Regpara

Regpara

Manufacturer:

Kyowa Kirin Asia Pacific

Distributor:

Steward Cross
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 to 25-75 mg once daily. Dose may be increased by 25 mg at least 3-wk intervals up to 100 mg once daily if required or if there is no improvement on the parathyroid hormone (PTH).
Administration
Should be taken with food: Take w/ food or shortly after food. Swallow whole, do not divide.
Contraindications
Special Precautions
Patients w/ hypocalcaemia; existing or history of seizure, GI hemorrhage &/or GI ulcer; hepatic impairment. Determine serum Ca & PTH level prior to & periodically during therapy. Do not use in pregnancy & in women who may possibly be pregnant. Lactation. Childn. Elderly ≥65 yr.
Adverse Reactions
Nausea/vomiting, gastric discomfort, anorexia, abdominal distention; hypocalcaemia/decreased serum Ca & prolonged QT interval.
Drug Interactions
May increase plasma conc w/ CYP3A4 inhibitors [eg, azole antifungals (eg, itraconazole), macrolides (eg, erythromycin, clarithromycin), amiodarone HCl, grapefruit juice]. May increase blood conc of CYP2D6 substrates [eg, TCAs (eg, amitriptyline HCl, imipramine HCl), butyrophenone antipsychotics (eg, haloperidol), flecainide acetate, vinblastine sulfate]. May decrease serum Ca level w/ calcitonin, bisphosphonates, bone absorption inhibitors (eg, pamidronate Na hydrate, alendronate Na hydrate, incadronate disodium), corticosteroids (eg, cortisol, prednisolone, dexamethasone). May affect 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
Regpara FC tab 25 mg
Packing/Price
100's
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