Medication info
Rosuvastatin 10/10 mg Tablet

Rosuvastatin 10/10 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
White to almost white round film-coated tablet
Packaging
30 tablets/box [(10 tablets/blister × 3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201601220 · Approved 2016.02.29 · Insurance code 657805790

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 dosage range is from 10/5 mg to 10/20 mg per day, with a recommended initial dose of 10/5 mg. If a patient requires a more significant reduction in LDL-cholesterol, the dose may be adjusted. After starting the treatment or adjusting the dose, lipid levels should be checked at least every four weeks before adjusting the dosage, and the maximum daily dose can be increased up to 10/20 mg.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and suppression 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 medication is used to control cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It particularly helps reduce elevated total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol while increasing HDL cholesterol. This medication is to be used in conjunction with an appropriate diet, as it is an adjunctive treatment when dietary measures alone are insufficient. Moreover, for patients at risk of atherosclerotic vascular disease due to hypercholesterolemia, it is essential to consider various risk factors when administering lipid-modifying drugs. Before administration, the causes of other dyslipidemias must be identified and treated if necessary, and the patient's status should be monitored through lipid tests during treatment. This medication is effectively used to improve lipid levels and lower the risk of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily, regardless of meals. The dosage range is from 10/5 mg to 10/20 mg per day, with a recommended initial dose of 10/5 mg. If a patient requires a more significant reduction in LDL-cholesterol, the dose may be adjusted. After starting the treatment or adjusting the dose, lipid levels should be checked at least every four weeks before adjusting the dosage, and the maximum daily dose can be increased up to 10/20 mg.

Precautions

This medication can rarely cause rhabdomyolysis, resulting in muscle tissue damage and rapid deterioration of kidney function. Therefore, if severe muscle pain or weakness occurs, it is essential to consult a doctor immediately. It should not be taken by individuals who are allergic to this medication, have very poor liver function, have myopathy, are using certain medications concurrently, or have severely impaired kidney function. Women who are pregnant or capable of becoming pregnant and those who are breastfeeding should also refrain from taking this medication. Patients with a history of alcohol abuse or liver disease, elderly patients, and patients with hypothyroidism who are at high risk for muscle damage should use this medication with caution and require regular blood tests and clinical monitoring. If symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, fever, etc., occur during the use of this medication, the doctor should be notified immediately, and appropriate tests should be conducted. Liver function abnormalities may occur; therefore, liver function tests should be conducted before and during treatment, and the treatment should be discontinued if liver enzyme levels rise significantly. This medication may slightly raise blood sugar levels, so patients at high risk for diabetes should check their blood sugar levels periodically. Because there may be interactions with other medications, it is crucial to inform the doctor or pharmacist of any currently taken medications, especially when used in conjunction with certain antibiotics, antifungals, antivirals, immunosuppressants, or anticoagulants. This medication contains lactose, so patients with lactose intolerance should not take it. One should be cautious of dizziness when driving or operating machinery. This medication is not recommended for children due to insufficient safety and efficacy data, and elderly patients should be closely monitored for the risk of muscle damage. In cases of overdose, there are no specific antidotes, and appropriate treatment and supportive care must be administered based on the symptoms, while monitoring liver function and muscle enzyme levels.

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 oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, disorientation, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Headache
  • joint pain
  • muscle pain
  • dizziness
  • nasopharyngitis
  • pruritus
  • acneiform dermatitis
  • constipation
  • nausea
  • abdominal pain
Show 28 more
  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • cough
  • sputum
  • runny nose
  • tremors
  • depression
  • urticaria
  • rash
  • itching
  • dermatitis
  • alopecia
  • increased plasma concentration
  • elevated blood pressure
  • thrombocytopenia
  • anemia
  • splenomegaly
  • conjunctival congestion
  • etc.

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. Additionally, storage should be at room temperature between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets/box [(10 tablets/blister × 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.