Medication info
Credable Tablet 10/10 mg (Ezetimibe, Rosuvastatin Calcium)

Credable Tablet 10/10 mg (Ezetimibe, Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets (10 tablets/PTP packaging x 3), 100 tablets/bottle
Approval status
Active

MFDS item code 201601208 · Approved 2016.02.29 · Insurance code 645305450

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and inhibition of the risk of atherosclerotic vascular diseases
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. For the treatment of primary hypercholesterolemia, the initial dose is 10/5 mg once daily, and the dose can be adjusted between 10/5 mg and 10/20 mg as needed. Cholesterol levels should be checked at intervals of more than 4 weeks after dose adjustment to decide on dose escalation. The maximum dose is 10/20 mg once daily.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and inhibition of the risk of atherosclerotic vascular diseases

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

This medication is used as an adjunct to dietary therapy to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol, while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. It is primarily prescribed in conjunction with dietary therapy that restricts the intake of saturated fats and cholesterol, and is added when dietary therapy alone is insufficient. Additionally, it is used as a lipid-modulating agent for patients at high risk of atherosclerotic vascular diseases due to hypercholesterolemia. Prior to treatment, other causes of dyslipidemia, such as diabetes and hypothyroidism, should be identified, and if necessary, those causes should be treated first. Regular monitoring of cholesterol levels during treatment is also important for proper management. In summary, this drug is used to improve blood lipid levels caused by hypercholesterolemia and dyslipidemia to reduce the risk of cardiovascular diseases.

How to take

Adult dose

This medication is administered once daily, regardless of meals. For the treatment of primary hypercholesterolemia, the initial dose is 10/5 mg once daily, and the dose can be adjusted between 10/5 mg and 10/20 mg as needed. Cholesterol levels should be checked at intervals of more than 4 weeks after dose adjustment to decide on dose escalation. The maximum dose is 10/20 mg once daily.

Precautions

This medication may cause serious muscle problems, so any symptoms such as muscle pain or muscle weakness should be reported to a doctor immediately. Particularly, patients at high risk for serious myopathy or rhabdomyolysis should temporarily suspend or discontinue the use of this medication. It should not be used in individuals with a known allergy to the active ingredients or excipients, severe hepatic impairment, muscle diseases, severe renal failure, pregnant or potentially pregnant women, or breastfeeding mothers. Additionally, this medication contains lactose and should not be administered to patients with lactose intolerance. Caution is also advised for alcoholics or patients with a history of liver disease, severe myasthenia gravis, the elderly, and patients with diminished renal function; they should use this medication cautiously and undergo regular tests under a doctor’s supervision. This medication may affect liver function; therefore, liver function tests should be performed before administration and regularly during treatment. It may slightly increase blood glucose levels, so patients at risk for diabetes should monitor their blood glucose periodically. There may be potential interactions when taken with other drugs, so patients should inform their doctor or pharmacist of any medications they are taking. This medication is not recommended for women who are pregnant or breastfeeding, and fertile women should use appropriate contraception while taking it. Safety in children or adolescents has not been sufficiently established, so it is advisable not to use it without a doctor’s judgment. In case of overdose, as there is no specific antidote, appropriate treatment and supportive care should be provided according to symptoms, and liver function and muscle enzyme levels should be monitored. This medication 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, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis,

Mild side effects

  • Headache
  • nasopharyngitis
  • arthralgia
  • dizziness
  • fatigue
  • abdominal pain
  • diarrhea
  • nausea
  • pruritus
  • acne-like dermatitis
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  • constipation
  • myalgia
  • itching
  • skin rash
  • asthenia
  • chest pain
  • cough
  • tremor
  • vomiting
  • cholelithiasis
  • alopecia
  • erectile dysfunction
  • thrombocytopenia
  • increased serum creatinine
  • elevated blood pressure
  • increased blood urea
  • paresthesia
  • muscle cramps
  • gout
  • syncope
  • generalized pain
  • musculoskeletal discomfort
  • muscle weakness
  • skin disorders

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture and is best kept at a temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

White to almost 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.