Medication info

Dirosta Tablets 5/10 mg

Prescription medicationTabletExpired
Ingredient · strength
Atorvastatin Calcium›10.36mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 201906402 · 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 (angina, myocardial infarction, etc.) and improvement of dyslipidemia
Who uses it
Adults
Adult dosage
As amlodipine (Es Amlodipine), administer 5 (2.5) mg once daily orally, and may increase to a maximum of 10 (5) mg once daily depending on the patient's response. For atorvastatin, the recommended initial dose for patients with primary hypercholesterolemia and mixed dyslipidemia is 10 mg once daily, and it may be initiated at 20 mg or 40 mg if necessary, with a range of 10 mg to 80 mg once daily.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

Reduction of hypertension and cardiovascular risk (angina, myocardial infarction, etc.) and improvement of dyslipidemia

  • Hypertension
  • fixed occlusion of coronary arteries
  • vascular spasm
  • vascular contraction
  • myocardial ischemia
  • angina
  • cardiovascular diseases
  • coronary artery disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • type 2 diabetes
View approved original text

This medication is used for patients who need to take the two drugs amlodipine and atorvastatin simultaneously. First, amlodipine is effective for cardiovascular diseases such as hypertension and stable angina, variant angina, etc. Additionally, in patients recently diagnosed with coronary heart disease who do not have heart failure, it reduces the risk of hospitalization due to angina and the risk of vascular intervention. Atorvastatin helps reduce the risk of coronary heart disease and stroke, and aids in controlling blood lipid levels due to hyperlipidemia and dyslipidemia. It is particularly useful for diabetic patients and those with multiple cardiovascular disease risk factors, as it also reduces the risks of heart failure and angina. Therefore, this medication is used for reducing risks associated with hypertension, angina, hyperlipidemia, and cardiovascular diseases.

Dosage and Administration

Adult dosage

As amlodipine (Es Amlodipine), administer 5 (2.5) mg once daily orally, and may increase to a maximum of 10 (5) mg once daily depending on the patient's response. For atorvastatin, the recommended initial dose for patients with primary hypercholesterolemia and mixed dyslipidemia is 10 mg once daily, and it may be initiated at 20 mg or 40 mg if necessary, with a range of 10 mg to 80 mg once daily.

Precautions

This medication should not be used in certain patients. Those who are allergic to this drug or similar medications, have severely impaired liver function, are pregnant or nursing, have muscle disorders, or have severe heart conditions should not take this medication. Additionally, patients with severely reduced kidney function, the elderly, those who consume excessive alcohol, and individuals with a history of liver disease should be cautious when taking this drug. Common side effects include flushing, fatigue, edema, dizziness, headache, and dyspepsia. Rarely, myalgia, liver function abnormalities, and allergic reactions may occur, so if symptoms worsen or adverse reactions are suspected, consult a doctor immediately. This medication may interact with other drugs, so inform your doctor or pharmacist of any current medications. Particularly, caution is required when taking with drugs that may affect liver function or muscle. Women who are pregnant or may become pregnant should use appropriate contraception while taking this medication, as it may pose a risk to the fetus; discontinue immediately if pregnancy is confirmed. Nursing mothers are also advised not to take this medication and should stop breastfeeding if it is necessary. Its safety and effectiveness in children or the elderly have not been sufficiently established, so it should be used with care. In cases of overdose, severe hypotension or cardiac issues may occur, necessitating immediate medical attention. Keep this medication out of reach of children and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, severe skin reactions, asthma attacks, respiratory issues accompanied by cough and fever, breathing difficulties, yellowing of the skin or eyes, jaundice, liver abnormalities, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances,

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 25 more
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • angiitis
  • muscle tension
  • sensory loss/abnormal sensations
  • peripheral neuropathy
  • fainting
  • dysgeusia
  • tremor
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • gum overgrowth
  • pancreatitis
  • vomiting
  • hyperglycemia
  • joint pain
  • lower 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 closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablets

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

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.