Medication info
Ritovazet Tablet 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Ritovazet Tablet 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)대웅제약
Appearance
White oval film-coated tablet
Packaging
Bottle - 30 Tablets/Bottle, Bottle - 100 Tablets/Bottle
Approval status
Active

MFDS item code 202101429 · Approved 2021.02.18 · Insurance code 641607520

Summary

Main use
Improvement of lipid levels by reducing cholesterol in hypercholesterolemia and dyslipidemia and increasing HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg per day, with an initial dose of 10/10mg or 10/20mg recommended. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40mg per day is recommended. After starting treatment or adjusting the dosage, confirm blood lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Improvement of lipid levels by reducing cholesterol in hypercholesterolemia and dyslipidemia and increasing HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, and it increases good cholesterol, HDL cholesterol. It is used in patients with homozygous familial hypercholesterolemia either in conjunction with other lipid-lowering therapies or when other treatments are not effective. Particularly, this drug is applied alongside dietary measures for patients at high risk of cardiovascular diseases, playing an important role in reducing the risk of atherosclerotic vascular diseases due to hypercholesterolemia. It is essential to identify other secondary causes before treatment and, if necessary, manage them together while monitoring cholesterol levels through lipid tests. Additionally, this drug can be used early in patients with acute coronary events to appropriately manage blood lipid levels. Therefore, this medication is effectively used for the improvement of dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg per day, with an initial dose of 10/10mg or 10/20mg recommended. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40mg per day is recommended. After starting treatment or adjusting the dosage, confirm blood lipid levels at intervals of more than 2 weeks.

Precautions

This medication may lead to muscle abnormalities, such as severe muscle pain or weakness, and in rare cases, muscle tissue destruction that could cause renal function issues, thus caution is required. Especially in situations where there is a high risk of muscle damage, such as severe infections, major surgery, trauma, or severe metabolic disorders, it is recommended to temporarily discontinue the medication or consult a physician. Patients with allergies to the ingredients in this medication, liver diseases, or persistent cryptogenic elevation of liver enzymes; patients with muscle disorders; pregnant or potentially pregnant women; nursing mothers; and those taking specific antiviral drugs should not take this medication. Additionally, patients with genetic issues such as lactose intolerance should also avoid this medication. Alcoholics, patients with poor liver function, patients with reduced kidney function, those with hypothyroidism, patients with a family history of muscle disorders, and the elderly who are at higher risk for muscle abnormalities should use this medication carefully. This medication may affect liver function, so regular liver function tests before and during treatment are necessary, and patients should inform their physician immediately if symptoms of liver damage (fatigue, nausea, vomiting, etc.) occur. If symptoms like muscle pain, weakness, fatigue, or fever appear during the treatment with this medication, patients should consult a physician and, if needed, verify possible muscle damage with blood tests. This medication may interact with other drugs; therefore, it is essential to inform healthcare personnel about any medications currently being taken, especially when taken with specific antibiotics, antivirals, immunosuppressants, etc. Women of childbearing potential should use appropriate contraception to avoid pregnancy while using this medication, and if pregnancy is confirmed, they should cease use immediately. This medication is not recommended for children due to the lack of established safety and efficacy, and elderly patients should be carefully monitored due to the risk of muscle abnormalities. In cases of overdose, there are no specific antidotes, so treatment should be symptomatic, and monitoring of liver function and muscle status is essential. This medication should be kept out of reach of children and should not be transferred to other containers. Caution is required as dizziness may occur while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Myopathy/rhabdomyolysis leading to acute renal failure, severe allergic reactions (urticaria, severe edema, skin rash, angioedema, anaphylaxis), severe skin adverse reactions (severe rash, vesicular dermatitis, erythema multiforme syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome), respiratory problems (dyspnea, asthma attacks), liver abnormalities (hepatitis, cholestatic jaundice, liver failure)

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • headache
  • dizziness
  • joint pain
  • musculoskeletal pain
  • cough
  • bronchitis
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  • sinusitis
  • fatigue
  • chest pain
  • chest discomfort
  • swelling
  • weakness
  • malaise
  • hypertension
  • anemia
  • hair loss
  • itching
  • rash
  • urticaria
  • flushing
  • upper respiratory tract infections
  • blurred vision
  • tinnitus
  • vomiting
  • dry mouth
  • glossitis
  • gallbladder pain
  • dysphagia
  • epistaxis
  • insomnia
  • nightmares
  • depression
  • thrombocytopenia
  • urinary tract infection
  • rash

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. Additionally, it is advisable to keep it at room temperature between 1°C and 30°C, avoiding extremely cold or hot places.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

Bottle - 30 Tablets/Bottle, 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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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.