Brand name:
Antiosteoporotic Products

ALFACIP (Alfacalcidol, One-Alpha. AlfaD)
Alfacalcidol Capsules

Composition

ALFACIP (Alfacalcidol, One-Alpha. AlfaD) 0.25 micro gm
Each soft gelatin capsule contains alfacalcidol (1-alpha hydroxyvitamin D 3 ) 0.25mcg (green capsule)

Description

Alfacalcidol (1-alpha hydroxy) undergoes rapid hepatic conversion to 1,25 – dihydroxyvitamin D 3 the vitamin D 3 metabolite which acts as a regulator of calcium and phosphate metabolism. The main effects are to increase circulating 1, 25 dihydroxyvitamin D­ 3 levels, and thereby to increase intestinal absorption of calcium and phosphate, promote bone mineralisation, decrease plasma parathyroid hormone levels as well as to decrease bone resorption, with relief of bone and muscle pain. Treatment of intestinal calcium malabsorption associated with post-menopausal, senile and steroid-induced osteoporosis, with ALFACIP (Alfacalcidol, One-Alpha. AlfaD) improves the negative calcium balance of these patients. The more positive calcium balance produced by alfacalcidol treatment in the osteoporotic patients, decreases bone loss and bone fracture rate.

Indications

ALFACIP (Alfacalcidol, One-Alpha. AlfaD) is used for treating conditions in which calcium metabolism is disturbed due to impaired 1-alpha hydroxylation, such as reduced renal function; in other disorders associated with Vitamin D resistance; and in calcium malabsorption of osteoporosis.

The main indications are:
• Renal bone disease (renal osteodystrophy)
• Hypoparathyroidism
• Hypoparathyroidism (with bone disease)
• Nutritional and malabsorptive rickets and osteomalacia
• Hypophosphataemic Vitamin D-resistant rickets and osteomalacia
• Pseudo-deficiency (D-dependent Type I) rickets with osteomalacia
• Osteoporosis

Dosage And Administration

General
The dosage and administration of ALFACIP (Alfacalcidol, One-Alpha. AlfaD) should be adjusted according to the indication-specific notes as follows:
The initial dose is
All indications, excepting osteoporosis:

Adults
1 mcg/day

Elderly patients
0.5 mcg /day

Children
20 kg and over
Excepting in renal osteodystrophy 1 mcg/day

In renal osteodystrophy
0.04-0.08 mcg /kg/day

Children under 20 kg
0.05 mcg /kg/day
Osteoporosis
0.5 mcg/day

The dose should subsequently be adjusted to avoid hypercalcaemia, according to the biochemical response. Plasma calcium levels (preferably corrected for protein binding) should initially be measured weekly. The dose of ALFACIP (Alfacalcidol, One-Alpha. AlfaD) can be increased by increments of 0.25 to 0.5 m cg /day. Most adults respond to doses of 1 to 3 mcg /day. Once the dose is stabilised, calcium levels should be measured periodically. Children with renal osteodystrophy seem to need relatively higher doses than adults and may even need the adult dose.

Contraindications

ALFACIP (Alfacalcidol, One-Alpha. AlfaD) should not be administered in the presence of hypercalcaemia, hyperphosphataemia (except when occurring with hypoparathyroidism) or hypermagnesaemia. ALFACIP (Alfacalcidol, One-Alpha. AlfaD) should not be used in patients with evidence of Vitamin D toxicity or known hypersensitivity to the effects of Vitamin D or any of its analogues.

Warnings and Precautions

Alfacalcidol increases the intestinal absorption of calcium and phosphate, serum levels of which should be monitored, particularly in patients with renal failure. Throughout treatment with Alfacalcidol regular plasma and urinary (24-hour collection) calcium levels should be determined at least once every three months months. Alfacalcidol therapy requires regular monitoring of calcium phosphate, alkaline phosphate, magnesium and creatinine levels as well as other appropriate biochemical parameters and should only be prescribed when suitable facilities are available. If there is biochemical evidence of bone healing (eg. return towards normal serum alkaline phosphate levels), hypercalcaemia may develop if the dose of Alfacalcidol is not decreased appropriately; if hypercalcaemia or hypercalcuria occur, this can be corrected rapidly by stopping treatment with Alfacalcidol and any calcium supplements until plasma calcium levels return to normal, usually in about a week.

Alfacalcidol should be administered with caution to patients with hypercalcaemia especially those with a history of renal calculi.

Drug interactions
Alfacalcidol/Digitalis/Glycosides
Hypercalcaemia in patients taking digitalis preparations may precipitate cardiac arrhythmias. Patients taking digitalis concurrently with alfacalcidol must therefore be closely monitored. Alfacalcidol/Barbiturates/Enzyme-inducing Anticonvulsant Drugs
Patients on barbiturates or other enzyme-inducing anticonvulsants may require an increased dose of alfacalcidol to produce the desired effect.
Alfacalcidol/Drugs affecting intestinal absorption
Absorption of alfacalcidol may be impaired by concurrent use of mineral oil (prolonged use), cholestyramine, colestipol, sucralfate or large amounts of aluminium-based antacids.
Alfacalcidol/Magnesium
Caution should be exercised in the use of magnesium-based antacids or laxatives for patients taking alfacalcidol who are on chronic renal dialysis. Hypermagnesaemia may occur.
Alfacalcidol/Calcium/Thiazides
The risk of hypercalcaemia is increased in patients taking calcium-containing preparations or thiazide diuretics concurrently with alfacalcidol.
Alfacalcidol/Vitamin D and Derivatives
Alfacalcidol is a potent derivative of Vitamin D. Pharmacological doses of vitamin D and its derivatives should not be given during alfacalcidol treatment because of the possibility of additive effects and an increased risk of hypercalcaemia.

Pregnancy
There is insufficient evidence on which to assess the safety of alfacalcidol use during pregnancy. Animal study has not revealed any hazard but as with all drugs ALFACIP (Alfacalcidol, One-Alpha. AlfaD) should only be used during pregnancy if treatment is essential and no better alternative is available.
Lactation
Although not definitely established, it is likely that increased levels of 1,25-dihydroxyvitamin D 3 will be found in the breast milk of mothers treated with alfacalcidol. This might have some influence on calcium metabolism in a breast-feeding infant and discontinuation of breast-feeding should be considered

Side effects

Adverse effects generally relate to hypercalcaemia and in the case of renal impairment, hyperphosphataemia which may be induced by alfacalcidol therapy.

Hypercalcaemia may manifest as malaise, fatigue, weakness, dizziness, headache, nausea, dry mouth, constipation, diarrhoea, heartburn, vomiting, abdominal pain or other gastrointestinal discomfort, muscle pain, bone pain, joint pain, pruritus or palpitations. In hypercalcaemic dialysis patients, the possibility of calcium influx from the dialysate should be considered. No other side effects associated directly with alfacalcidol therapy have been noted

Presentation

ALFACIP (Alfacalcidol, One-Alpha. AlfaD) Blister strip of 10 capsules