Medication info

Alphacalcidol Soft Capsules 1 Microgram

OTC medicationSoft capsule경구
Ingredient · strength
Alfacalcidol›1μg / 1 capsule
Manufacturer / importer
(주)알피바이오
Appearance
Transparent brown oval soft capsule containing a colorless to pale yellow clear oily substance
Packaging
60 capsules/box [10 capsules/PTP × 6]
Approval status
Active

MFDS item code 202302307 · Notified 2023.07.31

Summary

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

Ingredients

Manufacturer
(주)알피바이오

Efficacy & effects

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

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

This medication is used to improve symptoms such as hypocalcemia, muscle cramps (tetany), bone pain, and bone lesions due to vitamin D metabolism abnormalities. It is particularly effective in related diseases such as chronic kidney failure, hypoparathyroidism, vitamin D-resistant rickets, and osteomalacia. It is also used for the treatment of bone diseases such as osteoporosis. Overall, it helps enhance bone health and alleviate related symptoms.

How to take

Adult dose

Chronic kidney failure and osteoporosis: Administer 0.5 to 1 ㎍ orally once daily as alphacalcidol. Hypoparathyroidism and other diseases due to vitamin D metabolism abnormalities: Administer 1 to 4 ㎍ orally once daily as this medication.

Child dose

Osteoporosis: Administer 0.01 to 0.03 ㎍ per kg body weight orally once daily as alphacalcidol. Other diseases: Administer 0.05 to 0.1 ㎍ per kg body weight orally once daily as this medication.

Precautions

This medicine should not be taken by patients with certain electrolyte abnormalities such as hypercalcemia, hyperphosphatemia, or hypermagnesemia. Additionally, patients with a calcium and phosphorus product in the blood above a certain threshold or those with alkalosis should also avoid this medication. Those showing symptoms of vitamin D toxicity or allergic to any component of this medication should refrain from use. It is important not to take magnesium, vitamin D, calcium-containing medications, and certain diuretics concurrently while on this medication. This drug is not recommended for nursing women, and if it must be used, it is advisable to discontinue breastfeeding. Women who are pregnant or may become pregnant should consult a physician before taking this medication, and dosage adjustments and careful monitoring may be necessary for children and the elderly. Patients taking certain medications, such as digitalis, anticonvulsants, or estrogen preparations, should also consult a specialist. Caution is advised for patients with a history of kidney stones or sarcoidosis, and those allergic to any coloring agent included in this drug. If abnormal symptoms occur during administration, discontinue use immediately and consult a physician. Symptoms related to hypercalcemia may include gastrointestinal disturbances, neurological disorders, and decreased kidney function. Regularly monitoring serum calcium levels and kidney function while on this medication is important to prevent adverse effects from overdose. Additionally, regulating calcium intake, and for patients with hyperphosphatemia, taking phosphate binders may be helpful. Immediate treatment is necessary in case of overdose, potentially requiring emergency measures such as inducing vomiting, gastric lavage, or intravenous therapy. Store this medication out of reach of children, protect it from direct sunlight, and keep it in a cool, dry place. To maintain quality, do not transfer to other containers and strictly adhere to the prescribed usage and dosage.

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, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, disorientation, visual disturbances, paralysis, urination

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • stomach pain
  • discomfort in the upper abdomen
  • abdominal bloating
  • indigestion
  • thirst
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  • abnormal oral sensation
  • polydipsia
  • pancreatitis
  • metallic taste
  • leg muscle cramps
  • headache
  • heaviness of the head
  • insomnia
  • anxiety
  • fatigue
  • lethargy
  • dizziness
  • tingling
  • drowsiness
  • heartburn
  • shoulder stiffness
  • presbycusis
  • tinnitus
  • memory and concentration impairment
  • acute psychosis
  • consciousness disturbance
  • back pain
  • mild elevation of blood pressure
  • palpitations

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

Storage

This medication should be stored in a sealed container that can block light, maintaining a storage temperature between 1 to 30 degrees Celsius. Storing it this way will help preserve its effectiveness and safety.

Appearance and packaging

Appearance

Transparent brown oval soft capsule containing a colorless to pale yellow clear oily substance

Package unit

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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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.