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Osseka

Osseka

calcitriol

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab
Concise Prescribing Info
Contents
Calcitriol
Indications/Uses
Management of post-menopausal osteoporosis; hypocalcemia in patients w/ chronic renal failure or hypoparathyroidism.
Dosage/Direction for Use
Post-menopausal osteoporosis 1 cap bid. Hypocalcemia in patient w/ chronic renal failure or hypoparathyroidism 1 cap once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to calcitriol or drugs of same class. All diseases associated w/ hypercalcaemia. Evidence of metastatic calcification; vit D toxicity.
Special Precautions
Discontinue treatment immediately if serum Ca levels rise to 1 mg/100 mL (250 micromol/L) above normal (9-11 mg/100 mL or 2,250-2,750 micromol/L), or serum creatinine rises to >120 micromol/L until normocalcaemia occurs. Avoid development of hypervitaminosis D; prolonged use. Increased risk of hypercalcaemia in immobilised patients (eg, those who underwent surgery). Risk of ectopic calcification in patients w/ renal failure. Chronic hypercalcaemia associated w/ increased serum creatinine. Patient who switched from long acting vit D prep (eg, ergocalciferol (vit D2) or colecalciferol) to calcitriol. Advise patients to strictly adhere to prescribed diet & instruct on how to recognise symptoms of hypercalcaemia. Maintain phosphate levels at normal level (2-5 mg/100 mL or 0.65-1.62 mmol/L). Serum Ca x phosphate product should not exceed 70 mg2/dL2. Avoid dehydration in patients w/ normal renal function during treatment & maintain adequate fluid intake. Withhold all other vit D compd & derivatives including proprietary compd or food which may be fortified w/ vit D during treatment. Continue oral phosphate therapy in patients w/ vit D-resistant rickets (familial hypophosphataemia) while on therapy. Pregnancy & lactation.
Adverse Reactions
Hypercalcaemia. Headache; abdominal pain, nausea; rash; UTI.
Drug Interactions
Concomitant use w/ Ca supplements & Ca-containing prep; phosphate-binding agents. Increased risk of hypercalcaemia w/ thiazide diuretics. May precipitate cardiac arrhythmias w/ digitalis. Functional antagonism w/ corticosteroids. Hypermagnesaemia w/ Mg-containing drugs (eg, antacids) in patients on chronic renal dialysis. Possible stimulation of intestinal phosphate absorption in patients w/ vit D-resistant rickets (familial hypophosphataemia). Reduced intestinal absorption of fat-soluble vit w/ bile acid sequestrants including cholestyramine & sevelamer.
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
Osseka softcap 0.25 mcg
Packing/Price
10 × 10's
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