Buy Rocaltrol Online

Rocaltrol (calcitriol)

THERAPEUTIC CLASS

Vitamin D analogue

DEA CLASS

RX

INDICATIONS

Management of secondary hyperparathyroidism and resultant metabolic bone disease with moderate to severe chronic renal failure (CrCl 15-55mL/min) in patients not yet on dialysis. Management of hypocalcemia and resultant metabolic bone disease in patients undergoing chronic renal dialysis. Management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.

ADULT DOSAGE

Hypoparathyroidism

Initial: 0.25mcg/day qam
Titrate: May increase at 2- to 4-week intervals
Range: 0.5-2mcg/day

Secondary Hyperparathyroidism

Predialysis Patients:
Initial: 0.25mcg/day
Titrate: May increase to 0.5mcg/day

Hypocalcemia

Dialysis Patients:
Initial: 0.25mcg/day
Titrate: May increase by 0.25mcg/day at 4- to 8-week intervals

Patients w/ normal or only slightly reduced serum Ca2+ levels may respond to doses of 0.25mcg every other day; most patients respond to doses between 0.5 and 1 mcg/day

PEDIATRIC DOSAGE

Hypoparathyroidism

1-5 Years:
Usual: 0.25-0.75mcg/day qam

≥6 Years:
Range: 0.5-2mcg/day qam

Secondary Hyperparathyroidism

Predialysis Patients:
<3 Years:
Initial: 10-15ng/kg/day

≥3 Years:
Initial: 0.25mcg/day
Titrate: May increase to 0.5mcg/day

DOSING CONSIDERATIONS

Elderly
Start at lower end of dosing range

Adverse Reactions
Hypercalcemia: Immediately d/c until normocalcemia ensues; when normal levels return, continue treatment at a daily dose 0.25mcg lower than that previously used

ADMINISTRATION

Oral route

HOW SUPPLIED

Cap: 0.25mcg, 0.5mcg; Sol: 1mcg/mL [15mL]

CONTRAINDICATIONS

Hypercalcemia or evidence of vitamin D toxicity.

WARNINGS/PRECAUTIONS

Administration in excess of daily requirements may cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Chronic hypercalcemia may lead to generalized vascular calcification, nephrocalcinosis, and other soft tissue calcification. Serum Ca2+ times phosphate (Ca x P) product should not exceed 70mg2/dL2. May increase serum inorganic phosphate levels, leading to ectopic calcification in patients with renal failure; use non-aluminum phosphate binders and low phosphate diet to control serum phosphate in dialysis patients. Caution in elderly and immobilized patients. If treatment switched from ergocalciferol, may take several months for ergocalciferol level in blood to return to baseline. In patients with normal renal function, chronic hypercalcemia may be associated with an increase in SrCr. Avoid dehydration in patients with normal renal function. When indicated, estimate daily dietary Ca2+ intake and adjust accordingly.

ADVERSE REACTIONS

Hypercalcemia, hypercalciuria, SrCr elevation, weakness, N/V, dry mouth, constipation, muscle and bone pain, metallic taste, polyuria, polydipsia, weight loss, hypersensitivity reactions.

DRUG INTERACTIONS

Avoid pharmacological doses of vitamin D products and derivatives during therapy. Avoid uncontrolled intake of additional Ca2+-containing preparations. Avoid with Mg2+-containing preparations (eg, antacids) in patients on chronic renal dialysis; use may lead to hypermagnesemia. May impair intestinal absorption with cholestyramine. Reduced blood levels with phenytoin or phenobarbital. Caution with thiazides; may cause hypercalcemia. Reduced serum endogenous concentrations with ketoconazole reported. Hypercalcemia may precipitate cardiac arrhythmias in patients on digitalis; use with caution. Functional antagonism with corticosteroids. Adjust dose of concomitant phosphate-binding agent.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Synthetic vitamin D analogue; regulates absorption of Ca2+ from the GI tract and its utilization in the body.

PHARMACOKINETICS

Absorption: Rapid (intestine). Tmax=3-6 hrs, 8-12 hrs (hemodialysis); Cmax=116pmol/L (pediatrics). Distribution: Found in breast milk. Metabolism: Hydroxylation to 1α, 25R(OH)2-26, 23S-lactone D3 (major metabolite). Elimination: Feces (primary), urine (10%, 1mcg dose); T1/2=5-8 hrs (normal subjects), 16.2 hrs and 21.9 hrs (hemodialysis).

ASSESSMENT

Assess for hypercalcemia, evidence of vitamin D toxicity, renal function, presence of immobilization, pregnancy/nursing status, and possible drug interactions. Obtain baseline levels of serum Ca2+, P, alkaline phosphatase, creatinine, and intact parathyroid hormone (iPTH).

MONITORING

Monitor for hypercalcemia, hypercalciuria, and hyperphosphatemia. For dialysis patients, perform periodic monitoring of serum Ca2+, P, Mg2+, and alkaline phosphatase. For hypoparathyroid patients, perform periodic monitoring of serum Ca2+, P, and 24-hr urinary Ca2+. For predialysis patients, perform monthly monitoring of serum Ca2+, P, alkaline phosphatase, and creatinine for 6 months; then periodically, and periodic monitoring of iPTH every 3- to 4-months. Monitor serum Ca2+ levels ≥2X/week after all dosage changes and during titration periods.

PATIENT COUNSELING

Inform about compliance with dosage instructions, adherence to instructions about diet and Ca2+ supplementation, and avoidance of the use of unapproved nonprescription drugs. Carefully inform about symptoms of hypercalcemia. Advise to maintain adequate Ca2+ intake at a minimum of 600mg/day.

STORAGE

15-30°C (59-86°F). Protect from light.

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