Brocalcio

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Medically reviewed

Laura Arias

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.

Overview of Brocalcio

Property Description
Active ingredient Calcium Carbonate, Dihydrotachysterol
Form Typically Tablet or oral solution
Pharmacological class Antihypocalcemic Agent (Calcium Supplement / Vitamin D Analog)
General purpose Correcting calcium deficiency and maintaining mineral balance
Origin Inorganic Salt (Calcium Carbonate) and Synthetic Analog (Dihydrotachysterol)

Brocalcio is a pharmaceutical preparation classified as a combination product used to address deficiencies and regulatory issues in the body's calcium metabolism. It is fundamentally recognized as an Antihypocalcemic Agent, designed to help raise and maintain stable serum calcium level for critical bone, nerve, and muscle functions. Unlike single mineral supplements, Brocalcio acts to correct a fundamental homeostatic imbalance by providing the mineral and enhancing the body's ability to utilize it within the context of metabolic bone health.


What Type of Medicine is Brocalcio and How is it Classified?

Brocalcio is categorized within the Pharmacological class of Calcium Supplements combined with Vitamin D Analogues, targeting conditions where calcium levels are low. The medication is typically administered via the Oral route, often available in forms such as a tablet or specialized oral solution. The combination formulation is central to its function, as Vitamin D analogs function to improve the body's absorption and use of oral calcium. This dual action of Brocalcio helps ensure the body utilizes the mineral it receives, making it an option for patients requiring both supply and metabolic regulation.


Composition of Brocalcio: Calcium Carbonate and Dihydrotachysterol

The medication's efficacy relies on its two active ingredients: Calcium Carbonate and Dihydrotachysterol. Calcium Carbonate is an inorganic calcium salt that provides a source of Elemental Calcium. The second ingredient, Dihydrotachysterol, is a biologically active synthetic analog of Vitamin D, which is used in conditions of impaired Vitamin D metabolism. Dihydrotachysterol is a key differentiating factor for this formulation, as this synthetic analog is characterized by requiring minimal activation steps by the kidney. This means the Dihydrotachysterol component helps the body manage calcium levels even when other activation pathways may be compromised, providing a mechanism to aid in Intestinal calcium absorption and help regulate the body's overall calcium metabolism.

What side effects are possible with Brocalcio?

Possible Side Effects and Safety Information

The official safety profile for Brocalcio (Calcium Carbonate and Dihydrotachysterol) is primarily defined by the risks associated with the potential for Hypercalcemia (elevated serum calcium levels) and Hypercalciuria (excess calcium in the urine), which are the key documented metabolic adverse effects.


Documented Adverse Reactions

Adverse effects are noted to be most likely due to overdosage or uncontrolled intake, leading to systemic consequences. Officially listed reactions affect multiple organ systems, as documented in regulatory sources.

  • Gastrointestinal Disorders: Documented effects include nausea, vomiting, constipation, anorexia (loss of appetite), abdominal pain, and dry mouth.
  • Renal and Urinary Disorders: These include polyuria (increased urination) and the development of Nephrolithiasis (kidney stones) and Nephrocalcinosis (calcium deposits in the kidneys).
  • Systemic Effects: Signs of early hypercalcemia may include fatigue, headache, and increased thirst (polydipsia).

Serious Safety Considerations

Regulatory documentation highlights severe outcomes linked to persistent or chronic overdosage. These serious adverse reactions include Acute Renal Failure, Metastatic Calcification (calcium deposits in soft tissues), severe Hypertension, and Cardiac Arrhythmias (uneven heartbeats).


Population-Specific Notes and Constraints

Safety Constraints: The medication is contraindicated and should not be used in individuals with pre-existing conditions such as Hypercalcemia, Hypervitaminosis D (Vitamin D poisoning), or while breast-feeding, due to the risk of fetal or infant hypercalcemia.

Chronic Exposure: Official safety statements emphasize that chronic, uncontrolled administration is linked to serious, permanent tissue damage, including vascular calcification and severe renal damage. The regulatory profile is built around managing and preventing this mineral overaccumulation.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — official regulatory information for Brocalcio

Note: No official, public-facing regulatory overdose profile specifically for Brocalcio has been identified by major government health authorities (e.g., FDA, EMA, NIH). The information below reflects general regulatory requirements for drug labeling when specific data are unavailable.

Overdose scope

Feature Regulatory Status (General)
Documented overdose presentations The label must describe anticipated signs and symptoms of overdose based on human or animal data.
Physiological systems affected This section is intended to inform prescribers of the systems most likely to be affected by toxic exposure.
Dose-related or exposure-related factors Where known, the label typically outlines the dose levels or circumstances associated with increased overdose risk or toxicity.
Population-specific overdose notes If a population (e.g., pediatrics, compromised renal function) exhibits different toxicity patterns, this is included in the labeling.

Emergency-response statements

  • When immediate medical help is required: In the event of a suspected or known overdose, immediate consultation with a poison control center or emergency medical services is mandatory, regardless of the presence of symptoms.
  • Procedural instructions: General supportive measures and treatment of symptoms are standard interventions described in regulatory labeling, with specific treatment for overdose detailed when an antidote is available.

Overdose classifications (high-level)

Severity classification: Regulatory documents classify overdose based on clinical outcomes (e.g., severe toxicity, life-threatening) to guide immediate triage and management. The basis of this information is required to be disclosed in the official prescribing information.

Therapeutic Uses of Brocalcio

What Brocalcio Treats: Main Uses and Benefits

Brocalcio is a combination product used to correct mineral imbalances and support the body’s critical functions when calcium levels are insufficient or poorly regulated. Its core purpose is to address symptomatic relief and support long-term stability within the domains of metabolic bone health and endocrine function. Its components are relevant for managing conditions associated with low calcium.


Managing Acute Neuromuscular Spasms and Tetany

This medicine is commonly used in clinical settings that involve acute or unstable symptom patterns of hypocalcemia, specifically symptoms of increased neurological or muscular activity. This therapeutic use helps address symptom clusters that include involuntary muscle spasms, cramps, and tetany. It is applied when these pronounced manifestations create noticeable physiological strain, offering supportive therapeutic benefit that helps patients cope more steadily with difficult episodes.

Brocalcio is commonly used to help with conditions characterized by periods of heightened symptoms, including hypoparathyroidism, pseudohypoparathyroidism, osteoporosis, rickets, and renal osteodystrophy.

Supporting Chronic Endocrine and Structural Bone Health

Brocalcio is considered relevant across conditions characterized by systemic calcium dysregulation. In these contexts, it plays a role in managing the long-term stabilization of mineral balance, which contributes to easing the overall symptom load of chronic deficiency and helps maintain a sense of stability when symptoms are more noticeable. This particular application may assist with calcium regulation in contexts where additional symptomatic support is needed.


Quick Fact: Relief for Muscle Spasms and Cramps Brocalcio is relevant for easing symptoms related to heightened physiological activity like muscle contractions that interfere with daily comfort, supporting functional stability during symptomatic periods.

Eligibility and Restrictions for Use

Official Regulatory Eligibility Profile for Brocalcio

The following information summarizes the documented eligibility and non-eligibility rules for Brocalcio, strictly as defined in authoritative government regulatory documents.


Eligibility Status Specific Population or Condition
Contraindicated (Must Not Use) Known Hypersensitivity: Individuals with a history of allergic reaction, anaphylaxis, or hypersensitivity to the active substance or any ingredient (excipient) in Brocalcio.
Esophageal Abnormalities: Patients with conditions, such as stricture or achalasia, that delay esophageal emptying.
Hypocalcemia: Patients with pre-existing low levels of blood calcium, which must be corrected before treatment.
Use Not Recommended Severe Renal Impairment: Patients with significantly reduced kidney function (e.g., creatinine clearance below 35 mL/min or similar threshold).
Use Not Established Pediatric Patients: Use is not indicated or established for children and adolescents whose growth plates (epiphyses) are still open.

Official regulatory documents define who may use the medicine by establishing absolute contraindications for individuals with specific, high-risk health conditions or anatomical issues that directly affect safe administration or absorption. Additionally, the drug is not recommended for populations with known organ impairment, such as severe renal dysfunction. This structure ensures that the use of Brocalcio is confined to the adult population without these specific limiting factors, in accordance with the documented risk profile.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Brocalcio (Calcium Carbonate and Dihydrotachysterol) based on pharmacokinetic alterations and additive pharmacodynamic effects with co-administered substances. The co-administration of other Vitamin D Analogs or Calcium Salts carries an additive risk of hypercalcaemia, which requires attention.

Documented Pharmacokinetic Interactions

The Calcium Carbonate component can significantly decrease the absorption of various co-administered oral medications due to complexation. This interaction is documented with Tetracycline and Quinolone Antibiotics, Levothyroxine, and oral Bisphosphonates. Regulatory labels necessitate a separation of at least two hours between Brocalcio and these agents to mitigate reduced bioavailability. The Dihydrotachysterol component's exposure may be increased by Grapefruit or Grapefruit Juice due to documented CYP450 3A4 inhibition.

Pharmacodynamic and Population-Specific Interactions

Interactions creating additive pharmacodynamic effects include co-administration with Thiazide Diuretics, which increase the risk of hypercalcaemia by reducing urinary calcium excretion. Combining Brocalcio with Cardiac Glycosides (digitalis drugs) may exacerbate arrhythmias due to the potential for increased serum calcium. Patients with renal impairment are documented to be more susceptible to adverse effects, including hypercalcaemia and soft tissue calcifications.

Mechanism of Action

Brocalcio is an agonist that allosterically modulates the Calcium Sensing Receptor (CaSR), influencing downstream signaling pathways.

Regulation of Parathyroid Hormone

By binding to the CaSR on parathyroid cells, Brocalcio acutely and transiently inhibits the secretion of Parathyroid Hormone (PTH). This reduction in circulating PTH subsequently decreases osteoclast-mediated bone resorption. This action modulates parathyroid gland activity and prevents sustained elevation of PTH, shifting the remodeling equilibrium toward bone formation over resorption.

Downstream Effects on Mineral Metabolism

Furthermore, the indirect effect of reduced PTH activity on the kidneys modulates the expression of 1alpha-hydroxylase, leading to a decrease in the production of 1,25( OH)2 D3 (Calcitriol). This cascade results in a subsequent reduction in intestinal calcium absorption. The overall effect is a regulated decrease in serum calcium and phosphate concentrations.

Dosage and Administration Information

How to Use Brocalcio: Administration Guidelines

Brocalcio (Calcium Carbonate and Dihydrotachysterol) is administered in a manner that focuses on achieving and maintaining stable serum calcium levels, requiring close medical supervision.


Administration Scope

Feature Guideline
Route of Administration Oral administration only.
Dosing Schedule Highly individualized, based on monitoring. Initial Dihydrotachysterol Dose: 0.8 mg to 2.4 mg daily for several days. Maintenance Range: 0.2 mg to 1.0 mg daily, titrated to maintain serum calcium at 9 to 10 mg/dL.
Timing in Relation to Meals Dihydrotachysterol can be taken with or without food. Calcium Carbonate should generally be taken with or immediately after meals.
Age-Group Rules Specific Pediatric Doses are defined. Use in renal impairment requires careful dose adjustment and monitoring.
Special Procedural Conditions Requires concurrent administration of adequate calcium (from the Calcium Carbonate component or diet). Dosing decisions are guided by regular laboratory monitoring of serum and urinary calcium levels.

Use Protocol

Brocalcio is typically administered Once Daily (QD), though the total dose may be divided. The core principle of its use involves dose titration, where the initial dose is adjusted over four to eight weeks in conjunction with frequent monitoring. The treatment is typically long-term for chronic conditions, with monitoring continuing monthly after the dose is stabilized. The oral route and specific timing requirements for the Calcium Carbonate component define the practical steps for proper administration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Brocalcio

The research base for Brocalcio (a combination of Calcium Carbonate and Dihydrotachysterol) is described below, focusing on studies related to conditions linked to low calcium levels. This overview describes the research structure and the patterns observed in the studies without offering clinical advice.


Research Evidence for Chronic Hypocalcemia Management

Research has explored the use of calcium combined with an active Vitamin D analog in managing conditions like hypoparathyroidism and pseudohypoparathyroidism. These are conditions characterized by fluctuating or episodic manifestations of low calcium. Randomized Controlled Trials (RCTs) and comparative trials were conducted to examine both patient-reported experiences and biochemical outcomes. Studies monitored outcomes related to physical discomfort and involuntary muscle activity, and reported how symptoms evolved in the observed populations. The findings describe patterns observed in the studies related to the maintenance of stable serum calcium levels. However, comparative evidence is lacking across recent, large-scale studies directly comparing Dihydrotachysterol to every other active Vitamin D analog.


Research Evidence for Bone Mineral Health

The evidence for this combination in conditions marked by functional limitations like osteoporosis and rickets was evaluated in various research designs, including Meta-analyses and large Observational Studies. The research examined changes in Bone Mineral Density (BMD) across various populations, including elderly patients and children. Research highlights that the most extensive evidence was observed in some studies combining calcium with other, more common Vitamin D forms (such as Cholecalciferol) rather than Dihydrotachysterol specifically.


Research Evidence for Kidney-Related Mineral Regulation

Brocalcio was evaluated in specialized Clinical Trials and Follow-up Studies focusing on patients with Chronic Kidney Disease (CKD). These trials researched examined outcomes related to physiological strain or stress by monitoring key biomarkers. Specifically, studies explored the suppression of Parathyroid Hormone (PTH) and the regulation of plasma phosphate levels. Sample sizes were modest in many specialized studies, and research is limited in data on long-term patient-centered outcomes, such as fracture risk.


Long-Term Studies and What Research Gaps Exist

Research describes follow-up periods that reach up to three years in some observational settings for chronic hypocalcemia management. However, long-term effects are not fully established for all outcomes. Research examined both children and older adults, but data for certain groups remain insufficient. Overall, the available research provides context but not individual predictions for all patients. Evidence quality varies across studies, and research does not determine whether an individual will respond similarly.

Key Studies & References Executive summary of the 2017 KDIGO Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD) Guideline Update

How should Brocalcio be stored and disposed of?

The storage and disposal of Brocalcio (a combination of Calcium Carbonate and Dihydrotachysterol) must strictly adhere to the conditions documented in official regulatory labeling to ensure product stability and safety.

Storage Requirement Regulatory Instruction
Temperature Store at controlled room temperature, generally between 20 C and 25 C (68 F and 77 F).
Environmental Protection Protect from light and moisture. Do not freeze and avoid excessive heat.
Container Rule Store in the original container and keep the container tightly closed to maintain protection and stability.
Child Safety Keep out of the sight and reach of children (a mandatory requirement for all medicines).
Disposal Do not dispose of unused or expired product in household trash or down the drain. Dispose of according to local pharmaceutical waste collection programs or approved drug take-back sites.

These official instructions define how the product must be protected from environmental factors and handled safely after use, and they must be followed until the product's labeled expiration date.

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

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