Rocaltrol Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Calcitriol

Indications/Uses

Established postmenopausal osteoporosis; renal osteodystrophy in patients w/ chronic renal failure particularly those undergoing hemodialysis; postsurgical or idiopathic hypoparathyroidism; pseudohypoparathyroidism; vit D-dependent rickets; hypophosphatemic vit D-resistant rickets; secondary hyperparathyroidism & resultant metabolic bone disease in patients w/ moderate to severe chronic renal failure (pre-dialysis).

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Dosage/Direction for Use

Postmenopausal osteoporosis 0.25 mcg bd. Renal osteodystrophy (dialysis patient) Initially 0.25 mcg daily, may be increased by 0.25 mcg daily at 2-4 wk intervals. Max: 12 mcg/wk. Patient w/ normal or slightly reduced serum Ca level 0.25 mcg every other day. Hypoparathyroidism & rickets Initially 0.25 mcg daily, may be increased at 2-4 wk intervals. Secondary hyperparathyroidism & resultant metabolic bone disease (pre-dialysis patient) Adult & childn ≥3 yr 0.25 mcg daily, may be increased to 0.5 mcg daily, <3 yr Initially 10-15 ng/kg daily.

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Overdosage

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Contraindications

Hypersensitivity. All diseases associated w/ hypercalcemia. Evidence of vit D toxicity.

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Special Precautions

Discontinue use if serum Ca levels or serum creatinine rise above normal. Risk of hypercalcemia in immobilized patients eg, those who have undergone surgery. Increased inorganic phosphate serum levels. Do not take w/ other vit D prep. Maintain adequate fluid intake. Regular serum determinations of Ca, P, Mg & alkaline phosphatase; Ca & phosphate content in 24-hr urine. Check serum Ca levels at least twice wkly during stabilisation phase of treatment. Renal failure. Pregnancy & lactation. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypercalcaemia. Headache; abdominal pain, nausea; rash; UTI.

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Drug Interactions

Increased risk of hypercalcemia w/ thiazide diuretics. Precipitated cardiac arrhythmias w/ digitalis. Functional antagonism w/ corticosteroids. Hypermagnesemia w/ Mg-containing drugs eg, antacids (not to be taken by chronic renal dialysis patients). Phosphate-binding agents (adjust dosage). Possible stimulation of intestinal absorption of oral phosphate therapy. Impaired intestinal absorption by bile acid sequestrants eg, 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

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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.

Regulatory Classification

Presentation/Packing

Form

Rocaltrol cap 0.25 mcg

Packing/Price

100's;30's

Rocaltrol

calcitriol

Manufacturer:

Atnahs Pharma

Distributor:

DKSH