Calcelar 25: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Cinacalcet HCl

Indications/Uses

Secondary hyperparathyroidism in patients undergoing maintenance dialysis.

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Dosage/Direction for Use

Adult Secondary hyperparathyroidism 25 mg once daily. May be adjusted w/in 25-75 mg once daily. If no improvement in parathyroid hormone, dose may be increased up to 100 mg once daily by 25 mg at a time, at intervals of at least 3 wk.

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Overdosage

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Administration

Should be taken with food: Take w/ or immediately after meals. Swallow whole, do not divide.

Contraindications

Hypersensitivity. Serum Ca lower than LLN range.

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Special Precautions

QT interval prolongation & ventricular arrhythmia secondary to hypocalcemia. Patients w/ impaired cardiac function. Hypocalcemia; adynamic bone disease w/ intact parathyroid hormone levels <100 pg/mL may occur. Not to be used in patients not undergoing dialysis due to increased risk of hypocalcemia. Monitor patient for seizures. Hepatic impairment. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

HTN, hypotension; depression, dizziness, fatigue, headache, noncardiac chest pain, paresthesia, seizure; dehydration, hypercalcemia, hyperkalemia, hypocalcemia, hypoparathyroidism (intact parathyroid hormone); abdominal & upper abdominal pain, anorexia, constipation, decreased appetite, diarrhea, dyspepsia, nausea, vomiting; anemia; arthralgia, back & limb pain, bone fracture, muscle spasm, myalgia, weakness; cough, dypsnea, URTI; hypersensitivity reaction; localized infection (dialysis access site). Adynamic bone disease, cardiac arrhythmia & failure, hypotension (idiosyncratic), prolonged QT interval on ECG (secondary to hypocalcemia), ventricular arrhythmia (secondary to hypocalcemia).

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Drug Interactions

May increase exposure of & increase risk of adverse effects w/ clozapine. May increase exposure of nebivolol, donepezil, brexpiprazole, doxorubicin, amitriptyline, tamsulosin, oxycodone, propranolol & CYP2D6 inhibitors. May prolong QT interval & increase exposure of eliglustat, fluoxetine. May increase exposure & plasma conc of desipramine, flecainide, doxepin, clomipramine, imipramine, vinblastine, protriptyline, amoxapine, nortriptyline, thioridazine, carvedilol, or trimipramine. May increase bioavailability & risk of hypocalcemia w/ ketoconazole. May increase exposure & plasma conc w/ indinavir, erythromycin, ritonavir, clarithromycin, nelfinavir, nefazodone, atazanavir, telithromycin, voriconazole, saquinavir, fosamprenavir, or delavirdine. May increase plasma levels of tamoxifen.

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Storage

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Description

View Calcelar 25 description for details of the chemical structure and excipients (inactive components).

Action

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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.

Thai FDA Category

Presentation/Packing

Form

Calcelar 25 FC tab 25 mg

Packing/Price

1 × 10's;10 × 10's

Calcelar 25

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma