Clinimix E 4.25/5

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amino acids with electrolytes in dextrose with calcium injection in the pediatric population. However, infants and children receiving this medicine are more likely to have serious unwanted effects (including low or high blood sugar, aluminum toxicity, liver problems, or excess ammonia in the blood). Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amino acids in dextrose injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin
• Eltrombopag

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have 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 make these conditions worse.

• Electrolyte imbalance or
• Metabolic disorders, severe—Should be corrected first before using this medicine.

• Hyperglycemia (high blood sugar) worsened by dextrose or
• Weak immune system caused by poor nutrition or other medicines—May increase the risk for infections.

• Undernourished patients, severely—May cause refeeding syndrome. Monitor and increase nutrient intake slowly for the patients.

This section provides information on the proper use of a number of products that contain amino acids and electrolytes in dextrose with calcium. It may not be specific to Clinimix E 4.25/5. Please read with care.

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.

It is very important that your doctor check you or your child closely to make sure 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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• 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 occur in some patients. If you notice any other effects, check with your healthcare professional.

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