Medicine

Basic Information

Ingredients

Cholecalciferol in 1ml ………………………………………………7.5mg/ml(Vitamin D₃ 3000,000 I.U)

Component

Injections contained yellow cholecalciferol fluid that is visible colorless to green stored in brown glass ampoule.

Effects

Prevention and treatment of vitamin D deficiency in adults at high risk of absorption disorder of vitamin D.

Usage/Dosage

Use it according to the doctor's prescription, and check 25(OH)-vitamin D level in the blood.

Do not exceed the required dose as the adverse reaction increases with an overdose.

Adults: Intramuscular injection of 300,000IU of cholecalciferol.

Annual dose of cholecalciferol is to be kept within 600,000 IU.

Package

1mL/ampoule x 10 ampoules

Storage

Avoid direct sunlight and store it in a sealed container at room temperature (1~30℃).

Detail Information

Precautions

1. Warnings

    1) If treatments containing vitamin D and foods fortified with vitamin D are given to patients at the same time in order to avoid overdose, 

          the total amount of vitamin D should take into account.

    2) Observe calcium concentrations and stop administration if serum calcium exceeds 10.5 mg/dl or urinary calcium exceeds 4 mg/kg/day 

          in adults.

    3) If calcium intake is high, monitor calcium concentration in blood and urine regularly.

2. Do not administer to the following patient.

     1) A patient who is hypersensitive to the composition of this drug.

     2) A patient with hypercalcemia and hypercalciuria.

     3) A patient with calcium stone.

     4) Patients with history of kidney calcium stone or at risk of developing stones.

     5) A patient with nephropathy.

     6) A patient who is an immovable on the sickbed.

     7) A patient with sarcoidosis.

     8) A patient with pseudo-hypoparathyroidism.

     9) Pregnant and lactating women.

3. Abnormal reaction

     1) Administration of cholecalciferol can cause the following abnormal reactions.

           Headaches, asthenia, fatigue, muscle pain, loss of appetite, weight loss, poor growth, nausea, vomiting, constipation, diarrhea, 

           hyperuria and polydipsia, dehydration, hypertension, calcium stone, kidney and tissue calcification, kidney failure, excess bone 

           calcification, arrhythmia, perceptual disorders, joint pain, myasthenia, drowsiness, azotemia, allergic reaction (hypersensitivity), 

           thirst, confusion, tympanosis, stomachache, metallic taste, mouth dryness, rash, pruritus can be developed.

4. General precautions

    1) In the clinical trial, after patients with vitamin D deficiency were given cholecalciferol and their blood were tested for 25(OH) vitamin D 

          and parathyroid hormone levels.

    2) Patients with vitamin D deficiency (typically less than 10 ng/ml of 25(OH) vitamin D concentration in the blood) should be monitored 

          when administering this drug as abnormal reactions are increased due to excessive dosage.

    3) Measure and check serum creatinine level every 3-6 months. In particular, elderly people and patients who administer cardiac  

          glycoside in conjunction with diuretic are regularly monitored for serum creatinine levels. In case of renal dysfunctions, dose is reduced 

          appropriately or stopped in accordance with the patient's condition.

    4) Patients who have problems with nephritic excretion of calcium and phosphoric acid monitor calcium concentrations in the blood and 

          urine.

5. Interaction

    1) Anti-seizure drug such as phenytoin, barbiturates, and glucocorticoid can affect the functioning of vitamin D.

    2) Cholestyramine, colestipol and orlistat can reduce the absorption of vitamin D, and reduce the retention of vitamin D in the liver in the 

          case of chronic alcoholism.

    3) Thiazide diuretics can reduce calcium excretion in the kidneys, leading to hypercalcemia. Thus, calcium concentration in blood and 

          urine should be monitored during prolonged treatment.

    4) During vitamin D administration, arrhythmia can be developed and the toxicity of the cardiac glycoside increases as calcium 

          concentrations are increased. These patients should measure ECGs and monitor calcium concentrations in blood and urine.

    5) Aluminium-containing antacids can reduce the absorption of vitamin D, which can impair the efficacy of this drug, and magnesium-

          containing drugs can cause hypermagnesaemia.

    6) In animal testing, the function of warfarin was increased when calciferol and warfarin were administered together. Be careful when 

          administrating this medicine with warfarin together.

6. Administration to pregnant and lactating women

    1) Animal study has not been conducted into teratogenic test.

    2) Do not administer excess vitamin D during pregnancy. Prolonged hypercalcemia can cause physical and psychological retardation, 

          supravalvular-aortic stenosis, and retinopathy in children. Therefore, this drug is not used for pregnant or lactating women.

7. Administration to children

   Safety and effectiveness for children are not established.

8. Treatment when overdose

     1) When overdose on this drug, stop administrating vitamin D and reduce calcium intake. Furthermore, increase diuresis and increase 

           water intake.

     2) Hemodialysis can be carried out with a calcium-free dialysate in case of hypouresis.

     3) There is no particularly known antidote.

     4) Patients administered high-doses for long period are informed of the symptoms of overdose in advance.

9. Application precautions

     1) Don't take this medicine in conjunction with any other medication.

     2) Use the product quickly after opening and discard the residue.

10. Precautions for storage and handling

     1) Avoid direct sunlight and store at 1~30℃.