Medication info

Alfacidole Soft Capsules 0.5 Micrograms (Alfacalcidol)

OTC medicationSoft capsuleApproval withdrawn
Ingredient · strength
Alfacalcidol›0.5μg / 1 capsule
Manufacturer / importer
안국약품(주)
Appearance
Soft capsules in a light yellow color containing a yellowish transparent oily liquid.
Packaging
180 capsules/PTP
Approval status
Approval withdrawn

MFDS item code 199600953 · Notified 1996.09.25

This product's status changed to Approval withdrawn on 2025.11.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms of vitamin D metabolism abnormalities (hypocalcemia, bone pain, etc.) and osteoporosis.
Who uses it
Adults · Children
Adult dosage
Chronic renal failure and osteoporosis: Administer 0.5 to 1 µg of alfacalcidol orally once daily. Hypoparathyroidism and other diseases due to vitamin D metabolism abnormalities: Administer 1 to 4 µg of this medicine orally once daily.
Children's dosage
Osteoporosis: Administer 0.01 to 0.03 µg of alfacalcidol orally once daily per kg of body weight. Other diseases: Administer 0.05 to 0.1 µg of this medicine orally once daily per kg of body weight.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Improvement of symptoms of vitamin D metabolism abnormalities (hypocalcemia, bone pain, etc.) and osteoporosis.

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

This medicine is used to improve symptoms caused by vitamin D metabolism abnormalities, such as chronic renal failure, hypoparathyroidism, vitamin D resistant rickets, and osteomalacia. It alleviates hypocalcemia, tetany, bone pain, and bone lesions, thus enhancing the patient's bone health. Additionally, it is used in bone diseases such as osteoporosis to increase bone strength and reduce the risk of fractures. Overall, it effectively acts on bone-related diseases and vitamin D metabolism abnormalities to help maintain a healthy bone condition.

Dosage and Administration

Adult dosage

Chronic renal failure and osteoporosis: Administer 0.5 to 1 µg of alfacalcidol orally once daily. Hypoparathyroidism and other diseases due to vitamin D metabolism abnormalities: Administer 1 to 4 µg of this medicine orally once daily.

Children's dosage

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

Precautions

This medication should not be taken by patients with hypercalcemia, hyperphosphatemia, hypermagnesemia, or those with excessive levels of calcium and phosphorus in the blood. It should also be avoided by patients whose blood is excessively alkaline or who exhibit symptoms of vitamin D toxicity. Individuals with hypersensitivity to this drug should refrain from taking it. While on this medication, avoid taking it alongside drugs that increase the risk of hypercalcemia, such as magnesium-containing preparations, vitamin D and its derivatives, calcium-containing preparations, or certain diuretics. If breastfeeding, the safety of this medication has not been established, so it should be avoided if possible; if it must be taken, breastfeeding should be avoided. Women who are pregnant or may become pregnant should consult a doctor before taking this medication as it may be harmful to the fetus. Children, the elderly, individuals taking specific medications, and those with a history of kidney stones should consult a healthcare professional before taking this drug. During the course of treatment, serum calcium levels and kidney function should be monitored regularly, and if abnormalities are found, the medication should be discontinued immediately and a doctor consulted. Symptoms of hypercalcemia, such as nausea, vomiting, headaches, muscle cramps, and decreased kidney function, may occur, so if any of these symptoms arise, seek medical attention right away. To prevent overdose, adhere to prescribed dosages, watch calcium intake carefully, and manage calcium levels through blood tests as needed. This medication should be stored in a cool, dry place away from direct sunlight and kept out of reach of children.

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, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthmatic attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, confusion of consciousness, vision abnormalities, paralysis, urination changes.

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • abdominal pain
  • discomfort in the upper abdomen
  • abdominal bloating
  • dyspepsia
  • thirst
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  • unpleasant oral sensation
  • polydipsia
  • pancreatitis
  • metallic taste
  • muscle cramps in the legs
  • headaches
  • heaviness in the head
  • insomnia
  • anxiety
  • weakness
  • fatigue
  • dizziness
  • numbness
  • drowsiness
  • heartburn
  • shoulder pain
  • presbycusis
  • tinnitus
  • diminished memory and cognitive ability
  • acute psychosis
  • altered consciousness
  • back pain
  • mild elevation in blood pressure
  • 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 an opaque container that blocks light. It is also important to keep it in a sealed container to prevent air or moisture entry. Doing so will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Soft capsules in a light yellow color containing a yellowish transparent oily liquid.

Package unit

180 capsules/PTP

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.