Sinapara Tablet 25mg (Cinacalcet Hydrochloride)

Adult dose

Do not divide the dose when administering this medicine orally. The initial dose for adults is cinacalcet 25 mg orally once daily. Thereafter, while monitoring the patient's parathyroid hormone (iPTH) and serum calcium concentrations, adjust the dose to 25, 50, or 75 mg once daily based on serum calcium or parathyroid hormone (iPTH), and administer orally. However, if improvement in parathyroid hormone (iPTH) is not confirmed, administer orally up to a maximum single dose of 100mg. When increasing the dose, increase by 25mg at intervals of at least 3 weeks. Begin treatment after confirming that the serum calcium level is not low (as a guideline, at least 9.0 mg/dL). Measure serum calcium once weekly at initiation of this medicine and when adjusting the dose, and at least once every 2 weeks during maintenance. If the serum calcium level falls below 8.4 mg/dL, take the following actions. Below 8.4mg/dL: Consider administering calcium or vitamin D preparations. As a rule, do not increase the dose of this medicine (reduce the dose if necessary). Measure serum calcium at least once weekly. An electrocardiogram is preferably performed. If increasing the dose, do so only after confirming recovery to at least 8.4mg/dL. Below 7.5mg/dL: Discontinue treatment immediately. If treatment is resumed, do so at the dose used before discontinuation or a lower dose, only after confirming recovery to at least 8.4mg/dL. Serum calcium should preferably be measured before taking this medicine in order to appropriately assess its efficacy and safety. In cases of hypoalbuminemia (serum albumin below 4.0 g/dL), it is preferable to use the corrected value as an indicator. Calculation of corrected calcium: Corrected calcium (mg/dL) = serum calcium (mg/dL) − serum albumin (g/dL) + 4.0 Measure parathyroid hormone (iPTH) regularly to maintain it within the target range. It is preferable to measure parathyroid hormone (iPTH) twice monthly at initiation of this medicine and when adjusting the dose (as a guideline, for about 3 months after treatment initiation), and once monthly after confirming that parathyroid hormone (iPTH) has become relatively stable. In addition, parathyroid hormone (iPTH) should preferably be measured before taking this medicine to appropriately assess its efficacy and safety. PTH and serum calcium concentrations should be monitored closely when administering this medicine to patients with moderate or severe hepatic impairment.

This medication may cause seizures in patients with a history of seizure disorders, so caution is required. In heart failure patients, there is a risk of lowered blood pressure or exacerbation of heart failure symptoms, so it should be used carefully. Patients with allergies to any ingredient in this medication or genetic issues like lactose intolerance should not take it. Patients with hypocalcemia should be particularly cautious as symptoms may worsen. Patients with poor liver function may have slowed metabolism of this medication, requiring dose adjustment and monitoring. Patients with a history of gastrointestinal bleeding or ulcers should be careful as symptoms may worsen. During treatment, blood calcium levels should be regularly monitored to prevent the onset of hypocalcemia. Severe side effects such as hypocalcemia, prolonged QT interval, gastrointestinal bleeding, altered consciousness, and rarely, sudden death may occur; any abnormal symptoms should be immediately reported to healthcare professionals. Drug interactions may occur, so inform your doctor or pharmacist about any other medications being taken. Elderly patients over 65 years old are at higher risk for side effects and symptoms should be closely monitored. Pregnant or breastfeeding women should avoid use unless absolutely necessary and should consult a doctor before using. Safety in children and adolescents under 19 years old has not been established, so it is advisable not to use it in this population. In case of overdose, hypocalcemia may develop, so symptoms should be closely monitored and treatment sought immediately if necessary. This medication must be taken out from the PTP packaging before ingestion, as swallowing it in the packaging may cause damage to the esophagus.

• Convulsions
• hypotension
• worsening heart failure
• nausea
• vomiting
• gastric discomfort
• loss of appetite
• abdominal distension
• hypocalcemia
• decreased serum calcium

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature of between 1 and 30 degrees Celsius.

Appearance

Light green or light yellow-green round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaged x3], 100 tablets/box [10 tablets/PTP packaged x10]