Medication info
One Alpha Tablet (Alfacalcidol)

One Alpha Tablet (Alfacalcidol)

OTC medicationTablet경구
Ingredient · strength
Alfacalcidol›0.5μg / 1 tablet
Manufacturer / importer
일성아이에스(주)
Appearance
White round tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 199001232 · Notified 1990.06.11 · Insurance code 655401180

Summary

Main use
Symptoms of Vitamin D metabolism disorders (hypocalcemia, bone pain, etc.) and improvement of osteoporosis
Who takes it
Adults · Children
Adult dose
For chronic renal failure and osteoporosis: Administer 0.5 to 1 microgram of alfacalcidol orally once daily. For hypoparathyroidism and other disorders associated with vitamin D metabolic abnormalities: Administer 1 to 4 micrograms of this medication orally once daily.
Child dose
For osteoporosis: Administer 0.01 to 0.03 micrograms of alfacalcidol per kg of body weight orally once daily. For other conditions: Administer 0.05 to 0.1 micrograms of this medication per kg of body weight orally once daily.

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

Symptoms of Vitamin D metabolism disorders (hypocalcemia, bone pain, etc.) and improvement of osteoporosis

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

This medication is used to improve symptoms associated with vitamin D metabolic disorders, such as chronic renal failure, hypoparathyroidism, vitamin D-resistant rickets, and osteomalacia, including hypocalcemia, muscle cramps known as tetany, bone pain, and lesions. It is also effective for the prevention and treatment of osteoporosis. Therefore, this medication is widely used for metabolic bone diseases and diseases related to decreased bone density.

How to take

Adult dose

For chronic renal failure and osteoporosis: Administer 0.5 to 1 microgram of alfacalcidol orally once daily. For hypoparathyroidism and other disorders associated with vitamin D metabolic abnormalities: Administer 1 to 4 micrograms of this medication orally once daily.

Child dose

For osteoporosis: Administer 0.01 to 0.03 micrograms of alfacalcidol per kg of body weight orally once daily. For other conditions: Administer 0.05 to 0.1 micrograms of this medication per kg of body weight orally once daily.

Precautions

This medication should not be taken by individuals with high serum calcium levels. Patients with elevated phosphate and magnesium levels should also avoid this medication. Patients with metabolic alkalosis (high blood pH) should not use this medication. Individuals with toxic symptoms due to vitamin D overdose should avoid this medication, as well as those who are allergic to this medication or its components. During treatment with this medication, it is essential to avoid concurrent use of drugs containing magnesium, vitamin D or its derivatives, calcium-containing medications, or certain diuretics, as these can exacerbate side effects or increase risks associated with this medication. Women who are pregnant or may become pregnant should consult a doctor before taking this medication. Special caution is required for children and the elderly, especially children, who should have their serum calcium levels monitored frequently and should start with lower doses. Patients with a history of kidney stones or certain chronic diseases should consult a specialist before using this medication. It is advisable to avoid breastfeeding during use of this medication, and if unavoidable, it is recommended to stop breastfeeding. If adverse effects such as loss of appetite, vomiting, constipation, headaches, muscle cramps, dizziness, elevated blood pressure, or decreased kidney function occur during treatment, it is important to discontinue use immediately and consult a doctor. Regular blood tests and kidney function assessments are necessary due to the risk of elevated serum calcium levels. Strictly adhere to the prescribed dosage and dietary guidelines while taking this medication, and be cautious not to exceed calcium intake. In cases of overdose, emergency treatment may be required, so it's crucial to follow the dosage precisely. This medication should be stored out of reach of children, protected from direct sunlight, and kept in a cool, dry place. Additionally, it is advisable not to transfer this medication to another container to maintain product quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions
  • Severe rash with fever, blisters, skin peeling, pain in oral or ocular mucosa, severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever
  • Yellowing of the skin or eyes (jaundice), profound malaise, liver abnormalities (jaundice)
  • Sudden and severe headaches

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • abdominal pain
  • discomfort in the upper abdomen
  • abdominal bloating
  • indigestion
  • thirst
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  • metallic taste
  • leg muscle cramps
  • headaches
  • heaviness in the head
  • insomnia
  • anxiety
  • weakness
  • fatigue
  • dizziness
  • numbness
  • drowsiness
  • heartburn
  • shoulder stiffness
  • presbycusis
  • tinnitus
  • diminished memory and cognitive ability
  • transient psychosis
  • consciousness disorders
  • back pain
  • mild elevation in blood pressure
  • palpitations

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

Interactions

Drug interactions

This medication should be taken with caution when used with vitamin D and its derivatives, thiazide diuretics, digitalis, resins like cholestyramine, mineral oil laxatives, phenytoin, glucocorticoids, colesevelam, sucralfate or antacids containing significant amounts of aluminum, estrogen (ethinyl estradiol, norethisterone), barbiturates, and anticonvulsants. Consultation with a doctor or pharmacist is recommended.

Food interactions

This medication should not be taken with magnesium-containing preparations or calcium-containing preparations.

Storage

This medication should be stored in a tightly sealed container to prevent air infiltration, ideally in a cool place between 1 and 25 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

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.