Aminoleban (parenteral)

Uses

What is Aminoleban used for?

Aminoleban is a preparation of essential and non-essential amino acids. Amino acids are considered “incomplete proteins” or the building blocks of proteins, owing to their nitrogen content, and are necessary for the synthesis of biologically important substances like neurotransmitters, hormones, and muscle fibers.

Essential amino acids are the amino acids that cannot be synthesized by the human body and must be obtained through eating food such as meat and other sources of protein. Non-essential amino acids are normally obtained through a series of intracellular metabolic processes.

Aminoleban is mainly indicated to treat the following conditions:

• Hepatic encephalopathy
• Chronic liver disease

How should I take Aminoleban?

Aminoleban is available as a parenteral solution for infusion. It is injected through the intravenous (IV) route and should not be taken as an oral solution. The dose must be administered slowly via IV infusion to minimize injection site irritation and adverse effects. It should be administered by a licensed health professional.

How do I store Aminoleban?

This drug should be stored at room temperature (<30°C) and be protected from light and moisture. Do not allow this product to freeze. Crystallization may occur at low temperatures and should be warmed at 50-60°C to dissolve the crystals. Administer the solution when the temperature reaches normal body temperature (~37°C).

Always check the label before using this product. Do not use if the printed expiration date has passed, the product seal has been broken, or the product has changed in color, odor, or consistency. For safety, keep out of the reach of children and pets.

Do not dispose of this product by pouring it down the drain, toilet, or into the environment. Ask your pharmacist regarding the proper way and location of disposal.

Precautions & Warnings

What should I know before using Aminoleban?

Each amino acid preparation is uniquely blended and designed to treat metabolic disorders, supplement nutritional requirements, or correct deficiencies. Aminoleban may not be a suitable substitute for other amino acid solutions to treat a specific condition.

Aminoleban contains sodium and chloride in addition to amino acids so careful monitoring of electrolyte balance is necessary when given with an electrolyte solution or in large doses.

Before using this medication, inform your doctor if:

• You have ever had an adverse reaction to Aminoleban or other amino acid preparations
• You have a history of allergy to other medications, food, or other substances
• You are taking other medications, especially other sources of nitrogen or electrolytes
• You have underlying health conditions, such as renal disfunction

Is it safe during pregnancy or breastfeeding?

During pregnancy, protein and amino acid requirements are increased to support both maternal health and fetal growth. Generally amino acid administration is safe, even necessary in certain cases. However, the types and doses of amino acids should be individualized. This preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as determined by your doctor.

This drug may be excreted in breast milk. This drug should be used while breastfeeding only if the potential benefit justifies the potential risk to the child, as determined by your doctor.

Side Effects

What side effects can occur when using Aminoleban?

All drugs have the potential to elicit side effects even with normal use. Many side effects are dose-related and will resolve when it is adjusted or at the end of therapy.

Potential adverse effects while using this drug include:

• Hyperammonemia (excessive ammonia blood levels)
• Hypoglycemia
• Nausea, vomiting
• Vascular pain
• Headache
• Rash
• Chest pain
• Palpitations
• Acidosis
• Chills
• Fever

You may experience some, none, or other side effects not mentioned above. If you have any concerns about a side effect or it becomes bothersome, consult your doctor or pharmacist.

Interactions

What drugs may interact with Aminoleban?

This drug may interact with other medications. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and inform your doctor and pharmacist.

Known drugs and their interactions with Aminoleban include:

• Nitrogen-containing drugs

If you experience an adverse drug interaction, stop taking this drug and continue taking your other medication. Inform your doctor immediately to reevaluate your treatment plan. Your dose may need to be adjusted, substituted with another drug, or discontinue using the drug.

Does food or alcohol interact with Aminoleban?

There are no significant food or alcohol interactions with this drug.

Inform your doctor or pharmacist if you have any concerns regarding food-drug interactions.

What health conditions may interact with Aminoleban?

This drug should be taken with caution if you have any of the following conditions or risk factors:

• Abnormal amino acid metabolism
• Metabolic acidosis
• Electrolyte imbalance
• Congestive heart failure
• Renal disorders
• Elderly patients (>60 years)

Inform your doctor or pharmacist if you have any concerns regarding specific health conditions.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult your doctor or pharmacist before using Aminoleban.

What is the dose of Aminoleban for an adult?

Infusion via a peripheral vein

• Infuse 500 to 1000 mL per dose at a rate of 500 mL over 180 to 300 minutes.

For total parenteral nutrition (TPN)

• Combine 500 to 1000 mL of Aminoleban with glucose or other solutions. Administer the infusion via a central vein over the span of 24 hours.

Note: All doses should be calculated and adjusted based on the patient’s age, symptoms, and body weight.

What is the dose of Aminoleban for a child?

The use and safety of Aminoleban in children have not been established. Consult with a doctor or pharmacist for alternatives and more information.

How is Aminoleban available?

This drug is available in the following dosage forms and strengths:

• Parenteral solution for infusion in 500 mL bottle
  • Contents: L-threonine 2.25 g, L-serine 2.5 g, L-proline 4 g, L-cysteine HCl hydrate (equivalent L-cysteine 140 mg) 200 mg, glycine 4.5 g, L-alanine 3.75 g, L-valine 4.2 g, L-methionine 500 mg, L-isoleucine 4.50 g, L-leucine 5.5 g, L-phenylalanine 500 mg, L-tryptophan 350 mg, L-lysine HCl (equivalent L-lysine 3.04 g) 3.8 g, L-histidine HCl hydrate (equivalent L-histidine 1.18 g) 1.6 g, L-arginine HCl (equivalent L-arginine 3.02 g) 3.65 g. Fischer’s ratio 37.05. Total nitrogen 6.11 g. Na approx.. 7 mEq. Cl approx.. 47 mEq

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of this drug, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.