ONE ALPHA® 1mcg Caps 10×10 Blister
SKU: 6230410154602
DIN: 00474525
SIZE: 100 Capsules
INDICATIONS: ONE ALPHA® capsules are indicated for the management of hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in patients with chronic renal failure.
DIRECTIONS: An initial dose of 0.25 mcg/day is recommended for the first 2 months.
Product Description
INDICATIONS AND CLINICAL USE
ONE-ALPHA® (alfacalcidol) is indicated in adult patients with chronic renal failure for:
- Management of hypocalcemia
- Secondary hyperparathyroidism
- Osteodystrophy
Pediatrics: The safety and efficacy of ONE-ALPHA® in children has not been established; therefore, Health Canada has not authorized an indication for pediatric use
CONTRAINDICATIONS
ONE-ALPHA® 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 complete listing, please refer to the product monograph.
- when there is biochemical evidence of hypercalcemia, hyperphosphatemia, or evidence of vitamin D overdose.
WARNINGS
General
The therapeutic margin with ONE-ALPHA® is narrow, therefore, the optimal daily dose must be carefully titrated for each individual patient.
ONE-ALPHA® should not be used concomitantly with other vitamin D products or derivatives. ONE-ALPHA® is a potent cholecalciferol derivative with a profound positive effect on intestinal absorption of dietary calcium, which may lead to hypercalcemia. The occurrence of hypercalcemia depends on such factors as the degree of bone mineralization, the state of renal function, and the dose of ONE-ALPHA®. Excessive doses of the drug induce hypercalcemia and hypercalciuria.
The effect of ONE-ALPHA® on inorganic phosphorus absorption is less marked than its effect on calcium, although it is important to recognize that the drug may increase plasma phosphorus concentrations, which may increase the requirements for phosphate binding agents.
Regular monitoring of plasma calcium is essential.
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.
Please refer to the product monograph for a complete list of warnings and precautions
ADVERSE REACTIONS
In general, the adverse effects of ONE-ALPHA® are similar to those encountered with excessive vitamin D intake.
Hypercalcemia and possibly an exacerbation of hyperphosphatemia are the more frequent adverse reactions that have been reported with ONE-ALPHA® 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 nutrition disorders: hypercalcemia, hypercalciuria, hyperphosphatemia
Skin: rash
Gastrointestinal: abdominal pain, loss of appetite
Renal and urinary disorders: renal failure, kidney stones
Please refer to the product monograph for a complete list of adverse reactions
ABOUT THE DISEASE
Chronic Renal Failure:
Individuals with renal failure cannot transform enough vitamin D into calcitriol naturally, causing low levels of calcium in the blood and bone disorders. This medication helps to increase the amount of vitamin D in the body by overpassing the conversion step in the kidneys. Common disorders associated with chronic renal failure are:
- Hypocalcemia: when the body does not absorb enough calcium
- Secondary hyperparathyroidism: excess parathyroid hormone production as a result of renal failure
- Osteodystrophy: alterations in bones due to renal failure
CLINICAL TRIALS
Please check back later
RESOURCES
Click here to download the Product Monograph
Click here to download Prescribing Information
FREQUENTLY ASKED QUESTIONS
One Alpha® (alfacalcidol) is a vitamin D analog used for the management of hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adult patients with chronic renal failure
Common side effects include: pruritus, weakness, headache, red eyes, somnolence, nausea and vomiting, cardiac arrhythmia, dry mouth, and excessive thirst, constipation, muscle pain, metallic taste, polyuria, anorexia, weight loss, nocturia, conjunctivitis, corneal calcification, photophobia, rhinorrhea, pancreatitis, hyperthermia, decreased libido, albuminuria, and hypertension.
Each person may react differently to a treatment. If you think this medication may be causing side effects, talk to your doctor or pharmacist
Typically, this medication is taken once daily, though doctors’ orders should be followed if otherwise expressed.
If you forget to take a dose, take it as soon as you can. But, if it is almost time for your next dose, do not double the dose
- 25 mcg and 1 mcg capsule: below 25°C
- Drops: 2-8°C
- Injection liquid: 2-8°C
One Alpha® interacts with:
- Digitalis glycosides
- Mineral oil used as a laxative
- Thiazide diuretics or calcium containing preparations
- Vitamin D
- Anticonvulsants
- Antacids containing magnesium
- Aluminum containing preparations
- Bile acid sequestrants
If you are taking any of these medications, speak to your doctor or pharmacist before taking One Alpha products.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breastfeeding, and any other significant facts about your health. These factors may affect how you should use this medication.
The therapeutic margin with One Alpha® is narrow, therefore, the optimal daily dose must be carefully titrated for each individual patient.
One Alpha® should not be used in the following cases:
- Pregnancy, unless clearly necessary
- Concomitantly with other vitamin D products or derivates
One Alpha® should be used with caution in the following cases:
- Patients with calcification of pulmonary tissue as this may result in cardiac disease.
- While breastfeeding.
Patients with granulomatous diseases.