Aritone IV Injection or Infusion 10ml

✔️ Composition:

Each vial contains a carefully balanced blend of essential water-soluble vitamins necessary for energy metabolism, cellular function, and overall health maintenance:

• Vitamin B1 (Thiamine Mononitrate USP) – 2.5 mg: Supports energy production and nerve function.
• Vitamin B2 (Riboflavin Sodium Phosphate BP) – 3.6 mg: Plays a key role in metabolic processes and cellular energy production.
• Nicotinamide BP – 40 mg: Essential for enzyme function and skin health.
• Pantothenic Acid (Dexpanthenol USP) – 15 mg: Vital for synthesizing coenzyme A, necessary for metabolism.
• Vitamin B6 (Pyridoxine Hydrochloride BP) – 4 mg: Supports amino acid metabolism and neurotransmitter function.
• Biotin BP – 0.06 mg: Important for skin, hair, and metabolic health.
• Folic Acid BP – 0.4 mg: Crucial for DNA synthesis and red blood cell production.
• Vitamin B12 (Cyanocobalamin BP) – 0.005 mg: Necessary for nerve function and the formation of red blood cells.
• Ascorbic Acid (Sodium Ascorbate USP) – 100 mg: A powerful antioxidant that enhances immune function and collagen synthesis.

✔️ Dosage:

Dosage should be determined based on age, body weight, and clinical condition of the patient.

• For adults and children weighing 10 kg or more: The recommended dose is 1 vial (10 ml) per day.
• For children weighing less than 10 kg: The appropriate dosage is 1 ml per kg of body weight per day.

✔️ Reconstitution Process & Compatibility Considerations:

Before administration, the lyophilized powder must be dissolved using an appropriate diluent. The contents of one vial should be reconstituted by adding 10 ml of any of the following sterile solutions:

1. Water for Injection (WFI)
2. Fat Emulsion (10%)
3. Glucose Solution for Infusion (5% to 60%)
4. Normal Saline (0.9% Sodium Chloride)

Compatibility Considerations:

• This IV supplement can be safely added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes, and trace elements, provided compatibility and stability have been confirmed.

✔️ Method of IV Injection Preparation:

1. Using a sterile syringe, withdraw 10 ml of Water for Injection (WFI) from the provided ampoule.
2. Inject the WFI into the vial containing the lyophilized powder.
3. Mix the solution gently to ensure complete dissolution of the powder.
4. Withdraw the entire reconstituted solution into the syringe.
5. Administer via slow intravenous injection (over at least 10 minutes).

Always follow aseptic techniques during preparation and administration.

✔️ Overdose Effects:

• No significant adverse effects have been reported from excessive intake of water-soluble vitamins.
• However, extremely high parenteral doses may cause toxicity, particularly if the supplement is combined with another multivitamin injection containing fat-soluble vitamins (A & D).
• If an overdose occurs, medical supervision is required to monitor potential symptoms.

✔️ Potential Side Effects:

Most patients tolerate the formulation well. However, in rare cases, allergic reactions may occur, particularly in those sensitive to Thiamine or other components. Symptoms may include:

• Skin reactions (rash, itching, or redness).
• Swelling, difficulty breathing, or anaphylaxis (in severe cases).

✔️ Certain medications may interact with specific vitamins in the formulation:

• Vitamin B6 (Pyridoxine) may reduce the therapeutic effect of Levodopa, a medication used for Parkinson’s disease.
• Folic Acid may lower the serum concentration of Phenytoin, potentially reducing its effectiveness in controlling seizures.

Consult a physician before co-administering with other medications.

✔️ Multivitamin [Vitamin B complex + Vitamin C] should not be used in individuals with:

• Known hypersensitivity to any of the components, particularly Thiamine (Vitamin B1).
• Severe allergic reactions to B-complex vitamins in the past.

✔️ Use in Pregnancy & Lactation:

• No extensive clinical studies have been conducted to assess the safety of this IV supplement during pregnancy.
• However, water-soluble vitamins are generally considered safe for pregnant and lactating women when administered at recommended doses.
• Pregnant and breastfeeding women should use this supplement only under medical supervision.

✔️ Precautions & Warnings:

• When diluted with water-based solutions, the prepared mixture must be protected from light to prevent degradation of light-sensitive vitamins.
• If diluted with a fat emulsion (e.g., Intralipid), protection from light is not required as the fat emulsion acts as a protective barrier.
• Always check the compatibility of this supplement before mixing it with other IV solutions.

✔️ Before reconstitution:

• Store below 25°C in a cool, dry place, protected from light.
• Keep out of reach of children.

✔️ After reconstitution:

• The prepared solution should be aseptically added to the infusion solution immediately before administration.
• Use within 24 hours to maintain potency and prevent contamination.