Calcitriol


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Hypoparathyroidism Patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, or pseudohypoparathyroidism: Initial: 0.25 mcg/day given in the morning, may be adjusted at 2- to 4-week intervals if necessary. Renal osteodystrophy In patients undergoing haemodialysis: Initially, 0.25 mcg daily, or 0.25 mcg every other day (in those with normal or only slightly reduced Ca levels), may be increased by 0.25 mcg at 2- to 4-week intervals if necessary. Dosage adjustment, dosing interruption, or discontinuation may be required according to individual serum Ca levels (refer to detailed product guideline). Secondary hyperparathyroidism in moderate to severe chronic kidney disease Patients not yet on dialysis: Initial: 0.25 mcg/day, may be increased to 0.5 mcg/day if necessary. Postmenopausal osteoporosis 0.25 mcg bid. IV Hypocalcaemia; Secondary hyperparathyroidism in chronic kidney disease Patients undergoing chronic renal dialysis: Usual dose: Initial: 1-2 mcg 3 times weekly, approx every other day, depending on the severity of condition. Dosing range: 0.5-4 mcg 3 times weekly. Dose may be increased by 0.5-1 mcg at 2- to 4-week intervals if necessary. Dosage adjustment, dosing interruption, or discontinuation may be required according to individual PTH, serum Ca, and phosphorus levels (refer to detailed product guideline). Topical Mild to moderate plaque psoriasis Patients with up to 35% of BSA involvement: As 3 mcg/g ointment: Apply onto the affected area bid. Max: 30 g/day.
Administration
May be taken with or without food. May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypercalcaemia, metastatic calcification, vitamin D toxicity. Topical: History of abnormal Ca metabolism, concomitant systemic treatment of Ca homeostasis; renal and hepatic impairment.
Special Precautions
Patient with malabsorption syndrome. Immobilised patients (e.g. patients who undergone surgery). Renal impairment. Elderly. Pregnancy and lactation. Topical: Not evaluated for use in patients with erythrodermic, exfoliative, or pustular psoriasis. Patient Counselling Avoid excessive and uncontrolled intake of vitamin D and additional Ca-containing supplements; maintain appropriate daily fluid intake. Topical: Avoid or limit excessive exposure to natural or artificial sunlight (including tanning booths or sun lamps) and phototherapy. Avoid applying to >35% of BSA during daily treatments or covering affected area with occlusive dressings. Monitoring Parameters Monitor serum Ca and phosphorus (more frequently during initial phase, e.g. at least twice weekly); Mg, alkaline phosphatase, PTH levels, renal function tests, 24-hour urinary Ca and phosphorus periodically during treatment initiation and dose adjustments. Measurement frequency should be dependent on patient stability, presence and magnitude of abnormalities, rate of CKD progression, and treatments used for CKD-mineral and bone disorder. Assess for signs of high Ca levels (e.g. weakness, constipation, confusion, bone pain).
Adverse Reactions
Significant: Hypercalcaemia which may lead to generalised vascular calcification, other soft tissue calcification, nephrocalcinosis, and exacerbated nephrolithiasis; hypercalciuria, hyperphosphataemia, over suppression of PTH, adynamic bone disease (IV), ectopic calcification; severe irritation and contact allergy (topical). Eye disorders: Photophobia, calcific conjunctivitis. Gastrointestinal disorders: Nausea, abdominal pain, vomiting, constipation, dyspepsia, dry mouth, metallic taste. General disorders and administration site conditions: Asthenia, inj site pain. Immune system disorders: Hypersensitivity. Investigations: Increased blood creatinine, AST/ALT, and BUN; weight loss. Metabolism and nutrition disorders: Polydipsia, decreased appetite, dehydration, anorexia, hypercholesterolaemia. Musculoskeletal and connective tissue disorders: Myalgia, bone pain. Nervous system disorders: Headache, paraesthesia. Psychiatric disorders: Somnolence, apathy. Renal and urinary disorders: UTI, urine abnormality, polyuria, nocturia. Respiratory, thoracic and mediastinal disorders: Rhinorrhoea. Skin and subcutaneous tissue disorders: Rash, pruritus, erythema, skin discomfort or irritation, dry skin, aggravated psoriasis. Vascular disorders: Hypertension.
Drug Interactions
Increased risk of hypercalcaemia with thiazide diuretics. May cause cardiac arrhythmias with digitalis. May reduce and impair the intestinal absorption with bile acid sequestrants (e.g. colestyramine, sevelamer). May result to hypermagnesaemia with Mg-containing agents (e.g. antacids) in dialysis patients. May decrease the effects with CYP450-inducing anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin). Bone and mineral metabolism effects may be antagonised by corticosteroids. May enhance toxic effects with other vitamin D analogues.
ATC Classification
A11CC04 - calcitriol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
D05AX03 - calcitriol ; Belongs to the class of other antipsoriatics for topical use.
Disclaimer: This information is independently developed by CIMS based on calcitriol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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