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ONE-ALPHA is a brand name for Alfacalcidol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: One-Alpha* is indicated in all conditions where there is a disturbance of calcium metabolism due to impaired 1-α hydroxylation such as when there is reduced renal function. The main indications are: a) Renal osteodystrophy b) Hyperparathyroidism (with bone disease) c) Hypoparathyroidism d) Neonatal hypocalcaemia e)…
Verbatim from this product's MHRA label. Tap a section to expand.
05 microgram/kg/day Half-drop doses should be rounded up to the next whole number of drops. The dose of One-Alpha should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response. Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone, as well as radiographic and histological investigations.
Plasma levels should initially be measured at weekly intervals. 5 microgram. When the dose is stabilised, measurements may be taken every 2-4 weeks. Most adult patients respond to doses between 1 and 3 micrograms per day. When there is biochemical or radiographic evidence of bone healing (and in hypoparathyroid patients when normal plasma calcium levels have been attained), the dose generally decreases.
25 to 1 microgram per day. If hypercalcaemia occurs, One-Alpha should be stopped until plasma calcium returns to normal (approximately 1 week) then restarted at half the previous dose. (a) Renal bone disease: Patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidism, often unresponsive to One-Alpha.
Other therapeutic measures may be indicated. Before and during treatment with One-Alpha, phosphate binding agents should be considered to prevent hyperphosphataemia. It is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalcaemia may aggravate the decline of renal function.
(b) Hyperparathyroidism: In patients with primary or tertiary hyperparathyroidism about to undergo parathyroidectomy, pre-operative treatment with One-Alpha for 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia.
In order to decrease post-operative hypocalcaemia, One-Alpha should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs. (c) Hypoparathyroidism: In contrast to the response to parent vitamin D, low plasma calcium levels are restored to normal relatively quickly with One-Alpha.
g. 3-5 micrograms) together with calcium supplements. 1 microgram/kg/day (followed by careful titration) in severe cases doses of up to 2 microgram/kg/day may be required. Whilst ionised serum calcium levels may provide a guide to response, measurement of plasma alkaline phosphatase activity may be more useful.
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting. The most frequently reported undesirable effects are various skin reactions such as pruritus and rash, hypercalcaemia, gastrointestinal pain/discomfort and hyperphosphataemia.
Renal failure has been reported post-marketing. Undesirable effects are listed by MedDRA system organ class (SOC) and the individual undesirable effects are listed starting with the most frequently reported one. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) Metabolism and nutrition disorders Common: Hypercalcaemia Hyperphosphataemia Psychiatric disorders Not known: Confusional state Nervous system disorders Uncommon: Headache Rare: Dizziness Gastrointestinal disorders Common: Abdominal pain and discomfort Uncommon: Diarrhoea Vomiting Constipation Nausea Skin and subcutaneous tissue disorders Common: Rash* Pruritus *Various types of rash such as erythematous, maculo-papular and pustular have been reported Not known: Urticaria Musculoskeletal and connective tissue disorders Uncommon: Myalgia Renal and urinary disorders Common: Hypercalciuria Uncommon: Nephrolithiasis/Nephrocalcinosis Not known: Renal impairment (including acute renal failure) General disorders and administration site conditions Uncommon: Fatigue/asthenia/malaise Calcinosis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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During treatment with One-Alpha, serum calcium and serum phosphate levels should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses. PTH, alkaline phosphatase and calcium phosphates should be monitored as clinically indicated.
Hypercalcaemia might appear in patients treated with One-Alpha. For this reason, patients should be informed about the clinical symptoms connected with hypercalcaemia. Signs of hypercalcaemia are muscle and bone pain, muscle weakness, confusion, dehydration, anorexia, fatigue, nausea and vomiting, constipation, polyuria, sweating, headache, polydipsia, hypertension and somnolence.
Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (in about one week). One-Alpha may then be restarted at a reduced dose (half the previous dose) with monitoring of calcium. Prolonged hypercalcaemia may aggravate arteriosclerosis, cardiac valve sclerosis or nephrolithiasis and therefore prolonged hypercalcaemia should be avoided when One- Alpha is used in these patients.
Transient or even long-lasting deterioration of kidney function has been observed. One-Alpha should also be used with caution in patients with calcification of pulmonary tissue as this may result in cardiac disease. 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.
One-Alpha 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. Concurrent use of digitalis glycosides in the presence of hypercalcaemia due to vitamin D administration increases the potential for cardiac arrhythmias.
One-Alpha oral drops contain up to 340 mg ethanol per dose (corresponding to 6 micrograms of alfacalcidol), which is equivalent to 14 vol%. 5 ml wine. The small amount of ethanol in One-Alpha will not have any noticeable effect. 5 mg sorbitol/kg/day for an adult (70 kg).
1. Hypercalcaemia, metastatic calcification.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 times above the adult range indicates active disease. 1 microgram/kg/day of One-Alpha has proven effective as prophylaxis against early neonatal hypocalcaemia in premature infants. (e) Nutritional and malabsorptive rickets and osteomalacia: Nutritional rickets and osteomalacia can be cured rapidly with One-Alpha.
Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of One-Alpha. (f) Pseudo-deficiency (D-dependent) rickets and osteomalacia: Although large doses of parent vitamin D would be required, effective doses of One-Alpha are similar to those required to heal nutritional vitamin D deficiency rickets and osteomalacia.
(g) Hypophosphataemic vitamin D-resistant rickets and osteomalacia: Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory. Treatment with One-Alpha at normal dosage rapidly relieves myopathy when present and increases calcium and phosphate retention.
Phosphate supplements may also be required in some patients. Method of administration One-Alpha Drops should be administered orally, using the integral dropper. 1 microgram.
Patients with rare hereditary problems of fructose intolerance should not take this medicine. One-Alpha oral drops contain methylparahydroxybenzoate as an excipient. Methylparahydroxybenzoate may cause allergic reactions (possibly delayed).
One-Alpha oral drops contain macrogolglycerol hydroxystearate as an excipient. Macrogolglycerol hydroxystearate may cause stomach upset and diarrhoea. One-Alpha oral drops contain less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.