Medication info

Bonkey 1 Microgram (Calcitriol)

Prescription medicationInjections주사
Ingredient · strength
Calcitriol›1μg / 1mLCalcitriol(Export)›1μg / 1mL
Manufacturer / importer
(주)유유제약
Appearance
A brown ampoule injection containing a colorless to pale yellow transparent liquid
Packaging
10 ampoules (1 mL/ampoule x 10)
Approval status
Active

MFDS item code 199400239 · Notified 1994.10.14 · Insurance code 644500401

Summary

Main use
Management of hypocalcemia and improvement of renal osteodystrophy
Who receives it
Adults
Adult administration
The initial recommended regimen and dosage for this drug is to administer 0.5 ㎍ of calcitriol three times a week (approximately 0.01 ㎍ per kg body weight) on alternate days. This drug can be administered as an IV bolus through a catheter at the end of hemodialysis. If there is no satisfactory response after biochemical tests and clinical symptoms, the dosage may be increased by 0.25 to 0.50 ㎍ at intervals of 2 to 4 weeks. Most hemodialysis patients show effects with a dosage of 0.5 to 3 ㎍ three times a week.

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

Management of hypocalcemia and improvement of renal osteodystrophy

  • Hypocalcemia
  • elevated parathyroid hormone levels
  • renal osteodystrophy
View approved original text

This medication is used to manage hypocalcemia occurring in chronic renal dialysis patients and to significantly reduce elevated parathyroid hormone levels, thereby improving renal osteodystrophy.

How it is given

Adult administration

The initial recommended regimen and dosage for this drug is to administer 0.5 ㎍ of calcitriol three times a week (approximately 0.01 ㎍ per kg body weight) on alternate days. This drug can be administered as an IV bolus through a catheter at the end of hemodialysis. If there is no satisfactory response after biochemical tests and clinical symptoms, the dosage may be increased by 0.25 to 0.50 ㎍ at intervals of 2 to 4 weeks. Most hemodialysis patients show effects with a dosage of 0.5 to 3 ㎍ three times a week.

Precautions

Care should be taken to cut the glass ampoule carefully to avoid glass fragments when using an ampoule made of glass. Extra caution is required when used by children or the elderly. This medication should not be used in patients who are allergic to this drug or its ingredients or those who have hypercalcemia. Additionally, patients showing symptoms of vitamin D overdose should not be administered this medication. Women who are pregnant or breastfeeding should use this drug cautiously, considering the potential effects on the fetus or infant. Rarely, serious allergic reactions or redness and pain at the injection site may occur. In cases of overdose, various symptoms such as digestive disorders, neurological issues, cardiac problems, or skeletal pain may occur, so caution is required. To enhance treatment efficacy, patients should consume adequate calcium daily and regularly check calcium intake and blood calcium levels. In cases of overdose, dosing should be stopped immediately, and periodic checks of blood calcium levels should be conducted. This drug may interact with certain medications, so if other medications are being taken, consultation with a doctor or pharmacist is necessary. Caution is especially needed when using medications containing magnesium antacids, cardiac drugs, and anticonvulsants. During pregnancy or lactation, the use of this drug may pose risks to the fetus or infant, and should only be used when absolutely necessary. It is advisable to avoid administration during breastfeeding if possible. Safety in pediatric patients has not been established, so it should be used cautiously in children. Elderly patients may have reduced body functions, so dosing should be adjusted appropriately. In cases of overdose, administration should be stopped immediately, a low-calcium diet should be implemented, and blood calcium levels should be checked frequently. Dialysis or pharmacological treatment may be necessary according to need. Before administration, check for any abnormalities in the injection solution, do not mix with other medications, and use promptly after opening, disposing of any remaining medication.

Side effects and when to seek care immediately

Serious side effects

Anaphylaxis, high fever, chest tightness, liver abnormalities (including elevation of ALT and AST), confusion, severe edema, hypercalcemia, arrhythmias, palpitations, atrioventricular block, atrial fibrillation, osteomalacia, nephrocalcinosis, systemic vascular calcification, severe neurological symptoms, elevated blood pressure and severe edema

Mild side effects

  • Localized redness at the injection site
  • mild pain
  • thirst
  • polydipsia
  • nausea
  • vomiting
  • dry mouth
  • constipation
  • metallic taste
  • loss of appetite
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  • pancreatitis
  • abdominal cramps
  • headache
  • drowsiness
  • insomnia
  • numbness of hands
  • dizziness
  • confusion
  • worsening depression
  • anxiety
  • agitation
  • hypertension
  • arrhythmias
  • palpitations
  • prolonged QT interval
  • atrioventricular block
  • atrial fibrillation
  • bone pain
  • joint pain
  • runny nose
  • elevation of AST
  • elevation of ALT
  • high LDH

Not everyone experiences these, and they can vary from person to person.

Storage

This drug may be sensitive to light, so it should be stored in a light-tight sealed container. It is also advisable to store the drug at room temperature, meaning at a generally comfortable indoor temperature that is neither too hot nor too cold.

Appearance and packaging

Appearance

A brown ampoule injection containing a colorless to pale yellow transparent liquid

Package unit

10 ampoules (1 mL/ampoule x 10)

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.