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Альфадол-Ca

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Альфадол-Ca

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Treatment option: Osteoporosis

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Альфадол-Ca

Property Description
Active Ingredients Alfacalcidol, Calcium Carbonate
Form Oral capsule or tablet
Pharmacological Class Corrector of Vitamin D and calcium-phosphate metabolism
Common Use Maintaining mineral balance (Antihypocalcemic agent)
Origin Synthetic (Alfacalcidol) and Mineral (Calcium Carbonate)

Альфадол-Ca is a combination pharmaceutical preparation classified as a Corrector of Vitamin D and calcium-phosphate metabolism. It is an oral medicine, typically available as a capsule or tablet, designed for systemic administration to help maintain the body's essential mineral balance. This fixed-dose combination, containing both the synthetic active component and the mineral source, is pharmacologically recognized for its synergistic effect in addressing issues of calcium utilization.


Core Definition and General Purpose

The drug's primary role is as an Antihypocalcemic agent, meaning its purpose is to counteract abnormally low levels of calcium in the blood and restore overall mineral homeostasis. Альфадол-Ca is distinctively positioned for patients where both supplemental calcium and a highly effective Vitamin D derivative are necessary. For instance, it is commonly utilized to support individuals whose Vitamin D activation may be compromised due to factors like aging, thereby sustaining proper bone and muscle function.

Composition and Differentiating Features

The medicine contains two primary active substances: Alfacalcidol and Calcium Carbonate. The Alfacalcidol component is a key differentiating feature, as it is designed to efficiently stimulate the intestinal absorption of calcium by requiring fewer activation steps than standard Vitamin D. This mechanism ensures that the ample supply of Calcium Carbonate is effectively utilized, offering a direct approach to streamlining the correction of a deficiency state. The product's strength lies in its dual-component formulation, which is a concise alternative to managing multiple single-ingredient preparations.

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What side effects are possible with Альфадол-Ca?

Possible Side Effects and Safety Information

The safety profile of Альфадол-Ca is primarily defined by its effects on mineral metabolism, as documented in official regulatory sources. The most Common and clinically significant adverse reactions fall under Metabolism and Nutrition Disorders.


Adverse Reactions

Classification Examples of Reactions
Common (Affecting 1 in 10 to 1 in 100 people) High blood calcium (Hypercalcaemia), high phosphate levels (Hyperphosphataemia), abdominal discomfort, pruritus (itching), and rash.
Uncommon (Affecting 1 in 100 to 1 in 1,000 people) Headache, nausea, vomiting, constipation, diarrhoea, acute renal failure, kidney stones (Nephrolithiasis), and increased calcium in the urine (Hypercalciuria).
Serious Reactions Severe hypersensitivity (allergic) reactions, including those related to excipients like peanut oil; prolonged or severe Hypercalcaemia which may worsen conditions like arteriosclerosis or cardiac valve sclerosis.

Safety Restrictions and Monitoring

Contraindications (Situations where the medicine must not be used) include pre-existing Hypercalcaemia, Hypervitaminosis D, Metastatic calcification, and known Hypersensitivity to the active substance or any excipients.

Special Caution is required for use in patients with renal impairment, granulomatous diseases (such as sarcoidosis), and those receiving certain other medications like thiazide diuretics or digitalis glycosides.

Population-Specific Safety: Limited data necessitate use in pregnancy only if clearly necessary. The medication passes into breast milk, requiring medical consultation regarding breastfeeding. Regular monitoring of blood calcium and phosphate levels is mandated by regulatory bodies to manage the primary safety risk associated with this medicine.

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Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information for Альфадол-Ca

Overdose of Альфадол-Ca (Alfacalcidol and Calcium Carbonate) primarily results in hypercalcemia and hypercalciuria, reflecting an excess of calcium in the blood and urine. The official regulatory labeling documents the clinical syndrome of overdose, which may include symptoms such as anorexia, nausea, vomiting, weakness, headache, polyuria (excessive urination), polydipsia (excessive thirst), somnolence, and a confusional state.


Severe Outcomes and Required Actions

Classification Aspect Official Regulatory Statement
Severe Outcomes Prolonged, severe hypercalcemia is associated with risks of generalized vascular calcification, nephrolithiasis (kidney stones), deterioration of kidney function, and serious cardiac arrhythmias.
Antidote Information No specific antidote is known or mentioned in the official prescribing information.
Mandatory Action Stop taking the treatment immediately and seek medical help right away by contacting a hospital emergency department or a poison control centre. Emergency attention is required for progressive or acute hypercalcemia.

Supportive Management and Monitoring

Management of overdose is symptomatic and supportive, aiming to reverse hypercalcemia. Procedures may include measures to prevent further absorption, such as gastric lavage. Close monitoring of renal function, electrolytes, and electrocardiographs (ECGs) is required during the treatment of severe cases. Individuals with kidney failure or those receiving digitalis glycosides are noted as populations requiring specific consideration during overdose management.

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Therapeutic Uses of Альфадол-Ca

Альфадол-Ca is an established prescription medication used primarily to address conditions related to disturbed calcium and phosphate metabolism. The therapeutic goal is to help patients manage low calcium levels (hypocalcemia) associated with various disorders, particularly those related to Chronic Kidney Disease (CKD). The medication supports the body's processes to help maintain appropriate calcium balance in these patients.

A common clinical scenario for its use involves patients undergoing dialysis, where it is part of a comprehensive strategy to manage secondary hyperparathyroidism (SHPT). This use helps moderate elevated levels of parathyroid hormone. Альфадол-Ca is also intended to support bone mineralization and reduce the risk of complications associated with conditions like renal osteodystrophy in kidney patients.


Quick Fact: Management of Mineral Imbalances Альфадол-Ca is used to manage mineral imbalances in patients with chronic kidney disease, helping to support calcium balance and associated bone health.

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Eligibility and Restrictions for Use

The eligibility profile for Альфадол-Ca (a combination product containing Alfacalcidol and Calcium) is strictly defined by official regulatory documentation to minimize the risk of calcium excess.

Contraindicated Populations

The medicine is contraindicated and must not be used in patients with pre-existing biochemical evidence of hypercalcaemia (high blood calcium levels) or hypervitaminosis D (vitamin D overdose). It is also prohibited in those with metastatic calcification (generalized calcification of soft tissues) or a known hypersensitivity to Alfacalcidol, any excipients, or components like peanut or soy oil (if applicable to the formulation).

Conditional Use and Restrictions

Restricted use applies to patients with a history of calcium-containing kidney stones (nephrolithiasis) or certain granulomatous diseases (e.g., sarcoidosis), which may increase sensitivity to the active ingredient. Use requires caution in patients with existing cardiovascular diseases like arteriosclerosis due to the risk of exacerbation by hypercalcaemia.

Age and Life Stage Eligibility

  • Pregnancy and Lactation: Use is generally not recommended during pregnancy unless strictly necessary and is often advised against during breastfeeding, as the active substance can pass into breast milk.
  • Pediatric Use: Eligibility for children and adolescents varies by regulatory jurisdiction and indication, with some authorities limiting its use to adults or prescribing it under specialist monitoring.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Альфадол-Ca (Alfacalcidol and Calcium Carbonate) is defined by its effects on mineral metabolism and how other substances can alter its exposure, as documented in official regulatory sources.

Documented Interaction Patterns

Contraindicated Combinations

Co-administration with other Vitamin D analogues (e.g., calcitriol) is explicitly contraindicated in the label due to a significantly increased risk of hypercalcaemia (excessive calcium in the blood).

Interactions Affecting Calcium Balance

  • Thiazide Diuretics increase the potential for hypercalcaemia because they reduce the excretion of calcium by the kidneys.
  • Digitalis Glycosides (e.g., Digoxin) carry a restriction risk because hypercalcaemia, a potential effect of Альфадол-Ca, potentiates the toxicity of these agents, increasing the risk of serious cardiac arrhythmias.

Exposure and Absorption Interference

  • Anticonvulsants (e.g., Phenytoin) can increase the metabolism of Alfacalcidol, which may lead to a decrease in its therapeutic effect.
  • Bile Acid Sequestrants (e.g., Colestyramine) impair the absorption of Alfacalcidol. Official labeling mandates that Alfacalcidol must be administered at least 1 hour before or 4 to 6 hours after the sequestrant.
  • Co-administration with magnesium-containing preparations is associated with a heightened risk of hypermagnesaemia (high magnesium) in patients with chronic kidney failure.
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Mechanism of Action

Dual Activation of Mineral Transport and Supply

The drug operates through a precise, two-part mechanism focused on modulating calcium-phosphate homeostasis. The component Alfacalcidol acts as a prodrug, which is rapidly converted in the liver to the active hormone, calcitriol. This active form functions as an agonist of the Vitamin D Receptor (VDR), upregulating genes for intestinal calcium transporters (TRPV6, Calbindin). The second component, Calcium Carbonate, provides the necessary Ca^2+ substrate, supporting the newly increased absorptive capacity to increase systemic calcium levels.


Coordinated Systemic Regulation of PTH

The resultant increase in circulating calcium ions, combined with the direct VDR-mediated effects of calcitriol, triggers a powerful negative feedback loop on the parathyroid glands. Both the Ca^2+ (via the CaSR) and the calcitriol (via the VDR) work in synergy to suppress the release of Parathyroid Hormone (PTH). This coordinated suppression results in stabilization of the mineral equilibrium, which influences physiological processes dependent on appropriate levels of free calcium, such as nerve conduction and muscle contractility. This modulation of mineral homeostasis is the fundamental physiological change that affects calcium-dependent cellular processes.

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Dosage and Administration Information

How to Use Альфадол-Ca

The usage of Альфадол-Ca, a combination product containing Alfacalcidol and Calcium Carbonate, follows specific protocols focusing on individualized dosing and administration. The medicine is primarily taken orally as a capsule or drop formulation, although an intravenous route is approved for the active component, Alfacalcidol, in certain clinical settings.

Official Dosing and Frequency

Administration is typically structured as a once-daily regimen. The initial adult daily dose of the Alfacalcidol component often begins at 0.5 to 1.0 mcg, with the subsequent dose requiring careful and continuous individualization. Dosing is not static and must be regularly titrated based on the patient's biochemical response, specifically serum calcium, phosphorus, and parathyroid hormone (PTH) levels. Treatment is intended as a long-term, continuous protocol for managing chronic mineral imbalances.

Contextual Administration Requirements

The oral capsule can be taken with or without food. A critical condition for the proper use of this medicine is the achievement of an adequate daily intake of elemental calcium from all sources, often ranging from 800 to 1000 mg in adults. For pediatric patients, the initial daily dosage is typically calculated based on body weight (e.g., 0.01–0.1 μg/kg). If a dose is missed, the approach is to take it as soon as possible, or skip it entirely if it is near the next scheduled intake, without doubling the dose.

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Recent Clinical Evidence

Alfacalcidol: An Overview of Clinical Research

Alfacalcidol (the active component in Альфадол-Ca) is a synthetic analog of vitamin D that is widely studied for its role in calcium homeostasis and bone health. Clinical research has primarily focused on its use in conditions where the body's natural activation of vitamin D is impaired, particularly in patients with kidney function issues.

Key Areas of Study

Clinical trials and meta-analyses have investigated alfacalcidol's effects across several key conditions, including:

  • Renal Osteodystrophy: Studies have firmly established the use of alfacalcidol in managing the bone disease and secondary hyperparathyroidism often associated with chronic kidney disease (CKD). Its structure allows it to bypass the need for kidney-based activation, making it a critical tool for mineral balance in this population.
  • Osteoporosis: Research in postmenopausal osteoporosis has shown that alfacalcidol may contribute to improved bone mineral density (BMD) at sites such as the lumbar spine and may be associated with a reduction in the rate of new vertebral fractures. Some evidence also suggests a benefit in preventing non-vertebral fractures and reducing fall risk in elderly populations with high fall risk.
  • Corticosteroid-Induced Bone Loss: Alfacalcidol has been studied for its use in patients receiving high-dose corticosteroids, which can lead to rapid bone loss. Research indicates that alfacalcidol may help prevent this type of bone loss.

Safety Considerations

While studies suggest potential benefits, alfacalcidol, like other active vitamin D analogs, has been associated with an increased risk of hypercalcemia (high calcium levels in the blood) and hypercalciuria (high calcium levels in the urine). Close monitoring of calcium and phosphate levels is necessary during therapy to manage this risk.

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Frequently Asked Questions (FAQ)

Common questions about Альфадол-Ca (FAQ)


Q: Why is this drug called an 'active metabolite'?

Alfacalcidol, the key component, is described in regulatory documents as an active Vitamin D analog or metabolite. This is because it requires only one quick activation step in the liver to become calcitriol, the hormone that manages calcium levels. This characteristic supports its use in patients who may have difficulty activating standard Vitamin D in their kidneys.


Q: Can I take Альфадол-Ca if I have stomach problems?

Official documentation does not list pre-existing stomach problems as a general restriction for use. However, gastrointestinal discomfort, including nausea, vomiting, constipation, and diarrhoea, are noted in regulatory information as known possible side effects of the medication.


Q: Can I take Альфадол-Ca together with other vitamins?

While the official documents do not detail interactions with general vitamins, they strictly prohibit the use of this medicine alongside other Vitamin D analogues, such as calcitriol. This restriction is enforced to avoid a significant risk of developing hypercalcaemia (excessively high blood calcium levels).


Q: What is hypercalcaemia and how is it related to Альфадол-Ca?

Hypercalcaemia is defined as an abnormally high concentration of calcium in the blood. Because Альфадол-Ca is designed to increase calcium absorption, hypercalcaemia is noted in official sources as the most frequent and clinically significant adverse reaction. It is also a direct contraindication for the drug's use.


Q: What will happen if I take too much of the drug?

Taking doses that exceed the individual patient's daily requirements can lead to biochemical imbalances, including hypercalcaemia (high blood calcium), hypercalciuria (high calcium in the urine), and hyperphosphataemia (high phosphate levels). These conditions generally necessitate medical monitoring and management to achieve balance.


Q: Does Альфадол-Ca change the results of any lab tests?

The primary therapeutic purpose of the drug is to regulate mineral balance. Therefore, its use directly alters the results of biochemical analyses for serum calcium and phosphate. Regulatory bodies mandate regular laboratory monitoring of these specific indicators during treatment.


Q: Is it safe to drive while taking Альфадол-Ca?

Regulatory documents generally do not list specific warnings about the drug affecting the ability to drive or operate machinery. However, if side effects such as dizziness or headache occur, official guidance notes that a person's ability to drive may be affected.


Q: Can Альфадол-Ca cause headache or dizziness?

Yes, official documents list headache as an uncommon side effect associated with the medication. Dizziness may also be associated with systemic changes, though it is often a possible symptom of hypercalcaemia.


Q: Why must the drug be taken only under a doctor's supervision?

The medication has a narrow therapeutic range, meaning the dose must be highly individualized and constantly adjusted based on the patient's lab results (calcium, phosphates, and PTH levels). The necessity of consistent laboratory monitoring and dose adjustment is why the medication is typically administered under specialist supervision, aiming to minimize the risk of hypercalcaemia.


Q: Does Альфадол-Ca affect blood pressure?

The medication's direct effect on normal blood pressure is not specified in regulatory documents. However, official sources indicate that hypercalcaemia (a key risk associated with the drug) is known to potentially exacerbate existing cardiovascular diseases and arteriosclerosis. The drug can also interact with certain blood pressure medications, specifically thiazide diuretics.


Q: Should I avoid the sun while taking Альфадол-Ca?

Official guidance in some regulatory documents suggests that avoiding both uncontrolled Vitamin D supplementation and excessive exposure to sunlight is considered a protective measure while taking this medication. This helps minimize the potential cumulative risk of high Vitamin D activity and the resultant development of hypercalcaemia.


Q: What does 'alfacalcidol' mean in the composition?

Alfacalcidol is the primary active ingredient in the formulation, classified as a synthetic analog of Vitamin D. It is designed to be highly effective by bypassing the need for kidney activation, which is necessary for standard Vitamin D. It is chemically referred to by synonyms such as 1α-hydroxycholecalciferol.


Q: Is there information on the use of Альфадол-Ca in the elderly?

Yes, official sources provide information for use in the geriatric population. For this group, a lower initial starting dose may be considered, and therapy is required to be strictly individualized and monitored with careful attention to mineral levels.


Q: What are the alternative names or analogues of Альфадол-Ca?

The active component, Alfacalcidol, is also known by synonyms like 1α-hydroxyvitamin D₃ and 1α-hydroxycholecalciferol. The mono-product containing Alfacalcidol is known under various global trade names, such as One-Alpha.

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How should Альфадол-Ca be stored and disposed of?

How to Store and Dispose of Alfacalcidol (Альфадол-Ca)

The storage and disposal of Alfacalcidol must strictly adhere to the conditions mandated by regulatory labeling to maintain the product's stability.

Storage Requirements

  • Temperature: The medicine must not be stored above 25 C (or 77 F).
  • Protection: The capsules must be protected from light and kept within the original outer carton.
  • Child Safety: In line with official requirements, keep the medicine out of the sight and reach of children.
  • Stability: The product is stable until the expiry date printed on the packaging, provided these storage rules are followed.

Disposal Instructions

To prevent environmental contamination, unused or expired Alfacalcidol must not be thrown away in household waste or flushed down the drain. Instead, the medicine must be returned to a pharmacist for proper, safe pharmaceutical disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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