Product image of Hidroferol (Calcifediol Monohydrate) supplied by GNH India

Hidroferol

Active Ingredient:
Calcifediol Monohydrate
Origin:
EU

Hidroferol (Calcifediol Monohydrate)

Hidroferol is an oral, over‑the‑counter product that contains calcifediol monohydrate as its active ingredient. It is supplied in tablet or capsule form (strength not specified) and is marketed in the European Union as a vitamin D analog for supplementation. Calcifediol is the 25‑hydroxy metabolite of vitamin D3, directly raising circulating 25‑hydroxyvitamin D levels in adults with low vitamin D status. It is available without a prescription and can be used under medical guidance.

Manufacturer / TM Owner

Faes Farma, S.A.

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Indications & Clinical Uses

Hidroferol is used to address conditions related to inadequate vitamin D status.

  • Treatment of vitamin D deficiency in adults.
  • Management of secondary hyperparathyroidism, particularly in chronic kidney disease.
  • Support of bone mineralization in individuals at risk of osteomalacia.
  • Adjunct to calcium supplementation for maintaining normal serum calcium and phosphate concentrations.
  • Prevention of hypocalcemia in patients receiving long‑term glucocorticoid therapy.

How It Works

  • Calcifediol monohydrate is the 25‑hydroxy form of vitamin D3; after oral absorption it circulates as 25‑hydroxyvitamin D, the major storage form. Hepatic 25‑hydroxylase converts vitamin D3 to calcifediol, bypassing this step and allowing a rapid increase in serum 25‑hydroxyvitamin D. The elevated metabolite binds to the vitamin D receptor (VDR) in target tissues, promoting transcription of genes that enhance intestinal calcium and phosphate absorption and modulate parathyroid hormone secretion.

Side Effects

Adverse reactions to Hidroferol are generally related to excessive vitamin D activity.

Common

  • Mild hypercalcemia (elevated serum calcium)
  • Nausea or vomiting
  • Constipation or abdominal discomfort
  • Headache
  • Fatigue

Serious

  • Severe hypercalcemia with cardiac arrhythmia
  • Nephrolithiasis or renal impairment
  • Hypercalciuria leading to kidney stones
  • Allergic reactions such as rash or angioedema
  • Hyperphosphatemia in susceptible individuals

Precautions & Warnings

Before using Hidroferol, consider the following precautions.

  • Assess baseline serum calcium, phosphate, and 25‑hydroxyvitamin D levels.
  • Use cautiously in patients with a history of hypercalcemia, kidney stones, or renal disease.
  • Monitor for signs of hypercalcemia, especially when combined with calcium or vitamin D supplements.
  • Avoid use in individuals with known hypersensitivity to calcifediol or excipients.
  • Pregnant or breastfeeding women should consult a healthcare professional before use.
  • Adjust dosage in patients with malabsorption syndromes or liver impairment.

Avoid Interactions

Hidroferol may interact with several medications.

Avoid

  • High‑dose calcium supplements or vitamin D preparations that could cause hypercalcemia.
  • Thiazide diuretics, which reduce urinary calcium excretion and increase hypercalcemia risk.
  • Certain antacids containing calcium or magnesium that may affect absorption.

Use with caution

  • Corticosteroids, which can alter vitamin D metabolism.
  • Anticonvulsants (e.g., phenobarbital, phenytoin) that increase vitamin D catabolism.
  • Bisphosphonates, as altered calcium levels may affect their efficacy.
  • Loop diuretics, which increase calcium excretion and may require monitoring.

Frequently Asked Questions

The active ingredient in Hidroferol is calcifediol monohydrate, the 25‑hydroxy form of vitamin D3.

Hidroferol provides calcifediol, which is already 25‑hydroxylated, allowing a faster and more direct increase in serum 25‑hydroxyvitamin D levels compared with vitamin D3 that requires hepatic conversion.

Yes, Hidroferol is classified as an over‑the‑counter (OTC) product in the European Union and can be purchased without a prescription.

It is commonly used to treat vitamin D deficiency, manage secondary hyperparathyroidism, support bone mineralization, and prevent hypocalcemia when combined with calcium or certain medications.

Co‑administration can be safe but requires monitoring of serum calcium to avoid hypercalcemia, especially at high doses of either product.

Common side effects include mild hypercalcemia, nausea, constipation, headache, and fatigue.

Severe hypercalcemia, kidney stones, renal impairment, allergic reactions such as rash or angioedema, and significant changes in heart rhythm require immediate medical evaluation.

Patients with chronic kidney disease should use Hidroferol only under medical supervision and have their serum calcium and phosphate levels regularly monitored.

Pregnant or breastfeeding women should consult a healthcare professional before starting Hidroferol to assess benefits and risks.

High‑dose calcium or vitamin D supplements, thiazide diuretics, and certain antacids containing calcium or magnesium should be avoided to reduce the risk of hypercalcemia.

Monitoring is typically recommended after 4–8 weeks of therapy and thereafter as directed by a healthcare provider, especially when adjusting the dose.

Excessive intake can lead to hypercalcemia and related complications; therefore, dosing should follow professional guidance and periodic laboratory monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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