Prosol5%

This intravenous solution provides a source of essential and non-essential amino acids, together with D-sorbitol (a carbohydrate energy source) and electrolytes, for patients who are unable to meet their nutritional needs through oral or enteral (tube) feeding. It is used for:

• Protein synthesis support in patients requiring intravenous (parenteral) nutrition
• Nutritional support during recovery from surgery, burns, or trauma
• Nutritional support in patients with renal insufficiency, hepatic insufficiency, or certain cancers, as part of an overall nutrition plan directed by a physician

Marketed products under this generic name are available in different concentrations of amino acids and different electrolyte compositions; the generic name alone does not identify one specific formulation.

Contains a mixture of essential and non-essential crystalline amino acids, D-sorbitol, and electrolytes (such as sodium, potassium, magnesium, and acetate) as a sterile intravenous solution. The exact concentration of amino acids (commonly expressed as a percentage, such as 5% or similar), the specific electrolyte content, and the total nitrogen and energy content vary between marketed products. The generic name alone does not identify a single specific concentration; always confirm the exact composition on the specific product's own label.

This is an intravenous nutritional solution that supplies amino acids (the building blocks of protein), D-sorbitol (a carbohydrate that provides energy), and electrolytes. It is used in patients who cannot obtain adequate nutrition by mouth or through a feeding tube, such as those recovering from major surgery, burns, or serious illness, as part of a parenteral (intravenous) nutrition plan directed by a physician. It is administered only in a hospital or clinical setting.

Therapeutic Class: Parenteral Nutrition Solution (Amino Acid/Carbohydrate/Electrolyte)

The amino acids in this solution are used directly by the body for protein synthesis and tissue repair, supporting a positive nitrogen balance, particularly important during recovery from surgery, trauma, or serious illness. D-sorbitol provides a source of calories that can be metabolized independently of insulin to some extent. Intravenous amino acid infusion is accompanied by increased urinary excretion of trace elements such as copper and zinc, which should be considered when planning overall nutritional support.

• Administered only by slow intravenous infusion, typically through a central or peripheral venous catheter as directed by the treating physician
• Usually given together with a non-protein energy source (such as additional dextrose) and, where indicated, intravenous fat emulsion, vitamins, and trace elements, as part of a complete parenteral nutrition regimen
• Infusion rate should be increased gradually and monitored closely, particularly at the start of treatment
• Protect from light when used in neonates and children under 2 years of age, per general parenteral amino acid product guidance

At the recommended dosage, the amino acids in this type of solution generally have minimal pharmacological interaction with other medicines. However, the following should be assessed by the treating clinical team:

• Insulin or other glucose-lowering therapy, which may need adjustment due to the carbohydrate (D-sorbitol) content
• Other intravenous additives or medicines, which should be checked for compatibility with this solution by a pharmacist before mixing
• Diuretics or other medicines affecting electrolyte balance, given the electrolyte content of this solution

Possible adverse effects

• Nausea or discomfort during infusion
• Injection or infusion site irritation
• Electrolyte imbalances, particularly with prolonged use
• Elevated blood sugar (hyperglycemia), related to the carbohydrate content

Serious reactions

Hypersensitivity reactions have been reported and require immediate discontinuation of the infusion and medical attention. In severely malnourished patients, refeeding with carbohydrate-containing solutions can trigger thiamine (vitamin B1) deficiency (refeeding syndrome); those at higher risk include patients with a history of alcohol misuse, anorexia nervosa, or prolonged fasting.

Pregnancy

This type of parenteral nutrition solution is used in pregnancy when the mother cannot obtain adequate nutrition orally and intravenous nutritional support is clinically necessary, under close medical and, where relevant, obstetric supervision. Pregnant women with hyperemesis gravidarum are noted as a group at higher risk of refeeding-related thiamine deficiency if severely malnourished before treatment begins.

Breastfeeding

Use during breastfeeding should be guided by the treating medical team based on the mother's nutritional needs and clinical condition.

• Use with caution in patients with diabetes mellitus, severe heart failure, or renal impairment requiring fluid restriction, or in patients with oliguria/anuria from other causes.
• In patients with hyperglycemia, administration of exogenous insulin might be necessary alongside this solution.
• In severely malnourished patients, refeeding with carbohydrate-containing solutions can trigger thiamine deficiency syndrome; thiamine supplementation should be considered before or with the start of feeding in high-risk patients.
• Monitor plasma electrolytes, fluid balance, and blood glucose regularly during use, particularly with prolonged infusion.
• Intravenous amino acid infusion increases urinary loss of trace elements such as zinc and copper; this should be accounted for in long-term nutritional support.

Excessive or too-rapid infusion may cause fluid overload, electrolyte disturbances, or hyperglycemia related to the carbohydrate component. If overdose or an adverse reaction occurs, the infusion should be stopped immediately, the patient reassessed, and appropriate corrective measures instituted, such as fluid restriction or insulin administration, as clinically indicated by the treating physician.

Store at controlled room temperature as specified on the product container; protect from light, particularly for solutions used in neonates and young children. Do not use if the container seal is damaged or the solution appears cloudy, discolored, or contains particulate matter. Follow the specific product's own storage instructions, since these may vary by manufacturer and concentration.

• Elderly and severely ill patients: Infusion rate should be slowed and closely monitored.
• Neonates and children under 2 years: Solutions should be protected from light during administration; monitoring of phenylalanine levels is recommended in severely ill, premature infants, with infusion rate adjusted as needed.
• Patients with diabetes, severe heart failure, or renal impairment: Use with caution and close monitoring, as described under precautions.

Duration of parenteral nutrition support depends on how long the patient is unable to meet nutritional needs by mouth or enteral feeding, and is determined by the treating physician based on ongoing clinical assessment and nutritional requirements; it may range from a short course during acute illness to more extended support in prolonged recovery.

Drug Class: Intravenous amino acid and carbohydrate nutritional solution with added electrolytes

This solution bypasses the digestive system, delivering amino acids, carbohydrate calories, and electrolytes directly into the bloodstream, where the amino acids are used by the body's cells to build and repair proteins, and the carbohydrate component is metabolized for energy. This supports nutritional status in patients who cannot absorb or tolerate adequate nutrition through the gastrointestinal tract.

This type of amino acid, D-sorbitol, and electrolyte solution is used in pediatric patients, including infants, requiring parenteral nutrition, with dosing individualized based on the child's weight, nutritional requirements, and clinical condition. Solutions should be protected from light when used in neonates and children under 2 years of age, and premature or severely ill infants should have phenylalanine levels monitored, with the infusion rate adjusted as needed, under specialist supervision.