Medication info
Credible Tablets 10/20 mg (Ezetimibe, Rosuvastatin Calcium)

Credible Tablets 10/20 mg (Ezetimibe, Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
White to almost white round film-coated tablet
Packaging
30 tablets (10 tablets/PTP packaging X3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201601209 · Approved 2016.02.29 · Insurance code 645305460

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg per day. An initial dose of 10/5 mg per day is recommended. In patients requiring a greater reduction in LDL-cholesterol, the dosage may be adjusted accordingly. After starting treatment or adjusting the dosage, check blood lipid levels at intervals of more than 4 weeks. The maximum daily dosage can be increased up to 10/20 mg.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia

  • 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
  • decreased HDL cholesterol
  • increased risk of atherosclerotic vascular disease
View approved original text

This medication is used to improve blood lipid levels in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial forms, as well as mixed dyslipidemia. Specifically, it lowers levels of total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol, while increasing levels of HDL-cholesterol, thereby reducing the risk of atherosclerotic vascular diseases. This medication is administered as an adjunct to appropriate dietary measures when other non-pharmacological therapies do not provide sufficient effect. Furthermore, it is important to confirm the presence of secondary causes like diabetes or hypothyroidism before starting treatment and treat them if necessary. By checking and managing lipid levels, the patient's condition can be closely monitored, and assistance can be provided to quickly test and initiate treatment in cases of acute cardiovascular events. Therefore, this medication is safely and effectively used to improve hypercholesterolemia and dyslipidemia.

How to take

Adult dose

This medication is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg per day. An initial dose of 10/5 mg per day is recommended. In patients requiring a greater reduction in LDL-cholesterol, the dosage may be adjusted accordingly. After starting treatment or adjusting the dosage, check blood lipid levels at intervals of more than 4 weeks. The maximum daily dosage can be increased up to 10/20 mg.

Precautions

This medication can cause a rare serious side effect called rhabdomyolysis, which can lead to severe muscle problems. In particular, if there are risk factors such as severe infections, hypotension, major surgery, trauma, severe metabolic disorders, or uncontrolled seizures, the use of this medication should be temporarily stopped or discontinued. Patients with allergic reactions to the active ingredient or components of this medication should not take it, nor should it be administered to patients with severe liver dysfunction or muscle diseases. Additionally, it is contraindicated in patients with severely impaired renal function, women who are pregnant or may become pregnant, and women who are breastfeeding. Caution should be exercised when administering this medication to patients at high risk of developing myopathy or rhabdomyolysis, such as those with renal impairment, hypothyroidism, a history of genetic muscle disorders, a history of myotoxicity from statins or fibrates, alcoholics, and Asian patients. This medication may cause liver dysfunction, so liver function tests should be conducted before and during treatment, and treatment should be halted if liver enzyme levels significantly increase. If symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, fever, etc. occur during treatment, the physician should be informed immediately, and in severe cases, the medication should be discontinued. This medication can interact with other drugs, so patients must inform their physician or pharmacist, especially if they are taking anticoagulants, fibrates, certain antibiotics, antifungals, or immunosuppressants. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should employ appropriate contraception while on treatment. This medication requires special attention in children and the elderly, and safety in pediatric populations has not been adequately established. In cases of overdose, there is no specific antidote, so appropriate treatment and supportive therapy should be administered based on symptoms, and liver function and muscle enzyme levels should be regularly monitored. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Myopathy
  • rhabdomyolysis
  • acute renal failure
  • angioedema
  • urticaria
  • rash
  • chest tightness
  • difficulty breathing
  • cold sweats
  • pallor
Show 18 more
  • severe rash with high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
  • respiratory distress
  • jaundice
  • liver toxicity
  • acute hepatitis
  • toxic hepatitis
  • severe swelling
  • hypertension
  • sudden and severe headache
  • lightning headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • renal impairment

Mild side effects

  • Nasopharyngitis
  • joint pain
  • headache
  • ALT elevation
  • AST elevation
  • muscle pain
  • elevated blood bilirubin
  • acne-like dermatitis
  • pruritus
  • dizziness
Show 24 more
  • upper respiratory infection
  • cough
  • diarrhea
  • constipation
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • weakness
  • itching
  • rash
  • urticaria
  • hyperhidrosis
  • elevated blood creatinine

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging X3), 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.