Medication info
Calsibon Soft Capsule (Calcitriol)

Calsibon Soft Capsule (Calcitriol)

Prescription medicationSoft capsule경구
Ingredient · strength
Calcitriol›0.25μg / 1 capsule
Manufacturer / importer
(주)한국피엠지제약
Appearance
A milky, oval-shaped soft capsule containing a colorless or transparent emulsion.
Packaging
30 capsules per bottle, 300 capsules per bottle
Approval status
Active

MFDS item code 199500386 · Notified 1995.08.22 · Insurance code 697100020

Summary

Main use
Treatment of chronic renal failure (secondary hyperparathyroidism, metabolic bone disease) and bone diseases (osteomalacia, osteoporosis)
Who takes it
Adults · Children
Adult dose
Patients before the dialysis stage: Initiate with a starting dose of 0.25 ㎍ daily, which may be increased to 0.5 ㎍ daily if necessary. Renal osteodystrophy (dialysis patients): Initial dose is 0.25 ㎍ daily, and if serum calcium levels are within the normal range or slightly lowered, 0.25 ㎍ should be administered every other day, with possible increases of 0.25 ㎍ every 2-4 weeks. Most patients show effectiveness at a daily dose of 0.5-1.0 ㎍.
Child dose
Patients before the dialysis stage: For children aged 36 months and older, initiate with a starting dose of calcitriol at 0.25 ㎍ daily, which may be increased to 0.5 ㎍ daily if necessary. For children under 36 months

Ingredients

Manufacturer
(주)한국피엠지제약

Efficacy & effects

Treatment of chronic renal failure (secondary hyperparathyroidism, metabolic bone disease) and bone diseases (osteomalacia, osteoporosis)

  • Chronic kidney disease
  • secondary hyperparathyroidism
  • metabolic bone disease
  • hypoparathyroidism
  • rickets
  • osteomalacia
  • osteoporosis
  • renal osteodystrophy
View approved original text

This medication is used to treat secondary hyperparathyroidism and metabolic bone diseases occurring in patients with chronic kidney failure before dialysis. It is also helpful in improving renal osteodystrophy in patients receiving dialysis. It is effective for hypoparathyroidism, especially post-surgical or idiopathic hypoparathyroidism, and is used for treating rickets and osteomalacia, such as vitamin D-dependent rickets or hypophosphatemic vitamin D-resistant rickets. It is also used to improve bone health in osteoporosis patients. Overall, it is widely used for the treatment of various bone-related diseases.

How to take

Adult dose

Patients before the dialysis stage: Initiate with a starting dose of 0.25 ㎍ daily, which may be increased to 0.5 ㎍ daily if necessary. Renal osteodystrophy (dialysis patients): Initial dose is 0.25 ㎍ daily, and if serum calcium levels are within the normal range or slightly lowered, 0.25 ㎍ should be administered every other day, with possible increases of 0.25 ㎍ every 2-4 weeks. Most patients show effectiveness at a daily dose of 0.5-1.0 ㎍.

Child dose

Patients before the dialysis stage: For children aged 36 months and older, initiate with a starting dose of calcitriol at 0.25 ㎍ daily, which may be increased to 0.5 ㎍ daily if necessary. For children under 36 months

Precautions

This medication should not be used in patients with hypercalcemia or hypercalciuria causing calcium stones. Additionally, individuals allergic to this medication or similar drugs should not take it. Pregnant or breastfeeding women should exercise special caution when using this medication and should do so only after consulting a physician. There is limited experience with use in young children or pediatric patients receiving dialysis, so caution is advised. This drug is an active form of vitamin D, and overdose can lead to symptoms of hypercalcemia, which can cause nausea, vomiting, headache, lethargy, and dehydration if aggravated. Regular blood tests should be conducted to monitor calcium levels during use. It is important to maintain an adequate calcium intake while taking this medicine and to avoid excessive calcium supplementation. Additionally, since interactions with other medications may occur, especially with vitamin D preparations, calcium supplements, diuretics, and digitalis, consultation with a physician or pharmacist is essential when taking these medications together. Elderly patients or those with impaired kidney function should adjust dosing and be monitored frequently, and in the case of an overdose, immediate cessation of the medication and notification to healthcare personnel is necessary. Store this medication in a cool place below 25 degrees Celsius, protected from light and moisture, and out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), severe rash accompanied by fever, skin desquamation, pain in oral/ocular mucosa, severe allergic reaction, severe skin abnormal reaction, difficulty breathing or respiratory distress, asthma attack, respiratory abnormalities accompanied by cough and fever, respiratory issues, jaundice (yellowing of skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden and severe headache, lightning headache, seizure, consciousness confusion, visual disturbances

Mild side effects

  • Nausea
  • diarrhea
  • appetite loss
  • constipation
  • vomiting
  • gastrointestinal discomfort
  • abdominal pain
  • thirst
  • abdominal cramps
  • atonic intestinal obstruction
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  • gastric discomfort
  • upper abdominal pain
  • abdominal bloating
  • stomatitis
  • thirst
  • pancreatitis
  • metallic taste
  • restlessness
  • anxiety
  • insomnia
  • headache
  • apathy
  • drowsiness
  • delirium
  • depression
  • coma
  • palpitations
  • cardiac arrhythmia
  • hypertension
  • sensory disturbances
  • periarticular calcification
  • bone pain
  • rhinorrhea
  • epistaxis
  • urinary tract infection

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, and it is best stored at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

A milky, oval-shaped soft capsule containing a colorless or transparent emulsion.

Package unit

30 capsules per bottle, 300 capsules per bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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.