Drug Interaction:
Avoid concomittant treatment with calcium and Vitamin D supplements
Magnesium containing products e.g antacids should not be used with Calcitrol because of an increased risk of hypermagnesamia.
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
233. Calcitriol 04-11-08
+ Calcium
+ Zinc 90.25mcg+ 200mg+7.5mg) capsules
For the treatment of hypocalcemia and/or ostoeporosis
Post menopausal osteoporosis.
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Calcitrol injection Vit D3 , Biologically active March 1994
2.Calcitrol Metabolic Bone Disease August 1993
3. Calcitrol + Calcium +Zinc 04-11-2008
(0.25mcg + 200mg + 7.5mg) capsules
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Calcitrol + 4-11-2008
Calcium +
Zinc (0.25mcg+200mg +7.5mg) capsules
For the treatment of hypocalcemia and /or osteoporosis
2.Calcitrol 0.25mcg+ 11-04-2008
Calcium 200mg+
Zinc 7.5mg Capsules
For the treatment of hypocalcaemia and/or osteoporosis
Adverse Reaction:
Hypercalcemia may rarely occur in patients taking calcitrol . This is more likely in the early days and weeks of treatment, but theoretically may occur at any time of treatment.
Therfore all patients should be warned to cease therapy and consult doctor promptly if they develop unexplained symptoms of hypercalcemia, such as loss of appetite , nausea, vomiting, headache, constipation, weakness or drowsiness.
Rarely more severe symptoms such as dehydration, polyuria, abdominal pain, paralytic ileus, and cardiac arrhyhmias may occur.
Contra-Indications:
Calcitrol must not be given to patients with hypercalcemia or evidence of metastatic calcifications.
Patients with known hypersentivity to calcitrol or drugs of the same class or any of the excepients are also unsuitable for this therapy.
Calcitrol is not approved for use in pregnant or lactating women or children with osteoporosis.
Precautions-
Before treatment patients will need blood tests to check urea, electrolytes, cacium, creatinine, and liver function which will help rule out secondary causes of osteoporosis. Calcitrol may cause hypercalcemia or impaired liver function.
Therefore, all patients need serum calcium and creatinine leves checked at four weeks, three months, and six months after the start of therapy.
Clinicians will also want to monitor the clinical symptoms of bone mass changes in the usual way.
Calcitrol increases calcium absorption , dietary calcium intake should not exceed 600 -800mg daily and in the presence of normal diet, calcium supplements are not required.
Patients should be reminded not to take calcium or vitamin D supplements including those bought over-the -counter (OTC) such as certain fish, or cod liver oils or food fortified with Vitamin D (i.e. foods labelled as containing added amounts of vitamin D) as these may increase their risk of developing hypercalcemia.
Dosages/ Overdosage Etc:
Indication-
Post menopausal osteoporosis
Dosage-
Adult- 0.5mcg daily 3 times a week
Overdosage- Consider gastric lavage if less than 6-8 hours from ingestion
Hypercalcemia- stop drug and reduce calcium intake and in severe cases ensure adequate hydration, induce diuresis, and implement supportive measures.
Calcitonin may accelrate serum calcium reduction when bone resorption is increased. Low calcium dialysis is of low value in patients on intermittant dialysis.
Patient Information:
1. Therfore all patients should be warned to cease therapy and consult doctor promptly if they develop unexplained symptoms of hypercalcemia, such as loss of appetite , nausea, vomiting, headache, constipation, weakness or drowsiness.
2.Patients should be reminded not to take calcium or vitamin D supplements including those bought over-the -counter (OTC) such as certain fish, or cod liver oils or food fortified with Vitamin D (i.e. foods labelled as containing added amounts of vitamin D) as these may increase their risk of developing hypercalcemia.
Interaction with Food:
Take with or without food