Rocaltrol: Precision Calcium Regulation for Renal Health
| Product dosage: 0.25mcg | |||
|---|---|---|---|
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| 360 | $1.28
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Synonyms | |||
Rocaltrol (calcitriol) is a potent, active form of vitamin D3 specifically engineered for patients with compromised renal function. It is the definitive therapeutic agent for the management of hypocalcemia and secondary hyperparathyroidism in chronic kidney disease patients, particularly those undergoing dialysis. By directly supplying the biologically active metabolite, it bypasses the need for renal conversion—a critical advantage in this patient population. Its targeted mechanism ensures precise control over calcium and phosphorus homeostasis, reducing the risk of renal osteodystrophy and associated complications.
Features
- Contains calcitriol, the hormonally active form of vitamin D₃ (1,25-dihydroxycholecalciferol)
- Available in oral capsules (0.25 mcg and 0.5 mcg) and injectable formulations
- Specifically indicated for hypocalcemia in patients with chronic renal failure
- Functions independently of renal hydroxylation, making it ideal for impaired kidney function
- Regulates intestinal absorption of calcium and phosphate directly
- Manufactured under strict pharmaceutical compliance (USP/Ph. Eur. standards)
Benefits
- Effectively elevates serum calcium levels in renal-impaired individuals
- Reduces elevated parathyroid hormone (PTH) levels, mitigating secondary hyperparathyroidism
- Helps prevent or treat metabolic bone disease in chronic kidney disease
- Minimizes risk of hypocalcemic tetany and related neuromuscular symptoms
- Supports bone mineralization and reduces bone pain and fractures
- Provides predictable pharmacokinetics due to bypass of renal activation step
Common use
Rocaltrol is primarily prescribed for the management of hypocalcemia in patients with chronic renal failure, especially those undergoing dialysis. It is also used in the treatment of hypoparathyroidism and pseudohypoparathyroidism. Additionally, it may be indicated for certain patients with vitamin D-dependent rickets or familial hypophosphatemia. Its use is generally reserved for situations where native vitamin D compounds are ineffective due to impaired renal conversion.
Dosage and direction
Dosage must be individualized based on serum calcium levels. For hypocalcemia in dialysis patients, the initial dose is typically 0.25 mcg/day. Doses may be increased by 0.25 mcg/day at 4–8 week intervals. For hypoparathyroidism and pseudohypoparathyroidism, the usual initial dose is 0.25 mcg/day given in the morning. Dosage adjustments should be based on frequent monitoring of serum calcium, phosphorus, and creatinine levels. Administration with food may enhance absorption. The capsule should be swallowed whole and not crushed.
Precautions
Regular monitoring of serum calcium, phosphorus, magnesium, alkaline phosphatase, and 24-hour urinary calcium and phosphorus is essential. Patients should be advised to avoid concomitant use of non-prescribed calcium supplements or high calcium diets. Use with caution in patients with a history of renal stones or soft tissue calcification. Adequate hydration should be maintained. In patients with normal renal function, chronic administration may lead to hypercalcemia and hypercalciuria.
Contraindications
Rocaltrol is contraindicated in patients with hypercalcemia or vitamin D toxicity. It should not be used in patients with evidence of vitamin D hypersensitivity. Contraindicated in patients with abnormal sensitivity to the effects of vitamin D or those with malabsorption syndromes that may predispose to hypercalcemia. Should not be administered to patients with metastatic calcification or hypervitaminosis D.
Possible side effect
Common side effects include hypercalcemia, hypercalciuria, and hyperphosphatemia. Patients may experience nausea, vomiting, constipation, weakness, headache, somnolence, or dry mouth. Less frequently, rash, pruritus, photophobia, pancreatitis, and elevated liver enzymes may occur. Chronic overdose may lead to nephrocalcinosis, vascular calcification, or soft tissue calcification. Psychiatric disturbances such as overt psychosis have been rarely reported.
Drug interaction
Thiazide diuretics may increase the risk of hypercalcemia. Cholestyramine and mineral oil may reduce intestinal absorption of Rocaltrol. Phenytoin, phenobarbital, and other enzyme inducers may increase catabolism of vitamin D metabolites. Corticosteroids may antagonize the effects of vitamin D. Concurrent use with calcium supplements or phosphate binders containing calcium may increase the risk of hypercalcemia. Magnesium-containing antacids should be used with caution due to risk of hypermagnesemia.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next dose. Do not double the dose to make up for a missed one. Patients should maintain regular dosing schedules and contact their healthcare provider if multiple doses are missed, as dosage adjustments may be required based on calcium monitoring.
Overdose
Overdose may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia. Early symptoms include weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, and metallic taste. Later manifestations include confusion, psychosis, cardiac arrhythmias, and nephrocalcinosis. Treatment involves immediate discontinuation, low calcium diet, withdrawal of calcium supplements, generous hydration, and careful monitoring. In severe cases, hospitalization with intravenous fluids, loop diuretics, corticosteroids, or bisphosphonates may be required.
Storage
Store at controlled room temperature (20°–25°C or 68°–77°F), with excursions permitted between 15°–30°C (59°–86°F). Keep in original container, tightly closed, and protect from light and moisture. Do not freeze. Keep out of reach of children and pets. Do not use after expiration date printed on packaging.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Rocaltrol is a prescription medication and should only be used under the supervision of a qualified healthcare professional. Dosage and administration must be individualized based on patient condition and laboratory monitoring. The prescriber should be familiar with the complete prescribing information before initiating therapy.
Reviews
Clinical studies have demonstrated Rocaltrol’s efficacy in maintaining calcium homeostasis in renal-impaired patients. In a multicenter trial involving 78 dialysis patients, 89% achieved normalized serum calcium levels within 12 weeks of therapy. Another study showed a 62% reduction in PTH levels compared to placebo. Nephrologists frequently report improved bone mineral density and reduced fracture incidence with long-term use. Some clinicians note the need for careful dose titration to avoid hypercalcemia, particularly during initiation phase. Patient-reported outcomes indicate improvement in bone pain and muscle weakness in appropriately dosed individuals.