Medication info

Dirosta Tablet 5/20mg

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

MFDS item code 201906401 · Approved 2019.09.10

This product's status changed to Expired on 2024.09.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of hypertension and cardiovascular risk, improvement of dyslipidemia
Who uses it
Adults
Adult dosage
Dirosta Tablet 5/20mg is administered only to adults, and the dosage should be individualized based on the response to amlodipine and atorvastatin respectively. Amlodipine (S-amlodipine): Administer 5 (2.5) mg orally once daily, and may increase up to 10 (5) mg per day based on patient response. Atorvastatin: For patients with primary hypercholesterolemia and mixed dyslipidemia, 10 mg once daily is the recommended starting dose.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

Reduction of hypertension and cardiovascular risk, improvement of dyslipidemia

  • Hypertension
  • fixed occlusion of the coronary artery
  • vasospasm
  • vasoconstriction
  • myocardial ischemia
  • angina
  • coronary artery disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
View approved original text

This medication is used in patients who require the combination of the two ingredients amlodipine (S-amlodipine) and atorvastatin. Amlodipine treats hypertension and angina, particularly stable angina and myocardial ischemia due to vasospasm, and helps reduce the risk of hospitalization due to angina and the risk of vascular surgeries in patients with coronary artery disease. Atorvastatin reduces the risk of cardiovascular diseases, improves hypercholesterolemia and dyslipidemia, and lowers total cholesterol and LDL cholesterol levels. It is also effective in reducing the risk of myocardial infarction, stroke, angina, and congestive heart failure. Thus, the combination of these two ingredients is used to comprehensively improve cardiovascular health.

Dosage and Administration

Adult dosage

Dirosta Tablet 5/20mg is administered only to adults, and the dosage should be individualized based on the response to amlodipine and atorvastatin respectively. Amlodipine (S-amlodipine): Administer 5 (2.5) mg orally once daily, and may increase up to 10 (5) mg per day based on patient response. Atorvastatin: For patients with primary hypercholesterolemia and mixed dyslipidemia, 10 mg once daily is the recommended starting dose.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this drug or similar drugs, have severe liver dysfunction, are pregnant or breast-feeding women, or have severe muscle disorders should not use it. Additionally, patients who have recently experienced a myocardial infarction or are in severe hypotensive shock should also avoid this medication. This medication should be used with caution in patients with severely impaired kidney function, the elderly, alcoholics, or those with a history of liver disease. Individuals at high risk of muscle abnormalities should have their muscle enzyme levels checked before starting treatment to ensure careful administration. Generally, this medication is well tolerated, but side effects such as flushing, fatigue, edema, dizziness, headache, and dyspepsia may occur. Muscle pain or symptoms of liver dysfunction may rarely occur, so if any abnormal symptoms appear, it is important to inform healthcare professionals immediately. Women who are pregnant or may become pregnant must ensure appropriate contraception while taking this medication and should stop taking it immediately if pregnancy is confirmed. Breastfeeding women should also avoid taking this medication, and it is recommended to discontinue breastfeeding while on this medication. This medication can interact with many other drugs, so it is crucial to inform healthcare professionals about any concomitant medications. Special caution is needed when co-administering with drugs that are metabolized in the liver or those that can cause muscle toxicity. In cases of overdose, blood pressure may drop excessively or heart rhythms may become abnormal, necessitating immediate medical attention. The safety and efficacy of this medication in children and the elderly have not been sufficiently studied, and it should be used cautiously after consultation with healthcare professionals in these cases. Lastly, this medication should be kept out of the reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • difficulty breathing
  • yellowing of the skin or eyes (jaundice)
  • extreme lethargy
  • toxic epidermal necrolysis
  • severe allergic reaction
  • severe liver abnormalities
  • hepatitis
  • cholestatic jaundice
Show 13 more
  • angioedema
  • skin adverse reactions
  • severe skin adverse reactions
  • asthma attacks
  • respiratory difficulties
  • severe swelling
  • confusion
  • paralysis
  • severe liver failure
  • myocardial infarction
  • acute heart failure
  • hypertensive crisis
  • hemorrhagic stroke

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 25 more
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • muscle stiffness
  • sensory loss/perception abnormalities
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • tremor
  • extrapyramidal disorder
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hypertrophy
  • gingival overgrowth
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best stored at room temperature between 15 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 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.