Ostriol

Ostriol0.25 mcg

Capsule

Calcitriol

NIPRO JMI Pharma Ltd.

Product Code : 12895
MRP 10.03
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Medicine overview

Indications of Ostriol 0.25 mcg

Ostriol 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

Ostriol 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. Ostriol 0.25 mcg promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Ostriol 0.25 mcg is the regulation of calcium homeostasis, which includes stimulation effects on osteoblastic activity in the skeleton.

Dosage & Administration of Ostriol 0.25 mcg

The optimal daily dose of Ostriol 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 Ostriol 0.25 mcg capsule is 0.25 mcg twice daily.In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Ostriol 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 Ostriol 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 Ostriol 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 Ostriol 0.25 mcg

The optimal daily dose of Ostriol 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 Ostriol 0.25 mcg capsule is 0.25 mcg twice daily.In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Ostriol 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 Ostriol 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 Ostriol 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 Ostriol 0.25 mcg

Concomitant treatment with a thiazide diuretics increases the risk of hypercalcemia. Ostriol 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

Ostriol 0.25 mcg is contraindicated in patients with known hypersensitivity to any of its ingredients. Ostriol 0.25 mcg is also contraindicated in all diseases associated with hypercalcemia.

Side Effects of Ostriol 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. Ostriol 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 Ostriol 0.25 mcg but serum calcium levels of the mother and infant should be monitored.

Precautions & Warnings

During Ostriol 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 Ostriol 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 Ostriol 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 Ostriol 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

Ostriol 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. Ostriol 0.25 mcg promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Ostriol 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. Ostriol 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 Ostriol 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 Ostriol 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 Ostriol 0.25 mcg is 10 to 15 ng/kg/day. In Elderly: No dosage adjustment are required.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.