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Calcitriol capsules

Updated 2 Feb 2023 | Vitamin D


Oral formulations containing calcitriol

Drugs List

  • calcitriol 250nanogram capsules
  • calcitriol 500nanogram capsules
  • ROCALTROL 250nanogram capsules
  • ROCALTROL 500nanogram capsules
  • Therapeutic Indications


    Correction of calcium and phosphate metabolism in renal osteodystrophy
    Osteoporosis - postmenopausal

    Unlicensed Uses

    Hypocalcaemia due to hypoparathyroidism
    Treatment of rickets


    Dose should be determined individually according to biological response, to prevent hypercalcaemia.


    Renal osteodystrophy
    Initial dose: 250 nanograms daily.
    If no satisfactory response observed within two to four weeks, dosage may be increased by 250 nanograms daily at two to four week intervals. Serum calcium levels should be determined at least twice weekly, during this period.
    Average daily dose: 0.5 to 1.0 micrograms.

    In patients with normal or slightly reduced calcium levels, 250 nanograms on alternate days is sufficient.

    Renal osteodystrophy refractory to continuous therapy
    Oral intermittent pulse therapy with an initial dosage of 0.1 micrograms/kg/week divided into two or three equal doses given at the end of dialysis. A maximum total cumulative dosage of 12 micrograms per week should not be exceeded.

    Post-menopausal osteoporosis
    250 nanograms twice a day.


    Hypophosphataemic rickets, persistent hypocalcaemia due to hypoparathyroidism, pseudo-hypoparathyroidism, vitamin D dependent rickets (unlicensed)
    Children aged 12 to 18 years
    Initial dose: 250 nanograms once daily.
    Increase if necessary in steps of 5 nanograms/kg daily (maximum 250 nanograms per dose) every two to four weeks.
    Usual dose range: 0.5 microgram to 1 microgram daily.
    Children aged 1 month to 12 years
    Initial dose: 15 nanograms/kg (maximum 250 nanograms) once daily.
    Increase if necessary in steps of 5 nanograms/kg daily (maximum 250 nanograms per dose) every two to four weeks.

    Additional Dosage Information

    Serum calcium and creatinine levels should be determined at 1, 3 and 6 months and at 6 monthly intervals thereafter.

    If serum calcium levels rise to 1mg/100ml (250 micromol/l) above the normal range of 9 to 11mg/100ml (2250 to 2750 micromol/l) then discontinue therapy until levels return to normal.


    Hypervitaminosis D
    Hereditary fructose intolerance
    Metastatic calcification

    Precautions and Warnings

    Children under 18 years
    Tissue calcification
    Renal impairment

    Regular haemodialysis increases risk of hypercalcaemia
    Renal failure increases risk of hypercalcaemia
    Tertiary hyperparathyroidism increases risk of hypercalcaemia
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Ensure patient has adequate fluid intake
    Breastfeeding: Hypercalcaemia of infant possible if mother taking vitamin D
    Breastfeeding: Monitor infant for systemic effects of treating the mother
    Monitor serum calcium levels
    Monitor serum creatinine
    Monitor serum phosphate levels
    Discontinue if hypercalcaemia occurs
    Discontinue if serum creatinine rises to > 120 micro mol/l
    Dosage of phosphate binding agents may need to be modified
    Avoid other sources of vitamin D
    Dietary restrictions should be maintained
    Adequate daily intake of calcium essential

    During dose titration serum calcium should be determined twice weekly.

    Discontinue therapy if calcium levels rise to 1 mg/100 ml (250 micromol/l) above normal (9 to 11 mg/100 ml or 2250 to 2750 micromol/l) and do not resume until normal calcaemia ensues.

    Plasma phosphate levels should be monitored in patients with renal failure because of the danger of ectopic calcification. Plasma phosphate levels should be maintained at the normal level (2 to 5 mg/100 ml or 0.65 to 1.62 mmol/l) by the oral administration of appropriate phosphate-binding agents and low phosphate diet.

    The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg squared/dl squared.

    Patients with vitamin D-resistant rickets who are being treated with calcitriol must continue their oral phosphate therapy.

    Possible stimulation of intestinal absorption of phosphate by calcitriol should be taken into account since this effect may modify the need for phosphate supplementation.

    In patients that are switched from a long acting vitamin D preparation (e.g. ergocalciferol, colecalciferol) to calcitriol it may take several months for the level in the blood to return to the baseline value, so increasing the risk of hypercalcaemia.

    Pregnancy and Lactation


    Calcitriol should be used with caution in pregnancy.

    Reproductive toxicity studies in rats and dogs indicated that calcitriol at an oral dose of twice the usual human dosage for up to 6 months produced no or minimal adverse effects. A dose of 8 times the usual human dosage for up to 6 months produced moderate adverse effects, primarily due to prolonged hypercalcaemia. There is no evidence to suggest that vitamin D is teratogenic in humans even at very high doses.

    Schaefer concludes that very high doses of vitamin D are contraindicated in pregnancy due to the risk of hypercalcaemia but where there is a documented maternal vitamin D deficiency, supplementation should be administered until maternal plasma concentrations return to normal levels. In such instances however, maternal and neonatal calcium and phosphate levels should be monitored regularly.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Calcitriol should be used with caution in breastfeeding.

    Calcitriol is excreted in human breast milk. A direct relationship exists between maternal serum levels and the concentration in breast milk. Excessive maternal doses of calcitriol can cause hypercalcaemia and hypervitaminosis D in the breast-fed infant. If breast feeding is continued where the mother is taking calcitriol, the serum calcium levels of the mother and infant should be monitored.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Cardiac arrhythmias
    Decreased appetite
    Growth retardation (children)
    Hypersensitivity reactions
    Muscle weakness
    Paralytic ileus
    Psychiatric disorders
    Sensory disturbances
    Serum creatinine increased
    Soft tissue calcification
    Urinary tract infections
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2015.

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Rocaltrol 0.25mcg and 0.5mcg capsules. Roche Products Limited. Revised June 2014.

    NICE Evidence Services Available at: Last accessed: 22 August 2017

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