Medication info

Loselmeterak Tablets 20/10mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
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Approval withdrawn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 202007465 · Approved 2020.10.30

This product's status changed to Approval withdrawn on 2024.03.29. 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
Olmesartan medoxomil: The recommended starting dose is 10 mg once daily, taken irrespective of meals. If blood pressure is not adequately controlled at this dose, it may be increased to 20 mg once daily, with a maximum increase of up to 40 mg once daily. The blood pressure-lowering effect appears within 2 weeks of starting treatment and reaches maximum effect in about 8 weeks. If blood pressure is not adequately controlled on monotherapy, thiacide diuretics such as hydrochlorothiazide may be used.
Child dose
Safety and efficacy for pediatric patients under 18 years have not been established.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

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

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • hypercholesterolemia
View approved original text

This medication is used for patients who need to receive both olmesartan medoxomil and rosuvastatin simultaneously. Olmesartan medoxomil is primarily used for the treatment of essential hypertension. Rosuvastatin helps to treat primary hypercholesterolemia and combined hyperlipidemia that cannot be managed by dietary control. It is also used as an adjunct to diet in patients with homozygous familial hypercholesterolemia and dysbetalipoproteinemia. This medication lowers blood cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis and reducing the risk of cardiovascular disease. Particularly, depending on age and risk factors, it reduces the risk of complications after stroke, myocardial infarction, and vascular revascularization procedures. Due to these effects, this medication improves cardiovascular health by managing both hypertension and dyslipidemia.

How to take

Adult dose

Olmesartan medoxomil: The recommended starting dose is 10 mg once daily, taken irrespective of meals. If blood pressure is not adequately controlled at this dose, it may be increased to 20 mg once daily, with a maximum increase of up to 40 mg once daily. The blood pressure-lowering effect appears within 2 weeks of starting treatment and reaches maximum effect in about 8 weeks. If blood pressure is not adequately controlled on monotherapy, thiacide diuretics such as hydrochlorothiazide may be used.

Child dose

Safety and efficacy for pediatric patients 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. This medication should not be administered to patients with a history of allergic reactions, pregnant or potentially pregnant women, or nursing mothers. Patients with severely impaired kidney function, very poor liver function, bile duct obstruction, muscle diseases, or other specific conditions should not take this medication. Since this medication contains lactose, patients with genetic conditions such as lactose intolerance should not take it. Care is required for patients with low blood volume or insufficient sodium levels, as symptoms of hypotension may occur at the onset of taking this medication, and appropriate treatment is needed if hypotension occurs. This medication may affect kidney function, so patients with kidney disease should regularly check kidney function with blood tests. Due to the risk of hyperkalemia, blood potassium levels should be periodically monitored, and special caution is needed for patients with cardiovascular diseases. If symptoms such as myalgia or muscle weakness occur, medical personnel should be notified immediately, and the medication should be discontinued in severe cases. This medication may affect liver function, so patients with a history of liver disease should regularly have liver function tests. Dizziness or drowsiness may occur, so it is advisable to avoid dangerous machinery operation, including height work or driving. This medication may interact with other drugs, so if there are any other medications being taken, medical personnel must be informed. Pregnant or nursing women should not take this medication, and effective contraception should be used if planning to become pregnant. The safety and efficacy for children under 18 years have not been established, so use is not recommended. In the elderly, the concentration of this medication may increase, requiring dose adjustment and caution. In case of overdose, symptoms such as hypotension or arrhythmias may occur, so immediate medical assistance is required. This medication should be kept out of the reach of children, and transferring to other containers should be avoided.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory complications with cough + fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urine

Mild side effects

Headache, dizziness, decreased sensation, drowsiness, gastroesophageal reflux disease, constipation, dental caries, indigestion, gastric ulcer, gastritis, gastroenteritis, musculoskeletal stiffness, atrial fibrillation, hypoglycemia, chest pain, palpitations, chest discomfort, peripheral edema, rash, angioedema, asthenia, vomiting, chronic malabsorption disease-like intestinal disorders, hyperkalemia, elevated blood pressure, facial edema, low back pain, itching, cough, nosebleed, upper respiratory infection, asthma, thrombocytopenia, jaundice, hepatitis

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius room temperature to safely maintain the medication's effectiveness.

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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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.