Medication info

Olmesartan Medoxomil/Rosuvastatin 20/5 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
White or yellowish round film-coated tablets
Packaging
30 tablets/box [30 tablets (10 tablets/Alu-Alu) x 3]
Approval status
Approval withdrawn

MFDS item code 202003984 · Approved 2020.05.28

This product's status changed to Approval withdrawn on 2024.09.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in treating hypertension and hypercholesterolemia and reducing the risk of cardiovascular disease
Who takes it
Adults · Children
Adult dose
This medication is only for use in adults, and the dosage should be individualized based on the efficacy and tolerability of olmesartan medoxomil/rosuvastatin in each patient. ◆ Olmesartan Medoxomil The recommended initial dosage is 10 mg once daily, administered regardless of food. If blood pressure is not adequately controlled, the dosage may be increased to 20 mg once daily. The maximum dosage may be increased to 40 mg once daily.
Child dose
The safety and efficacy of this medication in children under 18 years have not been established.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Effectiveness in treating hypertension and hypercholesterolemia and reducing the risk of cardiovascular disease

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
View approved original text

This medication is used for patients who require simultaneous administration of olmesartan medoxomil and rosuvastatin. Olmesartan medoxomil primarily helps in the treatment of essential hypertension. Rosuvastatin is used as an adjunct when dietary therapy and exercise do not control hypercholesterolemia and mixed dyslipidemia. Additionally, it helps manage lipid levels in patients with familial hypercholesterolemia or dysbetalipoproteinemia. This medication lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis and reducing the risk of stroke, myocardial infarction, and arterial revascularization procedures in patients with specific cardiovascular risk factors. Therefore, it is used to improve cardiovascular health by managing blood pressure and cholesterol.

How to take

Adult dose

This medication is only for use in adults, and the dosage should be individualized based on the efficacy and tolerability of olmesartan medoxomil/rosuvastatin in each patient. ◆ Olmesartan Medoxomil The recommended initial dosage is 10 mg once daily, administered regardless of food. If blood pressure is not adequately controlled, the dosage may be increased to 20 mg once daily. The maximum dosage may be increased to 40 mg once daily.

Child dose

The safety and efficacy of this medication in children under 18 years have not been established.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. It is safest not to use this medication in individuals with allergies to its components, pregnant or breastfeeding women, or fertile women not using adequate contraception. Patients with severely impaired kidney function, those receiving kidney dialysis, patients with severe liver impairment, biliary obstruction, and those with muscle disease should not be administered this medication. Patients with a high risk of muscle-related side effects, such as those with moderate to severe kidney damage, hypothyroidism, a history of muscle disease, alcoholics, and those taking certain concomitant medications should consult their healthcare provider before using this medication. This medication contains lactose and should not be administered to patients with lactose intolerance or certain metabolic disorders. Patients with low blood pressure or reduced body sodium may experience hypotension symptoms when starting this medication; therefore, it is important to monitor their condition closely before administration and during treatment. Patients with dependent kidney function or kidney transplant recipients should have regular blood tests to check kidney function and electrolyte levels. If symptoms such as muscle pain, muscle weakness, or muscle cramps occur during the use of this medication, the healthcare provider should be notified immediately, and treatment should be discontinued if severe. Black patients with hypertension may experience a reduced blood pressure-lowering effect, so treatment efficacy should be closely monitored. This medication may affect liver function, so patients with a history of liver disease or excessive alcohol consumption should regularly undergo liver function tests. When performing activities that involve risk, such as driving or operating machinery, caution is advised, as side effects such as dizziness or drowsiness may occur. Interactions may occur when taken with other medications; therefore, all medications being taken should be reported to healthcare providers, especially when combined with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, certain antibiotics, and antifungals. Women of childbearing potential should use adequate contraception during treatment and immediately discontinue if pregnancy is suspected or confirmed. Breastfeeding women should avoid or discontinue this medication because it may be transferred into breast milk and affect the infant. The safety and efficacy of this medication in children under 18 years have not been fully established and are therefore not recommended for pediatric use. Elderly patients may have increased blood concentrations of this medication, requiring dosage adjustments and monitoring for side effects. In the event of an overdose, symptoms such as hypotension, palpitations, and bradycardia may occur; immediate medical attention is necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe lethargy, liver abnormalities (jaundice), sudden

Mild side effects

Headache, dizziness, decreased sensation, drowsiness, gastroesophageal reflux, constipation, dental caries, dyspepsia, gastric ulcer, gastritis, gastroenteritis, musculoskeletal stiffness, atrial fibrillation, hypoglycemia, chest pain, peripheral edema, angioedema, vomiting, chronic malabsorption syndrome-like intestinal disorders, hypercholesterolemia, hyperlipidemia, hyperuricemia, arthralgia, arthritis, myalgia, rash, itching, hair loss, urticaria, elevated serum creatinine, creatinine clearance

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

Storage

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. Additionally, it should be kept away from excessively cold or hot temperatures and stored at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White or yellowish round film-coated tablets

Package unit

30 tablets/box [30 tablets (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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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.