Medication info

Locatroll Soft Capsule 0.25 Micrograms (Calcitriol)

Prescription medicationSoft capsuleApproval withdrawn
Ingredient · strength
Calcitriol›0.25μg
Manufacturer / importer
지피테라퓨틱스코리아주식회사
Appearance
Orange on top and white on the bottom, oval soft capsule
Packaging
30 capsules (10 capsules/PTP packaging x 3)
Approval status
Approval withdrawn

MFDS item code 200610653 · Notified 2006.07.18

This product's status changed to Approval withdrawn on 2025.09.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic kidney failure (primary hyperparathyroidism, metabolic bone disease) and hypoparathyroidism, osteomalacia
Who uses it
Adults · Children
Adult dosage
○ For patients before the dialysis treatment phase: The dosage as calcitriol is 0.25 ㎍ per day and may be increased to 0.5 ㎍ per day if necessary. ○ Renal osteodystrophy (dialysis patients): The initial daily dose is 0.25 ㎍. For patients with serum calcium levels within normal range or slightly decreased, 0.25 ㎍ can be administered every other day. Dosage may be increased by 0.25 ㎍ every 2 to 4 weeks. Most patients show efficacy at a dose of 0.5 to 1.0 ㎍ per day.
Children's dosage
○ For patients before the dialysis treatment phase: For children aged 36 months or older, the dosage is 0.25 ㎍ per day and may be increased to 0.5 ㎍ per day if necessary. ○ Initial recommended dosage for children under 36 months

Ingredients

Importer
지피테라퓨틱스코리아주식회사

Efficacy & effects

Treatment of chronic kidney failure (primary hyperparathyroidism, metabolic bone disease) and hypoparathyroidism, osteomalacia

  • Chronic kidney failure
  • secondary hyperparathyroidism
  • metabolic bone disease
  • renal osteodystrophy
  • hypoparathyroidism
  • rickets
  • osteomalacia
  • osteoporosis
View approved original text

This medication is used for the treatment of secondary hyperparathyroidism and associated metabolic bone disease in patients with chronic kidney failure before dialysis. It also helps improve renal osteodystrophy in patients undergoing hemodialysis. It is also used in the treatment of hypoparathyroidism (post-surgical, idiopathic or pseudo). It is effective for rickets and osteomalacia, particularly vitamin D-dependent rickets and hypophosphatemic vitamin D-resistant rickets. Furthermore, it is used for the management of osteoporosis. In summary, it is effectively used for various bone-related conditions such as chronic kidney failure, hypoparathyroidism, rickets, osteomalacia, and osteoporosis.

Dosage and Administration

Adult dosage

○ For patients before the dialysis treatment phase: The dosage as calcitriol is 0.25 ㎍ per day and may be increased to 0.5 ㎍ per day if necessary. ○ Renal osteodystrophy (dialysis patients): The initial daily dose is 0.25 ㎍. For patients with serum calcium levels within normal range or slightly decreased, 0.25 ㎍ can be administered every other day. Dosage may be increased by 0.25 ㎍ every 2 to 4 weeks. Most patients show efficacy at a dose of 0.5 to 1.0 ㎍ per day.

Children's dosage

○ For patients before the dialysis treatment phase: For children aged 36 months or older, the dosage is 0.25 ㎍ per day and may be increased to 0.5 ㎍ per day if necessary. ○ Initial recommended dosage for children under 36 months

Precautions

This medication should not be used in patients with diseases related to hypercalcemia or hypercalciuria. Patients allergic to this medication or its components should also avoid administration. Care should be taken in patients who are pregnant, breastfeeding, children under 36 months, or have a history of kidney stones. This medication is an active form of vitamin D, and overdose may lead to elevated serum calcium levels, resulting in various side effects. Therefore, during the use of this medication, serum calcium levels should be regularly checked to ensure they remain within normal range. Calcium intake should also be monitored to avoid exceeding the recommended daily amount, and any calcium supplements or dietary advice should be followed as per the physician's instructions. This medication may increase the risk of hypercalcemia when used concurrently with other vitamin D preparations or calcium-containing medications, so concurrent use should be avoided. Extra caution is needed when taken in combination with diuretics, digitalis preparations, and steroids. If pregnant or breastfeeding, careful consideration should be given to the impact of this medication on the fetus or newborn and should only be used after consulting a physician. Elderly patients may have reduced renal and liver function, so dosage should be adjusted, and side effects should be monitored closely. Overdose may cause symptoms such as vomiting, headache, anorexia, constipation, and in severe cases, to seek appropriate treatment at a medical facility. This medication should be stored in a cool place, away from light and moisture, and securely out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, rarely severe erythematous skin reactions, hypercalcemia, hypercalciuria, systemic vascular calcification, renal calcification, soft tissue calcification, arrhythmia, hypertension, elevated AST, ALT, LDH, elevated BUN, creatinine, hypermagnesemia, kidney stones, significant increase in blood pressure, edema, severe swelling, confusion, headache, visual disturbances, paralysis, severe allergic reactions, chest tightness, difficulty breathing, cold sweats, pallor

Mild side effects

  • Nausea
  • diarrhea
  • anorexia
  • constipation
  • vomiting
  • gastric discomfort
  • abdominal pain
  • thirst
  • abdominal cramps
  • muscular ileus
Show 26 more
  • abdominal discomfort
  • epigastric pain
  • abdominal bloating
  • stomatitis
  • polyuria
  • polydipsia
  • pancreatitis
  • metallic taste
  • restlessness
  • anxiety
  • insomnia
  • headache
  • apathy
  • drowsiness
  • psychosis
  • depression
  • coma
  • palpitations
  • arrhythmia
  • hypertension
  • hypersensitivity
  • calcification around joints
  • bone pain
  • rhinorrhea
  • epistaxis
  • dysuria

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

Storage

This medication should be stored in a tightly sealed container that protects it from air, light, and moisture. Additionally, it is important to keep it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Orange on top and white on the bottom, oval soft capsule

Package unit

30 capsules (10 capsules/PTP packaging x 3)

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.

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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.