Clinutren Optimum (Food product) Instructions for Use

Marketing Authorization Holder

Nestle Suisse, S.A. (Switzerland)

ATC Code

V06DB (Complex of proteins, fats, carbohydrates, minerals and vitamins)

Dosage Form

Clinutren Optimum

Dry mixture 400 g: jars

Dosage Form, Packaging, and Product Composition

400 g – jars.

Indications

• Clinutren Optimum is indicated for the dietary management of patients with or at risk of disease-related malnutrition.
• It is suitable as a complete oral nutritional supplement or for enteral tube feeding for individuals who cannot meet their nutritional requirements through regular food intake alone.
• This product is specifically formulated to provide high-quality protein and a balanced mix of macronutrients and micronutrients to support nutritional status, muscle mass, and overall health.
• It may be used in a variety of clinical conditions associated with increased nutritional needs or reduced intake, such as during convalescence after illness or surgery, in the context of chronic diseases, or for geriatric patients with unintentional weight loss.

Therapeutic Category

Nutritional mixture for enteral tube or oral application

Dosage Regimen

The dosage of Clinutren Optimum must be individualized based on the patient’s nutritional requirements, clinical condition, and tolerance, under the supervision of a healthcare professional.

For oral administration: Shake the prepared liquid well before drinking. It can be consumed as a sip feed throughout the day. The recommended daily volume is typically 1 to 3 bottles (approximately 500 ml to 1500 ml of the ready-made mixture), but this can vary significantly.

For enteral tube administration: Administer via a suitable feeding tube. The flow rate and volume should be determined by a doctor or dietitian, starting with a lower rate and gradually increasing as tolerated to the target volume. Tube patency must be maintained by flushing with water before and after administration.

Preparation instructions: To prepare 200 ml of the ready-to-use mixture, gradually add 130 ml of drinking water at room temperature to 55 g (approximately 6 level scoops) of dry powder. Stir or shake vigorously until completely dissolved. For 1 liter, use 400 g of powder and 870 ml of water. Use the measuring scoop provided. The prepared mixture should be used immediately or stored in a sealed container in a refrigerator for up to 24 hours. Do not store the prepared mixture for longer than 24 hours.

Adverse Reactions

Adverse reactions to Clinutren Optimum are generally mild and transient, often related to the gastrointestinal system, especially at the start of therapy or with rapid introduction.

Common adverse reactions may include nausea, abdominal discomfort, bloating, flatulence, diarrhea, or constipation. These symptoms often subside as the patient’s system adapts to the nutritional formula.

Less frequently, vomiting or regurgitation may occur. In rare cases, allergic reactions to any of the ingredients, such as milk proteins or soy lecithin, may manifest as skin rashes, itching, or more severe symptoms. If any signs of intolerance or allergic reaction appear, discontinue use and consult a healthcare professional.

Long-term use at high volumes without medical supervision could potentially lead to electrolyte imbalances or vitamin and mineral excesses, particularly in patients with compromised renal or hepatic function.

Drug Interactions

As a nutritionally complete food for special medical purposes, Clinutren Optimum is not known to cause specific pharmacodynamic drug interactions. However, its composition should be considered in the context of the patient’s overall diet and medication regimen.

The product contains vitamin K (as menadione), which can potentially interfere with the activity of vitamin K antagonist anticoagulants such as warfarin. Patients on such therapy should have their INR monitored closely when starting, stopping, or changing the dosage of this nutritional supplement, and the dietary vitamin K intake should be kept consistent.

The high calcium and magnesium content may bind to certain oral medications, such as tetracycline and fluoroquinolone antibiotics or bisphosphonates, reducing their absorption. A time gap of at least 2 hours, and preferably 4 hours, is recommended between the administration of such drugs and the nutritional formula.

For patients with diabetes, the carbohydrate content (126.3 g/l) must be accounted for in the overall daily carbohydrate allowance and may necessitate adjustments in insulin or other glucose-lowering medications. Blood glucose should be monitored regularly.

Contraindications

• Absolute contraindications include known hypersensitivity (allergy) to any of the ingredients, such as milk proteins or soy lecithin.
• It is contraindicated in patients with severe renal impairment (not on dialysis) or severe hepatic impairment where protein, electrolyte, or fluid restriction is medically necessary, due to the product’s specific nutrient profile.
• This product is not suitable for patients with galactosemia, as it contains lactose.
• It is not intended for parenteral administration and is contraindicated for intravenous use.
• Use is contraindicated in conditions where enteral nutrition is not possible or is medically inappropriate, such as in complete intestinal obstruction, ileus, or severe acute pancreatitis where enteral feeding is not indicated.

Overdose

Overdose with Clinutren Optimum as a single acute event is unlikely. However, chronic excessive intake beyond prescribed nutritional goals can lead to complications.

Excessive consumption may result in hypervitaminosis or mineral toxicity, particularly with fat-soluble vitamins (A, D, E, K) which can accumulate in the body. Symptoms could include nausea, headache, hypercalcemia, or liver abnormalities.

Due to the high protein and electrolyte content, prolonged significant overdose in susceptible individuals, particularly those with pre-existing renal or cardiac conditions, could contribute to dehydration, electrolyte imbalances (hypernatremia, hyperkalemia), azotemia, or fluid overload.

Management of overdose involves discontinuing the product and providing supportive care based on the presenting symptoms. This may include correction of fluid and electrolyte imbalances. There is no specific antidote. In case of suspected overdose, seek immediate medical attention.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.