Medication info
Syubat Tablet 10/10 mg (Ezetimibe, Rosuvastatin)

Syubat Tablet 10/10 mg (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
안국약품(주)
Appearance
Light pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 201606047 · Approved 2016.10.12 · Insurance code 650204700

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, mixed type) and dyslipidemia, and suppression of cardiovascular disease risk by increasing HDL.
Who takes it
Adults
Adult dose
This medication should be taken once daily, regardless of meals. The initial recommended dose is 10/5 mg once daily. For patients requiring more substantial LDL cholesterol reduction, the dosage can be adjusted. After dosage adjustment, the lipid levels should be checked at intervals of more than four weeks, and it can be increased up to a maximum daily dose of 10/20 mg.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, mixed type) and dyslipidemia, and suppression of cardiovascular disease risk by increasing HDL.

  • 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 helps lower total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, particularly in familial and non-familial hypercholesterolemia and mixed dyslipidemia, while increasing the good cholesterol HDL cholesterol levels. It is primarily used alongside dietary therapy and is given as an adjunct when non-pharmacological treatments, such as limiting saturated fat and cholesterol intake, are not sufficiently effective. Moreover, this medication is a safe treatment option for those at high risk of atherosclerotic vascular diseases due to hypercholesterolemia. It is important to identify and manage secondary causes of dyslipidemia, such as diabetes and hypothyroidism, appropriately before treatment. During treatment, lipid levels should be regularly monitored to assess and adjust effectiveness. Through systematic management and treatment, it improves blood lipid levels and enhances cardiovascular health.

How to take

Adult dose

This medication should be taken once daily, regardless of meals. The initial recommended dose is 10/5 mg once daily. For patients requiring more substantial LDL cholesterol reduction, the dosage can be adjusted. After dosage adjustment, the lipid levels should be checked at intervals of more than four weeks, and it can be increased up to a maximum daily dose of 10/20 mg.

Precautions

This medication can affect muscles and, rarely, cause rhabdomyolysis, leading to acute renal failure. Therefore, if symptoms of severe muscle pain or myopathy occur, treatment should be stopped immediately, and medical consultation is required. This medication may be contraindicated or require caution for patients with specific diseases or taking certain medications. In particular, patients with liver disease, renal impairment, muscle disease, pregnant or nursing women should not take this medication. Additionally, this medication contains lactose, so patients with lactose intolerance should not take it. Regular liver function and muscle-related tests should be performed during treatment, and any unusual symptoms should be reported to medical staff promptly. Care must be taken when consuming alcohol excessively or if there is a problem with liver function. This medication may interact with other drugs, so if other medications are being taken, it is essential to inform the healthcare provider. Women who are pregnant or potentially pregnant should use appropriate contraception while taking this medication, and if pregnancy is confirmed, they should stop taking it immediately. Special care is needed when administering this medication to children or the elderly, particularly those over 65, as they may have a higher risk of myopathy. This medication may cause dizziness as a side effect when driving or operating machinery, so caution is needed. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and monitoring of liver function and muscle enzyme levels is necessary. Keep out of reach of children, and do not transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, edema, facial swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin shedding, oral/ocular mucosal pain, severe skin adverse reactions, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, toxic hepatitis, liver abnormalities, acute hepatitis, acute renal failure, oliguria,

Mild side effects

  • Headache
  • arthralgia
  • myalgia
  • dizziness
  • nasopharyngitis
  • fatigue
  • itching
  • rash
  • pruritus
  • constipation
Show 27 more
  • nausea
  • abdominal pain
  • diarrhea
  • abdominal distension
  • chest pain
  • chest discomfort
  • weakness
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • sensory disturbances
  • syncope
  • tremor
  • depression
  • bronchitis
  • rhinitis
  • cystitis
  • dermatophyte infection of toenails
  • soft tissue infection
  • dermatitis
  • skin burning sensation
  • alopecia
  • oropharyngeal pain
  • nasal congestion
  • breast cysts
  • eyes

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. It is best to maintain the storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Light pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 3]

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.