Alcee

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Alcee

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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 Alcee

Quick Facts

Property Description
Active Ingredients Calcitriol, Calcium Carbonate, Zinc
Form Oral Dosage Form (Capsule or Tablet)
Pharmacological Class Vitamin D Analog, Mineral Supplement
General Purpose Support bone health and mineral balance
Origin Synthetic (Calcitriol) and Elemental (Calcium, Zinc)

What is Alcee?

Alcee is defined as a combination medicine administered via the oral route, classified within the therapeutic groups of Vitamin D Analogs and Mineral Supplements. The formulation contains the three active ingredients Calcitriol, Calcium Carbonate, and Zinc, distinguishing it as a multimineral preparation intended for systemic support of mineral balance.

What Type of Medicine is Alcee and What is its Composition?

Alcee is classified as a potent Vitamin D Analog and Mineral Supplement used to ensure crucial nutritional support. The composition is defined by its core active substances: Calcitriol, Calcium Carbonate (a source of Elemental Calcium), and the trace element Zinc. Calcitriol is the synthetic, hormonally active form of Vitamin D3 (1,25-dihydroxycholecalciferol), clinically recognized for its ability to bypass metabolic steps required by simpler Vitamin D forms. The other components are essential minerals supplied in a suitable oral dosage form, typically presented in capsule or tablet format.

Calcitriol, Calcium, and Zinc: The Synergy of Active Ingredients

The medicine leverages a synergistic mechanism centered on optimizing the absorption and utilization of calcium for bone formation. The inclusion of Calcitriol provides the body with the most potent active metabolite, which acts as a ligand for the Vitamin D receptor to greatly enhance the intestinal absorption of Elemental Calcium from the Calcium Carbonate component. This crucial process is fundamental to calcium homeostasis. The Zinc component, an essential trace element, further contributes to the overall physiological action by supporting enzymatic processes necessary for tissue and bone maintenance, a synergistic approach often highlighted in literature concerning mineral supplementation.

General Purpose: Who is this Combination Medicine Intended For?

The general purpose of this combination medicine is to correct or prevent the deficiencies of calcium and active vitamin D in the body, which are necessary for maintaining mineral balance. This unique formulation, often intended for adults and postmenopausal women, delivers a direct source of active Vitamin D alongside calcium and zinc. Alcee is generally designed to assist individuals with deficiencies or those with increased metabolic demands, such as in the context of needs arising from metabolic bone disease.

Regulatory References

  1. Calcitriol (Oral Route) - MedlinePlus

What side effects are possible with Alcee?

The safety profile for Alcee, a combination of Calcitriol and minerals, is dominated by the effects of Calcitriol, the active vitamin D component, which regulates calcium and phosphate levels. The most frequently documented adverse reaction in official labeling is Hypercalcemia (high blood calcium levels), which is classified as a Very Common event (occurring in 10% or more of patients).

Documented Adverse Reactions and Frequencies

Adverse reactions are formally grouped by System-Organ-Class. Common documented effects, occurring in 1% to 10% of patients, include Headache, Abdominal pain, Nausea, Rash, and Hypercalciuria (high calcium levels in urine). Effects classified as Uncommon (0.1% to 1%) include Vomiting and an Increased Blood Creatinine level.

Signs of excessive vitamin D and calcium intake are often categorized by onset: Early Signs may involve metallic taste, muscle/bone pain, or loss of appetite, while Late Signs can include polyuria (frequent urination), weight loss, or pancreatitis.

Serious Safety Considerations

The most serious safety consideration documented is severe, progressive Hypercalcemia, which can lead to clinically significant events such as Cardiac Arrhythmias and, in rare instances, Seizures. Other serious reactions officially noted include Anaphylaxis and the risk of Ectopic Calcification (calcium deposits in soft tissues).

Population-Specific Safety Notes

The medicine is Contraindicated in patients with pre-existing Hypercalcemia or documented evidence of Vitamin D Toxicity. Specific regulatory caution is required for patients with Renal Impairment (e.g., those on dialysis) due to the risk of soft tissue calcification; mandatory safety guidance requires the product of serum calcium and phosphate concentrations to be monitored regularly. Caution is also advised when co-administered with cardiac glycosides (like Digitalis) due to the heightened risk of cardiac arrhythmia if hypercalcemia develops.

Overdose and Emergency Response

Overdose involving Alcee, which contains Calcitriol, Calcium Carbonate, and Zinc, is defined by the risk of progressive hypercalcemia resulting from excessive Vitamin D analog and mineral exposure. The officially documented clinical manifestations begin with early symptoms such as weakness, headache, somnolence (drowsiness), metallic taste, nausea, vomiting, dry mouth, and constipation. If overdose continues, late manifestations may appear, including polyuria (increased urination), polydipsia (increased thirst), weight loss, and confusion. Laboratory findings associated with this toxicity include high serum calcium (Hypercalcemia) and high urinary calcium (Hypercalciuria), alongside changes in liver enzymes (SGOT/SGPT).

The regulatory documentation notes that severe hypercalcemia may necessitate emergency attention. Chronic overdose is associated with life-threatening systemic outcomes, including the risk of generalized vascular calcification, nephrocalcinosis (soft-tissue kidney calcification), and the potential to precipitate cardiac arrhythmias, especially in patients receiving digitalis.

If an overdose is suspected, immediate medical attention must be sought, and emergency services or the Poison Help line should be contacted. As officially described in regulatory guidance, management primarily involves symptomatic and supportive care, which includes the immediate discontinuation of the medicine. Specific measures described may include fluid replacement, and procedural steps such as the use of activated charcoal or gastric lavage may be considered. Continuous monitoring of serum calcium and phosphorus levels is a mandatory requirement following an overdose event.

Therapeutic Uses of Alcee

What Alcee Treats: Main Uses and Benefits

Alcee is commonly used as therapeutic support for chronic conditions that compromise skeletal structure, including Osteoporosis and Osteomalacia (softening of the bones). It is applied in situations where bone mineral density is reduced, which may assist with managing the symptoms related to fragility fracture risk and subsequent structural pain. The medication plays a role in managing symptoms related to skeletal weakness and supporting general well-being during symptomatic phases, particularly in postmenopausal women and older adults. This medication is applied across domains where additional symptomatic support is needed.

The formulation is also relevant for managing clinical conditions stemming from insufficient blood calcium levels, specifically Hypocalcemia and decreased function of the parathyroid gland (Hypoparathyroidism). It helps to address the associated symptoms of increased neurological or muscular activity, such as muscle cramps and spasms. The use of calcitriol is recognized in conditions like hypocalcemia, assisting with easing the impact of symptoms on routine activities and contributing to improved comfort during periods of heightened symptoms.

Alcee is also commonly used in specialized clinical contexts, particularly for patients with Chronic Kidney Disease (CKD), including those undergoing dialysis. In these scenarios, it is relevant in contexts involving heightened systemic burden, which helps manage resulting mineral and bone disorders, such as Renal Osteodystrophy. This supportive relief is considered relevant in contexts involving heightened systemic burden and assists with maintaining functional stability.


Quick Fact: Relief for Skeletal and Muscular Symptoms
Key Symptom Clusters Bone pain, muscle spasms and cramps, reduced mobility due to skeletal weakness.
Typical Patient Benefit Supports the patient by easing the overall symptom burden and maintaining a sense of functional stability.
Relevant Conditions Osteoporosis, Osteomalacia, Hypocalcemia, and Renal Osteodystrophy.

Regulatory References

  1. NIH StatPearls overview

Eligibility and Restrictions for Use

Who can and cannot use Alcee?

Alcee’s use is strictly defined by regulatory eligibility criteria, focusing on the potent effects of its active components, Calcitriol and Calcium. The medicine is contraindicated, meaning it must not be used, in patients with Hypercalcemia (abnormally high serum calcium levels) or any confirmed evidence of Vitamin D Toxicity. These are absolute prohibitions set by official labeling.

Age-Related and Condition Restrictions

Population Regulatory Status
Adults Permitted for managing mineral disorders and hypocalcemia, including in patients with Chronic Kidney Disease.
Children Not recommended for routine use. Safety and effectiveness for general supplementation are not established.

Use is restricted and requires careful monitoring in patients with severe renal impairment to prevent excessive calcium-phosphate accumulation. The medicine is classified as Pregnancy Category C, meaning it should only be used if the potential benefit outweighs the potential risk, and close monitoring of calcium levels is mandatory during both pregnancy and lactation.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Alcee

Property Description
Medicinal product categories with documented interactions Other Vitamin D and its Derivatives, Cytochrome P450 Enzyme-Inducing Anticonvulsants, Cardiac Glycosides, Thiazide Diuretics, Magnesium-containing Antacids, Tetracyclines, Fluoroquinolones, Thyroid Hormones.
Timing-based interaction rules Required administration separation is necessary for co-administration with Bisphosphonates, Tetracyclines, Fluoroquinolones, Thyroid Hormones (e.g., Levothyroxine), and Iron Supplements due to interference with absorption.
Interaction-related restrictions Contraindicated co-administration with Magnesium-containing Antacids in patients undergoing chronic renal dialysis.

Interaction classifications (high-level) Interaction severity is officially classified as Contraindicated when used with Magnesium-containing Antacids in dialysis patients. Other clinically significant interactions involve pharmacodynamic potentiation and pharmacokinetic changes.

Official interaction statements:

  • Co-administration with Magnesium-containing Antacids is contraindicated in patients on chronic renal dialysis due to the risk of hypermagnesemia.
  • Other Vitamin D derivatives and Thiazide Diuretics cause additive pharmacodynamic effects that increase the risk of hypercalcemia.
  • Calcitriol-induced hypercalcemia is documented to precipitate cardiac arrhythmias in patients receiving Cardiac Glycosides.
  • CYP450 Enzyme-Inducing Anticonvulsants are documented to reduce the effects of Calcitriol by increasing its catabolism.
  • Calcium and Zinc components reduce the absorption of oral antibiotics like Tetracyclines and Fluoroquinolones, necessitating dose separation.
  • Grapefruit or Grapefruit Juice may alter plasma concentrations of Calcitriol via established CYP450 3A4 inhibition.

Connection to the overall interaction profile (2–4 sentences): The regulatory profile for Alcee is defined by a distinct, officially classified contraindicated combination specific to patients on dialysis and by several pharmacodynamic interactions driven by the additive risk of excessive mineral levels. Further constraints result from pharmacokinetic interactions involving the metabolic effects of certain enzyme inducers on Calcitriol and the physical absorption interference of Calcium and Zinc with other oral medications.

Mechanism of Action

The compound, elacestrant (referred to as Alcee), functions as an oral selective estrogen receptor degrader (SERD).

It targets and binds to the estrogen receptor-alpha (ERalpha) protein, primarily within ER-expressing cells. This interaction involves a direct antagonism of the ER’s transcriptional activity. Following binding, Alcee promotes the ubiquitination of ERalpha, leading to its subsequent degradation via the 26S proteasomal pathway. This molecular event results in a substantial reduction in the overall intracellular concentration of functional ERalpha protein. The downstream cascade involves the disruption of ER-mediated genomic and non-genomic signaling pathways, which normally drive cell proliferation. The system-level physiological consequence of this targeted action is a modulation of the cellular microenvironment by decreasing the receptor population available for endogenous ligand binding, thereby inhibiting proliferative signaling characteristic of this tissue type.

Dosage and Administration Information

Alcee is an oral combination medicine prescribed to deliver its active components, including the Vitamin D analog Calcitriol, alongside Calcium and Zinc. The medication is to be swallowed whole with water, with no preparation or dilution required prior to ingestion.

The administration is defined by a specific dosing and titration protocol contingent on the indication. For chronic conditions such as renal osteodystrophy, the standard initial dose of the Calcitriol component is 0.25 mcg taken once daily. For post-menopausal osteoporosis, the usual labeled regimen is 0.25 mcg twice daily. Dosage adjustments, when necessary, must be made incrementally and only after observing the patient for 2 to 4-week intervals to guide optimal dosing.

Usage is conditional on two procedural requirements. First, the treatment requires the simultaneous consumption of an adequate daily intake of elemental calcium (e.g., 800 to 1000 mg) from diet or other supplements. Second, during the initial titration phase, the protocol mandates determining serum calcium levels at least twice weekly to inform the next steps in administration. While specific dose modifications for older adults are typically not specified, it is noted that safety and efficacy are generally not established for pediatric dosing.

Recent Clinical Evidence

Research evidence / Overview of Studies for Alcee

Evidence for Use in Osteoporosis and Bone Loss Prevention

Research examined the use of the Calcitriol and Calcium components in populations facing the studied conditions, such as osteoporosis in postmenopausal women and older adults. The main focus of this research has been to explore outcomes, specifically looking at changes in Bone Mineral Density (BMD) and the occurrence of bone fractures.

The studies monitored these populations over defined time intervals. Findings describe patterns observed in the studies related to BMD, indicating that changes in density measurements were tracked in some trials over the observation period. However, when research examined the outcome of fracture incidence, findings were mixed. High-level evidence from systematic reviews has indicated that data show patterns related to fracture incidence that were inconsistent across different study populations and trial designs.

Evidence for Use in Chronic Kidney Disease (CKD-MBD)

The components of Alcee was studied for understanding mineral balance in patients with severe Chronic Kidney Disease (CKD). Research focused on specific biochemical markers, tracking levels of Parathyroid Hormone (iPTH), serum calcium, and serum phosphorus within specific clinical ranges.

Studies report that when active Vitamin D sterols were administered, researchers often observed patterns related to the change in measured iPTH levels in patients with elevated hormone markers. This evidence contributes to the broader evidence landscape for understanding CKD-MBD. However, studies reported that the use of active Vitamin D analogs requires careful and continuous monitoring to track levels of calcium and phosphorus.

Evidence for Use in Hypocalcemia Management

Research examined temporary physiological imbalance in patients with low blood calcium levels (Hypocalcemia). Studies monitored the ability to achieve and maintain target serum calcium levels, which is a key outcome related to systemic imbalance. Research also examined patient-reported outcomes describing perceived discomfort related to symptoms such as muscle cramps or spasms.

In these studies, findings describe patterns observed in the studies, where administration of Calcitriol and Calcium was associated with measured increases in serum calcium levels. These same trials reported that changes in the intensity and frequency of symptoms were tracked during the study period. This evidence contributes to understanding symptom patterns.

What is Still Uncertain About Alcee's Evidence

While research contributes to the broader evidence landscape, several limitations and uncertainties remain. The vast majority of high-level evidence describes the use of Calcitriol and Calcium together, meaning there are limited data on the triple combination with Zinc. Therefore, comparative evidence for this specific formulation's effects on primary outcomes is lacking, and findings describe group patterns related to the two main components, not necessarily the three together. The consistency of findings related to the reduction of all fracture types in osteoporosis is also uncertain.

Key Studies & References

  1. The Role of Calcitriol in Mineral Metabolism and Bone Disease: NIH StatPearls

Frequently Asked Questions (FAQ)

Common questions about Alcee (FAQ)

Q: How long does it usually take to notice the effects of Alcee?

A: According to official regulatory information, the pharmacological activity of the calcitriol component—which is the main active ingredient—is described as having a duration of effect for approximately 3 to 5 days after a single dose.


Q: Is Alcee considered a long-term treatment?

A: Yes, official labeling describes the use of the active component for the management of chronic conditions. These conditions, such as hypocalcemia in patients undergoing chronic renal dialysis, are often managed over a long period of time.


Q: Is a metallic taste in the mouth a known side effect of Alcee?

A: Metallic taste is described in official documentation as a possible sign associated with high calcium levels (hypercalcemia), which is a frequently documented adverse reaction.


Q: Can Alcee cause trouble sleeping or insomnia?

A: Official regulatory documents list trouble sleeping or insomnia as a documented side effect or symptom that may be associated with the use of this medicine.


Q: Is it normal to feel a little dizzy when starting Alcee?

A: Official information indicates that dizziness and vertigo are possible symptoms that have been associated with the use of the calcitriol component.


Q: Does Alcee have an effect on birth control pills?

A: Official drug interaction summaries note that using the active component alongside some combination oral contraceptives (containing estradiol) may occasionally be linked to blood calcium levels becoming too high.


Q: Does the time of day matter when taking Alcee?

A: Official administration guidance often describes the medicine as usually taken once daily or every other day, often in the morning. However, the guidance generally permits the dose to be taken with or without food.


Q: Is Alcee a controlled substance or addictive?

A: Regulatory status documents for the calcitriol component classify it as a Prescription Only Medicine (Rx-only). It is not typically listed as a controlled substance by major regulatory authorities.


Q: Can Alcee cause weight gain or weight loss?

A: Weight loss is described in official documents as a possible sign or symptom associated with excessive intake, or hypercalcemia. Weight gain is not listed as a side effect.


Q: How quickly does Alcee leave the body?

A: The pharmacological activity of the calcitriol component is described in regulatory information as having a duration of effect for about 3 to 5 days.


Q: Why are there warnings about vision changes with Alcee?

A: Official documentation lists several possible eye-related reactions, including eye pain, redness, sensitivity to light, and blurred vision. These effects may be interpreted by users as 'vision changes'.


Q: Do I need to have regular blood tests while taking Alcee?

A: Official guidance indicates that serum calcium and phosphorus levels are required to be determined frequently, such as twice weekly during the initial treatment phase, and periodically thereafter. This monitoring is necessary to inform the next steps of management.


Q: Are headaches common when first starting Alcee?

A: Headache is documented in official sources as a common side effect of the medicine. It is also noted that headache may be an early sign of hypercalcemia, which is high calcium in the blood.


Q: What does the manufacturer say about missing a dose of Alcee?

A: Official information states that if a dose is missed, it should be used as soon as it is remembered, but the missed dose should be skipped if it is almost time for the next dose. The advice provided is never to use two doses at one time.


Q: Is Alcee available over the counter in any country?

A: The active component, calcitriol, is classified as a Prescription Only Medicine (Rx-only) in major regulatory jurisdictions. This means it is generally not available over the counter.


Q: Are there different forms of Alcee available (e.g., tablet, liquid)?

A: Official drug information lists the available oral dosage forms of the active component as both oral capsules and oral liquid.


Q: Is Alcee known to cause dry mouth?

A: Dry mouth is described in official documents as a documented side effect or symptom associated with the use of this medicine.


Q: Why are people talking about Alcee causing joint pain?

A: Official documentation describes bone or muscle pain as a symptom associated with high calcium levels (hypercalcemia). This bone or muscle pain may be interpreted by users as joint pain.


Q: How long has Alcee been available on the market?

A: The primary active component of this medicine, calcitriol, was identified as the active form of vitamin D in the early 1970s and was approved for medical use in the United States in 1978.


Q: Is Alcee used to treat anything else besides its main purpose?

A: The medicine is indicated for several uses beyond general bone health support. This includes the management of hypocalcemia (low blood calcium) in patients undergoing chronic renal dialysis, hypocalcemia in hypoparathyroidism, and secondary hyperparathyroidism in moderate to severe kidney disease.


Q: What kind of drugs or supplements should not be mixed with Alcee?

A: Regulatory documents list several medicinal product categories with documented interactions. These include Magnesium-containing Antacids (which are contraindicated in dialysis patients), other Vitamin D derivatives, calcium and zinc supplements, and Thiazide Diuretics.


Q: Are there any known issues with taking Alcee with high blood pressure medication?

A: Thiazide Diuretics, a class of medication sometimes used for high blood pressure, are documented to cause additive pharmacodynamic effects. This means using them together increases the risk of hypercalcemia (high blood calcium levels).


Q: Can women who are pregnant or trying to conceive take Alcee?

A: The medicine is classified as Pregnancy Category C. This classification indicates that the medicine is considered for use when the potential benefit is considered to outweigh the potential risk. Official guidance requires close monitoring of calcium levels throughout both pregnancy and lactation.


Q: Are there special considerations for children using Alcee?

A: Dosage information for the active component is provided for pediatric patients for specific conditions. However, official documentation states that precautions and careful use apply.


Q: Is it necessary to avoid certain foods or drinks while using Alcee?

A: Official guidance advises patients that diet may require a close review, specifically concerning foods rich in calcium, Vitamin D, and phosphate, to prevent excessive mineral levels. Grapefruit juice may also alter the plasma concentrations of the active component.


Q: Can Alcee be taken with food?

A: Official administration guidance states that the medicine can be taken with or without food. Taking the medicine with a meal that contains some fat may modestly improve the absorption of the active component.

How should Alcee be stored and disposed of?

The storage and disposal of Alcee (calcitriol, calcium, and zinc) must comply with the conditions required by regulatory labeling to maintain product stability and ensure safety.

Official Storage Requirements

Storage Condition Type Regulatory Requirement
Temperature Store at 20 C to 25 C (68 F to 77 F), with excursions permitted to 15 C to 30 C (59 F to 86 F) [Controlled Room Temperature].
Protection The product must be protected from light and stored away from excess moisture. Do not store in the bathroom.
Packaging Keep the medication in the original container and ensure the cap or closure is tightly closed.

Disposal and Safety Rules

Alcee must be kept out of the sight and reach of children. Unused or expired medicine must be discarded properly according to local guidelines. Official instructions advise against flushing medications down the toilet or pouring them into a drain unless a health authority specifically directs it. The best option is typically a community drug take-back program.

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

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