Devarol 1Amp

Devarol 1Amp

Description:

Devarol 1Amp (Devarol-S 200,000 iu / 2 ml i.m. ampoule) is a prescription vitamin d3 (cholecalciferol) injectable medicine used to treat and prevent vitamin d deficiency and related bone and mineral disorders. Each intramuscular ampoule delivers a high-potency dose of vitamin d3 to rapidly correct deficiency when oral supplementation is insufficient or not suitable. Devarol is commonly used under medical supervision in adults and children with severe deficiency, refractory rickets, hypoparathyroidism, familial hypophosphatemia, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis. It may also be used with calcium in the prevention and management of primary or corticosteroid-induced osteoporosis.

Indications:

• Treatment of vitamin d deficiency or insufficiency confirmed by clinical assessment and/or laboratory tests.
• Refractory rickets (vitamin d–resistant rickets), as part of a comprehensive treatment plan.
• Familial hypophosphatemia and hypoparathyroidism, to help normalize calcium and phosphate metabolism.
• Management of hypocalcemia associated with chronic kidney disease and renal osteodystrophy, especially in patients undergoing dialysis.
• Adjunctive therapy with calcium supplements in the management and prevention of primary osteoporosis.
• Adjunctive therapy with calcium in the prevention and management of corticosteroid-induced osteoporosis.
• Conditions where rapid correction of vitamin d deficiency is required or where oral vitamin d is not tolerated or not feasible (as determined by a physician).

Active Ingredients / Key Components:

• Cholecalciferol (vitamin d3) – 200,000 iu per 2 ml intramuscular ampoule.
• Excipients: Other inactive ingredients in the solution (such as solvents, stabilizers, or preservatives) are not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.).

Dosage & Administration / How to Use:

• Devarol 1Amp is for intramuscular (i.m.) injection only and must be administered by a healthcare professional.
• Typical dosing regimens vary according to age, severity of deficiency, underlying disease, and physician judgment. The exact dose, frequency, and duration must be determined by the treating doctor.
• Adults: High-dose vitamin d3 injections may be given as a single ampoule or repeated at intervals (for example, every few weeks or months) depending on vitamin d levels and clinical response. Do not repeat dosing without medical advice.
• Children: Pediatric dosing must be carefully adjusted by a pediatrician or specialist based on body weight, diagnosis (e.g., rickets, hypoparathyroidism), and blood test results.
• Administration: Inject deeply into a large muscle (e.g., gluteal muscle) using aseptic technique. Do not inject intravenously.
• With or without food: As this is an injectable product, timing with meals is not applicable; however, your doctor may prescribe concurrent oral calcium or other medications.
• Monitoring: Regular monitoring of serum calcium, phosphate, alkaline phosphatase, parathyroid hormone (pth), and 25-oh vitamin d levels is recommended, especially in patients with renal impairment or disorders of calcium metabolism.
• Do not self-inject or adjust the dose without medical supervision. Follow your doctor’s instructions and the product leaflet carefully.

Clinical Benefits:

• Helps correct vitamin d deficiency, supporting normal calcium and phosphate absorption from the gut.
• Contributes to the maintenance of healthy bones and teeth and supports the prevention and management of osteoporosis (including corticosteroid-induced osteoporosis) when used with calcium.
• Assists in the treatment of rickets and osteomalacia by promoting proper bone mineralization and skeletal development.
• Supports the management of hypocalcemia, hypoparathyroidism, familial hypophosphatemia, and renal osteodystrophy in patients with chronic renal failure on dialysis.
• Provides a high-potency, long-acting dose of vitamin d3, which can be beneficial in patients with poor adherence or malabsorption of oral vitamin d.

Warnings & Contraindications:

• Use only under medical supervision. High-dose vitamin d3 injections can cause serious side effects if misused.
• Contraindicated in patients with hypercalcemia, hypervitaminosis d, severe renal impairment not under specialist care, or known hypersensitivity to cholecalciferol or any component of the formulation.
• Use with extreme caution in patients with renal insufficiency, nephrolithiasis (kidney stones), sarcoidosis or other granulomatous diseases, or conditions predisposing to hypercalcemia and hypercalciuria.
• Regular monitoring of serum calcium, phosphate, and vitamin d levels is essential, especially with repeated dosing or in high-risk patients.
• Consult your doctor before use if pregnant or breastfeeding; prolonged high-dose vitamin d may affect the fetus or nursing infant and must be carefully supervised.
• Inform your doctor about all medications and supplements you are taking, especially other vitamin d products, calcium supplements, thiazide diuretics, digitalis (cardiac glycosides), anticonvulsants, or corticosteroids, as interactions may increase the risk of toxicity or alter effectiveness.
• Not intended for routine self-treatment of mild deficiency; it is a prescription medicine for specific clinical indications.
• Do not exceed the prescribed dose. Overdose can lead to vitamin d toxicity and serious complications.
• Consult your doctor before use if you have liver disease, kidney disease, heart disease, diabetes, or any chronic medical condition.
• Keep out of reach of children.

Side Effects:

• Common or mild side effects (usually related to injection or dosing) may include pain, redness, or swelling at the injection site, mild fatigue, or headache.
• Signs of vitamin d overdose or hypercalcemia may include nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, muscle weakness, bone pain, confusion, or irregular heartbeat.
• Serious side effects can include severe hypercalcemia, kidney stones, kidney impairment, cardiac arrhythmias (especially in patients on digitalis), and calcification of soft tissues.
• Allergic reactions (rash, itching, swelling, dizziness, difficulty breathing) are rare but require immediate medical attention.
• Stop treatment and seek urgent medical advice if you experience symptoms suggestive of high calcium levels or any severe or unexpected reaction.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Protect from excessive heat and freezing. Keep ampoules in the original packaging until use. Keep container tightly closed if applicable. Keep out of reach of children.

Specifications:

• Product form: Intramuscular injection ampoule.
• Strength: 200,000 iu cholecalciferol (vitamin d3) per 2 ml ampoule.
• Pack size: 1 ampoule (1 i.m. amp).
• Route of administration: Intramuscular only, administered by a healthcare professional.

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.