Medication info
Duotorin Tablets 10/10mg

Duotorin Tablets 10/10mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Biconvex rectangular tablets, white to pale yellow
Packaging
PTP Packaging: 30 tablets
Approval status
Active

MFDS item code 201601714 · Approved 2016.03.31 · Insurance code 648603260

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, and the generally recommended initial dosage is 10/20mg daily. Patients with less need for LDL-cholesterol reduction may start with 10/10mg daily. After initiation or dosage adjustment, lipid levels should be checked at intervals of at least 4 weeks.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication helps lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia, particularly in those with heterozygous familial and non-familial hypercholesterolemia and mixed hyperlipidemia, and increases good cholesterol (HDL). It is also used in patients with homozygous familial hypercholesterolemia when other treatments are ineffective or require adjunct therapy. This medication effectively regulates blood lipid levels when used alongside dietary management and contributes to reducing the risk of cardiovascular diseases. It is important to identify and treat underlying causes such as diabetes or hypothyroidism before administration. Lipid levels should also be tested upon hospital admission as a reference for treatment plans. Therefore, this medication is used to treat hypercholesterolemia and reduce the risk of atherosclerotic vascular diseases.

How to take

Adult dose

This medication is administered once daily in the evening regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, and the generally recommended initial dosage is 10/20mg daily. Patients with less need for LDL-cholesterol reduction may start with 10/10mg daily. After initiation or dosage adjustment, lipid levels should be checked at intervals of at least 4 weeks.

Precautions

This medication is primarily used to lower blood cholesterol levels and help reduce the risk of cardiovascular diseases. When taking this medication, there is a risk of severe muscular side effects such as myopathy or rhabdomyolysis; caution is advised. If muscle pain, weakness, or unexplained muscle aches occur, consult a physician immediately. It is advisable for individuals with liver dysfunction or those with ongoing liver disease to avoid this medication. Additionally, women who are pregnant or breastfeeding should not take this drug. The risk of side effects may increase when taken with certain medications, so if you are taking other drugs, be sure to inform your doctor or pharmacist. Care should be taken to avoid co-administration with potent CYP3A4 inhibitors or certain antibiotics, antiviral agents, and immunosuppressants. Elderly patients, those with hypothyroidism, or those with renal impairment are at an increased risk for myopathy and should be particularly cautious when taking this medication. It is recommended to regularly monitor for muscle-related symptoms and liver function tests when starting this medication or changing dosages, and to report any symptoms to healthcare professionals immediately. Furthermore, as this medication contains lactose, patients with lactose intolerance should not take it. This medication has not been sufficiently proven to be safe and effective in children and adolescents, so caution is required. In the case of overdose, there is no specific antidote, and general treatment will be administered according to the symptoms. Finally, this medication should be used in conjunction with lifestyle improvements, and clinical trials have confirmed its effectiveness in reducing the risk of cardiovascular diseases.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), severe skin reactions including erythema multiforme, severe edema, hepatitis, pancreatitis, liver abnormalities (including jaundice), acute renal failure, rhabdomyolysis, myopathy, severe muscle pain, severe muscle weakness, oculomotor weakness, severe headache, altered consciousness, seizures, visual disturbances, paralysis, dyspnea

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • myalgia
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
Show 26 more
  • abdominal discomfort
  • vomiting
  • itching
  • nocturia
  • hematuria
  • facial swelling
  • edema
  • thirst
  • dizziness
  • sensory disturbances
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus stools
  • irritable bowel syndrome
  • sore throat
  • alopecia
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract
  • oculomotor paralysis
  • anemia
  • thyroid dysfunction

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. Avoid placing it in excessively hot or cold locations, and it is best stored at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Biconvex rectangular tablets, white to pale yellow

Package unit

PTP Packaging: 30 tablets

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.