May be taken with or without food. May be taken w/ meals to reduce GI discomfort.
Administration
May be taken with or without food. May be taken w/ meals to reduce GI discomfort.
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Contraindications
Hypercalcaemia, metastatic calcification, vitamin D toxicity. Topical: History of abnormal Ca metabolism, concomitant systemic treatment of Ca homeostasis; renal and hepatic impairment.
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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).
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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.
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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.
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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. |