Medication info
Credible Tablets 10/5 mg (Ezetimibe, Rosuvastatin Calcium)

Credible Tablets 10/5 mg (Ezetimibe, Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
White to nearly white round film-coated tablets
Packaging
30 tablets (10 tablets/PTP packaging x 3), 100 tablets/bottle
Approval status
Active

MFDS item code 201601207 · Approved 2016.02.29 · Insurance code 645305440

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed) and suppression of the risk of atherosclerotic vascular disease.
Who takes it
Adults
Adult dose
Administer this medication once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. In patients requiring further reduction of LDL cholesterol, dosage may be adjusted. Check lipid levels in the blood at intervals of more than four weeks after starting treatment or adjusting the dose, and the maximum daily dose may be increased up to 10/20 mg.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed) 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
View approved original text

This medication is used to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, and to increase HDL cholesterol levels in patients with primary hypercholesterolemia, including familial and non-familial hypercholesterolemia, and mixed dyslipidemia. It is important to restrict the intake of saturated fats and cholesterol as it is administered alongside diet therapy and is recommended as an adjunctive treatment when diet therapy alone is insufficient. Furthermore, it is used to reduce the risk of atherosclerotic vascular disease caused by hypercholesterolemia, and prior to treatment, it is essential to confirm secondary causes such as diabetes and hypothyroidism and treat them if necessary. During the treatment process, total cholesterol, LDL, HDL, and triglycerides should be regularly monitored to evaluate the treatment effect. In cases of acute coronary syndrome, lipid levels should be measured upon admission or within 24 hours, and LDL-lowering treatment may be initiated before discharge. This medication helps reduce health risks associated with dyslipidemia.

How to take

Adult dose

Administer this medication once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. In patients requiring further reduction of LDL cholesterol, dosage may be adjusted. Check lipid levels in the blood at intervals of more than four weeks after starting treatment or adjusting the dose, and the maximum daily dose may be increased up to 10/20 mg.

Precautions

There is a risk of serious muscle problems with this medication, so if symptoms of muscle pain or weakness occur, notify a doctor immediately. In cases of severe infection, hypotension, major surgery or trauma, metabolic abnormalities, etc., the use of this medication may need to be temporarily halted or stopped. Patients with allergies to the components of this medication, severe liver disease, muscle disorders, severely impaired kidney function, or who are pregnant or nursing should not use this medication. Patients at high risk for myopathy or rhabdomyolysis should use this medication with caution and should have muscle enzyme levels checked before and during treatment. Patients with liver dysfunction or alcohol dependency should also be cautious when using this medication. This medication may elevate liver enzyme levels, requiring regular liver function tests before and during treatment. If symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, fever, etc., occur during the use of this medication, inform a doctor immediately, and if necessary, blood tests should be performed to check for muscle damage. This medication may interact with other drugs, so inform a doctor or pharmacist of any other medications being taken. Particularly caution is needed when used with anticoagulants, fibrates, certain antibiotics, antifungal agents, etc. Women of childbearing age must use appropriate contraception while taking this medication, and if pregnancy is confirmed, discontinue immediately. Safety in children and adolescents has not been sufficiently established, thus it is not recommended. Elderly patients are at higher risk for muscle issues and should use this medication cautiously, with dosage adjustments as necessary. There is no specific antidote for overdose, and treatment should be symptomatic with supportive care, along with liver function and muscle enzyme tests required. This medication should be kept out of the reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues

Mild side effects

  • Headache
  • arthralgia
  • dizziness
  • myalgia
  • constipation
  • nausea
  • abdominal pain
  • itching
  • diarrhea
  • fatigue
Show 27 more
  • asthenia
  • chest pain
  • cough
  • sweating
  • rash
  • dermatitis
  • alopecia
  • vomiting
  • dyspepsia
  • loss of appetite
  • muscle cramps
  • gout
  • erectile dysfunction
  • tremors
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • bronchitis
  • rhinitis
  • cystitis
  • onychomycosis
  • soft tissue infection
  • drowsiness
  • neurodegenerative disorders
  • orthostatic dizziness
  • migraine

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

Storage

This medication should be stored in a tightly closed container to avoid contact with air or moisture, and it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and ensure safety during use.

Appearance and packaging

Appearance

White to nearly white round film-coated tablets

Package unit

30 tablets (10 tablets/PTP packaging x 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.