Drugs List

Therapeutic Indications

Uses

Hypophosphataemia: secondary to vitamin D malabsorption
Osteomalacia: secondary to vitamin D malabsorption
Rickets: secondary to vitamin D malabsorption

Dosage

Doses are given as international units (units). Ergocalciferol injection may be administered as a single dose or repeated daily dependent on requirements and clinical response.

Dosage should be individualised with serum and urinary calcium, phosphate and blood urea nitrogen (BUN) monitored initially weekly and then at regular intervals to achieve optimum response and to avoid hypercalcaemia.

Administration

For intramuscular injection only.

Contraindications

Hypervitaminosis D
Hypercalcaemia
Metastatic calcification
Severe renal impairment

Precautions and Warnings

Breastfeeding
Cardiovascular disorder
Hypoparathyroidism
Nephrolithiasis
Pregnancy
Renal impairment

Not recommended for treatment of hypoparathyroidism
Advise patient drowsiness may affect ability to drive or operate machinery
Ensure patient has adequate fluid intake
Breastfeeding: Hypercalcaemia of infant possible if mother taking vitamin D
Monitor blood urea nitrogen (BUN)
Monitor serum calcium levels
Monitor serum phosphate levels
Monitor urinary calcium level
Discontinue immediately if hyperglycaemia occurs
Dosage must be individualised for each patient, especially children
Adequate daily intake of calcium essential

If hypoparathyroidism occurs during use of calciferol concurrent calcium, parathyroid hormone or dihydrotachysterol may be required.

Use with caution in patients with vitamin D resistant rickets as the range between the toxic and therapeutic dosage is narrow.

Pregnancy and Lactation

Pregnancy

Caution is advised when treating pregnant women. Animal studies have shown foetal abnormalities associated with administration of high doses of vitamin D during pregnancy although evidence for these effects in humans is lacking. There is however a risk of hypercalcaemia in the mother and neonate, particularly when ergocalciferol is given late in the pregnancy. In a study the offspring of a woman administered 17 to 144 times the recommended dose of calcitriol during pregnancy manifested mild hypercalcaemia during the first 2 days of life which resolved to normal levels at day 3.

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Caution is advised when treating a patient with ergocalciferol who is breastfeeding.

Calciferol is excreted in limited amounts in human breast milk. A direct relationship exists between maternal serum levels and the concentration in breast milk. Excessive maternal doses of ergocalciferol can cause hypercalcaemia and hypervitaminosis D in the breast-fed infant. If breast feeding is continued where the mother is taking pharmacological doses of ergocalciferol, monitoring of the infants serum and urinary calcium, phosphate and blood urea nitrogen (BUN) is recommended.

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Acidosis
Albuminuria
Anorexia
Azotaemia
Bone pain
Cardiac arrhythmias
Conjunctivitis (calcific)
Constipation
Diarrhoea
Dry mouth
Ectopic calcification
Fatigue
Headache
Hypercalcaemia
Hypercalciuria
Hypercholesterolaemia
Hypertension
Hyperthermia
Increase in blood urea nitrogen
Increases in hepatic enzymes
Irritability
Metallic taste
Myalgia
Nausea
Nephrocalcinosis
Nocturia
Pancreatitis
Photophobia
Polydipsia
Polyuria
Pruritus
Psychosis
Reduced libido
Rhinorrhoea
Serum creatinine increased
Somnolence
Vascular calcification
Vomiting
Weakness
Weight loss

Presentation

Solution for injection containing 300,000 units/ml (0.75% w/v) ergocalciferol.

Drugs List

Therapeutic Indications

Uses

Hypophosphataemia: secondary to vitamin D malabsorption
Osteomalacia: secondary to vitamin D malabsorption
Rickets: secondary to vitamin D malabsorption

Dosage

Doses are given as international units (units). Ergocalciferol injection may be administered as a single dose or repeated daily dependent on requirements and clinical response.

Dosage should be individualised with serum and urinary calcium, phosphate and blood urea nitrogen (BUN) monitored initially weekly and then at regular intervals to achieve optimum response and to avoid hypercalcaemia.

Administration

For intramuscular injection only.

Contraindications

Hypervitaminosis D
Hypercalcaemia
Metastatic calcification
Severe renal impairment

Precautions and Warnings

Breastfeeding
Cardiovascular disorder
Hypoparathyroidism
Nephrolithiasis
Pregnancy
Renal impairment

Not recommended for treatment of hypoparathyroidism
Advise patient drowsiness may affect ability to drive or operate machinery
Ensure patient has adequate fluid intake
Breastfeeding: Hypercalcaemia of infant possible if mother taking vitamin D
Monitor blood urea nitrogen (BUN)
Monitor serum calcium levels
Monitor serum phosphate levels
Monitor urinary calcium level
Discontinue immediately if hyperglycaemia occurs
Dosage must be individualised for each patient, especially children
Adequate daily intake of calcium essential

If hypoparathyroidism occurs during use of calciferol concurrent calcium, parathyroid hormone or dihydrotachysterol may be required.

Use with caution in patients with vitamin D resistant rickets as the range between the toxic and therapeutic dosage is narrow.

Pregnancy and Lactation

Pregnancy

Caution is advised when treating pregnant women. Animal studies have shown foetal abnormalities associated with administration of high doses of vitamin D during pregnancy although evidence for these effects in humans is lacking. There is however a risk of hypercalcaemia in the mother and neonate, particularly when ergocalciferol is given late in the pregnancy. In a study the offspring of a woman administered 17 to 144 times the recommended dose of calcitriol during pregnancy manifested mild hypercalcaemia during the first 2 days of life which resolved to normal levels at day 3.

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Caution is advised when treating a patient with ergocalciferol who is breastfeeding.

Calciferol is excreted in limited amounts in human breast milk. A direct relationship exists between maternal serum levels and the concentration in breast milk. Excessive maternal doses of ergocalciferol can cause hypercalcaemia and hypervitaminosis D in the breast-fed infant. If breast feeding is continued where the mother is taking pharmacological doses of ergocalciferol, monitoring of the infants serum and urinary calcium, phosphate and blood urea nitrogen (BUN) is recommended.

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Acidosis
Albuminuria
Anorexia
Azotaemia
Bone pain
Cardiac arrhythmias
Conjunctivitis (calcific)
Constipation
Diarrhoea
Dry mouth
Ectopic calcification
Fatigue
Headache
Hypercalcaemia
Hypercalciuria
Hypercholesterolaemia
Hypertension
Hyperthermia
Increase in blood urea nitrogen
Increases in hepatic enzymes
Irritability
Metallic taste
Myalgia
Nausea
Nephrocalcinosis
Nocturia
Pancreatitis
Photophobia
Polydipsia
Polyuria
Pruritus
Psychosis
Reduced libido
Rhinorrhoea
Serum creatinine increased
Somnolence
Vascular calcification
Vomiting
Weakness
Weight loss

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: March 2014

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.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Ergocalciferol Injection BP 300,000U. RPH Pharmaceuticals AB. Dated April 2012

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 28 June 2017

UK Drugs in Lactation Advisory Service.
Available at: https://www.ukmicentral.nhs.uk/drugpreg/guide.htm
Last accessed: March 20, 2014