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Calcitriol

Decostriol, Rocaltrol · ATC code A11CC04

Also known as: Kalsitriol · Brand names: Decostriol, Rocaltrol, Calcitriol Gry, Calcitriol Mibe, Calcitriol-Nefro Medice Arzneimittel Pütter, Osteotriol, Silkis, Cajex, Calcitron, Calderol, Ostriol, Qalyviz, Teory, Vectical

Key facts
Active substance
Calcitriol
Drug class
Vitamin D receptor modulator
ATC code
A11CC04
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Calcitriol is, per the US prescribing information, the active form of vitamin D₃, used for secondary hyperparathyroidism and hypocalcemia in kidney disease and for hypoparathyroidism.

What it is used for

  • Secondary hyperparathyroidism and metabolic bone disease in moderate to severe chronic renal failure (creatinine clearance 15 to 55 mL/min) not yet on dialysis.
  • Hypocalcemia and metabolic bone disease in patients on chronic renal dialysis.
  • Hypocalcemia in postsurgical or idiopathic hypoparathyroidism and pseudohypoparathyroidism.

Dosing

  • The dose is determined individually; always start at the lowest possible dose and increase only with careful monitoring of serum calcium (at least twice weekly during titration).
  • Dialysis: start with 0.25 mcg/day, increase by 0.25 mcg/day at 4 to 8 week intervals if needed; most hemodialysis patients respond to 0.5 to 1 mcg/day.
  • Hypoparathyroidism: start with 0.25 mcg/day in the morning, increasing at 2- to 4-week intervals; most adults and children age 6 years and older respond to 0.5 mcg to 2 mcg daily.
  • Predialysis: adults and children 3 years and older 0.25 mcg/day, increased to 0.5 mcg/day if necessary; children under 3 years 10 to 15 ng/kg/day.
  • Adequate calcium intake (a dietary minimum of 600 mg daily) is assumed.

Contraindications

  • Hypercalcemia or evidence of vitamin D toxicity.
  • Hypersensitivity to calcitriol, drugs of the same class or any inactive ingredient.

Important warnings

  • Vitamin D overdosage is dangerous: progressive hypercalcemia may need emergency attention; chronic hypercalcemia can lead to vascular calcification and nephrocalcinosis.
  • Pharmacologic doses of other vitamin D products should be withheld during treatment.
  • If hypercalcemia develops, stop calcitriol immediately; once levels are normal, continue at a daily dose 0.25 mcg lower.
  • Calcitriol raises serum phosphate; in renal failure there is a danger of ectopic calcification.
  • Immobilized patients are at particular risk of hypercalcemia; patients with normal renal function should avoid dehydration.

Side effects

  • Adverse effects are generally those of excessive vitamin D intake (hypercalcemia syndrome).
  • Early signs: weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle and bone pain, metallic taste.
  • Late signs include polyuria, polydipsia, weight loss, pancreatitis, ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias and, rarely, overt psychosis.
  • In hypoparathyroidism studies, hypercalcemia occurred at least once in about 1 in 3 patients.
  • Hypersensitivity reactions such as pruritus, rash and urticaria have been reported.

Interactions

  • Thiazides may induce hypercalcemia.
  • Digitalis: hypercalcemia may precipitate cardiac arrhythmias; determine the dose with care.
  • Magnesium-containing preparations (e.g. antacids) should not be used in chronic dialysis patients (hypermagnesemia).
  • Cholestyramine may impair absorption; phenytoin or phenobarbital may make higher doses necessary.
  • Avoid uncontrolled intake of additional calcium-containing preparations.

Pregnancy and breastfeeding

  • Use in pregnancy only if the benefit justifies the risk to the fetus; teratogenic in rabbits.
  • A mother should not nurse while taking calcitriol.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • DecostriolDermapharm Gmbh · 1 register entry
  • RocaltrolAtnahs Pharma Netherlands B.V. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Calcitriol GryTeva Gmbh · 1 register entry
  • Calcitriol MibeMibe Gmbh Arzneimittel · 1 register entry
  • Calcitriol-Nefro Medice Arzneimittel PütterMedice Arzneimittel Pütter Gmbh & Co. Kg · 1 register entry
  • DecostriolMibe Gmbh Arzneimittel · 2 register entries
  • OsteotriolTeva Gmbh · 1 register entry
  • RocaltrolAtnahs Pharma Netherlands B.V. · 1 register entry
  • SilkisKohlpharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • CajexGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 2 register entries
  • CalcitronDAVİVA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • CalderolPHARMADA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • OstriolVEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • QalyvizSABA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • TeoryPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • VecticalGalderma Laboratories, L.P. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 22 more European countries
Belgium
Rocaltrol
Bulgaria
Остеод
Croatia
Detriol, Rocaltrol
Cyprus
Votrace
Czechia
Rocaltrol
Estonia
Rocaltrol
Finland
Silkis
France
Rocaltrol, Silkis
Greece
Votrace
Hungary
Rocaltrol
Ireland
Silkis
Italy
Calcitriolo Doc Generici, Calcitriolo Eg, Calcitriolo Mylan Generics, Calcitriolo Teva, Rocaltrol, Silkis
Latvia
Rocaltrol
Luxembourg
Rocaltrol
Netherlands
Rocaltrol, Silkis
Norway
Rocaltrol, Silkis
Poland
Detriol
Portugal
Rocaltrol, Silkis
Romania
Decostriol
Slovenia
Rocaltrol
Spain
Calcitriol Kern Pharma, Rocaltrol, Silkis
Sweden
Rocaltrol

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Calcitriol (Strides Pharma Science Limited) – Prescribing Information, 2026-06-23. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bebefb2a-7365-48e2-9681-83ed4b41e26e
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC A11CC.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.