Medication info
Rotive Tablets 10/20 mg

Rotive Tablets 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP × 3], 30 tablets/bottle
Approval status
Active

MFDS item code 202004601 · Approved 2020.06.23 · Insurance code 642707010

Summary

Main use
Improvement of lipid levels and reduction of the risk of atherosclerotic vascular disease through the treatment of hypercholesterolemia (primary and mixed type)
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dose range is from 10/5 mg to 10/20 mg per day. A starting dose of 10/5 mg once daily is recommended. The dosage may be adjusted for patients requiring more significant LDL cholesterol reduction. Lipid levels should be checked at least 4 weeks after starting treatment or after any dose adjustments to regulate the dosage.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Improvement of lipid levels and reduction of the risk of atherosclerotic vascular disease through the treatment of hypercholesterolemia (primary and mixed type)

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

This medication is used to improve cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Specifically, it helps lower total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels, while increasing HDL cholesterol levels, thereby reducing the risk of cardiovascular disease. This medication is to be used in conjunction with dietary changes and is prescribed when dietary adjustments alone do not provide sufficient effect. Additionally, it is important to check for other diseases or medications that may cause dyslipidemia. Lipid tests are recommended before initiating treatment in patients with acute coronary disease. This medication is used to effectively control cholesterol and reduce the risk of atherosclerotic vascular disease associated with hypercholesterolemia.

How to take

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dose range is from 10/5 mg to 10/20 mg per day. A starting dose of 10/5 mg once daily is recommended. The dosage may be adjusted for patients requiring more significant LDL cholesterol reduction. Lipid levels should be checked at least 4 weeks after starting treatment or after any dose adjustments to regulate the dosage.

Precautions

This medication can rarely cause severe damage to muscle tissue, which can lead to a rapid worsening of kidney function. Therefore, patients should immediately inform their doctor if they experience severe muscle pain or weakness. Additionally, the medication should be temporarily discontinued or stopped in cases of severe infections, hypotension, major surgery, or trauma that may affect kidney function. This medication should not be used in certain patients, such as those with allergies to this drug, severe hepatic impairment, individuals with muscle diseases, patients with significantly reduced kidney function, or women who are pregnant or breastfeeding. Especially, patients at high risk for muscle damage, such as those with hypothyroidism or family history, those with alcoholism, Asian patients, and patients taking fibrate medications should not take this medication at a dose of 40 mg. Patients with genetic metabolic disorders such as lactose intolerance should also avoid this medication. Patients with a history of alcoholism or liver disease, impaired kidney function, elderly individuals, and those with risk factors for myopathy should use this medication with caution. Such patients should be monitored regularly for muscle and liver function under a physician's supervision. Patients taking this medication should undergo regular liver function tests and muscle-related examinations, and must inform healthcare providers immediately if any abnormal symptoms occur. Symptoms such as muscle pain, weakness, fatigue, fever must be closely monitored, and if necessary, the medication should be discontinued. This medication may interact with other drugs, so it is essential to inform your doctor or pharmacist about any medications currently being taken. Special caution is needed when used in combination with anticoagulants, fibrate medications, certain antibiotics, and antifungals. Women who are pregnant or planning to become pregnant should not take this medication, and if pregnancy occurs during treatment, it should be discontinued immediately. Breastfeeding women should also avoid taking this medication. Safety in children and adolescents has not been sufficiently confirmed; therefore, this medication is not recommended for pediatric use. In elderly patients, the risk of myopathy may increase; therefore, seniors should take this medication cautiously under a physician's directive. In case of overdose, there is no specific antidote, and appropriate treatment and supportive care must be administered based on the symptoms, while monitoring liver function and muscle enzyme levels. Keep this medication out of the reach of children, and avoid transferring it to another container as it may adversely affect the quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, sores in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, changes in vision, paralysis, urination problems.

Mild side effects

  • Headache
  • dizziness
  • dyspepsia
  • ALT elevation
  • edema
  • muscle pain
  • dry mouth
  • liver enzyme elevation
  • increased blood lactate dehydrogenase
  • pruritus
Show 21 more
  • upper respiratory tract infection
  • increased blood glucose
  • elevated CPK levels
  • AST elevation
  • chest discomfort
  • itching
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal distension
  • syncope
  • general pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • cough
  • bronchitis
  • rhinitis
  • cystitis
  • onychomycosis.

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be kept between 1 and 30 degrees Celsius to safely maintain the effectiveness of the drug.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP × 3], 30 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.