Cinaca

Cinaca

Manufacturer:

AUPA Biopharm

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Cinacalcet HCl
Indications/Uses
Secondary hyperparathyroidism in patients undergoing maintenance dialysis.
Dosage/Direction for Use
Adult Initially 25 mg once daily. May be adjusted w/in a range of 25-75 mg once daily w/ careful management of the patient's serum parathyroid hormone (PTH). If no improvement, increase up to 100 mg once daily. Increase dose by 25 mg at a time, at intervals of at least 3 wk.
Contraindications
Special Precautions
Ca level should not be low (≥9 mg/dL) prior to administration. Avoid hypocalcaemia during treatment. Determine serum Ca level once wkly at the start of administration & during the dose adjustment period, & at least once every 2 wk during the maintenance period. Determine serum PTH level twice mthly at the start of administration & during the dose adjustment period, & at least once mthly after the serum PTH level is confirmed to be almost stable. Caution in patients w/ hypocalcaemia; seizure or a history of seizure; hepatic function disorder; GI hemorrhage &/or ulcer or a history of GI hemorrhage &/or ulcer; risk factors for QT prolongation. Use in patients w/ chronic renal failure accompanied by secondary hyperthyroidism & not on dialysis has not been approved. Reports of adynamic bone disease; hungry bone syndrome accompanied by hypocalcaemia & hypophosphataemia. Not recommended during pregnancy. Avoid use in nursing mothers. Elderly ≥65 yr.
Adverse Reactions
Nausea/vomiting, gastric discomfort, anorexia, abdominal distention, hypocalcaemia/decreased serum Ca, prolonged QT interval.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors eg, azole antifungals (eg, itraconazole), macrolide antibiotics (eg, erythromycin, clarithromycin), amiodarone HCl, grapefruit juice. Increased blood conc of CYP2D6 substrates eg, TCAs (eg, amitriptyline HCl, imipramine HCl), butyrophenone antipsychotics (eg, haloperidol), flecainide acetate, vinblastine sulfate. Additive effect on serum Ca level w/ calcitonin, bisphosphonates (eg, pamidronate, alendronate, incadronate), corticosteroids (eg, cortisol, prednisolone, dexamethasone). Altered plasma conc w/ digitoxin, diazepam.
MIMS Class
Other Agents Affecting Metabolism
ATC Classification
H05BX01 - cinacalcet ; Belongs to the class of other anti-parathyroid agents. Used in the management of calcium homeostasis.
Presentation/Packing
Form
Cinaca tab 25 mg
Packing/Price
30's
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