Medication info
Dualatojeong 10/20 mg

Dualatojeong 10/20 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
일양약품(주)
Appearance
White to pale white, biconvex, rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202101511 · Approved 2021.02.18 · Insurance code 641705930

Summary

Main use
Improvement of lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage ranges from 10/10 mg to 10/80 mg daily, with an initial dose of either 10/10 mg or 10/20 mg recommended. For patients requiring a greater reduction in LDL cholesterol (more than 55%), an initial dose of 10/40 mg is recommended. Dose adjustments should be made based on lipid levels after intervals of at least 2 weeks.

Ingredients

Manufacturer
일양약품(주)

Efficacy & effects

Improvement of lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This drug is used as an adjunct to diet for lowering elevated total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels and increasing HDL cholesterol levels in patients with primary hypercholesterolemia, particularly in familial and non-familial cases. It may also be given alone or in conjunction with other lipid-lowering therapies to patients with homozygous familial hypercholesterolemia. This drug is used alongside appropriate dietary measures and is effective when dietary measures alone are insufficient. Prior to administration, secondary causes of dyslipidemia should be identified and treated as necessary, and lipid levels should be monitored periodically. This drug helps improve cholesterol levels in patients at high risk for cardiovascular diseases. Therefore, it is used for the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage ranges from 10/10 mg to 10/80 mg daily, with an initial dose of either 10/10 mg or 10/20 mg recommended. For patients requiring a greater reduction in LDL cholesterol (more than 55%), an initial dose of 10/40 mg is recommended. Dose adjustments should be made based on lipid levels after intervals of at least 2 weeks.

Precautions

This drug can cause rare side effects that may lead to muscle damage, such as rhabdomyolysis, so if serious muscle pain or weakness occurs, the patient should inform their doctor immediately. Additionally, patients with impaired kidney function or at high risk for muscle damage, such as those with severe infections, or those recovering from major surgery, may need to temporarily discontinue or stop taking this drug. This drug should not be administered to individuals allergic to the active or inactive ingredients, those with active liver disease or significantly elevated liver enzyme levels, those with muscle disorders, women who are pregnant or may become pregnant, nursing mothers, those taking certain antiviral medications, or individuals with lactose intolerance. Care should be taken in alcoholics or those with a history of liver disease, those with severe liver dysfunction, those with kidney dysfunction or hypothyroidism, and elderly patients (aged 70 and older) who are at higher risk for muscle-related side effects. During treatment with this drug, regular checks of liver function and muscle condition should be conducted, and if symptoms indicating liver dysfunction, muscle pain, fatigue, or fever appear, medical consultation should be sought immediately. This drug may interact with other medications, so patients taking other drugs must inform their doctor or pharmacist, especially when used with drugs that affect liver metabolism or may cause muscle side effects. Women of childbearing potential should use appropriate contraceptive methods while taking this drug, and if they are planning to become pregnant or are pregnant, they should consult their doctor. This drug is not recommended for children since safety and efficacy have not been established. Elderly patients have a higher risk of muscle side effects, so caution is advised, but no specific dose adjustment is usually necessary. In the case of overdose, there is no specific antidote, and treatment should focus on symptomatic relief while monitoring liver function and muscle condition. This drug should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, hypersensitivity reactions including rash and angioedema, myopathy/rhabdomyolysis, elevated liver enzymes, hepatitis, thrombocytopenia, severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), severe cutaneous adverse reactions including erythema multiforme, jaundice, renal failure (kidney disease), intracranial aneurysms, restless legs syndrome, capillary bronchitis, dental abscesses, vestibular neuritis

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • headache
  • dizziness
  • cough
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • indigestion
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • altered perception
  • sensory loss
  • altered taste
  • memory loss
  • peripheral neuropathy
  • muscle cramps
  • muscle fatigue
  • complications due to rupture
  • lupus

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White to pale white, biconvex, rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP 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.

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.