Aritone IV

Indications

This product serves as an intravenous nutritional supplement designed to fulfill the daily requirements for water-soluble vitamins in patients who are NPO (nothing by mouth) or undergoing surgery.
Consult a registered healthcare professional before use.

Composition

Each vial includes:

• Vitamin B1 (as Thiamine Mononitrate USP) – 2.5 mg
• Vitamin B2 (as Riboflavin Sodium Phosphate BP) – 3.6 mg
• Nicotinamide BP – 40 mg
• Pantothenic Acid (as Dexpanthenol USP) – 15 mg
• Vitamin B6 (as Pyridoxine Hydrochloride BP) – 4 mg
• Biotin BP – 0.06 mg
• Folic Acid BP – 0.4 mg
• Vitamin B12 (as Cyanocobalamin BP) – 0.005 mg
• Ascorbic Acid (as Sodium Ascorbate USP) – 100 mg

Pharmacology

This sterile, lyophilized powder consists of essential water-soluble vitamins intended for infusion. It provides a balanced mix of vital water-soluble vitamins that act as coenzymes for crucial enzymes involved in essential physiological functions, energy metabolism, cell growth, and maintenance, particularly in brain and nerve cells. Vitamin C serves as an antioxidant and plays a role in collagen synthesis. Administering this combination intravenously ensures rapid action.

Dosage & Administration

• Adults and children weighing 10 kg or more: 1 vial (10 ml) daily.
• Children weighing less than 10 kg: Administer 1 ml of the reconstituted solution per kg of body weight per day.

To prepare the contents of one vial, dissolve the lyophilized powder by aseptically adding 10 ml of one of the following:

• Water for injection
• 10% Fat emulsion
• Glucose solution for infusion (5% to 60%)
• Normal saline (0.9% Sodium Chloride)

The IV injection may also be incorporated into parenteral nutrition mixtures containing carbohydrates, lipids, amino acids, electrolytes, and trace elements, provided that compatibility and stability are confirmed.

IV Injection Preparation Method:

1. Using a sterile syringe, draw 10 ml of Water for Injection (WFI) from the provided ampoule.
2. Transfer it into the vial and gently mix to dissolve the lyophilized powder.
3. Withdraw all the reconstituted solution into the syringe.
4. Administer the solution slowly via IV injection, ensuring it is delivered over at least 10 minutes.

Consult a registered healthcare professional before use.

Interactions

Vitamin B6 may reduce the efficacy of Levodopa. Additionally, Folic Acid may decrease the serum levels of Phenytoin.

Contraindications

This product should not be used by individuals with known hypersensitivity to any of its components, such as Thiamine.

Side Effects

Allergic reactions may occur in individuals sensitive to any component of the formulation, including Thiamine.

Pregnancy & Lactation

While animal reproduction studies and clinical trials during pregnancy have not been conducted with this formulation, existing literature suggests that the administration of water-soluble vitamins is generally safe for this population.

Precautions & Warnings

When reconstituted with water-based solutions, the admixture should be shielded from light. This is unnecessary if diluted with intralipid due to the protective qualities of the fat emulsion.

Overdose Effects

Generally, no adverse effects from an overdose of water-soluble multivitamins have been reported, except in cases of excessively high parenteral dosages. Consider the risk of hypervitaminosis A and D if the lyophilized powder is diluted in another multivitamin injection.

Therapeutic Class

Multi-vitamin and Multi-mineral combined preparations.

Storage Conditions

Before reconstitution: Store below 25°C in a dry area, protected from light, and out of reach of children.
After reconstitution: The mixture should be added to the infusion solution aseptically immediately before the infusion begins and used within 24 hours.