Colecalciferol oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of colecalciferol.
Drugs List
Therapeutic Indications
Uses
Osteoporosis - adjunct to treatment
Rickets
Vitamin D deficiency
Vitamin D deficiency in at risk patients: prophylaxis
Dosage
Adults
Vitamin D deficiency (serum levels less than 25nanomol/l or less than 10nanogram/ml)
800units to 4000units daily for up to 12 weeks, or alternatively 28,000units to 50,000units weekly for 6 to 8 weeks followed by a maintenance dose of 1400units to 2000units daily or 50,000units per month.
Vitamin D insufficiency (serum levels 25nanomol/l to 50nanomol/l or 10nanogram/ml to 20nanogram/ml)/Long term maintenance therapy following treatment of deficiency
800units to 2000units daily and occasionally up to 4000units daily may be required. Alternatively, 25,000units to 50,000units per month may be given.
Prevention of vitamin D deficiency
400units to 2000units daily, alternatively the 5600unit product recommends 5600unit per week up to a maximum of 28,000units per week if required, while some other brands recommend 20,000units to up to 50,000units per month.
Adjunct to specific therapy for osteoporosis
600units to 1500units daily, alternatively the 5600unit product recommends 5600unit per week up to a maximum of 28,000units per week if required or 20,000units to 25,000units per month.
Children
Prevention of Vitamin D deficiency
Children aged 1 to 18 years: 200units to 1000units daily in children aged up to 12 years or up to 1600units daily in children aged 12 to 18 years. Alternatively, 20,000units to 25,000units every 6 weeks.
Children aged under 1 year: 200units to 1000units daily or 25,000units every 8 weeks.
Treatment of vitamin D deficiency
Children aged under 18 years: 400units to 2000units daily or up to 4000units in adolescents. Alternatively, 20,000units to 25,000units once every 2 weeks for 6 weeks followed by maintenance therapy of 200units to 2000units daily.
Treatment of rickets
Initial: 200,000units daily (pulse therapy).
Maintenance: 1000units to 5000units daily.
Patients with Renal Impairment
In patients with severe renal impairment, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used.
In case of hypercalciuria (exceeding 300mg (7.5mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued.
Contraindications
Hypervitaminosis D
Hypercalcaemia
Hypercalciuria
Metastatic calcification
Nephrocalcinosis
Nephrolithiasis
Pseudohypoparathyroidism
Severe renal impairment
Precautions and Warnings
Children under 18 years
Prolonged immobilisation
Breastfeeding
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of nephrolithiasis
Hyperparathyroidism
Pregnancy
Renal impairment
Sarcoidosis
Allow for vitamin D intake from other sources
Not all available brands are licensed for all indications
Not all available products are licensed for all age groups
Some forms contain isomalt: unsuitable in hereditary fructose intolerance
Some formulations contain sucrose
Monitor plasma calcium in patients receiving pharmacological doses of drug
Monitor serum and urinary calcium in patients with sarcoidosis
Monitor serum calcium levels in patients with renal impairment
Monitor serum calcium levels on prolonged use
Monitor serum phosphate levels in patients with renal impairment
Monitor urinary calcium in patients on prolonged therapy
Monitor urinary calcium in patients with a history of renal stones
Reduce dose/temporarily withdraw treatment if hypercalcaemia occurs
Risk of cardiac arrhythmias in patients treated with digitalis and other cardiac glycosides (especially the elderly). Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. In such cases, strict medical supervision is required and monitor ECG and calcium if necessary.
Consider the need for additional calcium supplements.
Monitoring during long-term treatment is especially important in the elderly and in patients with a high tendency to calculus formation.
There have been reports of an increased risk of fractures in elderly patients with oral administration of high dose vitamin D (500,000units by single annual bolus), particularly occurring during the first 3 months after dosing.
In patients with renal impairment, take into account the risk of soft tissue calcification. Calcium and phosphate levels should be monitored in these patients.
Pregnancy and Lactation
Pregnancy
Use colecalciferol with caution during pregnancy.
The manufacturers of the high strength formulations recommend that the low strength formulations should be used in pregnancy.
During pregnancy, requirements for vitamin D are increased. The recommended daily intake in the UK for pregnant women is 400units (10micrograms), however, in women who are considered to be vitamin D deficient a higher dose may be required.
Studies in animals have shown reproductive toxicity with high doses of vitamin D.
Lactation
Use colecalciferol with caution during breastfeeding.
Vitamin D and its metabolites pass into breast milk. This should be taken into consideration when giving additional vitamin D to a child.
Breast milk from women taking pharmacological doses of vitamin D may cause hypercalcaemia if given to an infant. The manufacturers of the high strength formulations recommend that the low strength formulations should be used in breastfeeding.
LactMed (2020) recommended daily intake of vitamin D in the UK in breastfeeding women is 400unit (10micrograms).
Side Effects
Angioedema
Diarrhoea
Flatulence
Hypercalcaemia
Hypercalciuria
Hypersensitivity reactions
Laryngeal oedema
Nausea
Pruritus
Rash
Stomach pain
Urticaria
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2019
Reference Sources
Summary of Product Characteristics: Aviticol 800 IU capsules. Colonis Pharma Ltd. Revised December 2017.
Summary of Product Characteristics: Aviticol 1000 IU capsules. Colonis Pharma Ltd. Revised December 2017.
Summary of Product Characteristics: Aviticol 20,000 IU capsules. Colonis Pharma Ltd. Revised March 2018.
Summary of Product Characteristics: Colecalciferol 3000 IU/ml Oral Solution. Thame Laboratories. Revised March 2020.
Summary of Product Characteristics: Colecalciferol 10,000 IU capsules, soft. Alissa Healthcare Research Limited. Revised Agust 2017.
Summary of Product Characteristics: Desunin 800 IU tablets. Mylan Products Ltd. Revised August 2018.
Summary of Product Characteristics: Desunin 4000 IU tablets. Mylan Products Ltd. Revised August 2018.
Summary of Product Characteristics: Fultium-D3 800 IU capsules. Internis Pharmaceuticals Ltd. Revised January 2018.
Summary of Product Characteristics: Fultium-D3 Drops. Internis Pharmaceuticals Ltd. Authored August 2015.
Summary of Product Characteristics: Fultium-D3 3,200 IU capsules. Internis Pharmaceuticals Ltd. Revised January 2018.
Summary of Product Characteristics: Fultium-D3 20,000 IU capsules. Internis Pharmaceuticals Ltd. Revised January 2018.
Summary of Product Characteristics: InVita D3 2,400 IU/ml oral drops, solution. Consilient Health Limited. Revised January 2015.
Summary of Product Characteristics: InVita D3 5,600 IU soft capsules. Consilient Health Limited. Revised December 2016.
Summary of Product Characteristics: InVita D3 25,000 IU oral solution. Consilient Health Limited. Revised May 2017.
Summary of Product Characteristics: InVita D3 50,000 IU oral solution. Consilient Health Limited. Revised July 2015.
Summary of Product Characteristics: InVita D3 400 IU soft capsules. Consilient Health Limited. Revised July 2016.
Summary of Product Characteristics: InVita D3 800 IU soft capsules. Consilient Health Limited. Revised December 2016.
Summary of Product Characteristics: InVita D3 25,000 IU soft capsules. Consilient Health Limited. Revised July 2016.
Summary of Product Characteristics: InVita D3 50,000 IU soft capsules. Consilient Health Limited. Revised July 2016.
Summary of Product Characteristics: Plenachol D3 20,000 IU capsules. Accord UK Ltd. Revised July 2019.
Summary of Product Characteristics: Plenachol 40,000 IU capsules. Auden Mckenzie (Pharma Division) Ltd. Revised November 2018.
Summary of Product Characteristics: Thorens 10,000 I.U./ml oral drops, solution. Galen Limited. Revised January 2018.
Summary of Product Characteristics: Thorens 25,000 I.U./2.5 ml oral solution. Galen Limited. Revised January 2018.
Summary of Product Characteristics: Thorens 25,000 IU capsules, hard. Galen Limited. Revised June 2020.
Summary of Product Characteristics: Sapvit-D3 14,400 IU/ml oral drops, solution. Stirling Anglian Pharmaceuticals Ltd. Revised January 2017.
Summary of Product Characteristics: Stexerol-D3 tablets. Kyowa Kirin Ltd. Revised September 2018.
Summary of Product Characteristics: Strivit-D3 800 IU Capsules, Soft. Strides Pharma UK Ltd. Revised December 2018.
Summary of Product Characteristics: Strivit-D3 3,200 IU Capsules, Soft. Strides Pharma UK Ltd. Revised April 2019.
Summary of Product Characteristics: Strivit-D3 20,000 IU Capsules, Soft. Strides Pharma UK Ltd. Revised March 2019.
NICE - Evidence Services Available at: www.nice.org.uk
Last accessed: 4 October 2019.
Specialist Pharmacy Service (SPS)
Available at: https://www.sps.nhs.uk/
Safety in Lactation: Vitamins. Last revised: 19 April 2016
Last accessed: 4 October 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed). Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
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