Medication info
Rosuvastatin Calcium/Ezetimibe Tablet 10/10 mg

Rosuvastatin Calcium/Ezetimibe Tablet 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
Yellow oblong film-coated tablet
Packaging
30 tablets (10 tablets/PTP × 3), 100 tablets/bottle
Approval status
Active

MFDS item code 201600317 · Approved 2016.01.19 · Insurance code 642104820

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and inhibition of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This drug is administered once daily without regard to meals. For primary hypercholesterolemia, it starts at 10/5 mg per day and can be increased up to 10/20 mg as needed. The lipid levels in the blood should be checked at intervals of 4 weeks or more following initiation of treatment or dose adjustments to adjust the dosage. Patients taking Ezetimibe and Rosuvastatin together may switch to a combination product with the same active ingredient content for convenience.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and inhibition of the risk of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This drug is used to improve cholesterol and lipid levels in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial hypercholesterolemia or mixed dyslipidemia. It decreases total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol, while increasing HDL cholesterol to help vascular health. This drug is used in conjunction with an appropriate diet and is prescribed when dietary control and non-drug therapies are insufficient. Additionally, secondary causes of dyslipidemia should be identified, and treatment should be implemented if necessary. This helps reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia and improves overall blood lipid status.

How to take

Adult dose

This drug is administered once daily without regard to meals. For primary hypercholesterolemia, it starts at 10/5 mg per day and can be increased up to 10/20 mg as needed. The lipid levels in the blood should be checked at intervals of 4 weeks or more following initiation of treatment or dose adjustments to adjust the dosage. Patients taking Ezetimibe and Rosuvastatin together may switch to a combination product with the same active ingredient content for convenience.

Precautions

This drug may carry a risk of muscle abnormalities, so immediate medical attention should be sought if serious muscle pain or weakness occurs. In particular, if severe infections, hypotension, major surgery or trauma, or hypothyroidism are present, the use of this drug may need to be temporarily stopped or discontinued. Patients with allergies to any components of this drug, severely impaired liver or kidney function, pregnant women, or nursing women should not use this drug. Additionally, caution is required if there is a history of muscle disease or if this drug is used in conjunction with certain medications. Liver function and muscle status should be regularly monitored during treatment, and if there are significant increases in liver enzyme levels or worsening of muscle-related abnormal symptoms, dosing should be discontinued. Patients with a history of alcohol abuse or liver disease, the elderly, and those taking certain medications should use this drug carefully. This drug can rarely cause serious skin reactions or severe muscle weakness, so medical consultation should be sought immediately if skin rashes or muscle weakness occur. Pregnant or nursing women should not use this drug, and women of childbearing age should ensure effective contraception during treatment. Safety in children and adolescents has not been sufficiently confirmed, so it is not recommended. This drug may interact with other medications, so it is essential to inform your doctor or pharmacist of any other medications being taken. In cases of overdose, as there is no specific antidote, appropriate treatment and monitoring based on symptoms are necessary. This drug should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues along with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues

Mild side effects

  • Pharyngitis
  • dyspepsia
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • dry mouth
  • elevated liver enzymes
  • abnormal liver function tests
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  • increased serum lactate dehydrogenase
  • pruritus
  • myalgia
  • weakness
  • discomfort in the chest
  • cold sweat
  • diarrhea
  • upper respiratory tract infection
  • elevated blood sugar
  • increased serum CPK
  • fatigue
  • numbness
  • paresthesia
  • itching
  • rash
  • alopecia
  • muscle cramps
  • gout
  • erectile dysfunction
  • syncope
  • generalized pain
  • joint pain
  • vomiting
  • gastritis

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

Storage

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3), 100 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

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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.