risk of blood clots forming in the lungs or veins. This can be life-threatening and needs immediate medical attention. Contact your doctor right away if you experience a cough, chest pain, fast heartbeat, trouble breathing, dizziness, lightheadedness, or fainting, or if you notice tenderness, pain, swelling, warmth, skin discoloration, or prominent superficial veins in the affected area.

Serious allergic reactions may happen while you are using this medicine. Inform your doctor immediately if you have any of the following symptoms: rapid, shallow breathing, trouble breathing, fast heartbeat, lightheadedness, dizziness, or fainting, nausea or vomiting, rash or itching skin, or fever or chills.

This medicine may increase your risk of getting infections. Call your doctor immediately if you develop 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 unwell), painful or difficult urination, or sores, ulcers, or white spots in your mouth or on your lips.

This medicine may affect your blood sugar levels. Contact your doctor right away if you have increased thirst or increased urination. If you notice a change in your urine or blood sugar test results, or if you have any questions, talk to your doctor.

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

This medicine may lead to liver problems, including parenteral nutrition associated liver disease (PNALD). This usually occurs in patients who have been on parenteral nutrition for a long time, especially preterm infants. Contact your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin.

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

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

Allergies

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

Pediatric

Studies have not shown any specific problems in children that would limit the use of amino acids with electrolytes in dextrose with calcium injection in this age group. However, infants and children receiving this medicine may experience more 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 established.

Geriatric

Studies have not identified any specific problems in older adults that would limit the usefulness of amino acids in dextrose injection. However, older patients may have age-related liver, kidney, or heart issues, which may require caution and possible dose adjustments for those using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction might occur. In these cases, 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 following medicines while receiving this medicine. The interactions listed here are significant but may not be all-inclusive.

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, 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 may be the best treatment for you. If prescribed together, your doctor may change 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 used around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also result in interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Acidosis (too much acid in the blood) or
• Errors in amino acid metabolism, inborn or
• Pulmonary edema (fluid in the lungs) — 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 — Should be corrected first before using this medicine.

• Hyperglycemia (high blood sugar) worsened by dextrose or
• A weak immune system due to poor nutrition or other medicines — May increase the risk of infections.

• Severely undernourished patients — May cause refeeding syndrome. Monitor and gradually increase nutrient intake for these patients.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may 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, 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.