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Rocaltrol

Rocaltrol

calcitriol

Manufacturer:

Catalent Germany

Distributor:

Zuellig
Concise Prescribing Info
Contents
Calcitriol
Indications/Uses
Established postmenopausal osteoporosis. Renal osteodystrophy in patients w/ chronic renal failure, particularly those undergoing hemodialysis. Secondary hyperparathyroidism in patients w/ moderate to severe chronic renal failure (pre-dialysis). Postsurgical or idiopathic hypoparathyroidism. Pseudohypoparathyroidism. Vit D-dependent rickets. Hypophosphatemic vit D-resistant rickets.
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Dosage/Direction for Use
Postmenopausal osteoporosis 0.25 mcg bid. Renal osteodystrophy (dialysis patient) Initially 0.25 mcg daily. Patient w/ normal or only slightly reduced serum Ca levels 0.25 mcg every other day, may be increased by 0.25 mcg daily at 2-4 wk intervals. Dose range: 0.5-1 mcg daily. Pulse therapy in patient refractory to continuous therapy Initially 0.1 mcg/kg/wk into 2 or 3 equal doses given at night. Max total cumulative dose: 12 mcg/wk. Secondary hyperparathyroidism (pre-dialysis patient) & resultant metabolic disease Moderate to severe renal failure ie, CrCl 15-55 mL/min Initially 0.25 mcg daily, may be increased to 0.5 mcg daily if necessary. Hypoparathyroidism & rickets Initially 0.25 mcg daily in the morning, may be increased at 2-4 wk intervals.
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Overdosage
View Rocaltrol overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to calcitriol or drugs of the same class. All diseases associated w/ hypercalcemia. Evidence of vit D toxicity.
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Special Precautions
May trigger hypercalcemia w/ abrupt increase in Ca intake as a result of changes in diet or uncontrolled intake of Ca prep. Stop treatment immediately until normocalcemia ensues when serum Ca levels rise to 1 mg/100 mL above normal or serum creatinine rises to >120 μmol/L. Risk of hypercalcemia in immobilized patients eg, those who have undergone surgery. Danger of ectopic calcification in patients w/ renal failure. Do not allow serum Ca x P to exceed 70 mg2/dL2. Continue oral phosphate therapy in patients w/ vit D-resistant rickets (familial hypophosphatemia). Do not take w/ other vit D prep. Switching from ergocalciferol (vit D2). Avoid dehydration in patients w/ normal renal function; maintain adequate fluid intake. Regular serum determinations of Ca, P, Mg & alkaline phosphatase, & of the Ca & phosphate content in 24-hr urine. Check serum Ca levels at least twice wkly during stabilization phase of treatment. Pregnancy & lactation. Childn.
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Adverse Reactions
Hypercalcemia. Headache; abdominal pain, nausea; rash; UTI.
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Drug Interactions
Increased risk of hypercalcemia w/ thiazide diuretics. May precipitate cardiac arrhythmias w/ digitalis. Functional antagonism between vit D analogues which promote Ca absorption & inhibit corticosteroids. Hypermagnesemia w/ Mg-containing drugs (eg, antacids) in patients on chronic renal dialysis. May affect phosphate transport of phosphate-binding agents in the intestine, kidneys & bones. Stimulation of intestinal phosphate absorption for phosphate supplements in vit D-resistant rickets (familial hypophosphatemia). Reduced intestinal absorption w/ bile acid sequestrants including cholestyramine & sevelamer.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Rocaltrol detailed prescribing information
Storage
View Rocaltrol storage conditions for details to ensure optimal shelf-life.
Description
View Rocaltrol description for details of the chemical structure and excipients (inactive components).
Action
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MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
A11CC04 - calcitriol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Presentation/Packing
Form
Rocaltrol soft-gelatin cap 0.25 mcg
Packing/Price
100's
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