Decapreno Amp

Decapreno Amp

Description:

Decapreno Amp (Decapreno 200,000 iu/1 ml solution for intramuscular or oral use, 2 ampoules) is a high‑potency vitamin d3 (cholecalciferol) medicinal preparation used to correct and prevent severe vitamin d deficiency and related bone and mineral disorders. Each ampoule contains concentrated cholecalciferol designed for use under medical supervision in patients requiring rapid or intensive vitamin d repletion, such as refractory rickets, hypocalcemia, and renal osteodystrophy. It is classified as a medicine and should be used strictly according to a physician’s prescription and dosing schedule.

Indications:

• Treatment of vitamin d deficiency or insufficiency confirmed or suspected by a healthcare professional.
• Refractory rickets (vitamin d–resistant rickets) in children and adults as part of a comprehensive treatment plan.
• Familial hypophosphatemia associated with disordered phosphate and vitamin d metabolism.
• Hypoparathyroidism requiring vitamin d3 support to help maintain normal calcium levels.
• Management of hypocalcemia in patients where vitamin d deficiency contributes to low serum calcium.
• Renal osteodystrophy in patients with chronic renal failure undergoing dialysis, as part of bone and mineral disorder management.
• Adjunctive therapy with calcium in the management and prevention of primary osteoporosis.
• Adjunctive therapy with calcium in the management and prevention of corticosteroid‑induced osteoporosis.

Active Ingredients / Key Components:

• Cholecalciferol (Vitamin D3) – 200,000 iu per 1 ml solution (per ampoule).
• Pharmaceutical form: Sterile solution for intramuscular injection or oral administration.
• Excipients: Specific excipients and their concentrations are not provided in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.).

Dosage & Administration / How to Use:

• Decapreno Amp is a prescription‑only high‑dose vitamin d3 medicine; dosing must be individualized by a physician based on age, severity of deficiency, underlying disease, and laboratory results (serum calcium, phosphate, and 25‑oh vitamin d).
• Route of administration: Intramuscular (i.m.) injection or oral use, as directed by the prescribing doctor.
• Typical medical practice (for reference only, not a prescription): High‑dose vitamin d3 such as 200,000 iu may be given as a single dose or repeated at intervals (e.g., every few weeks or months) depending on indication and response. Exact regimen must be set by the treating physician.
• For intramuscular use, the ampoule should be administered slowly and deeply into a large muscle (e.g., gluteal muscle) by trained healthcare personnel under aseptic conditions.
• For oral use, the content of the ampoule may be mixed with a small amount of liquid or taken directly into the mouth, as instructed by the healthcare provider. It may be taken with or without food, but consistent administration as advised is recommended.
• Regular monitoring of serum calcium, phosphate, and vitamin d levels is recommended during treatment, especially in patients with renal impairment, sarcoidosis, or other granulomatous diseases.
• Do not exceed the prescribed dose or frequency. High doses of vitamin d3 can cause serious toxicity if misused.
• If a dose is missed, contact your doctor for advice; do not double the next dose without medical approval.

Clinical Benefits:

• Helps correct severe vitamin d deficiency, supporting normal calcium and phosphate absorption from the gut.
• Contributes to the prevention and treatment of rickets and osteomalacia by promoting proper bone mineralization.
• Supports management of osteoporosis (primary and corticosteroid‑induced) when used with adequate calcium intake, helping maintain bone strength and reduce fracture risk.
• Assists in the control of hypocalcemia and bone disease in patients with chronic kidney disease and renal osteodystrophy.
• Supports neuromuscular function and may help reduce symptoms related to low calcium such as muscle cramps and tetany when part of a complete treatment plan.

Warnings & Contraindications:

• Contraindicated in patients with hypersensitivity to cholecalciferol (vitamin d3) or any component of the formulation.
• Contraindicated in hypercalcemia, hypervitaminosis d, and most cases of severe hyperparathyroidism unless specifically directed by a specialist.
• Use with extreme caution in patients with renal impairment, nephrolithiasis (kidney stones), sarcoidosis or other granulomatous diseases, and in those with a history of vitamin d hypersensitivity.
• High‑dose vitamin d3 can cause prolonged hypercalcemia; regular monitoring of serum calcium, phosphate, and renal function is essential, especially with repeated dosing.
• Consult your doctor before use if pregnant or nursing; vitamin d requirements may change during pregnancy and lactation, and high doses must be medically justified.
• Consult your doctor before use if you are taking other medications such as thiazide diuretics, digoxin or other cardiac glycosides, anticonvulsants (e.g., phenytoin, phenobarbital), corticosteroids, or other vitamin d or calcium products, due to potential interactions and risk of hypercalcemia or altered vitamin d metabolism.
• Not intended for self‑medication or routine supplementation; this is a high‑dose medicinal product that must be used under medical supervision only.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical evaluation and prescription.
• Keep out of reach of children.
• If symptoms of vitamin d overdose or hypercalcemia occur (such as nausea, vomiting, constipation, excessive thirst, frequent urination, weakness, confusion), stop treatment and seek medical attention immediately.

Side Effects:

• Possible side effects are mainly related to excessive vitamin d and resulting hypercalcemia, especially with high or prolonged dosing.
• Common signs of hypercalcemia may include nausea, vomiting, constipation, abdominal pain, loss of appetite, excessive thirst, increased urination, muscle weakness, fatigue, headache, and dry mouth.
• Serious side effects of prolonged hypercalcemia can include kidney stones, nephrocalcinosis, renal impairment, cardiac rhythm disturbances (especially in patients on cardiac glycosides), confusion, or altered mental status.
• Local reactions at the injection site (pain, redness, swelling) may occur after intramuscular administration.
• Allergic reactions (rash, itching, swelling, dizziness, breathing difficulties) are rare but require immediate medical attention.
• If you experience any unusual or severe symptoms, stop using the product and contact your doctor or seek emergency medical care.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed and protect ampoules from light and heat. Do not use after the expiry date printed on the pack. Keep out of reach of children.

Specifications:

• Form: Solution for intramuscular or oral use.
• Strength: 200,000 iu cholecalciferol (vitamin d3) per 1 ml ampoule.
• Pack size: 2 ampoules per pack.
• Intended use: Prescription medicine for treatment and prevention of vitamin d deficiency and related bone and mineral disorders, under medical supervision.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.