Valupak Vitamin D3 5000IU Tablets 30’s

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Valupak Vitamin D3 5000IU Tablets 30’s

Review By MIYINGO Ivan, B. Pharm, MPS.


1. Product Name

Valupak Vitamin D3 5000IU Tablets 30’s

Generic Name: Cholecalciferol (Vitamin D3)

Dosage Form: Film-coated tablet

Strength: 5000 International Units (IU) per tablet

Pack Size: 30 tablets per blister pack

2. Composition

IngredientAmount per TabletRole
Cholecalciferol (Vitamin D3)5000 IUActive ingredient; supports calcium absorption, bone health, and immune function
Microcrystalline celluloseq.s.Binder/filler
Sodium starch glycolateq.s.Disintegrant
Magnesium stearateq.s.Lubricant
Hypromelloseq.s.Tablet coating
Titanium dioxideq.s.Opacifier/colorant
Lactose monohydrateq.s.Filler

Excipients are pharmaceutically inactive but essential for tablet stability, release, and patient compliance.

3. Pharmacological Properties

3.1. Pharmacodynamics

Vitamin D3 (Cholecalciferol) is a fat-soluble secosteroid essential for calcium and phosphorus homeostasis. It is metabolized in the liver to 25-hydroxyvitamin D (calcidiol) and then in the kidneys to 1,25-dihydroxyvitamin D (calcitriol), the biologically active form.

  • Enhances intestinal absorption of calcium and phosphorus.

  • Regulates bone mineralization and remodeling.

  • Modulates immune system activity, contributing to both innate and adaptive immunity.

  • Supports normal muscle function and cellular growth and differentiation.

3.2. Pharmacokinetics

  • Absorption: Rapidly absorbed in the small intestine with dietary fat; peak plasma levels occur within 12–24 hours.

  • Distribution: Highly lipophilic; stored in liver, adipose tissue, and muscle.

  • Metabolism: Converted in the liver to 25-hydroxycholecalciferol (calcidiol) and then in kidneys to 1,25-dihydroxycholecalciferol (calcitriol).

  • Elimination: Half-life of 25-hydroxycholecalciferol ~15 days; excreted primarily in bile and feces.

4. Indications

  • Prevention and treatment of vitamin D deficiency.

  • Support of bone health, particularly in adults at risk of osteoporosis or osteomalacia.

  • Adjunct therapy for calcium supplementation.

  • Maintenance of normal immune system function.

  • Individuals with limited sun exposure or malabsorption syndromes.

5. Dosage and Administration

  • Adults: 1 tablet (5000 IU) daily, preferably with food to enhance absorption.

  • Duration: As prescribed by a healthcare provider; typically short-term correction of deficiency or as maintenance in high-risk patients.

  • Special Populations:

    • Elderly: Same dose, monitor serum vitamin D levels.

    • Renal impairment: Monitor calcium and vitamin D levels.

    • Pregnancy/lactation: Only if indicated by a physician; avoid excessive dosing.

Do not exceed recommended dosage to prevent hypervitaminosis D.

6. Contraindications

  • Hypercalcemia or hypervitaminosis D.

  • Severe renal impairment without supervision.

  • Known hypersensitivity to vitamin D3 or any excipients.

7. Warnings and Precautions

  • Excessive intake may cause hypercalcemia, hypercalciuria, and soft tissue calcification.

  • Patients with sarcoidosis, tuberculosis, or other granulomatous diseases should use cautiously.

  • Monitor serum calcium and vitamin D levels during prolonged use.

  • Not a substitute for a balanced diet and sunlight exposure.

8. Drug Interactions

  • Corticosteroids: May reduce vitamin D activity.

  • Orlistat and cholestyramine: May decrease absorption.

  • Thiazide diuretics: Risk of hypercalcemia increases.

  • Anticonvulsants (e.g., phenytoin, phenobarbital): May increase vitamin D metabolism, reducing efficacy.

9. Adverse Effects

Generally well tolerated; adverse effects are rare at recommended doses:

  • Mild: Constipation, nausea, stomach discomfort.

  • Moderate: Hypercalcemia (fatigue, headache, polyuria).

  • Severe (rare, usually with overdose): Kidney stones, vascular calcification, arrhythmias.

10. Overdose

  • Symptoms: Hypercalcemia, nausea, vomiting, polyuria, dehydration, kidney damage.

  • Management: Discontinue supplement, supportive therapy, hydration, monitoring of calcium and renal function.

11. Storage

  • Store at 20–25°C (room temperature).

  • Protect from moisture, heat, and light.

  • Keep out of reach of children.

12. Shelf Life

  • Typically 24 months from date of manufacture.

13. Pharmaceutical Packaging

  • Blister pack of 30 tablets per box.

  • Each tablet: Film-coated, white to off-white, round.

  • Packaging designed to maintain stability and prevent moisture ingress.

14. Regulatory Status

  • Classified as a dietary supplement / vitamin preparation.

  • May require local registration depending on country regulations.

____________________________
AUTHOR
MIYINGO Ivan
B. Pharm, MPS
+256700991510
miyingoivan@gmail.com


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