Active Substance: Cinacalcet (as HCl).
Overview
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This medicine contains an important and useful components, as it consists of
Cinacalcet (as HCl)is available in the market in concentration
Cinacalcet
Moderate-to-severe hepatic impairment, CV diseases. Not indicated for chronic kidney disease patients who are not receiving dialysis. Do not initiate Cinacalcet in hypocalcaemic patients. For secondary hyperparathyroidism, measure serum calcium and phosphorus (prior to- and within 1 wk after initiation/dose adjustment; mthly during maintenance) and iPTH (prior to- and within 1-4 wk after initiation/dosage adjustment; every 1-3 mth during maintenance). iPTH levels should drawn at least 12 hr after Cinacalcet dosing. For parathyroid carcinoma and primary parathyroidism, measure serum calcium prior-to and within 1 wk after initiation/dose adjustment; and every 2-3 mth during maintenance. Vitamin D sterols, calcium-containing phosphate binder and/or adjustment of calcium contents of dialysis fluid can be used to raise serum calcium in the event of hypocalcaemia. Reduce dose or withhold therapy if hypocalcaemia persists; may reinstate treatment at the next lowest dose after calcium levels normalised. Significant reduction in serum calcium may lower seizure threshold. Adynamic bone disease may develop if iPTH level is suppressed to < 100 pg/mL. May decrease total and free testosterone levels. Safety and efficacy not established in patients ?18 yr. Pregnancy and lactation. Lactation: excretion in milk unknown/not recommended
Hyperparathyroidism, Hypercalcemia, Parathyroid carcinoma
Hypersensitivity.
>10% Secondary Parathyroidism Diarrhea (20%),Nausea (19%),Vomiting (15%),Myalgia (14%) 1-10% Secondary Parathyroidism Dizziness (8%),Hypertension (5%),Access infection (4%),Anorexia (4%),Asthenia (4%),Noncardiac chest pain (4%),Seizures 1.4% Frequency Not Defined Parathyroid CA Nausea/vomiting,Hypocalcemia Potentially Fatal: Hypersensitivity reaction including angioedema.
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Cinacalcet is a calcimimetic agent. It lowers parathyroid hormone (PTH) secretion by increasing the sensitivity of the calcium-sensing receptor of the parathyroid gland to activation by extracellular calcium. PTH reduction leads to concomitant decrease in serum calcium and phosphorus concentrations.
Cinacalcet is a strong CYP2D6 inhibitor and may increase serum concentrations of amitriptyline, nortriptyline and desipramine. Cinacalcet may decrease serum concentrations of tacrolimus. CYP3A4 inhibitors such as ketoconazole, erythromycin may increase plasma concentrations of Cinacalcet.
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