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

Eshuba Tablets 10/5 mg (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
White oval film-coated tablets
Packaging
30 tablets (10 tablets PTP x 3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201601201 · Approved 2016.02.29 · Insurance code 670607440

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (primary, mixed) and dyslipidemia, and reduction of the risk of atherosclerotic vascular disease through increased HDL.
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. An initial dose of 10/5 mg is recommended. The dosing range is 10/5 mg to 10/20 mg daily, with a maximum dose of 10/20 mg daily possible. After initiation or adjustment of the dose, blood lipid levels should be checked at least 4 weeks apart.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Reduction of cholesterol in primary hypercholesterolemia (primary, mixed) and dyslipidemia, and reduction of the risk of atherosclerotic vascular disease through increased HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • increased apolipoprotein B
  • increased triglycerides
  • increased non-HDL cholesterol
  • decreased HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia.
View approved original text

This medication helps lower total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels, known as good cholesterol. It is primarily used as an adjunct to diet, effective when used alongside proper dietary modifications, including restrictions on saturated fat and cholesterol. When prescribing lipid-lowering medications to patients at high risk for atherosclerotic vascular disease, various risk factors should be considered, and it is important to first identify and treat secondary causes of dyslipidemia. Additionally, regular testing is necessary to accurately assess blood lipid levels, and in special cases, ultracentrifugation may be used to measure LDL cholesterol concentrations. This medication is effectively used for the treatment of hypercholesterolemia by assisting in the management of healthy blood lipid levels.

How to take

Adult dose

This medication is administered once daily, regardless of meals. An initial dose of 10/5 mg is recommended. The dosing range is 10/5 mg to 10/20 mg daily, with a maximum dose of 10/20 mg daily possible. After initiation or adjustment of the dose, blood lipid levels should be checked at least 4 weeks apart.

Precautions

This medication carries a risk of muscle-related side effects; therefore, if severe muscle pain or weakness occurs, the doctor should be notified immediately. Especially in patients with serious infections, hypotension, significant surgery or trauma, severe metabolic or endocrine disorders, uncontrolled seizures, it may be necessary to temporarily discontinue or stop this medication. Patients allergic to any of the components of this medication, those with active liver disease, muscle disorders, severe kidney function impairment, women who are pregnant or breastfeeding should not take this medication. Additionally, caution is advised for those with a history or family history of certain muscle disorders, hypothyroidism, alcoholism, or those taking specific medications. This medication contains lactose; therefore, patients with genetic predispositions to lactose intolerance should avoid taking it. Patients with poor liver function or a history of alcoholism, the elderly, and those with impaired kidney function should use this medication cautiously. This medication may increase liver enzyme levels; therefore, liver function tests should be conducted before initiation, and regular monitoring of liver condition should continue during treatment. If any unusual liver symptoms or jaundice occur during treatment, administration should be stopped immediately. This medication may slightly raise blood sugar levels; hence, patients at risk for diabetes should regularly monitor their blood sugar. There may be interactions with other drugs; therefore, patients taking other medications should inform their doctor or pharmacist. Caution is particularly necessary when taken with anticoagulants, fibrates, certain antibiotics, and antifungals. This medication should not be taken by women who are pregnant or may become pregnant, and appropriate contraception should be used while taking it. It is also advised that breastfeeding women avoid this medication. Safety for children and adolescents has not been sufficiently established; therefore, it is not recommended. In cases of overdose, no specific antidote exists, and symptomatic treatment and supportive care are necessary while monitoring liver function and muscle status. 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

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin shedding, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, reduced urine output.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • nasopharyngitis
  • fatigue
  • itching
  • rash
  • muscle pain
Show 25 more
  • hives
  • diarrhea
  • cold sweats
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • cough
  • bronchitis
  • rhinitis
  • cystitis
  • dermatitis
  • skin burning sensation
  • hair loss
  • oropharyngeal pain
  • nasal congestion
  • osteoarthritis
  • osteoporosis
  • musculoskeletal stiffness.

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is recommended to keep it at room temperature between 1 to 30 degrees Celsius, avoiding extreme heat or cold.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets (10 tablets PTP x 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.