ED-3 5 mg / 1 mL Injection (Cholecalciferol / Vitamin D3) — 1 Ampoule

Description

ED-3 is an injectable preparation of vitamin D3 (cholecalciferol) intended for intramuscular administration. It is often used in cases of severe vitamin D deficiency or when rapid replenishment is needed. It comes as a sterile solution in a 1 mL ampoule containing 5 mg of cholecalciferol (≈ 200,000 IU).

Ingredients

• Active ingredient: Cholecalciferol (Vitamin D3), 5 mg per 1 mL ampoule

• Excipients: As per manufacturer’s formulation (may include oils or solubilizers; check the specific leaflet)

Drug Class

• Vitamin / Nutritional supplement

• In particular, a fat-soluble vitamin (vitamin D3) used for correction of deficiency

Dosage Form

• A sterile solution in a 1 mL ampoule for intramuscular injection

• Single-use ampoule

Uses / Indications

ED-3 injection is indicated for:

• Treatment of vitamin D deficiency in cases where high dose or parenteral administration is required 

• Prevention of deficiency in individuals with malabsorption or gastrointestinal disorders impairing oral absorption

• In bone disease contexts such as osteomalacia, osteoporosis, or rickets (in conjunction with calcium)

Dosage

• A single dose of 5 mg (≈ 200,000 IU) is common for correction of deficiency in many protocols. Depending on response, repeat doses may be given (e.g. after several months) if deficiency persists.

• The exact dose and frequency should be determined by a physician based on patient’s vitamin D levels, calcium status, kidney function, and other clinical factors.

In Case of Overdose

• Vitamin D toxicity (hypervitaminosis D): May lead to hypercalcemia, which can cause symptoms such as nausea, vomiting, weakness, polyuria, polydipsia, confusion, arrhythmias, renal damage, and calcification of soft tissues.  

• Management is supportive: discontinue vitamin D, limit dietary calcium, ensure hydration, consider use of corticosteroids, bisphosphonates, or other measures to reduce calcium levels under medical supervision.

Missed Dose

• Infrequent dosing makes “missed dose” less critical; administer as soon as possible if safe and within protocol, or follow physician’s plan.

• Avoid doubling the next dose due to risk of toxicity.

How To Use / Administration Instructions

1. Inspect the ampoule visually; the solution should be clear (or as per label) and free of particulate matter or discoloration.

2. Use aseptic technique.

3. Administer via intramuscular injection, typically into large muscle (e.g. deltoid or gluteal).

4. Apply light pressure at injection site after administering; avoid rubbing.

5. Monitor for local reaction and general symptoms.

When Not to Use / Contraindications

• Known hypersensitivity / allergy to vitamin D3 or any excipient

• Hypercalcemia or hypercalciuria

• Conditions predisposing to hypercalcemia (e.g. sarcoidosis, certain granulomatous diseases)

• Severe renal impairment or sarcoidosis (unless benefits clearly outweigh risks)

• Patients with kidney stones or predisposition to calcification

Side Effects / Adverse Reactions

Common / mild:

• Pain or mild irritation at injection site

• Nausea, vomiting

• Weakness

• Increased thirst, frequent urination

Serious / less common:

• Hypercalcemia symptoms (as above)

• Kidney stones, renal impairment

• Soft tissue calcification

• Cardiac arrhythmias

• Neurological symptoms (confusion, lethargy)

Precautions & Warnings

• Monitor serum calcium, phosphate, and renal function periodically.

• Use caution in patients with renal disease.

• Avoid concomitant high-dose calcium supplements unless monitored.

• Be cautious when using with other vitamin D supplements to avoid cumulative overdose.

• Monitor for signs of hypercalcemia.

Drug Interactions

• Thiazide diuretics: may increase risk of hypercalcemia. Phenytoin, barbiturates: may increase metabolism of vitamin D, reducing its effect. 

• Glucocorticoids: may antagonize vitamin D effects on calcium absorption.

• Digoxin: risk of arrhythmias may increase with hypercalcemia.  

• Magnesium / aluminum antacids, cholestyramine: may impair absorption if oral forms used; less relevant for injection but may influence overall vitamin D status. 

Storage / Disposal

• Store at temperatures as per label (avoid excessive heat).

• Protect from light.

• Do not freeze.

• Dispose of used ampoules in sharps containers / follow biomedical waste regulations.

Control Drug / Prescription Status

• May be prescription or controlled, depending on local regulation (vitamin D injections usually require medical supervision).

• Should only be administered by a qualified healthcare professional.

Quick Tips

• Always verify the cumulative vitamin D intake from all sources (oral supplements, diet, injection) to avoid overdose.

• Use this injection especially in cases where oral absorption is impaired or rapid correction is needed.

• Monitor calcium and renal indicators before repeating doses.

• Educate patient on signs of hypercalcemia (nausea, confusion, frequent urination, muscle weakness).

• Label clearly and keep away from children.