Medication info

Olmesartan Medoxomil and Rosuvastatin Tablet 20/10 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
White or yellowish round film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Expired

MFDS item code 202003968 · Approved 2020.05.28

This product's status changed to Expired on 2025.05.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in improving hypertension and hypercholesterolemia, and reducing cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The recommended initial dose of Olmesartan Medoxomil is 10 mg once daily, without regard to meals. If blood pressure is not adequately controlled, the dose can be increased to 20 mg once daily, with a maximum of 40 mg. The initial dose of Rosuvastatin is 5 mg once daily, with 10 mg once daily typically used for the maintenance dose. It can be increased up to a maximum of 20 mg once daily if necessary.
Child dose
Safety and effectiveness in children under 18 years of age have not been established.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Effectiveness in improving hypertension and hypercholesterolemia, and reducing cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • stroke
  • myocardial infarction
View approved original text

This medication is prescribed for patients who need to use the two drugs Olmesartan Medoxomil and Rosuvastatin in combination. Olmesartan Medoxomil is used to treat essential hypertension, helping to lower blood pressure and reduce the risk of cardiovascular disease. Rosuvastatin assists in the treatment of hypercholesterolemia and dyslipidemia, serving as an adjunctive treatment when dietary management alone is insufficient. Additionally, it is effective in reducing the risk of cardiovascular diseases and slowing the progression of atherosclerosis, as well as lowering the risk of stroke and myocardial infarction. Thus, this medication is used to manage hypertension and hyperlipidemia simultaneously to improve cardiovascular health.

How to take

Adult dose

The recommended initial dose of Olmesartan Medoxomil is 10 mg once daily, without regard to meals. If blood pressure is not adequately controlled, the dose can be increased to 20 mg once daily, with a maximum of 40 mg. The initial dose of Rosuvastatin is 5 mg once daily, with 10 mg once daily typically used for the maintenance dose. It can be increased up to a maximum of 20 mg once daily if necessary.

Child dose

Safety and effectiveness in children under 18 years of age have not been established.

Precautions

This medication may cause severe harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; hence, it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to this medication or its components, pregnant women or those who may become pregnant, breastfeeding women, and patients with severely impaired kidney or liver function should not use this medication. It should also not be given to patients undergoing kidney dialysis, patients with severely impaired kidney function, those with severe liver dysfunction, patients with bile duct obstruction, and individuals with certain muscle disorders. Since this medication contains lactose, it should not be taken by patients with lactose intolerance or certain genetic metabolic disorders. Patients with low blood volume or insufficient sodium levels may experience low blood pressure symptoms upon initial use of this medication, so they must be monitored carefully, and appropriate treatment is necessary if low blood pressure occurs. Patients with reduced kidney function should regularly check their serum potassium and creatinine levels, and safety has not been established for patients who have undergone kidney transplantation. As there is a risk of hyperkalemia, patients with heart failure or kidney issues should periodically check their serum potassium levels. This medication can lower blood pressure, so it should be used cautiously in patients with aortic or mitral valve stenosis and obstructive heart disease. Muscle-related side effects such as myalgia, myopathy, and rarely rhabdomyolysis may occur; thus, any unusual symptoms should be reported to a healthcare professional immediately. During the use of this medication, it is advisable to avoid alcohol consumption and undergo regular liver function tests, with even greater caution advised for those with a history of hypothyroidism or other muscular disorders. This medication may interact with other drugs, so it is essential to inform healthcare professionals about any other medications being taken. Pregnant or breastfeeding women should not take this medication, and women planning to become pregnant should use appropriate contraception. The safety and efficacy in children and adolescents under 18 years of age have not been established. In cases of overdose, symptoms such as low blood pressure and palpitations may occur; therefore, immediate consultation with medical staff and appropriate treatment are necessary. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound malaise, sudden and severe headaches, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

  • Headache
  • dizziness
  • sensory impairment
  • drowsiness
  • gastroesophageal reflux
  • constipation
  • dental caries
  • dyspepsia
  • gastric ulcer
  • gastritis
Show 22 more
  • gastroenteritis
  • musculoskeletal stiffness
  • atrial fibrillation
  • hypoglycemia
  • chest pain
  • back pain
  • cough
  • nosebleed
  • upper respiratory tract infection
  • asthma
  • vomiting
  • chronic malabsorption syndrome
  • hair loss
  • itching
  • rash
  • elevated serum creatinine
  • reduced creatinine clearance
  • thrombocytopenia
  • immune-mediated necrotizing myopathy
  • elevated blood pressure
  • palpitations
  • hypercholesterolemia

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 best to maintain the storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness and ensure safe usage.

Appearance and packaging

Appearance

White or yellowish round film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu 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

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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.