Medication info
Dutorex 10/10 mg

Dutorex 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
White, biconvex, film-coated oblong tablet
Packaging
30 tablets/PTP [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202101414 · Approved 2021.02.18 · Insurance code 652904510

Summary

Main use
Reduction of cholesterol levels and improvement of lipids by increasing HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dosage can be adjusted from 10/10 mg to 10/80 mg, with a starting dose of 10/10 mg or 10/20 mg recommended. For patients requiring greater LDL cholesterol reduction, a starting dose of 10/40 mg may be given. After initiation of therapy or dose adjustment, lipid levels should be checked at intervals of at least 2 weeks.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Reduction of cholesterol levels and improvement of lipids by increasing HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol.
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels while raising HDL cholesterol levels when used alongside dietary therapy in patients with primary hypercholesterolemia. It is also used to help or substitute cholesterol control in patients with homozygous familial hypercholesterolemia when other lipid-lowering therapies are insufficient. This medication should be administered with appropriate dietary control and non-pharmacological treatments, considering individual risk factors and secondary causes in treatment planning. Regular blood lipid tests will confirm its effectiveness during treatment. This medication is used to reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dosage can be adjusted from 10/10 mg to 10/80 mg, with a starting dose of 10/10 mg or 10/20 mg recommended. For patients requiring greater LDL cholesterol reduction, a starting dose of 10/40 mg may be given. After initiation of therapy or dose adjustment, lipid levels should be checked at intervals of at least 2 weeks.

Precautions

This medication is used to lower blood cholesterol levels. There is a risk of muscle problems, so if sudden muscle pain or weakness occurs, inform your doctor immediately. Special caution is needed as severe muscle pain or damage can lead to kidney function issues. It may affect liver function, so liver function tests should be conducted before starting this medication and regularly monitored during treatment. It is advisable not to take this medication if you have liver disease or abnormally high liver enzyme levels. Women who are pregnant, may become pregnant, or are nursing should not take this medication. Patients with a history of heavy alcohol consumption, liver disease, elderly patients, or those with impaired kidney function should be extra cautious when taking this medication. The risk of muscle damage may increase when taken with other medications, so inform healthcare providers of any medications being taken. This medication contains lactose, so those with lactose intolerance should be cautious. Side effects such as dizziness, muscle pain, or abdominal pain may occur, and if symptoms are severe, consult a doctor. Regular blood tests to check liver function and muscle condition are important during treatment. Safety and efficacy in children have not been established, so it is not recommended. Caution is advised when driving or operating machinery as dizziness may occur. In case of overdose, there is no specific antidote, so immediate medical attention should be sought for appropriate treatment, and liver function and muscle condition should be monitored.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory problems accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine retention.

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 26 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • malaise
  • headache
  • vomiting
  • indigestion
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • sensory abnormalities
  • paresthesia
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • visual impairment
  • tinnitus

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

White, biconvex, film-coated oblong tablet

Package unit

30 tablets/PTP [(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

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.