Usage
This combination medication is primarily prescribed for the treatment of nutritional deficiencies, especially deficiencies in B vitamins (including B12, B6, and B3), vitamin D3, copper, and zinc. It is indicated for conditions like:
- Megaloblastic anemia: Folic acid and Vitamin B12 are crucial for red blood cell formation, and their deficiency can lead to this type of anemia.
- Peripheral neuropathy: Methylcobalamin, a form of Vitamin B12, is essential for nerve health. This combination can help manage nerve damage symptoms like numbness, tingling, and pain.
- Vitamin D deficiency: This formulation can help address insufficient vitamin D levels, which are important for bone health, immune function, and overall well-being.
- General nutritional support: This combination may be prescribed to support overall health in individuals with poor nutrition, malabsorption issues, or increased nutritional needs.
Pharmacological Classification: This combination falls under several classifications including vitamin supplement, mineral supplement, and hematinic.
Mechanism of Action: This combination works by replenishing essential nutrients needed for various bodily functions: Folic acid is crucial for DNA synthesis and cell division; vitamin B12 (including methylcobalamin) is essential for nerve function and red blood cell production; vitamin D3 aids calcium absorption and bone health; niacinamide is involved in energy metabolism; zinc oxide contributes to immune function and wound healing; pyridoxine hydrochloride (vitamin B6) participates in various metabolic processes; and copper sulfate aids iron absorption and red blood cell formation.
Alternate Names
There’s no single non-proprietary name for this specific combination. It’s usually identified by its component ingredients. Brand names like Oxyrac-XT and Vitbuz are available in India. Regional variations in brand names may exist.
How It Works
Pharmacodynamics: Each component exerts its specific effects as described above. Collectively, they contribute to improved red blood cell production, nerve function, bone health, immune response, and energy metabolism.
Pharmacokinetics:
- Absorption: The individual components are absorbed through the gastrointestinal tract, with varying degrees and mechanisms.
- Metabolism: Some components, such as vitamin D3, undergo metabolic activation in the liver and kidneys.
- Elimination: The elimination pathways vary for each ingredient. Water-soluble vitamins like B vitamins and niacinamide are primarily excreted renally. Vitamin D3 metabolites are eliminated through bile and feces. Zinc and copper are excreted primarily in feces.
Mode of Action (at cellular/molecular level):
- Folic acid: Converted to tetrahydrofolic acid, a cofactor in DNA synthesis and amino acid metabolism.
- Methylcobalamin: A coenzyme for methionine synthase, involved in myelin formation and DNA synthesis.
- Vitamin D3: Binds to vitamin D receptors, regulating calcium absorption, bone metabolism, and immune function.
- Niacinamide: Precursor to NAD and NADP, essential coenzymes for various metabolic reactions.
- Pyridoxine: Converted to pyridoxal 5’-phosphate, a coenzyme in various metabolic pathways.
Dosage
Dosage is individualized based on the specific deficiency, patient age, and other factors. Always follow the physician’s prescribed dosage.
Standard Dosage
Adults: No standard adult dosage exists for this specific combination. Dosage will depend on the specific deficiency.
Children: Pediatric dosing must be determined by a physician based on the child’s age, weight, and specific needs.
Special Cases:
- Elderly Patients: Dosage may require adjustment based on renal function and other health factors.
- Patients with Renal Impairment: Dose adjustment may be required.
- Patients with Hepatic Dysfunction: Dose adjustments may be considered for some components, particularly vitamin D.
- Patients with Comorbid Conditions: Dosage should be individualized based on specific comorbidities.
Clinical Use Cases: This combination is typically not used in acute clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. Its primary role is in addressing nutritional deficiencies.
Dosage Adjustments: Dosages need adjustments depending on individual patient needs and factors such as renal/hepatic function and other health conditions.
Side Effects
Common Side Effects: This combination is generally well-tolerated. Some possible side effects may include mild gastrointestinal upset, nausea, or allergic reactions in susceptible individuals.
Rare but Serious Side Effects: Rare but serious side effects can include hypercalcemia (with excessive vitamin D intake), copper toxicity (rare), or severe allergic reactions.
Long-Term Effects: Long-term effects are uncommon with appropriate dosing. However, excessive vitamin D intake can lead to chronic hypercalcemia and its associated complications.
Adverse Drug Reactions (ADR): Clinically significant ADRs are rare but can occur.
Contraindications
- Hypersensitivity: Known allergy to any of the components.
- Hypercalcemia: In patients with pre-existing hypercalcemia, excessive vitamin D may exacerbate the condition.
- Wilson’s disease: Patients with Wilson’s disease should avoid copper supplementation.
- Severe renal impairment: Dose adjustments may be needed.
Drug Interactions
- Levothyroxine: Zinc may interfere with the absorption of levothyroxine. Separate administration by several hours is recommended.
- Certain antibiotics: Some antibiotics like tetracyclines and quinolones may interact with zinc and copper, reducing their absorption.
- Antacids: Antacids can decrease the absorption of some components, particularly copper and zinc.
- Anticonvulsants: May interact with certain B vitamins.
Pregnancy and Breastfeeding
This combination is generally considered safe during pregnancy and breastfeeding when taken in recommended doses. However, always consult with a physician to ensure appropriate dosing and to evaluate potential risks and benefits. Excessive vitamin D intake during pregnancy should be avoided.
Drug Profile Summary
- Mechanism of Action: Replenishes essential vitamins and minerals.
- Side Effects: Generally well-tolerated. Potential for GI upset, allergic reactions.
- Contraindications: Hypersensitivity, hypercalcemia, Wilson’s disease.
- Drug Interactions: Levothyroxine, certain antibiotics, antacids.
- Pregnancy & Breastfeeding: Generally safe in recommended doses.
- Dosage: Individualized based on specific needs.
Popular Combinations: This combination is often prescribed alone. However, it might be combined with other supplements like iron in certain cases.
Precautions
Assess for existing deficiencies, renal/hepatic function, and potential drug interactions before prescribing. Monitor for adverse effects.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Copper Sulphate + Folic Acid + Methylcobalamin + Niacinamide + Pyridoxine Hydrochloride + Vitamin B12 + Vitamin D3 + Zinc Oxide?
A: There is no standard recommended dosage. It is individualized based on specific deficiency and patient factors. Consult a physician for proper dosage determination.
Q2: Can pregnant women take this combination?
A: Generally considered safe in recommended doses, but consult a physician for proper evaluation.
Q3: Are there any interactions with alcohol?
A: Alcohol can interfere with the absorption and metabolism of certain B vitamins.
Q4: What should I do if I miss a dose?
A: Take the missed dose as soon as remembered, unless it is close to the next dose. Do not double up on doses.
Q5: Can this combination be used in children?
A: Yes, but dosing must be determined by a physician.
Q6: What are the signs of vitamin D toxicity?
A: Nausea, vomiting, constipation, weakness, confusion, and irregular heart rhythm.
Q7: How long does it take to see improvement with this combination?
A: This depends on the severity of the deficiency and individual response.
Q8: Can this combination be crushed or chewed?
A: Consult a physician or pharmacist for appropriate administration instructions based on the specific product formulation (e.g., softgel capsule).
Q9: What are the storage recommendations?
A: Store as directed on the product packaging, typically in a cool, dry place away from direct sunlight.
