Medication info
Theracalcidol Soft Capsule 1 Microgram (Alfacalcidol)

Theracalcidol Soft Capsule 1 Microgram (Alfacalcidol)

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

MFDS item code 202502754 · Notified 2025.10.27 · Insurance code 698505130

Summary

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

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Improvement of symptoms related to vitamin D metabolism disorders (hypocalcemia, bone lesions, etc.) and osteoporosis

  • Hypocalcemia
  • tetany
  • bone pain
  • bone lesions
  • chronic kidney disease
  • hypoparathyroidism
  • vitamin D resistant rickets
  • osteomalacia
  • osteoporosis
View approved original text

This medication is used to improve symptoms resulting from abnormalities in vitamin D metabolism, such as hypocalcemia, muscle cramps known as tetany, bone pain, and bone lesions. It is also effective for conditions like chronic kidney disease, hypoparathyroidism, vitamin D resistant rickets, and osteomalacia. Moreover, it helps in diseases that weaken bones, such as osteoporosis. It improves overall skeletal health by normalizing bone health and calcium metabolism.

How to take

Adult dose

Chronic kidney disease and osteoporosis: Administer 0.5–1 ㎍ of alfacalcidol orally once a day. Hypoparathyroidism, and other diseases due to vitamin D metabolism disorders: Administer 1–4 ㎍ of this medication orally once a day.

Child dose

Osteoporosis: Administer 0.01–0.03 ㎍ of alfacalcidol per kg body weight orally once a day. Other diseases: Administer 0.05–0.1 ㎍ of this medication per kg body weight orally once a day.

Precautions

This medication should not be taken by patients with hypercalcemia, hyperphosphatemia, or hypermagnesemia. Patients whose calcium and phosphate concentration product in the blood exceeds a certain level or those who are in a state of alkalosis, where blood becomes alkaline, should also avoid taking this medication. Individuals showing symptoms of vitamin D toxicity or those allergic to this medication or its components should not take it. During the use of this medication, it should not be taken in conjunction with drugs containing magnesium, vitamin D or its derivatives, or preparations containing calcium and certain diuretics, which may induce hypercalcemia. Pregnant women or those who may become pregnant should consult a doctor before taking this medication, as it may have side effects on the fetus. It is also advisable for children, the elderly, those with a history of kidney stones, or patients taking certain medications to consult with professionals before use. While taking this medication, symptoms related to hypercalcemia, such as dyspepsia, nausea, muscle cramps, headache, cardiac irregularities, renal function deterioration, liver function impairment, skin rash, and visual disturbances, may occur; if any of these symptoms appear, the patient should immediately stop taking the medication and consult a healthcare professional. Routine monitoring of serum calcium levels is necessary, and the dosage must be adhered to accurately to prevent overdose. Additionally, the calcium intake should be controlled, and in cases of hyperphosphatemia, phosphate binding agents can be taken together. In case of overdose, emergency measures such as inducing vomiting or gastric lavage may be necessary, and if renal function is normal, diuretics or dialysis treatment may be required. Lastly, this medication should be stored out of reach of children, away from direct sunlight, in a cool and dry place. It is important not to transfer it to other containers to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, breathlessness or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • gastric pain
  • discomfort in the upper abdomen
  • abdominal distension
  • dyspepsia
  • dry mouth
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  • oral dysesthesia
  • thirst
  • pancreatitis
  • metallic taste
  • leg muscle cramps
  • headache
  • heaviness of the head
  • insomnia
  • anxiety
  • weakness
  • fatigue
  • dizziness
  • numbness
  • drowsiness
  • chest burning
  • shoulder stiffness
  • presbycusis
  • tinnitus
  • memory and cognitive decline
  • acute mental disorders
  • consciousness disturbances
  • back pain
  • mild hypertension
  • palpitations

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

Storage

This medication may be sensitive to light, so it should be stored in containers that block light. Additionally, it is recommended to store the medication at room temperature between 1 to 30 degrees Celsius. By doing so, the medication's effectiveness and safety can be maintained.

Appearance and packaging

Appearance

An orange oval soft capsule containing a colorless or transparent oily solution

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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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.