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Regpara

Regpara

Manufacturer:

Kyowa Kirin

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Cinacalcet HCl
Indications/Uses
Secondary hyperparathyroidism in patients undergoing maintenance dialysis. Hypercalcemia patients w/ parathyroid carcinoma. Hypercalcemia patients w/ primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
Dosage/Direction for Use
Secondary hyperparathyroidism Initially 25 mg once daily, may be adjusted to 25-75 mg once daily. Increase dose by 25 mg at 3-wk intervals up to 100 mg once daily if required or if there is no improvement on the parathyroid hormone (PTH). Primary hyperparathyroidism Initially 25 mg bd, may be adjusted to 25-75 mg bd. Increase dose by 25 mg at 2-wk intervals up to 75 mg tds or qds.
Contraindications
Special Precautions
Determine serum Ca & PTH level prior to & periodically during therapy. Decrease dose as needed if serum Ca level is ≤8.4 mg/dL or w/draw if ≤7.5 mg/dL. Hypocalcaemia, seizure, hepatic dysfunction, GI hemorrhage &/or ulcer. Patients not on dialysis. Adynamic bone disease, hungry bone syndrome. Pregnancy & lactation. Infant, childn, elderly.
Adverse Reactions
GI disturbances, hypocalcaemia, prolonged QT interval. GI hemorrhage &/or ulcer, decreased level or temporary loss of consciousness.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors eg, azole antifungals, macrolides, amiodarone HCl, grapefruit juice. Increased blood conc of TCAs, butyrophenone antipsychotics, flecainide, vinblastine. Blood Ca-decreasing effect may be strengthened w/ calcitonin, bisphosphonates, corticosteroids. Plasma conc may be affected 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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