Medication info
Alpha Calm Soft Capsule 0.5 Micrograms (Alfacalcidol)

Alpha Calm Soft Capsule 0.5 Micrograms (Alfacalcidol)

OTC medicationSoft capsule경구
Ingredient · strength
Alfacalcidol›0.5μg / 1 capsule
Manufacturer / importer
(주)마더스제약
Appearance
Pink oval soft capsule containing a colorless transparent or light yellow oily solution
Packaging
30 capsules/box [(10 capsules/PTP) X 3], 60 capsules/box [(10 capsules/PTP) X 6], 90 capsules/box [(10 capsules/PTP) X 9]
Approval status
Active

MFDS item code 202400991 · Notified 2024.04.25 · Insurance code 622805420

Summary

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

Ingredients

Importer
(주)마더스제약

Efficacy & effects

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

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

This medication helps improve symptoms such as hypocalcemia, tetany, bone pain, and bone lesions caused by vitamin D metabolism disorders. It is especially effective in conditions such as chronic renal failure, hypoparathyroidism, vitamin D resistant rickets, and osteomalacia. Additionally, it is utilized for the prevention and treatment of osteoporosis, contributing to maintaining bone health and improving bone density. This medication is used to address bone damage caused by vitamin D-related issues and to enhance overall bone health.

How to take

Adult dose

Chronic renal failure and osteoporosis: administer 0.5 to 1 µg of Alfacalcidol orally once a day. Hypoparathyroidism and other diseases due to vitamin D metabolism disorders: administer 1 to 4 µg of this medication orally once a day.

Child dose

Osteoporosis: administer 0.01 to 0.03 µg per kg of body weight orally once a day. Other conditions: administer 0.05 to 0.1 µg per kg of body weight orally once a day.

Precautions

This medication should not be taken by patients with hypercalcemia, hyperphosphatemia, or hypermagnesemia, or by patients with a certain level of calcium and phosphate product in their blood, or by those with alkalosis. Furthermore, individuals who exhibit symptoms of vitamin D toxicity or are allergic to this medication or its components should avoid it. During the course of this medication, it is advisable to avoid taking drugs containing magnesium, vitamin D and its derivatives, calcium-containing drugs, or certain diuretics. Nursing women should avoid this medication as its safety has not been established, and if it must be taken, it is recommended to stop breastfeeding. Women who are pregnant or may become pregnant should take it cautiously after consulting a doctor, due to the risk of harm to the fetus. Children, the elderly, patients on specific medications, and those with kidney stones or sarcoidosis should consult with a professional before taking this medication. While taking this medication, various symptoms related to hypercalcemia may appear, so if abnormal symptoms occur, the medication should be discontinued immediately and consultation should be sought. Serum calcium levels and kidney function should be checked regularly, and if abnormalities are found, appropriate measures must be taken. It is important to adhere to the prescribed dosage, avoid overdose, and follow instructions regarding calcium intake. In case of overdose, discontinue use immediately and seek appropriate treatment; if necessary, emergency measures such as inducing vomiting or gastric lavage may be implemented. This medication should be stored out of reach of children, away from direct sunlight, and in a cool, dry place. Additionally, to maintain quality, it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever and respiratory distress, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • stomach pain
  • abdominal discomfort
  • bloating
  • indigestion
  • thirst
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  • oral discomfort
  • polydipsia
  • pancreatitis
  • metallic taste
  • leg muscle cramps
  • headache
  • heaviness in the head
  • insomnia
  • anxiety
  • weakness
  • fatigue
  • dizziness
  • numbness
  • drowsiness
  • heartburn
  • shoulder stiffness
  • age-related hearing loss
  • tinnitus
  • decreased memory and cognitive function
  • psychosis
  • consciousness disturbance
  • back pain
  • mild blood pressure increase
  • 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 a light-blocking container. It is also recommended that the medication be stored at room temperature between 1 to 30 degrees Celsius. Storing it this way will maintain its effectiveness and allow for safe use.

Appearance and packaging

Appearance

Pink oval soft capsule containing a colorless transparent or light yellow oily solution

Package unit

30 capsules/box [(10 capsules/PTP) X 3], 60 capsules/box [(10 capsules/PTP) X 6], 90 capsules/box [(10 capsules/PTP) X 9]

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.