Medication info

Asical Soft Capsule (Alfacalcidol)

OTC medicationSoft capsule경구
Ingredient · strength
Alfacalcidol›1μg / 1 capsule
Manufacturer / importer
메딕스제약(주)
Appearance
Yellow soft capsule containing a colorless transparent oily substance
Packaging
60 capsules/PTP [(10 capsules/PTP * 6)], 120 capsules/box [(10 capsules/PTP * 6) x 2], 30 capsules/bottle
Approval status
Active

MFDS item code 202402002 · Notified 2024.08.19

Summary

Main use
Improvement of symptoms related to vitamin D metabolism abnormalities (hypocalcemia, bone pain, etc.) and osteoporosis
Who takes it
Adults · Children
Adult dose
Chronic renal failure and osteoporosis: Administer 0.5-1 ㎍ orally once daily as Alfacalcidol. Hypoparathyroidism and other diseases associated with vitamin D metabolic abnormalities: Administer 1-4 ㎍ orally once daily as this medication.
Child dose
Osteoporosis: Administer 0.01-0.03 ㎍ per kg of body weight orally once daily as Alfacalcidol. Other conditions: Administer 0.05-0.1 ㎍ per kg of body weight orally once daily as this medication.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

Improvement of symptoms related to vitamin D metabolism abnormalities (hypocalcemia, bone pain, etc.) and osteoporosis

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

This medication helps improve hypocalcemia, tetany, bone pain, and bone lesion symptoms associated with vitamin D metabolic abnormalities, such as chronic renal failure, hypoparathyroidism, vitamin D resistant rickets, and osteomalacia. It is also used to maintain bone health and reduce fracture risk in patients with osteoporosis.

How to take

Adult dose

Chronic renal failure and osteoporosis: Administer 0.5-1 ㎍ orally once daily as Alfacalcidol. Hypoparathyroidism and other diseases associated with vitamin D metabolic abnormalities: Administer 1-4 ㎍ orally once daily as this medication.

Child dose

Osteoporosis: Administer 0.01-0.03 ㎍ per kg of body weight orally once daily as Alfacalcidol. Other conditions: Administer 0.05-0.1 ㎍ per kg of body weight orally once daily as this medication.

Precautions

This medication should not be administered to patients with hypercalcemia, hyperphosphatemia, or hypermagnesemia. It should also be avoided in individuals with a product of calcium and phosphorus in the blood exceeding a certain level, or those with excessive alkalinity in the blood, or those with symptoms of vitamin D overdose. Individuals who are hypersensitive to any of the ingredients in this medication or to vitamin D should avoid taking it. During treatment, it is advisable not to take medications that contain magnesium, vitamin D or its derivatives, calcium-containing medications, or certain diuretics concurrently. If the medication is taken during breastfeeding, it is advisable to avoid taking it if possible, and if it must be taken, to stop breastfeeding. Women who are pregnant or may become pregnant should consult a doctor before taking it, as it may affect the fetus. The safety of this medication in children and the elderly has not been fully established, so dosage adjustment and monitoring of blood calcium levels are necessary. Patients taking certain drugs should consult a doctor or pharmacist regarding possible interactions with this medication. If any adverse effects occur during treatment, discontinue use immediately and consult a healthcare professional, as symptoms can appear in various systems including digestive, nervous, cardiac, renal, liver, skin, eyes, and bone. Regularly check serum calcium levels and kidney function, and seek appropriate measures if abnormalities are detected. In case of overdose, emergency treatment such as inducing vomiting or gastric lavage may be necessary, and medication should be stopped until serum calcium levels return to normal. This medication should be stored out of reach of children, protected from direct sunlight, and kept in a cool, dry place. To maintain quality, it is important not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusional state, visual disturbances, paralysis, urination changes

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • stomach pain
  • discomfort in the upper stomach
  • abdominal bloating
  • indigestion
  • thirst
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  • oral discomfort
  • polydipsia
  • pancreatitis
  • metallic taste
  • muscle cramps in legs
  • headache
  • heaviness of the head
  • insomnia
  • anxiety
  • weakness
  • fatigue
  • dizziness
  • numbness
  • drowsiness
  • heartburn
  • shoulder stiffness
  • presbycusis
  • tinnitus
  • memory decline
  • psychosis
  • altered consciousness
  • back pain
  • mild hypertension
  • palpitations
  • deep vein thrombosis

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 tightly sealed container that blocks light. Moreover, it is important to keep it at room temperature, which means not too hot or cold, to maintain the efficacy of the medication.

Appearance and packaging

Appearance

Yellow soft capsule containing a colorless transparent oily substance

Package unit

60 capsules/PTP [(10 capsules/PTP * 6)], 120 capsules/box [(10 capsules/PTP * 6) x 2], 30 capsules/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.