Description

(Sterile Cholecalciferol in Oil Suspension for IM Use – Hormonal & Immune Support)

Clinically Compounded Oil-Based Vitamin D3 for Hormone Balance, Immune Resilience, and Bone Health

Vitamin D3 (Cholecalciferol) 500 IU/mL – 10 mL Injection is a sterile, oil-based formulation of fat-soluble vitamin D3, designed for intramuscular (IM) use under clinical supervision. Suspended in a biocompatible oil carrier, this injectable form delivers consistent absorption and long-acting effects for patients with deficient serum 25(OH)D levels, fat malabsorption syndromes, or high physiological demand.

Cholecalciferol (vitamin D3) is an essential prohormone involved in bone mineralization, calcium and phosphate homeostasis, immune system modulation, and mood stabilization. This injectable form bypasses the gastrointestinal tract, offering a highly bioavailable and tolerable solution for replenishing low vitamin D levels in individuals who may not respond well to oral supplementation.

Product Specifications

• Active Ingredient: Cholecalciferol (Vitamin D3)

• Concentration: 500 IU/mL

• Formulation: Sterile oil-based solution for IM injection

• Total Volume: 10 mL (multi-dose vial)

• Route: Intramuscular (IM) only – not for intravenous use

• Preservative-Free: Minimizes injection site reactions and hypersensitivity risk

• Carrier: Sterile natural oil (e.g., sesame, olive, or MCT – varies by compounding pharmacy)

• Storage: Refrigerated (2–8°C); protect from light

Key Clinical Benefits

1. Corrects Deficiency Efficiently

Vitamin D3 injections are ideal for patients with:

• Chronic vitamin D deficiency (25(OH)D <30 ng/mL)

• Fat malabsorption syndromes (e.g., celiac disease, IBS, bariatric surgery)

• Non-compliance or poor absorption with oral supplements

IM injection ensures predictable absorption and long-term storage in body fat, with less frequent dosing required compared to oral forms.

2. Bone and Calcium Homeostasis

• Promotes calcium and phosphorus absorption in the gut

• Reduces risk of osteopenia, osteoporosis, and fractures

• Supports bone remodeling and muscle strength, especially in aging populations

3. Immune Function and Inflammation Modulation

• Enhances innate and adaptive immune responses

• Reduces risk and severity of respiratory infections, including influenza and viral illnesses

• Plays a regulatory role in autoimmune disorders (e.g., MS, RA, IBD)

4. Mood and Hormonal Regulation

• Influences dopaminergic and serotonergic pathways

• May alleviate depressive symptoms and improve seasonal affective disorder (SAD)

• Supports testosterone and estrogen balance indirectly through hormone-sensitive tissues

Clinical Use Cases

• Severe or chronic vitamin D deficiency requiring parenteral correction

• Supportive therapy in patients with osteoporosis, osteomalacia, or low BMD

• Prevention of falls and fractures in geriatric populations

• Adjunct in immune or chronic inflammatory conditions

• Post-bariatric or GI surgery nutrient repletion

• Hormonal health optimization (e.g., male and female HRT protocols)

Dosage and Administration

• Route: Intramuscular only – typically administered into the gluteal muscle

• Dosage: Clinician-determined based on baseline 25(OH)D level and maintenance goals
  • Common protocols include weekly or monthly dosing

  • 1 mL = 500 IU; typical repletion ranges from 2,000–10,000 IU/week

• Monitoring: Serum 25(OH)D levels should be reassessed every 8–12 weeks during repletion

Caution: Over-supplementation may lead to hypervitaminosis D and hypercalcemia. Dosing must be clinically supervised.

Tolerability and Safety

This formulation is well tolerated when administered properly and monitored.

Potential adverse effects (typically from overdose):

• Hypercalcemia (nausea, vomiting, muscle weakness, kidney stones)

• Local irritation at injection site (rare with oil-based, preservative-free formulation)

Contraindications:

• Known hypercalcemia or hypervitaminosis D

• Active sarcoidosis or granulomatous disorders

• Hypersensitivity to oil carrier (specify before use)

Storage and Handling

• Store in a refrigerator at 2–8°C

• Protect from light and freezing

• Use aseptic technique for every vial access

• Discard any unused portion within 28 days of first puncture (multi-dose protocol)

Ideal For Use In:

• Endocrinology and HRT clinics

• Functional and integrative medicine centers

• Primary care or geriatrics managing osteoporosis risk

• Wellness and longevity practices

• IV and injection-based nutrient therapy settings

Summary

Vitamin D3 Injection – 500 IU/mL, 10 mL Oil-Based Vial delivers targeted, long-lasting vitamin D support for patients requiring non-oral administration, offering a highly effective solution for correcting deficiencies, optimizing calcium balance, and enhancing immune and mood stability. Safe, reliable, and clinically versatile, it is a cornerstone therapy for nutrient optimization protocols.