Indications of Caltrol 1 mcg/ml
Caltrol 1 mcg/ml is indicated in-
Post-menopausal osteoporosis
Renal osteodystrophy
Postsurgical hypoparathyroidism
Idiopathic hypoparathyroidism
Pseudohypoparathyroidism
Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)
Vitamin D dependent rickets
Theropeutic Class
Vitamin in bone formation, Vitamin-D preparations
Pharmacology
Caltrol 1 mcg/ml is one of the most important active metabolites of vitamin D3. It is normally formed in the kidneys from its precursor, 25-hydroxycholecalciferol. Caltrol 1 mcg/ml promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Caltrol 1 mcg/ml is the regulation of calcium homeostasis, which includes stimulation effects on osteoblastic activity in the skeleton.
Dosage & Administration of Caltrol 1 mcg/ml
The optimal daily dose of Caltrol 1 mcg/ml capsule must be carefully determined for each patient on the basis of serum calcium level.In Post-menopausal Osteoporosis: The recommended dose of Caltrol 1 mcg/ml capsule is 0.25 mcg twice daily.In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Caltrol 1 mcg/ml capsule. In patients with normal or only slightly reduced calcium levels, doses of 0.25 mcg every other day are sufficient.In Hypoparathyroidism and Rickets: The recommended initial dosage of Caltrol 1 mcg/ml capsule is 0.25 mcg/day which given in the morning. If within 2-4 weeks satisfactory response is not observed by usual dose then dose may be increased at 2-4 weeks intervals. The recommended intravenous initial dose of Caltrol 1 mcg/ml injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals.
Dosage of Caltrol 1 mcg/ml
The optimal daily dose of Caltrol 1 mcg/ml capsule must be carefully determined for each patient on the basis of serum calcium level.In Post-menopausal Osteoporosis: The recommended dose of Caltrol 1 mcg/ml capsule is 0.25 mcg twice daily.In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Caltrol 1 mcg/ml capsule. In patients with normal or only slightly reduced calcium levels, doses of 0.25 mcg every other day are sufficient.In Hypoparathyroidism and Rickets: The recommended initial dosage of Caltrol 1 mcg/ml capsule is 0.25 mcg/day which given in the morning. If within 2-4 weeks satisfactory response is not observed by usual dose then dose may be increased at 2-4 weeks intervals. The recommended intravenous initial dose of Caltrol 1 mcg/ml injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals.
Interaction of Caltrol 1 mcg/ml
Concomitant treatment with a thiazide diuretics increases the risk of hypercalcemia. Caltrol 1 mcg/ml dosage must be determined with care in patients undergoing treatment with digitalis as hypercalcemia in such patients may precipitate cardiac arrhythmias. Magnesium containing drugs (e.g.,antacids) may cause hypermagnesemia.
Contraindications
Caltrol 1 mcg/ml is contraindicated in patients with known hypersensitivity to any of its ingredients. Caltrol 1 mcg/ml is also contraindicated in all diseases associated with hypercalcemia.
Side Effects of Caltrol 1 mcg/ml
Occasional symptoms include anorexia, headache, vomiting and constipation. Chronic effects may include dystrophy, fever, polyuria, dehydration, apathy and urinary tract infection.
Pregnancy & Lactation
There is no evidence that vitamin D is teratogenic in humans. Caltrol 1 mcg/ml may be used during pregnancy only if the benefits outweigh the potential risk to the fetus. Mothers may breast feed while taking Caltrol 1 mcg/ml but serum calcium levels of the mother and infant should be monitored.
Precautions & Warnings
During Caltrol 1 mcg/ml therapy if the serum calcium levels rise to 1 mg/100 ml above normal or serum creatinine rises to >120 µmol/l, the dosage of Caltrol 1 mcg/ml should be substantially reduced or treatment stopped.
Storage Conditions
keep in a dry place away from light and heat. Keep out of the reach of children.
Use In Special Populations
Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)-
The recommended initial dosage of Caltrol 1 mcg/ml is 0.25 mcg/day in adults and pediatric patients 3 years of age or older. This dosage may be increased if necessary to 0.5 mcg/day.
For pediatric patients less than 3 years of age, the recommended initial dosage of Caltrol 1 mcg/ml is 10 to 15 ng/kg/day.
In Elderly: No dosage adjustment are required.
Drug Classes
Vitamin in bone formation, Vitamin-D preparations
Mode Of Action
Caltrol 1 mcg/ml is one of the most important active metabolites of vitamin D3. It is normally formed in the kidneys from its precursor, 25-hydroxycholecalciferol. Caltrol 1 mcg/ml promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Caltrol 1 mcg/ml is the regulation of calcium homeostasis, which includes stimulation effects on osteoblastic activity in the skeleton.
Pregnancy
There is no evidence that vitamin D is teratogenic in humans. Caltrol 1 mcg/ml may be used during pregnancy only if the benefits outweigh the potential risk to the fetus. Mothers may breast feed while taking Caltrol 1 mcg/ml but serum calcium levels of the mother and infant should be monitored.
Pediatric Uses
Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)-
The recommended initial dosage of Caltrol 1 mcg/ml is 0.25 mcg/day in adults and pediatric patients 3 years of age or older. This dosage may be increased if necessary to 0.5 mcg/day.
For pediatric patients less than 3 years of age, the recommended initial dosage of Caltrol 1 mcg/ml is 10 to 15 ng/kg/day.
In Elderly: No dosage adjustment are required.