Medication info
Udambajeong 10 mg (Atorvastatin Calcium Hydrate)

Udambajeong 10 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Hydrate›10.85mg / 1 tablet
Manufacturer / importer
미래바이오제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201209008 · Approved 2012.11.30

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
Hyperlipidemia: The recommended initial dose is 10 mg of atorvastatin once daily, but for patients requiring greater reductions in LDL cholesterol levels, it can be started at 20 mg or 40 mg once daily. Doses can range from 10 mg to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and responses while monitoring lipid levels within 2 to 4 weeks after starting treatment or adjusting doses. The goal of treatment is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol levels to evaluate treatment response. However, if LDL cholesterol levels cannot be used, total cholesterol levels can be employed for monitoring treatment response. For patients with homozygous familial hypercholesterolemia, the treatment dosage ranges from 10 mg to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when those therapies are not possible. For heterozygous familial hypercholesterolemia pediatric patients (ages 10 to 17), the recommended initial dose is 10 mg of this medication once daily, and the recommended maximum dose is 20 mg (there are no clinical data on doses higher than 20 mg in pediatric patients). Dosing should be appropriately adjusted according to the recommended treatment goals in individual patients. Dosing adjustments should be made at intervals of 4 weeks or more. ○ For patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering effectiveness of atorvastatin, so dose adjustments are not necessary. ○ For elderly patients: The efficacy and safety in elderly patients aged 70 and older are comparable to those of normal adult patients.
Children's dosage
Heterozygous familial hypercholesterolemia pediatric patients (ages 10 to 17): The recommended initial dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dosing should be adjusted at intervals of 4 weeks or longer.

Ingredients

Manufacturer
미래바이오제약(주)

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia

  • Myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
  • homozygous familial hypercholesterolemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases. In particular, it decreases the risk of myocardial infarction and stroke in adults with multiple risk factors or patients with type 2 diabetes, and lowers the risk of vascular interventions and angina. Furthermore, in patients who already have coronary heart disease, it effectively reduces the occurrence of myocardial infarction, stroke, vascular interventions, congestive heart failure, and angina. It is also useful in treating hyperlipidemia, improving cholesterol and triglyceride levels in patients with various types of dyslipidemia and increasing HDL cholesterol. It is used to lower cholesterol levels in pediatric patients with heterozygous familial hypercholesterolemia. In summary, this drug is widely used for reducing the risk of cardiovascular diseases and improving hyperlipidemia.

Dosage and Administration

Adult dosage

Hyperlipidemia: The recommended initial dose is 10 mg of atorvastatin once daily, but for patients requiring greater reductions in LDL cholesterol levels, it can be started at 20 mg or 40 mg once daily. Doses can range from 10 mg to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and responses while monitoring lipid levels within 2 to 4 weeks after starting treatment or adjusting doses. The goal of treatment is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol levels to evaluate treatment response. However, if LDL cholesterol levels cannot be used, total cholesterol levels can be employed for monitoring treatment response. For patients with homozygous familial hypercholesterolemia, the treatment dosage ranges from 10 mg to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when those therapies are not possible. For heterozygous familial hypercholesterolemia pediatric patients (ages 10 to 17), the recommended initial dose is 10 mg of this medication once daily, and the recommended maximum dose is 20 mg (there are no clinical data on doses higher than 20 mg in pediatric patients). Dosing should be appropriately adjusted according to the recommended treatment goals in individual patients. Dosing adjustments should be made at intervals of 4 weeks or more. ○ For patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering effectiveness of atorvastatin, so dose adjustments are not necessary. ○ For elderly patients: The efficacy and safety in elderly patients aged 70 and older are comparable to those of normal adult patients.

Children's dosage

Heterozygous familial hypercholesterolemia pediatric patients (ages 10 to 17): The recommended initial dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dosing should be adjusted at intervals of 4 weeks or longer.

Precautions

This medication can cause muscle-related side effects. If symptoms such as muscle pain or weakness worsen, or if there is a significant increase in creatine kinase levels, stop taking the medication immediately and consult a doctor. This drug can affect liver function, so patients with liver disease or elevated liver enzyme levels should not take it, and regular liver function tests should be conducted during treatment. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication. This drug should not be administered to children, especially those under 10 years of age. Patients with a history of alcohol abuse or liver disease should take caution when taking this medication, and elderly patients are at a higher risk for muscle-related side effects and should be monitored closely. This drug may interact with other medications, so it is essential to consult a doctor or pharmacist, especially if taking specific antibiotics, antifungals, antivirals, certain antihypertensives, antidiabetics, or oral contraceptives. Grapefruit juice can increase the blood concentration of this medication, so it is advisable to avoid consuming grapefruit juice. If symptoms such as muscle pain, weakness, or fever occur while taking this medication, notify a doctor immediately and undergo testing. This drug contains lactose, so patients with lactose intolerance should not take it. Store this medication out of the reach of children, in its original container, and seek medical attention immediately in case of overdose. This medication should be administered with caution to patients with a history of liver disease, kidney disease, endocrine disorders, or muscle disorders, and any adverse effects that occur during treatment should be reported to a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe allergic reactions, high fever with severe rashes, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver issues (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • decreased sensation
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1°C and 30°C. This helps maintain the medication's efficacy over time.

Appearance and packaging

Appearance

White round film-coated 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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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.