Medication info
Dutadine Tablet 5/20 Milligrams

Dutadine Tablet 5/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium›20.72mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201901593 · Approved 2019.03.15 · Insurance code 652904140

Summary

Main use
Improvement of myocardial ischemia (hypertension, angina) and reduction of the risk of myocardial infarction and stroke (cardiovascular risk factors)
Who takes it
Adults
Adult dose
This medication is administered only to adults, and the dosage should be individualized based on the effectiveness and tolerability of each component, amlodipine/atorvastatin, for each patient. Amlodipine (Es Amlodipine): Adults should take 5 (2.5) mg orally once daily, and the dose may be increased to a maximum of 10 (5) mg daily based on the patient's response. Atorvastatin: 1. For patients with primary hypercholesterolemia and mixed dyslipidemia:

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement of myocardial ischemia (hypertension, angina) and reduction of the risk of myocardial infarction and stroke (cardiovascular risk factors)

  • Hypertension
  • fixed obstruction of coronary arteries
  • vascular spasm
  • vascular constriction
  • myocardial ischemia
  • angina
  • myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
View approved original text

This medication is used for patients who require combination therapy with two drugs, amlodipine and atorvastatin. Amlodipine helps treat hypertension and myocardial ischemia due to stable or variant angina. It also reduces the risk of hospitalization for angina and the risk associated with vascular surgeries in some patients with confirmed coronary artery disease. Atorvastatin is effective in reducing the risk of cardiovascular disease and is used to improve blood lipid levels in patients with hyperlipidemia and dyslipidemia. Specifically, it lowers the risks of myocardial infarction, stroke, and angina and also reduces the risk of hospitalization for heart failure. Thus, this medication improves overall cardiovascular health by managing blood pressure and cholesterol levels.

How to take

Adult dose

This medication is administered only to adults, and the dosage should be individualized based on the effectiveness and tolerability of each component, amlodipine/atorvastatin, for each patient. Amlodipine (Es Amlodipine): Adults should take 5 (2.5) mg orally once daily, and the dose may be increased to a maximum of 10 (5) mg daily based on the patient's response. Atorvastatin: 1. For patients with primary hypercholesterolemia and mixed dyslipidemia:

Precautions

This medication should not be used in individuals with allergies to specific drugs or components. It is not to be administered to patients with severely impaired liver function, active liver disease, or extremely elevated liver enzyme levels of unknown origin. It is safer not to use this medication in pregnant women, women of childbearing potential, or nursing mothers. Use should be avoided in patients with muscle disorders or severe aortic stenosis, patients in shock, those within one month after myocardial infarction, and patients with unstable angina. Patients currently taking certain antiviral agents should also avoid this medication. Care should be taken when using this drug in patients with severely impaired kidney function, elderly patients, those with a history of alcohol abuse or liver disease. Patients at risk of muscle damage should have their muscle status checked with a blood test before starting treatment. Caution is also necessary for patients with acute heart failure or hypertensive crises, patients with mild to moderate liver dysfunction, and patients with severe muscular weakness. While this medication is generally well tolerated, mild side effects such as fatigue, edema, dizziness, headaches, and dyspepsia may occur. Rarely, muscle pain, rashes, liver dysfunction, and allergic reactions may occur, so any abnormal symptoms should be reported to a doctor immediately. It is important to regularly monitor liver function tests to assess liver health while on this medication. There are many drug interactions, so patients taking other medications must inform their physicians or pharmacists, particularly when combined with certain antibiotics, antifungals, or antivirals. Pregnant or nursing women should not take this medication, and women of childbearing potential should implement appropriate contraception. Safety in children and the elderly has not been adequately studied, so consultation with a specialist is advised. In cases of overdose, severe hypotension or heart-related issues may occur, requiring immediate hospital attention and potential emergency measures. This medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever accompanied by severe rashes, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or breathing difficulties, asthma attacks, respiratory issues accompanied by cough and fever, respiratory problems, yellowing of the skin or eyes (jaundice), profound lethargy, liver dysfunction (jaundice), sudden onset

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headaches
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • weight gain/loss
  • hypotension
  • vasculitis
  • muscle tension
  • sensory loss/paresthesia
  • peripheral neuropathy
  • fainting
  • dysgeusia
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hypertrophy
  • gum overgrowth
  • pancreatitis
  • vomiting
  • hyperglycemia
  • joint pain
  • lower back pain
  • muscle cramps
  • myalgia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 15 to 30 degrees Celsius. This will help preserve the medication's effectiveness over time.

Appearance and packaging

Appearance

White oval 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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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.