Description
CHEMICAL NAME AND DESCRIPTION
Chemically Alphadol is (5Z,7E)-9,10-secocholesta-5,7,10(19)-treine-1α,31i-diol. Alphadol is a red, transparent, round, soft gelatin capsules containing pale yellow colored, clear any liquid. Alphadol-1 is a green, transparent. round. soft gelatin capsules containing pale yellow colored. clear oily liquid.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alphadol
Each soft gelatin capsule contains:
Alfacalcidol Ph. Eur. 0.25 mcg
Colour – Ponceau 4R Supra
Alphadol–1
Each soft gelatin capsule contains:
Alfacalcidol Ph. Eur. 1.0 mcg
Approved colours used in capsule shells
PHARMACEUTICAL FORM
Soft gelatin capsules
ROUTE OF ADMINISTRATION
Oral
CLINICAL PARTICULARS
Pharmacotherapeutic Group
Vitamins
Therapeutic indications
Alfacalcidol is used for treating conditions in which calcium metabolism is disturbed due to impaired 10-hydroxylation such as reduced renal function: osteoporosis associated with Vitamin D resistance and calcium malabsorption.
The main indications are
- Osteoporosis
- Renal bone disease (renal osteodystrophy)
- Hypoparathyroidisrn
- Hyperparathyroidism (with bone disease)
Rickets and osteomalacia
Usage
Posology and Method &Administration
The dosage and administration of ALPHADOL should be adjusted according to the indication. The initial dosage in all indications, excepting osteoporosis:
Adults: 1 mcg/day
Elderly patients: 0.5mcg/day
Children 20 kg and over, excepting in renal osteodystrophy, 1 rncg/day
Renal osteodystrophy: 0.04 -0.08 mcg/kg/day
Side Effects
ALPHADOL should not be administered in the presence of hypercalcemia, hyperphosphataemia (except when occuring with hypoparathyroidism) or hypermagnesaemia.
Special Warnings and Precautions for use
Use in pregnancy
There is insufficient evidence which establishes the safety of alfacalcidol use during pregnancy. Animal studies have not revealed any hazard but as with all drugs, alfacalcidol should only be used during pregnancy if treatment is essential and no better altemative is available.
Use in Breast feeding
Although not definitely established, it is likely that increased levels of 1, 25-dihydroxyvitamin D3 will be found in the breast milk of mothers treated with alfacalcidol. This might have some influence on calcium metabolism in a breast-fed infant and discontinuation of breast-feeding should be considered.
Alfacalcidol increases the intestinal absorption of calcium and phosphate, serum levels of which should be monitored, particularly in patients with renal failure. Periodic and regular monitoring of calcium. phosphate, alkaline phosphatase, magnesium and creatinine levels as well as other appropriate biochemical parameters should be done. If hypercalcemia or hypercalciuna occur, this can be corrected rapidly by stopping treatment until plasma calcium levels relum to normal. Alfacalcidol may then be restarted at half the last dose used or as per response of the patient. Alfacalcidol should be administered with caution to patients with hypercalciuria, especially those with a history of renal calculi.
Warnings
Interaction with other Medicinal Products and forms of Interaction
Digitalis Glycosides, Hypercalcemia in patients taking digitalis preparations may precipitate cardiac an–hythmias. Patients taking digitalis concurrently with alfacalcidol must therefore be closely monitored.
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.
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.
Magnesium: Cautions should be exercised in the use of magnesium based antacids or laxatives for patients taking alfacalcidol who are on chronic renal dialysis. hypermagnesaemla may occur.
Thiazides: The Fisk of hypercalcaemia is increased in patients taking calcium-containing preparations or thiazide diuretics concurrently with 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 hypercalcemia.
PregnaneyandLecfation
Use in pregnancy
There is insufficient evidence which establishes the safety of alfacalcidol use during pregnancy. Animal studies have not revealed any hazard but as with all drugs, alfacalcidol should only be used during pregnancy if treatment is essential and no better alternative is available.
Use in Breast feeding
Although not definitely established, it is likely that increased levels of 1, 25-dihydroxyvitamin D3 will be found in the breast milk of mothers treated with alfacalcidol. This might have some influence on calcium metabolism in a breast-fed infant and discontinuation of breast-feeding should be considered.
Effects on Ability to Drive and use Machine
Alfacalcidol has no or negligible influence on the ability to drive or use machines
Undesirable effects
Adverse effects generally relate to hypercalcemia and, in the case of renal impairment, hyperphosphataemia which may be induced by alfacalcidol therapy. In hypercalcemic 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.
Overdose
Manifestations: Hypercalcemia which may manifest clinically as malaise, fatigue, weakness, dizziness, drowsiness, headache, nausea, dry mouth, constipation, diarrhoea, heartburn, vomiting, abdominal pain, gastrointestinal discomfort, muscle pain, bone pain, joint pain, pruitus or palpitations.
Treatment
Administration of alfacalcidol should be stopped if hypercalcemia occurs. Severe hypercalcemia may require treatment with general supportive measures, with intravenous fluids, and if needed, with a loop diuretic or corticosteroids.
In acute over dosage, early treatment with gastric lavage and/ or the administration of mineral oil may reduce absorption and promote fecal elimination.
References
Information provided for this medicine has been retrieved from the leaflet in the box.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Alfacalcidol is used for treating conditions in which calcium metabolism is disturbed due to impaired 1 a-hydroxylation such as reduced renal function; osteoporosis associated with Vitamin D resistance and calcium malabsorption.
Pharmacokinetk Properties
Alfacalcidol is a fat soluble analogue of cholecalciferol and upto 100% absorption normally takes place. After absorption, alfacalcidol is rapidly hydroxylated at 2 position, predominantly in liver although the enzyme is widely distributed in body tissues. 1 Alfacalcidol (1a-hydroxyvitamin D3) undergoes rapid hepatic conversion to 1,25-dihydroxyvitamin D3, which acts as a regulator of calcium and phosphate metabolism. Due to this rapid conversion, the therapeutic benefits of alfacalcidol are virtually the same as those of 1,25-dihydroxyvitamin D3. 2 The main effects are to increase circulating 1,25-dihydroxyvitamin 03 levels, and thereby to increase intestinal absorption of calcium and phosphate, promote bone mineralisation, regulate plasma parathyroid hormone levels as well as to decrease bone resorption. with relief of bone and muscle pain.
PHARMACEUTICAL PARTICULARS
List of Exciplents
Alohadol: Butylated Hydroxyanisole. Corn Oil, Dehydrated Alcohol, Gelatin, Glycerin, Sorbitol Solution (70%) (Non-crystallizing), Methylparaben, Propylparaben, Purified Water, Ponceau 4R Supra.
Alnh dol-1: Butylated Hydroxyanisole, Corn Oil, Dehydrated Alcohol, Gelatin, Glycerin, Sorbitol Solution (70%) (Non-crystallizing), Methylparaben, Propylparaben, Purified Water, Brilliant Blue Supra, Tartrazine Supra.
Shelf – Life : Do not use the product after Expiry Date indicated on Carton.
Special Precautions for Storage: Store at a temperature not more than 25°C, protect from light and moisture. Keep the medicine out of reach of children.
Nature and Contents of Container:
Alohadol: Blister pack, box of 3 X 10 and 10 X 10 capsules.
&Ugh cnInt-LI: Blister pack, box of 3 X 10 and 10 X 10 capsules.
Special precautions for disposal and other handling: No special requirements.
For more information and details contact :
Panacea Biotec Pharma Ltd.
Wholly-owned Subsidiary of Panacea Blotec Ltd.
E-B–1Extn./A–27, Mohan Co-op. Indl. Estate, 0_
Last updated February 2020
Mathura Road, New Delhi – 110 044, India.
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