Medication info
New Alpha Tablet 1 Microgram (Alfacalcidol)

New Alpha Tablet 1 Microgram (Alfacalcidol)

OTC medication
Ingredient · strength
Alfacalcidol›Strength being verified
Manufacturer / importer
대한뉴팜(주)
Appearance
White round tablet
Packaging
30 tablets/bottle, 100 tablets/bottle

MFDS item code 202600653 · Insurance code 669908610

Summary

Main use
Symptoms of vitamin D metabolism disorder (hypocalcemia, bone pain, etc.) and improvement of osteoporosis
Who uses it
Adults · Children
Adult dosage
Chronic kidney disease 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 medication 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 conditions: Administer 0.05 to 0.1 µg of this medication orally once daily per kg of body weight.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Symptoms of vitamin D metabolism disorder (hypocalcemia, bone pain, etc.) and improvement of osteoporosis

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

This medication improves symptoms such as hypocalcemia, muscle spasms (tetany), and bone pain and lesions caused by vitamin D metabolism disorders. It also helps treat chronic kidney disease, hypoparathyroidism, vitamin D resistant rickets, and osteomalacia. Additionally, it is used to enhance bone health in patients with osteoporosis, increasing bone strength and reducing the risk of fractures.

Dosage and Administration

Adult dosage

Chronic kidney disease 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 medication 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 conditions: Administer 0.05 to 0.1 µg of this medication orally once daily per kg of body weight.

Precautions

This medication should not be taken by patients with hypercalcemia, hyperphosphatemia, or hypermagnesemia. Additionally, patients with a calcium-phosphate product in their blood above a certain threshold or those with alkalosis should avoid taking it. It should not be taken by those with symptoms of vitamin D toxicity or allergies to the ingredients in this medication. Patients with genetic disorders affecting lactose digestion should not take this medication. During the course of treatment, it is advisable not to take this medication in combination with magnesium-containing drugs, vitamin D preparations, calcium supplements, or certain diuretics, as this may dangerously increase serum calcium levels. Lactating women should avoid taking this medication as it may not be safe, and if it must be taken, cessation of breastfeeding is recommended. Women who are pregnant or may become pregnant should consult a physician to determine whether to take this medication due to potential risks to the fetus. Children and the elderly also require dosage adjustments and monitoring of serum calcium levels when taking this medication. Patients taking certain medications, such as digitoxin, phenytoin, glucocorticoids, estrogen, or barbiturates, should exercise caution due to potential interactions with this medication. Patients with a history of kidney stones or certain diseases such as sarcoidosis should consult a specialist before taking this medication. During treatment, various symptoms related to hypercalcemia may occur, including gastrointestinal disturbances, neurological abnormalities, cardiac irregularities, decreased kidney function, liver dysfunction, skin rashes, visual symptoms, and skeletal pain. If any abnormal symptoms occur, the medication should be discontinued immediately, and consultation with a specialist is necessary. Regular serum calcium and kidney function tests should be performed while taking this medication, and treatment should be discontinued if hypercalcemia occurs, followed by appropriate care. Calcium intake should be adjusted according to physician's instructions, and serum calcium levels should be monitored periodically to avoid overdose. In case of suspected overdose, immediate emergency measures should be taken, which may include inducing vomiting, gastric lavage, and appropriate medical treatment. This medication should be kept out of reach of children and stored away from direct sunlight in a cool, dry place. Do not transfer to another container and exercise caution to prevent misuse.

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 mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, breathing anomalies accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • stomach pain
  • discomfort in the gastric area
  • abdominal bloating
  • indigestion
  • thirst
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  • oral dysgeusia
  • polydipsia and polyuria
  • metallic taste
  • muscle cramps in the legs
  • headache
  • heaviness of the head
  • insomnia
  • anxiety
  • weakness
  • fatigue
  • dizziness
  • paresthesia
  • drowsiness
  • heartburn
  • shoulder stiffness
  • presbycusis
  • tinnitus
  • decreased memory and recall ability
  • psychosis
  • consciousness disturbances
  • back pain
  • mild hypertension
  • palpitations
  • deep vein issues

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 ingress. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White round tablet

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.