Medication info
Rosuvastatin/Ezetimibe Tablet 10/10 mg

Rosuvastatin/Ezetimibe Tablet 10/10 mg

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

MFDS item code 202004595 · Approved 2020.06.23 · Insurance code 663608270

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. The initial dose of 10/5mg daily is recommended. The dosage range is between 10/5mg to 10/20mg daily. Dose adjustments can be made for patients who require a greater reduction in LDL-cholesterol. Following the initiation of treatment or dose adjustment, cholesterol levels should be checked at intervals of four weeks or more, and doses can be adjusted accordingly, up to a maximum of 10/20mg per day.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and suppression of the risk of atherosclerotic vascular disease

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

This medication helps lower total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, including familial and non-familial hypercholesterolemia or mixed dyslipidemia, and helps to raise levels of good cholesterol, HDL-cholesterol. It is primarily used in conjunction with dietary measures as an adjunct when non-pharmacological treatments, such as restriction of saturated fat and cholesterol intake, are insufficient. Additionally, this medication is used to manage lipid levels in patients at high risk for atherosclerotic vascular disease due to hypercholesterolemia. It is essential to check for other causes, such as diabetes and hypothyroidism, before administration and treat secondary causes if necessary. During treatment, total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglyceride levels should be regularly monitored, and appropriate testing methods should be chosen based on the condition. This approach effectively regulates blood lipid levels, contributing to the prevention of cardiovascular diseases.

How to take

Adult dose

This medication is administered once daily regardless of meals. The initial dose of 10/5mg daily is recommended. The dosage range is between 10/5mg to 10/20mg daily. Dose adjustments can be made for patients who require a greater reduction in LDL-cholesterol. Following the initiation of treatment or dose adjustment, cholesterol levels should be checked at intervals of four weeks or more, and doses can be adjusted accordingly, up to a maximum of 10/20mg per day.

Precautions

This drug can rarely cause severe damage to the muscles, and if symptoms such as muscle aches or weakness occur, you should consult a doctor immediately. In particular, if you are in a state with a high risk of muscle damage, such as severe infections, hypotension, major surgery, trauma, or metabolic disorders, you should temporarily pause or discontinue the use of this medication. This medication should not be taken by those allergic to its main ingredients or those with liver disease, muscle disease, severe renal impairment, or those who are pregnant or breastfeeding. Patients with moderate to severe liver dysfunction are also not advised to take this medication. Alcoholics or individuals with a history of liver disease should take this medication with caution, and elderly individuals over 70 are at higher risk for muscle damage, thus requiring careful consideration. This medication contains lactose, so it should not be taken by those with lactose intolerance. Regular liver function and muscle-related tests are necessary during the use of this medication, and any abnormal symptoms should be reported to healthcare providers immediately. There may be interactions with other medications, so it is essential to report any currently taken drugs. Pregnant women or those who may become pregnant should use appropriate contraception while taking this medication and stop immediately if pregnancy is confirmed. This medication is not recommended for children as its safety and efficacy in this population have not been adequately established. In cases of overdose, treatment should be symptomatic, along with liver and muscle function tests. This medication should be kept out of reach of children, and it is advisable not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, changes in urinary output

Mild side effects

  • Nasopharyngitis
  • dyspepsia
  • headache
  • dizziness
  • increased blood sugar
  • elevated serum lactate dehydrogenase
  • increased serum creatinine
  • itching
  • rash
  • sweating
Show 25 more
  • dermatitis
  • burning sensation of the skin
  • alopecia
  • edema
  • weakness
  • arthralgia
  • myalgia
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • oropharyngeal pain
  • nasal congestion
  • cough
  • sputum
  • runny nose

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture, and the storage temperature should be maintained between 1 degree and 30 degrees Celsius. Therefore, it is important to avoid direct sunlight, high temperatures, and humid places for storage.

Appearance and packaging

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×3], 30 tablets/bottle, 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.