Interaksi Parikalsitol

Paricalcitol Injection is contraindicated in patients with: Hypercalcemia [see Warnings and Precautions (5.1) ] Vitamin D toxicity [see Warnings and Precautions (5.1) ] Known hypersensitivity to paricalcitol or any of the inactive ingredients in Paricalcitol Injection. (label Parikalsitol, Kontraindikasi)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

All patients should be instructed about the symptoms of hypocalcemia and the importance of calcium and vitamin D supplementation in maintaining serum calcium levels [see Dosage and Administration ( 2.8 ), Adverse Reactions ( 6.1 ), Patient Counseling Information ( 17 )]. (label Asam zoledronat, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Danazol can increase the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism. (label Danazol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. (label Denosumab, Peringatan dan perhatian)

Digitalis Toxicity: Risk increases with hypercalcemia. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Effects on Vitamin D and Bone The chronic use of phenytoin in patients with epilepsy has been associated with decreased bone mineral density (osteopenia, osteoporosis, and osteomalacia) and bone fractures. (label Fenitoin, Peringatan dan perhatian)

Table 2: Oral drugs that can be administered concomitantly with Ferric Citrate Tablets Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan Metoprolol Pravastatin Propranolol Sitagliptin Warfarin Oral drugs that have to be separated from Ferric Citrate Tablets and meals… (label Feri sitrat, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Other Corticosteroids, doxycycline, estrogens, furosemide, oral contraceptives, paroxetine, quinidine, rifampin, sertraline, theophylline, and vitamin D Drugs whose level is decreased by phenytoin Anticoagulants Apixaban, dabigatran, edoxaban, rivaroxaban Antiepileptic drugs The effect of phenytoin on phenobarbital, valproic acid and sodium valproate serum levels… (label Fosfenitoin, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Examples Clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, and voriconazole Intervention If a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor, dose adjustment of Paricalcitol Injection may be necessary. (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate (see Dosage and Administration [2.3] ) . (label Ibandronat, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Use of Miacalcin injection for the treatment of Paget’s disease or postmenopausal osteoporosis is recommended in conjunction with an adequate intake of calcium and vitamin D [see Dosage and Administration (2.5) ] . (label Kalsitonin salmon, Peringatan dan perhatian)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Drugs That Increase the Risk of Hypercalcemia Increase frequency of monitoring of calcium concentrations in patients taking concomitant Calcium Chloride Injection and other drugs that increase the risk of hypercalcemia (e.g., calcipotriene, estrogen, lithium, parathyroid hormone, teriparatide, thiazide diuretics, Vitamin A, and Vitamin D). (label Kalsium klorida, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7) ] . (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The effect of ORLISTAT on the absorption of supplemental vitamin D, vitamin A, and nutritionally-derived vitamin K is not known at this time [see Clinical Pharmacology (12.3) , and Warnings and Precautions (5.1) ] . (label Orlistat, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

• Electrolyte disorders (e.g., hypophosphatemia, hypokalemia, hypomagnesemia, hypocalcemia): Monitor phosphorus, potassium, magnesium, calcium and vitamin D and adequately supplement as appropriate. (label Pamidronat, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Calcium Supplements/Antacids When Risedronate sodium delayed-release was administered following breakfast, the co-administration of a tablet containing 600 mg of elemental calcium and 400 international units vitamin D reduced risedronate bioavailability by approximately 38% [ see Clinical Pharmacology (12.3) ] . (label Risedronat, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

If corrected serum calcium falls below the lower limit of normal or symptoms of hypocalcemia develop, start or increase calcium supplementation (including calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration). (label Sinakalset, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. (label Parikalsitol, Peringatan dan perhatian)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Exposure of Paricalcitol Injection will increase upon coadministration with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ] . (label Parikalsitol, Interaksi obat)

Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. (label Alendronat, Peringatan dan perhatian)

• Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed ( 5.2 ). (label Eksemestan, Peringatan dan perhatian)

Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving TDF. (label Emtrisitabin, rilpivirin, dan tenofovir, Peringatan dan perhatian)

Drugs that may cause hypercalcemia: Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. (label Kalsium glukonat, Interaksi obat)

Other Medications Used for the Management of Fanconi Syndrome PROCYSBI can be administered with other electrolyte and mineral replacements necessary for management of Fanconi syndrome, as well as vitamin D and thyroid hormone. (label Sisteamin, Interaksi obat)

Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving VIREAD. (label Tenofovir, Peringatan dan perhatian)