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SANDOZ ALFACALCIDOL is a brand name for Alfacalcidol, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Alfacalcidol is indicated in adult patients with chronic renal failure for: • Management of hypocalcemia • Secondary hyperparathyroidism • Osteodystrophy 1.1 Pediatrics Pediatrics (< 18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of alfacalcidol capsules in…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment). Other factors that should be taken into consideration are urinary calcium excretion, plasma parathyroid hormone (PTH) and phosphorus. Laboratory tests considered essential for adequate patient monitoring include serum calcium, inorganic phosphorus, magnesium, alkaline phosphatase, creatinine, BUN and protein (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
• The success of treatment with Sandoz Alfacalcidol is also dependant on the patient receiving an adequate daily intake of calcium during treatment. The recommended daily allowance of calcium in adults is about 800-1000 mg (from all sources such as dialysate, diet and calcium supplements).
The treating physician should ensure that each patient receives an adequate daily intake of calcium by prescribing a calcium supplement or instructing the patients in appropriate dietary measures. Calcium supplements should not exceed 500 mg of elemental calcium per day.
Sandoz Alfacalcidol (alfacalcidol) Product Monograph Page 5 of 30 • Treatment with Sandoz Alfacalcidol may lead to hypercalcemia with its occurrence dependent on such factors as the degree of bone mineralization, the state of renal function, and the dose of Sandoz Alfacalcidol.
Dosages of Sandoz Alfacalcidol in excess of daily requirements can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Concomitant high intake of calcium and phosphate with therapeutic doses of Sandoz Alfacalcidol may also cause similar abnormalities.
Regular monitoring of plasma calcium is essential (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). • To prevent hyperphosphatemia and extra-skeletal calcifications, appropriate oral phosphate binding agents in association with a low phosphate diet may be necessary (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
• For treatment of hypercalcemia due to overdose, see
). Monitoring and Laboratory Tests Regular monitoring of plasma calcium is essential. Indeed, Sandoz Alfacalcidol should only be used when adequate facilities are available for monitoring of blood and urine chemistries on a regular basis.
During treatment with Sandoz Alfacalcidol, progressive hypercalcemia either due to hyper-responsiveness or overdose may become so severe that it requires emergency treatment. Hypercalcemia can be rapidly corrected by stopping treatment until plasma calcium levels returnto normal (in about one week).
Sandoz Alfacalcidol may then be restarted at a reduced dose (half the previous dose) with monitoring of calcium. Laboratory tests considered essential to adequate patient monitoring include serum calcium, inorganic phosphorus, magnesium, alkaline phosphatase, creatinine, BUN and protein (for correction of plasma calcium in instances of hypercalcemia).
For pre-dialysis patients treated with Sandoz Alfacalcidol, serum calcium and phosphate levels should be monitored at monthly intervals or as is considered necessary if hypercalcemia develops. For patients undergoing dialysis serum calcium should be determined at least twice weekly during dose titration.
During maintenance therapy with Sandoz Alfacalcidol 24-hour urinary calcium and phosphorus should be determined periodically. Periodic ophthalmological examinations and radiological evaluation of suspected anatomical regions for early detection of ectopic calcifications are advisable.
Renal The appearance of hypercalcemia is predicated on the ease with which calcium is utilized for bone mineralization and on renal excretion. Thus, chronic renal failure is a condition whichwould dispose patients toward hypercalcemia.
Prolonged hypercalcemia may aggravate nephrolithiasis and therefore prolonged Sandoz Alfacalcidol (alfacalcidol) Product Monograph Page 12 of 30 hypercalcemiashould be avoided when Sandoz Alfacalcidol is used in these patients. Transient or even long-lasting deterioration of kidney function has been observed.
, Monitoring and Laboratory Tests). • The success of treatment with Sandoz Alfacalcidol is also dependant on the patient receiving an adequate daily intake of calcium during treatment. The recommended daily allowance of calcium in adults is about 800-1000 mg (from all sources such as dialysate, diet and calcium supplements).
The treating physician should ensure that each patient receives an adequate daily intake of calcium by prescribing a calcium supplement or instructing the patients in appropriate dietary measures. Calcium supplements should not exceed 500 mg of elemental calcium per day.
Sandoz Alfacalcidol (alfacalcidol) Product Monograph Page 5 of 30 • Treatment with Sandoz Alfacalcidol may lead to hypercalcemia with its occurrence dependent on such factors as the degree of bone mineralization, the state of renal function, and the dose of Sandoz Alfacalcidol.
Dosages of Sandoz Alfacalcidol in excess of daily requirements can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Concomitant high intake of calcium and phosphate with therapeutic doses of Sandoz Alfacalcidol may also cause similar abnormalities.
Regular monitoring of plasma calcium is essential (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). • To prevent hyperphosphatemia and extra-skeletal calcifications, appropriate oral phosphate binding agents in association with a low phosphate diet may be necessary (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
• For treatment of hypercalcemia due to overdose, see 5 OVERDOSAGE. • Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis, or calcifications of the cornea or other soft tissues (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
• Periodic ophthalmological examinations and radiological evaluation of suspected anatomical regions for early detection of ectopic calcifications are advisable (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). • Prolonged hypercalcemia may aggravate nephrolithiasis and should be avoided when Sandoz Alfacalcidol is used in patients with chronic renal failure who have a disposition toward hypercalcemia.
• Alfacalcidol is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a completelisting, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Alfacalcidol is contraindicated when there is biochemical evidence of hypercalcemia, hyperphosphatemia, or evidenceof vitamin D overdose.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In patients with renal bone disease or severely reduced renal function, a phosphate binding agent could be used simultaneously with alfacalcidol to prevent increased serum phosphate andpotential metastatic calcification. 1 Pregnant Woman.
• Fertility No data are available. Sensitivity Sandoz Alfacalcidol should be used with caution in patients with granulomatous diseases such as sarcoidosis where the sensitivity to vitamin D is increased due to increased hydroxylation activity.
1 Pregnant Woman Sandoz Alfacalcidol should not be used in pregnancy unless clearly necessary, as hypercalcemia during pregnancy may produce congenital disorders in the offspring. The safety of Sandoz Alfacalcidol in pregnant women has not been established.
Studies in animals have shown reproductive toxicity, which include reduced pregnancy rates, litter sizes, and birth weights (see 16 NON-CLINICAL TOXICOLOGY). 2 Breastfeeding Sandoz Alfacalcidol may be excreted in human milk. Therefore, breast feeding during treatment should be avoided.
1 Pediatrics). A rise in plasma creatinine (or a fall in glomerular filtration rate) has been reported in children with renal failure who are treated with alfacalcidol. However, it is unclear whether this response was due to the action of the drug or to increased creatinine production during growth.
2 Geriatrics). 1 Adverse Reaction Overview In general, the adverse effects of Sandoz Alfacalcidol are similar to those encountered with excessive vitamin D intake. 2 Clinical Trial Adverse Reactions This information is not available for this drug product.
3 Less Common Clinical Trial Adverse Reactions This information is not available for this drug product. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data This information is not available for this drug product.
5 Post-Market Adverse Reactions Hypercalcemia and possibly an exacerbation of hyperphosphatemia are the more frequent adverse reactions that have been reported with alfacalcidol capsules in patients with renal osteodystrophy. Elevated levels of calcium and phosphorus increase the risk of metastatic calcification and may accelerate the decline in renal function in some patients with chronic renal failure.
Metabolism and […]
Transient or even long-lasting deterioration of kidney function has been observed. In patients with renal bone disease or severely reduced renal function, a phosphate binding agent could be used simultaneously with alfacalcidol to prevent increased serum phosphate and potential metastatic calcification (see 7 WARNINGS AND PRECAUTIONS, Renal).
Patients with renal bone disease and a relatively high initial plasma calcium and "autonomous" hyperparathyroidism are liable to early hypercalcemia, as are the minority of dialysis patients with low plasma alkaline phosphatase (see 7 WARNINGS AND PRECAUTIONS, General).
• Prolonged hypercalcemia may aggravate arteriosclerosis or cardiac valve sclerosis and therefore, it should be avoided when Sandoz Alfacalcidol is used in patients with these conditions. Sandoz Alfacalcidol should also be used with caution in patients with calcification of pulmonary tissue as this may result in cardiac disease (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
• Sandoz Alfacalcidol should be used with extreme caution in patients concomitantly using cardiac glycosides. Concurrent use of digitalis glycosides may trigger cardiac arrhythmias in patients with heart disease due to the risk of hypercalcaemia.
4 Drug-Drug Interactions). Sandoz Alfacalcidol (alfacalcidol) Product Monograph Page 6 of 30 • Sandoz Alfacalcidol should not be used concomitantly with other vitamin D products or derivatives (see 7 WARNINGS AND PRECAUTIONS, General).
Concurrent use of other vitamin D-containing preparations may enhance the risk of hypercalcaemia. 4. Drug-Drug Interactions). • Concurrent use of Sandoz Alfacalcidol with thiazide diuretics or calcium containing preparations may enhance the risk of hypercalcaemia.
4 Drug-Drug Interactions). g. barbiturates, phenytoin, carbamazepine or primidone) have enzyme-inducing effects resulting in an increased metabolism of alfacalcidol. 4 Drug-Drug Interactions). • Absorption of magnesium-containing antacids may be enhanced by Sandoz Alfacalcidol, increasing the risk of hypermagnesemia.
4. Drug-Drug Interactions). • Sandoz Alfacalcidol may increase the serum concentration of aluminium. g. 4. Drug-Drug Interactions). • Mineral oil used as a laxative may interfere with the intestinal absorption of oral Sandoz Alfacalcidol formulations.
4. Drug-Drug Interactions). • Concomitant oral administration of bile acid sequestrants such as cholestyramine may impair the intestinal absorption of oral Sandoz Alfacalcidol formulations. 4. Drug-Drug Interactions). • Sandoz Alfacalcidol should be used with caution in patients with granulomatous diseases such as sarcoidosis where the sensitivity to vitamin D is […]