Indications of Colitrol 0.25 mcg
Colitrol 0.25 mcg 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
Colitrol 0.25 mcg is one of the most important active metabolites of vitamin D3. It is normally formed in the kidneys from its precursor, 25-hydroxycholecalciferol. Colitrol 0.25 mcg promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Colitrol 0.25 mcg is the regulation of calcium homeostasis, which includes stimulation effects on osteoblastic activity in the skeleton.
Dosage & Administration of Colitrol 0.25 mcg
The optimal daily dose of Colitrol 0.25 mcg capsule must be carefully determined for each patient on the basis of serum calcium level.In Post-menopausal Osteoporosis: The recommended dose of Colitrol 0.25 mcg capsule is 0.25 mcg twice daily.In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Colitrol 0.25 mcg 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 Colitrol 0.25 mcg 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 Colitrol 0.25 mcg 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 Colitrol 0.25 mcg
The optimal daily dose of Colitrol 0.25 mcg capsule must be carefully determined for each patient on the basis of serum calcium level.In Post-menopausal Osteoporosis: The recommended dose of Colitrol 0.25 mcg capsule is 0.25 mcg twice daily.In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Colitrol 0.25 mcg 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 Colitrol 0.25 mcg 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 Colitrol 0.25 mcg 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 Colitrol 0.25 mcg
Concomitant treatment with a thiazide diuretics increases the risk of hypercalcemia. Colitrol 0.25 mcg 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
Colitrol 0.25 mcg is contraindicated in patients with known hypersensitivity to any of its ingredients. Colitrol 0.25 mcg is also contraindicated in all diseases associated with hypercalcemia.
Side Effects of Colitrol 0.25 mcg
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. Colitrol 0.25 mcg may be used during pregnancy only if the benefits outweigh the potential risk to the fetus. Mothers may breast feed while taking Colitrol 0.25 mcg but serum calcium levels of the mother and infant should be monitored.
Precautions & Warnings
During Colitrol 0.25 mcg 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 Colitrol 0.25 mcg 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 Colitrol 0.25 mcg 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 Colitrol 0.25 mcg 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
Colitrol 0.25 mcg is one of the most important active metabolites of vitamin D3. It is normally formed in the kidneys from its precursor, 25-hydroxycholecalciferol. Colitrol 0.25 mcg promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Colitrol 0.25 mcg 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. Colitrol 0.25 mcg may be used during pregnancy only if the benefits outweigh the potential risk to the fetus. Mothers may breast feed while taking Colitrol 0.25 mcg 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 Colitrol 0.25 mcg 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 Colitrol 0.25 mcg is 10 to 15 ng/kg/day.
In Elderly: No dosage adjustment are required.