Medication info
Theracalcidol Soft Capsule 0.5 Micrograms (Alfacalcidol)

Theracalcidol Soft Capsule 0.5 Micrograms (Alfacalcidol)

OTC medicationSoft capsule경구
Ingredient · strength
Alfacalcidol›0.5μg / 1 capsule
Manufacturer / importer
(주)테라젠이텍스
Appearance
Yellow oval soft capsule containing clear or transparent oily content
Packaging
30 capsules/bottle, 100 capsules/bottle, 100 capsules/box [10 capsules/PTPX10]
Approval status
Active

MFDS item code 202502753 · Notified 2025.10.27 · Insurance code 698505120

Summary

Main use
Improvement of symptoms due to vitamin D metabolism disorder (hypocalcemia, bone lesions, etc.) and treatment of osteoporosis
Who takes it
Adults · Children
Adult dose
Chronic kidney disease and osteoporosis: Administer orally 0.5 to 1 ㎍ once daily as alfacalcidol. Hypoparathyroidism and other diseases due to vitamin D metabolism disorders: Administer orally 1 to 4 ㎍ once daily.
Child dose
Osteoporosis: Administer orally 0.01 to 0.03 ㎍ per kg of body weight once daily as alfacalcidol. Other conditions: Administer orally 0.05 to 0.1 ㎍ per kg of body weight once daily.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Improvement of symptoms due to vitamin D metabolism disorder (hypocalcemia, bone lesions, etc.) and treatment of osteoporosis

  • Hypocalcemia
  • tetany
  • bone pain
  • bone lesions
View approved original text

This medication helps improve symptoms such as hypocalcemia, tetany, bone pain, and lesions due to vitamin D metabolism disorders. It is particularly effective in conditions such as chronic renal failure, hypoparathyroidism, vitamin D resistant rickets, and osteomalacia. It is also used in the treatment of osteoporosis, contributing to strengthening bone health and improving bone density. With these effects, it can systematically manage the bone health of patients.

How to take

Adult dose

Chronic kidney disease and osteoporosis: Administer orally 0.5 to 1 ㎍ once daily as alfacalcidol. Hypoparathyroidism and other diseases due to vitamin D metabolism disorders: Administer orally 1 to 4 ㎍ once daily.

Child dose

Osteoporosis: Administer orally 0.01 to 0.03 ㎍ per kg of body weight once daily as alfacalcidol. Other conditions: Administer orally 0.05 to 0.1 ㎍ per kg of body weight once daily.

Precautions

This medication should not be taken by patients with hypercalcemia, hyperphosphatemia, or hypermagnesemia. It should also be avoided in cases where the product of calcium and phosphorus in the blood exceeds a certain value or in cases of alkalosis. Patients with symptoms of vitamin D toxicity or those allergic to this medication or its ingredients should not take it. During treatment with this medication, it is advised to avoid taking magnesium-containing agents, vitamin D and its derivatives, calcium-containing agents, or certain diuretics. For those who are breastfeeding, as the safety of this medication is not established, it is preferable to avoid taking it, and if inevitable, it is advisable to stop breastfeeding. Women who are pregnant or may become pregnant should consult a physician before taking it due to potential toxicity risks to the fetus. Children, elderly individuals, patients taking specific medications, those with a history of kidney stones, or patients with sarcoidosis should consult a professional before taking this medication. If any unusual symptoms or symptoms related to hypercalcemia occur during taking, it should be stopped immediately, and consultation with healthcare professionals is necessary. Serum calcium levels and kidney function should be regularly monitored, and in case of overdose, emergency treatment may be necessary. Adhere strictly to prescribed dosage and dietary guidelines when taking, recognize symptoms of hypercalcemia and take immediate action if abnormalities occur. This medication should be stored in a cool, dry place out of reach of children, avoiding direct sunlight, and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination changes

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • stomach pain
  • abdominal discomfort
  • bloating
  • dyspepsia
  • thirst
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  • metallic taste
  • muscle cramps in legs
  • headache
  • heaviness in the head
  • insomnia
  • anxiety
  • weakness
  • fatigue
  • dizziness
  • numbness
  • drowsiness
  • heartburn
  • shoulder stiffness
  • presbycusis
  • tinnitus
  • decline in memory and cognitive function
  • delirium
  • consciousness disorders
  • back pain
  • mild hypertension

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

Storage

This medication should be stored in a lightproof, tightly sealed container and kept at room temperature between 1 degree and 30 degrees Celsius. By doing so, the effectiveness of the medication can be maintained and deterioration can be prevented.

Appearance and packaging

Appearance

Yellow oval soft capsule containing clear or transparent oily content

Package unit

30 capsules/bottle, 100 capsules/bottle, 100 capsules/box [10 capsules/PTPX10]

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.