Colecalciferol

Registered South African indications:

• Vitamin D deficiency

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypercalcaemia and/or hypercalciuria
• Nephrolithiasis and/or nephrocalcinosis
• Severe renal impairment
• Hypervitaminosis D
• Pseudohypoparathyroidism as the vitamin D requirement may be reduced due to phases of normal vitamin D sensitivity, involving the risk of prolonged overdose. Better-regulatable vitamin D derivatives are available for this
• Pregnancy
• Children and adolescents under 18 years of age 

South African recommendations

Caution recommended in the following patient groups

• Breastfeeding
• Mild to moderate renal impairment
• Elderly

Impaired renal function

• Regularly monitor calcium and phosphate levels. Be aware of the potential for soft tissue calcification

Cardiovascular disease

• Caution required in patients receiving treatment for cardiovascular diseases

Sarcoidosis

• Prescribe colecalciferol with caution in patients with sarcoidosis due to possible increased metabolism of vitamin D into its active form
• Regularly check serum and urinary calcium levels in these patients

Vitamin D supplementation

• Be mindful of the high dose of vitamin D (50 000 IU per unit) and concurrent vitamin D prescriptions
• Consider total vitamin D intake from other treatments, vitamin D-enriched foods, milk, and sun exposure
• Additional vitamin D administration should be under strict medical supervision

Calcium supplements

• Though causation is unclear, the risk of renal stones, particularly with concomitant calcium supplementation, is plausible
• Consider the need for additional calcium supplementation on an individual basis
• Administer calcium supplements under close medical supervision

Fractures risk in the elderly

• Oral administration of high-dose vitamin D (500 000 IU annually) has been associated with increased fracture risk, especially within the first 3 months post-dosing

Forms avail. in SA and covered in this monograph: cap

South African registered indications and dosages

Vitamin D deficiency
- Serum 25-hydroxycalciferol (25(OH)D) <25nmol/L)

• Oral (cap): Initial treatment phase: 50000 IU (fifty thousand IU)/week for 6-8 weeks; Maintenance: 50000 IU (fifty thousand IU)/month

Follow-up measurements of 25(OH)D levels should be checked upon completion of the treatment phase and approximately 3-4 months after initiating maintenance therapy to confirm that blood levels have normalized or the set target level within the normal range has been achieved

For higher doses and monitoring of 25(OH)D that may be required in certain populations at high risk of vitamin D deficiency, see Additional Prescribing Points. Specific dosing adjustments should be guided by serum 25(OH)D levels and clinical judgment

The capsules should be swallowed whole with water, and should preferably be taken with a meal

Contraindicated

Pregnancy 

South African recommendations

• Contraindicated
• Due to insufficient clinical data, colecalciferol is not recommended in pregnancy

Breastfeeding

South African recommendations

• Caution; not recommended
• Due to insufficient clinical data, colecalciferol should not be taken by mothers who are breastfeeding

Fertility

South African recommendations

• There is no data regarding treatment with vitamin D3 and its effects on fertility

South African recommendations

• Mild to moderate: Caution; no dose adjustment recommended
  Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account
• Severe: Contraindicated
  Colecalciferolshould not be used in combination with calcium in patients with severe renal impairment

South African recommendations

• No dose adjustment recommended

South African recommendations

• Caution; no dose adjustment recommended
  Oral administration of high-dose vitamin D (500 000 IU by single annual bolus) was reported to result in an increased risk of fractures in elderly subjects, with the greatest increase occurring during the first 3 months after dosing

Metabolism and Nutrition Disorders

Frequency not specified

• Hypercalcaemia
• Hypercalciuria

Skin and Subcutaneous Tissue Disorders

Frequency not specified

• Pruritus
• Rash
• Urticaria

• Anticonvulsants
• Phenytoin
• Barbiturates
• Medicines that induce hepatic enzymes
• Thiazide diuretics
• Glucocorticoids
• Cardiac glycosides
• Digitalis
• Serum calcium concentrations
• Ion exchange resin
• Cholestyramine
• Colestipol hydrochloride
• Orlistat
• Laxatives such as paraffin oil
• Actinomycin
• Imidazole antifungal medicines

• Serum 25-hydroxycalciferol (25(OH)D)

Specific cases may require

• Serum phosphate
• Serum and urinary calcium
• Electrocardiography
• Parathyroid hormone (PTH)
• Alkaline Phosphatase (ALP)
• Magnesium
• X-ray
• Urine calcium/creatinine ratio

Additional observations

• Signs and symptoms of vitamin D toxicity

Certain populations at high risk of vitamin D deficiency, that may require higher doses and monitoring of serum 25(OH)D

• Institutionalised or hospitalised individuals
• Individuals with Fitzpatrick IV and upwards skin type
• Individuals with limited effective sun exposure due to protective clothing or consistent use of sunscreens
• Obese individuals
• Patients being evaluated for osteoporosis
• Use of certain concomitant medications (e.g. anticonvulsant medications, glucocorticoids)
• Patients with malabsorption, including inflammatory bowel disease and coeliac disease
• Those recently treated for vitamin D deficiency and requiring maintenance therapy

In its biologically active form vitamin D3 stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of vitamin D3. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active vitamin D3.

Capsule 50 000iu

• Soskain (Austell Pharmaceuticals)