Miura-D 5 mg/mL Injection – Vitamin D3 Solution, 1 Ampoule

Description

Miura-D is an injectable formulation of cholecalciferol (vitamin D3) in a concentration of 5 mg/mL. It is used in medical settings to rapidly correct or prevent vitamin D deficiency, especially when oral supplementation is inadequate or not possible. 

Ingredients

• Active ingredient: Cholecalciferol (Vitamin D3) – 5 mg per mL

• Excipients / vehicle: as per manufacturer (sterile solvent, stabilizers) 

Drug Class

• Vitamin / Nutritional supplement

• Fat-soluble vitamin (Vitamin D3 class)

Dosage Form

• Sterile solution in 1 mL ampoule

• Single-use injection

Uses / Indications

Miura-D is indicated for:

• Prevention and treatment of vitamin D deficiency / insufficiency due to malabsorption, gastrointestinal disease, or inadequate dietary intake 

• Conditions such as rickets, osteomalacia, hypocalcemia, or bone health support in patients at risk of deficiency 

• Adjunct therapy in bone disorders (for example osteoporosis) in some clinical settings

Dosage

• Typical injectable dose and schedule should be determined by a physician, based on serum vitamin D levels, patient condition, and route of administration (e.g. 5 mg = 200,000 IU approximate).

• In many protocols, a single high dose is given initially, followed by maintenance with oral vitamin D. 

• Repeat dosing only under supervision, considering risk of toxicity.

In Case of Overdose

• Vitamin D overdose can lead to hypervitaminosis D, manifesting as hypercalcemia: nausea, vomiting, weakness, polyuria, polydipsia, confusion, arrhythmias, soft tissue calcification, kidney damage.

• Management includes discontinuation of vitamin D, limiting calcium intake, hydration, use of corticosteroids or bisphosphonates, and monitoring/evaluation by a specialist.

Missed Dose

• Infrequent dosing schedule – if a dose is missed, administer as soon as possible if safe.

• Avoid doubling doses or aggressive catch-up dosing, as this raises risk of toxicity.

How To Use / Administration Instructions

1. Inspect ampoule: the solution should be clear, free from visible particles or discoloration.

2. Use aseptic technique to open ampoule and draw dose with sterile syringe.

3. Administer intramuscular (IM) or slow intravenous (IV) injection (depending on protocol).

4. Avoid rapid injection to reduce local irritation.

5. Monitor the patient for adverse reactions.

When Not to Use / Contraindications

• Known hypersensitivity to cholecalciferol or excipients

• Hypercalcemia or hypercalciuria

• Disorders associated with high vitamin D levels (e.g., sarcoidosis, certain granulomatous diseases)

• Conditions predisposing to soft tissue calcification or kidney stones

• Severe renal impairment (unless under specialist direction)

Side Effects / Adverse Reactions

Common / mild:

• Injection site discomfort, pain, redness

• Nausea, vomiting

• Weakness, fatigue

• Hypercalcemic symptoms when excessive (as above)

Serious / rare:

• Hypercalcemia complications (renal damage, arrhythmias, neurologic changes)

• Soft tissue / vascular calcification

• Allergic reactions (rash, itching, swelling, anaphylaxis)

Precautions & Warnings

• Monitor serum calcium, phosphate, renal function, and vitamin D levels during therapy

• Use caution in patients with renal disease or risk of hypercalcemia

• Avoid concurrent high-dose calcium supplementation unless warranted

• In chronic use, periodic reassessment is necessary

• Use minimal effective dose to reduce risk of toxicity

Drug Interactions

• Thiazide diuretics: can increase risk of hypercalcemia

• Glucocorticoids: may antagonize vitamin D’s effects on calcium absorption

• Anticonvulsants (e.g. phenytoin, phenobarbital): may increase catabolism of vitamin D

• Magnesium deficiency: may impair vitamin D’s efficacy

• Other interactions depending on calcium and phosphate balance

Storage / Disposal

• Store ampoules as per label (typically cool, protected from light)

• Do not freeze

• Use immediately after opening; discard any unused portion

• Dispose of used ampoules and needles per biomedical waste protocols

Control Drug / Prescription Status

• This is a prescription medication (not typically available over the counter)

• Use should be supervised by a healthcare professional

Quick Tips

• Miura-D delivers a high dose of vitamin D3 in injectable form, useful where oral absorption is impaired or rapid correction is required

• Monitor labs (calcium, vitamin D, renal) before repeating doses

• Avoid overlapping with large oral vitamin D/calcium supplements without supervision

• Educate patients to report symptoms of hypercalcemia (thirst, weakness, frequent urination, confusion)