Skip to Content

ERGOCALCIFEROL INJECTION BP 600 000 UNITS

Active substance(s): ERGOCALCIFEROL

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ergocalciferol Injection BP 600,000U

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ergocalciferol BP 0.75% W/V
For excipients see 6.1.

3

PHARMACEUTICAL FORM
Solution for Injection

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Intramuscular therapy with Ergocalciferol Injection is used in patients with
gastrointestinal, liver or biliary disease associated with malabsorption of
Vitamin D, resulting in hypophosphataemia, rickets, and osteomalacia.

4.2

Posology and method of administration
Route of Administration: IM injection
Adults, Children and Elderly:
Dosage should be individualised by the clinician for each patient. Serum and
urinary calcium concentrations, phosphate and BUN should be monitored at
regular intervals, initially weekly, in order to achieve optimum clinical
response and to avoid
hypercalcaemia.
Doses should not normally exceed 40,000 units/day (1.0mg/day) for adults and
10,000 units/day (0.25mg/day) for children.
Ergocalciferol Injection may be administered as a single dose or repeated
daily, dependent upon clinical response and requirements. Calcium and
phosphorous supplements should be administered where necessary.

4.3

Contraindications
Hypercalcaemia, evidence of vitamin D toxicity, hypervitaminosis D,
decreased renal function, metastatic calcification.

4.4

Special warnings and precautions for use
Adequate dietary calcium is necessary for clinical response to Ergocalciferol
therapy.
Caution should be used when the injectable forms are used in patients with
vitamin D resistant rickets as the range between the toxic and therapeutic
dosage is narrow.
Vitamin D should be administered with caution to infants and patients who
may have an increased sensitivity to its effects. Use with care in patients with
renal impairment, renal calculi or heart disease or arteriosclerosis who might
be at increased risk of organ damage if hypercalcaemia were to occur.
Ergocalciferol is not recommended for use in hypoparathyroidism. In the
event of hypoparathyroidism when Ergocalciferol is used, calcium,
parathyroid hormone or dihydrotachysterol may be required.
Dosage should be individualised. Frequent serum and urinary calcium,
phosphate and urea nitrogen determinations should be carried out. Adequate
fluid intake should be maintained.
Should hyperglycaemia develop, Ergocalciferol should be discontinued
immediately.
Because of the effect on serum calcium, Ergocalciferol should only be
administered to patients with renal stones when potential benefits outweigh
possible hazards.

4.5

Interaction with other medicinal products and other forms of interaction
Ergocalciferol and:i)
Magnesium-containing antacids : hypermagnesaemia may develop in
patients on chronic renal dialysis.
ii)
Digitalis glycosides : hypercalcaemia in patients on digitalis may
precipitate cardiac arrhythmias.
iii)
Verapamil atrial fibrillation has recurred when supplemental calcium
and Ergocalciferol have induced hypercalcaemia.

iv)

v)

4.6

Anti-convulsants: vitamin D requirements may be increased in patients
taking anti-convulsants (e.g. carbamazepine, phenobarbital, phenytoin
and primidone).
Thiazide diuretics : hypoparathyroid patients on Ergocalciferol may
develop hypercalcaemia due to increased Ergocalciferol (although
Ergocalciferol is not recommended for use in hypoparathyroidism).

Pregnancy and lactation
Pregnancy : There are no adequate data on the use of Ergocalciferol in
pregnant women. Ergocalciferol Injection should not be used in pregnancy
unless the potential benefit outweighs the potential hazards to the foetus.
Animal studies have shown foetal abnormalities associated with
hypervitaminosis D. Calcifediol and calcitriol are teratogenic in animals when
given in doses several times the human dose. The offspring of a woman
administered 17-144 times the recommended dose of calcitriol during
pregnancy manifested mild hypercalcaemia in the first 2 days of life, which
returned to normal at day 3.
Lactation : Ergocalciferol is excreted in breast milk in limited amounts. In a
mother given large doses of Ergocalciferol, 25-hydroxycholecalciferol
appeared in the milk and caused hypercalcaemia in the child. Monitoring of
the infants serum calcium is required in such cases. Ergocalciferol should not
be administered to breast-feeding mothers.

4.7

Effects on ability to drive and use machines
Ergocalciferol may cause drowsiness and, if affected, patients should not drive
or operate machinery.

4.8

Undesirable effects
Adverse events are generally associated with excessive intake of ergocalciferol
leading to the development of hypercalcaemia.
The symptoms of
hypercalcaemia can include:
Early : weakness; headache; somnolence; nausea; vomiting; dry mouth;
constipation; diarrhoea; abdominal pain; fatigue; muscle weakness or pain;
bone pain; metallic taste.
Late : polyuria; polydipsia; anorexia; irritability; weight loss; nocturia; mild
acidosis; reversible azotaemia; generalised vascular calcification;
nephrocalcinosis; conjunctivitis (calcific); pancreatitis; photophobia;
rhinorrhoea; pruritis; hyperthermia; decreased libido; elevated BUN;
albuminuria; hypercholesterolaemia; elevated AST and ALT; ectopic
calcification; hypertension; cardiac arrhythmias; overt psychosis (rare).

In clinical studies on hypoparathyroidism and pseudohypopathyroidism,
hypercalcaemia was noted on at least one occasion in about 1 in 3 patients and
hypercalciuria in about 1 in 7. Elevated serum creatinine levels were observed
in about 1 in 6 patients (approximately one half of whom had normal levels at
baseline).

4.9

Overdose
Administration to patients in excess of their daily requirement can cause
hypercalcaemia (see Section 4.8 Undesirable Effects), hypercalciuria and
hyperphosphataemia. Concomitant high intake of calcium and phosphate may
lead to similar abnormalities.
Treatment of chronic overdose with resulting hypercalcaemia consists of
immediate withdrawal of the vitamin, a low calcium diet and generous fluid
intake. Severe cases may require hydration with intravenous saline together
with symptomatic and supportive treatment as indicated by the patient’s
clinical condition. Plasma calcium U & E’s should be monitored.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: A11 CC 01 — Vitamin D and analogues.
Ergocalciferol (vitamin D) is a fat soluble vitamin. In conjunction with
parathyroid hormone and calcitonin, it regulates calcium haemostasis.
Ergocalciferol metabolites promote active absorption of calcium and
phosphorous by the small intestine, increase rate of excretion and resorption of
minerals in bone and promote resorption of minerals in bone and promote
resorption of phosphate by renal tubules.
Ergocalciferol deficiency leads to rickets in children and osteomalacia in
adults.
Ergocalciferol reverses symptoms of nutritional rickets or
osteomalacia unless permanent deformities have occurred.

5.2

Pharmacokinetic properties
Distribution - Stored chiefly in the liver, ergocalciferol is also found in fat,
muscle, skin and bones. In plasma, it is bound to alpha globulins and albumin.
Metabolism - There is a lag of 10 to 24 hours between administration of
ergocalciferol and initiation of its action in the body. Maximal
hypercalcaemic effects occur about 4 weeks after daily administration of a

fixed dose and the duration of action can be ≥ 2 months. Ergocalciferol is
hydroxylated in the liver and further metabolism occurs in the kidney.
Excretion - The primary route of excretion of Ergocalciferol is in the bile.
Additionally, some is excreted in the urine and faeces. There is also
enterohepatic re-cycling.
5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Ethyl oleate

6.2

Incompatibilities
None stated

6.3

Shelf life
36 months

6.4

Special precautions for storage
Store below 25°C
Protect from light

6.5

Nature and contents of container
Ergocalciferol Injection BP 600,000U - 2ml neutral glass (Type 1) ampoules

6.6

Special precautions for disposal
Plastic syringes should not be used to administer Ergocalciferol Injection

7

MARKETING AUTHORISATION HOLDER
RPH Pharmaceuticals AB,
Lagervägen 7,
136 50 Haninge,
Sweden

8

MARKETING AUTHORISATION NUMBER
PL 36301/0009

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/04/2006

10

DATE OF REVISION OF THE TEXT
13/05/2011

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide