Medication info
Olmesartan Medoxomil and Rosuvastatin Tablets 20/5 mg

Olmesartan Medoxomil and Rosuvastatin Tablets 20/5 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
White or yellowish round film-coated tablets
Packaging
30 tablets/box [30 tablets (10 tablets/Alu-Alu)x3]
Approval status
Active

MFDS item code 202100100 · Approved 2021.01.06

Summary

Main use
Treatment of hypertension and hyperlipidemia (cholesterol control, etc.)
Who takes it
Adults · Children
Adult dose
The recommended initial adult dose of olmesartan medoxomil is 10 mg once daily and can be taken regardless of meals. If blood pressure is not adequately controlled, the dose may be increased to 20 mg once daily, with a maximum dose of 40 mg once daily. The initial dose for rosuvastatin is 5 mg once daily, and the maintenance dose is 10 mg once daily; most patients are controlled at this dose. The maintenance dose can be adjusted to 4 weeks or more depending on LDL cholesterol levels, therapeutic goals, and patient response.
Child dose
Safety and efficacy in children under 18 have not been established.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Treatment of hypertension and hyperlipidemia (cholesterol control, etc.)

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary heart disease
View approved original text

This medication is used for patients who need to take both olmesartan medoxomil and rosuvastatin at the same time. Olmesartan medoxomil helps treat essential hypertension. Meanwhile, rosuvastatin is used as an adjunctive treatment in cases of hypercholesterolemia and mixed hyperlipidemia where dietary changes are ineffective, and it is particularly effective in treating primary dyslipidemia and familial hypercholesterolemia. Additionally, rosuvastatin lowers total cholesterol and LDL cholesterol levels, which helps delay the progression of atherosclerosis and reduces the risk of stroke, myocardial infarction, and arterial revascularization in certain cardiovascular disease risk groups. Therefore, this medication is used to manage both hypertension and dyslipidemia to improve cardiovascular health.

How to take

Adult dose

The recommended initial adult dose of olmesartan medoxomil is 10 mg once daily and can be taken regardless of meals. If blood pressure is not adequately controlled, the dose may be increased to 20 mg once daily, with a maximum dose of 40 mg once daily. The initial dose for rosuvastatin is 5 mg once daily, and the maintenance dose is 10 mg once daily; most patients are controlled at this dose. The maintenance dose can be adjusted to 4 weeks or more depending on LDL cholesterol levels, therapeutic goals, and patient response.

Child dose

Safety and efficacy in children under 18 have not been established.

Precautions

This medication poses a risk of severe harm or death to the fetus and newborns if administered to women in the second and third trimesters of pregnancy, so use should be discontinued immediately upon confirmation of pregnancy. This medication should not be administered to patients with known allergies to this medication or its components, pregnant women or women who may become pregnant, nursing mothers, patients with severely impaired kidney function, patients with severe liver impairment, patients with biliary obstruction, and patients with myopathy. When administering to patients with reduced blood volume or sodium, there is a possibility of hypotension, so caution is necessary, and renal function should be periodically monitored as there may be changes in renal function. This medication may cause hyperkalemia, so serum potassium levels should be regularly monitored, and caution is required when engaging in hazardous activities such as operating dangerous machinery or driving, as dizziness may occur. This medication may affect liver function; therefore, liver function tests should be performed before and during treatment, and greater caution is required for patients with a history of liver disease. If symptoms of muscle pain, muscle weakness, or myopathy occur, it is essential to immediately notify healthcare professionals and undergo testing, and in severe cases, use should be discontinued. This medication may interact with other drugs, so it is crucial to inform healthcare providers of any current medications, especially when used concurrently with potassium-sparing diuretics, lithium, nonsteroidal anti-inflammatory drugs, certain antibiotics, and antifungals. Women who are pregnant or planning to become pregnant should avoid using this medication and use appropriate contraception. Nursing mothers should also avoid using this medication or discontinue breastfeeding. Safety and efficacy in children under 18 years have not been established, hence it is recommended against use in this population. For elderly patients, dosage adjustment may be necessary, and in the case of overdose, symptoms such as hypotension and palpitations may occur, requiring immediate visit to a healthcare facility. This medication should be stored out of reach of children, and it is safest not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reactions, rhabdomyolysis, hyperkalemia, acute renal failure, hair loss, severe allergic reactions, severe skin reactions, respiratory issues, liver disturbances (jaundice), severe neurological symptoms, severe edema or urinary problems, multiple organ failure syndrome, viral pneumonia, angioedema, autoimmune hepatitis, Stevens-Johnson syndrome, eosinophilia and systemic symptoms accompanying drug reaction syndrome.

Mild side effects

  • Headache
  • dizziness
  • decreased perception
  • drowsiness
  • gastroesophageal reflux
  • constipation
  • dental caries
  • dyspepsia
  • gastric ulcer
  • gastritis
Show 26 more
  • gastroenteritis
  • musculoskeletal rigidity
  • atrial fibrillation
  • hypoglycemia
  • chest pain
  • palpitations
  • itching
  • rash
  • hematuria
  • hypercholesterolemia
  • hyperlipidemia
  • hyperuricemia
  • arthralgia
  • arthritis
  • myalgia
  • abdominal pain
  • nausea
  • diarrhea
  • cough
  • epistaxis
  • upper respiratory infection
  • asthma
  • weakness
  • increased blood pressure
  • low back pain
  • increased serum creatinine.

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

Storage

This medication may be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius. Storing it correctly ensures the medication's effectiveness and safety.

Appearance and packaging

Appearance

White or yellowish round film-coated tablets

Package unit

30 tablets/box [30 tablets (10 tablets/Alu-Alu)x3]

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.