Marketed in 45 countries across Europe, the Americas, and the Asia-Pacific region, Rocaltrol is a globally distributed brand of calcitriol, classified within the vitamin D and calcium-phosphorus regulating category. The page you are reading is intended for travellers, expatriates, and family members trying to identify whether the medication they take at home is the same product they are seeing — or being prescribed — in another country.
Calcitriol is prescribed in the management of conditions linked to disturbed calcium and phosphorus metabolism, including osteoporosis, osteodystrophy, and renal osteodystrophy associated with chronic kidney disease. The structured indication block further down this page lists the registered uses recognised by national regulators in the markets where Rocaltrol is sold, and the wording of those indications can vary slightly between jurisdictions.
Because Rocaltrol has such a broad international footprint, the same product is encountered under the same brand name in markets as varied as Brazil, Australia, China, Belgium, and Canada. Regulatory packaging, prescription pathways, and locally available generics differ from one country to another, and a calcitriol-containing product on a foreign pharmacy shelf may carry a different brand name entirely. A pharmacist in the destination market is generally well placed to confirm whether a given product corresponds to what the patient is used to.
Other medications within the broader vitamin D analogue category exist in many of the same markets, sometimes under different molecules and different brand names, and the appropriate choice depends on the underlying condition rather than on brand familiarity. Anyone taking Rocaltrol, weighing whether to start it, or trying to identify a local equivalent during travel should treat that decision as a clinical one and discuss it with a healthcare provider who knows their full medical history.
3 years.
None.
Content
Butylhydroxyanisole
Butylhydroxytoluene
Medium-chain triglycerides
Shell
Gelatin
Glycerol
Karion 83 (Sorbitol, Mannitol, Hydrogenated hydrolysed starch)
Titanium dioxide E171
Iron oxide red E172
Iron oxide yellow E172
Subchronic toxicity studies in rats and dogs indicated that calcitriol at an oral dose of 20 ng/kg/day (twice the usual human dosage) for up to 6 months produced no or minimal adverse effects. A dose of 80 ng/kg/day (8 times the usual human dosage) for up to 6 months produced moderate adverse effects; changes seen appeared to be primarily the result of prolonged hypercalcaemia.
Reproductive toxicity studies in rats indicated that oral doses up to 300 ng/kg/day (30 times the usual human dose) did not adversely affect reproduction. In rabbits, multiple foetal abnormalities were observed in two litters at an oral maternally toxic dose of 300 ng/kg/day and one litter at 80 ng/kg/day, but not at 20 ng/kg/day (twice the usual human dose). Although there were no statistically significant differences between treated groups and controls in the numbers of litters or foetuses showing abnormalities, the possibility that these findings were due to calcitriol administration could not be discounted.
Absorption
Calcitriol is rapidly absorbed from the intestine. Peak serum concentrations following a single oral dose of 0.25-1µg Rocaltrol in healthy subjects were found within 2-6 hours.
After a single oral dose of 0.5 mcg Rocaltrol in healthy subjects, the average serum concentrations of calcitriol rose from a baseline value of 40.0 ± 4.4 pg/ml to 60.0 ± 4.4 pg/ml after two hours, and then fell to 53.0 ± 6.9 after four hours, to 50.0 ± 7.0 after eight hours, to 44 ± 4.6 after twelve hours and to 41.5 ± 5.1 pg/ml after 24 hours.
Distribution
During transport in the blood at physiological concentrations, calcitriol is mostly bound to a specific vitamin D binding protein (DBP), but also, to a lesser degree, to lipoproteins and albumin. At higher blood calcitriol concentrations, DBP appears to become saturated, and increased binding to lipoproteins and albumin occurs.
Metabolism
Calcitriol is hydroxylated and oxidised in the kidney and in the liver by a specific cytochrome P450 enzyme: CYP24A1.
Several metabolites with different degrees of vitamin D activity have been identified.
Elimination
The elimination half-life of calcitriol in plasma ranges between 5 to 8 hours. However, the pharmacological effect of a single dose of calcitriol lasts at least 4 days. The elimination and absorption kinetics of calcitriol remain linear in a very broad dose range and up to 165 µg single oral dose. Calcitriol is excreted in the bile and may undergo an enterohepatic circulation.
24 June 2014
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom.
Do not store above 25°C. Store in the original package and keep the blisters in the outer carton in order to protect from light and moisture.
PVC opaque blisters containing 100 capsules (5 strips of 20 capsules).
Rocaltrol 0.25 microgram Capsules: PL 00031/0122
Rocaltrol 0.5 microgram Capsules: PL 00031/0123
Not applicable.
13 January 2003
Rocaltrol is prescribed in the management of conditions linked to calcium and phosphorus metabolism, including osteoporosis, osteodystrophy, and renal osteodystrophy associated with chronic kidney disease. As a vitamin D analogue, it plays a role in the regulation of calcium-phosphorus exchange. The structured indication section below this introduction details each registered use as recognised by regulators in the markets where Rocaltrol is sold.
Rocaltrol contains calcitriol, an active form of vitamin D classified among agents that regulate calcium-phosphorus exchange. Calcitriol is the same molecule whether sold under the Rocaltrol brand or as a generic, and internationally the same active ingredient circulates under several different commercial names depending on the manufacturer and the regulatory market.
Rocaltrol carries marketing authorisation in 45 countries, spanning Europe, the Americas, and parts of Asia and Oceania. Examples include Brazil, Australia, China, Canada, Belgium, Bangladesh, and Chile. If your country is not represented in the list shown on this page, a local pharmacist can usually confirm whether calcitriol is available locally under a different brand name or as a generic product.
Calcitriol is sold under several brand names worldwide, particularly in markets where the original patent has long expired and multiple manufacturers produce calcitriol-containing products in parallel. Other vitamin D analogues also exist within the broader category, although they are not freely interchangeable — clinical positioning differs between molecules. To identify a local calcitriol product, search the active ingredient on Pill2Trip or ask a pharmacist in your country.
Yes. Rocaltrol is a prescription medication, and therapy involving calcium-phosphorus regulation is calibrated to the patient's underlying condition, kidney function, concurrent medications, and laboratory monitoring. This is especially relevant for travellers and people relocating between countries, since prescription requirements, available brands, and monitoring practices can differ significantly. Any decision to start, stop, switch, or substitute calcitriol should involve a healthcare provider familiar with the patient.
