Medication info
Alphael Soft Capsule 0.5 Micrograms (Alfacalcidol)

Alphael Soft Capsule 0.5 Micrograms (Alfacalcidol)

OTC medicationSoft capsule경구
Ingredient · strength
Alfacalcidol›0.5μg / 1 capsule
Manufacturer / importer
에이치엘비제약(주)
Appearance
A transparent oval soft capsule of amber color containing a colorless to light yellow transparent emulsion.
Packaging
240 capsules/box [10 capsules/PTP×24], 60 capsules/box [10 capsules/PTP×6]
Approval status
Active

MFDS item code 202501950 · Notified 2025.07.28 · Insurance code 647304710

Summary

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

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Improvement of vitamin D metabolic disorders (hypocalcemia, bone lesions, etc.) and osteoporosis.

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

This medication is used to improve symptoms of hypocalcemia, tetany, bone pain, and lesions resulting from vitamin D metabolic disorders such as chronic kidney failure, hypoparathyroidism, vitamin D resistant rickets, and osteomalacia. It is also used in the treatment of osteoporosis to promote bone health and reduce fracture risk. In summary, this drug is effectively used for symptoms related to vitamin D metabolic disorders and osteoporosis.

How to take

Adult dose

Chronic kidney failure, osteoporosis: Administer orally once daily at 0.5 to 1 microgram as alfacalcidol. Hypoparathyroidism, other diseases due to vitamin D metabolic disorders: Administer orally once daily at 1 to 4 micrograms.

Child dose

Osteoporosis: Administer orally once daily at 0.01 to 0.03 micrograms per kg of body weight. Other diseases: Administer orally once daily at 0.05 to 0.1 micrograms per kg of body weight.

Precautions

This drug should not be taken by patients with hypercalcemia, hyperphosphatemia, or hypermagnesemia, or by those whose calcium and phosphorus product in the blood exceeds a certain level, and by individuals with alkalosis. Furthermore, those with vitamin D toxicity symptoms or allergies to this drug and its ingredients should also avoid taking it. While taking this drug, it should not be combined with magnesium-containing medications, vitamin D preparations, calcium-containing agents, or certain diuretics, as these can dangerously increase blood calcium levels. For those who are breastfeeding, safety has not been sufficiently established, so it is better to avoid use if possible, and if unavoidable, stopping breastfeeding is recommended. Pregnant women or women who may become pregnant should consult a doctor before taking this medication due to the risk of harm to the fetus, and caution should be taken by children, the elderly, and patients on specific medications, with advice from specialists. Regular blood tests to check calcium levels and kidney function should be performed during treatment, and if any abnormal symptoms occur, use should be stopped immediately, and medical advice should be sought. Symptoms of hypercalcemia may include indigestion, nausea, vomiting, muscle cramps, headache, insomnia, heart palpitations, and reduced kidney function, so caution is necessary if these symptoms appear. This drug helps regulate calcium and phosphorus levels, so it is important to adhere strictly to dietary guidelines and dosage instructions, and emergency treatment may be required in case of overdose. Lastly, store this medication in a cool, dry place out of reach of children, avoiding direct sunlight, and do not transfer to other containers to maintain the quality of the medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities with cough and fever, jaundice of the skin or eyes, systemic fatigue, severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output, severe systemic swelling, blood pressure changes.

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • stomach pain
  • discomfort in the stomach area
  • abdominal bloating
  • indigestion
  • thirst
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  • oral dysesthesia
  • polydipsia
  • pancreatitis
  • metallic taste
  • cramps in leg muscles
  • headache
  • heaviness in the head
  • insomnia
  • anxiety
  • weakness
  • fatigue
  • dizziness
  • paresthesia
  • drowsiness
  • heartburn
  • shoulder stiffness
  • presbycusis
  • tinnitus
  • decreased memory and attention
  • psychosis
  • altered consciousness
  • back pain
  • slight increase in blood pressure
  • palpitations.

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 recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it in this manner will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

A transparent oval soft capsule of amber color containing a colorless to light yellow transparent emulsion.

Package unit

240 capsules/box [10 capsules/PTP×24], 60 capsules/box [10 capsules/PTP×6]

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.