Medication info
Rotimib Tablet 10/10 mg

Rotimib Tablet 10/10 mg

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

MFDS item code 201601199 · Approved 2016.02.29 · Insurance code 642003760

Summary

Main use
Effect of reducing total cholesterol and LDL-C, and increasing HDL-C in the treatment of hypercholesterolemia (primary and mixed types)
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosing range is from 10/5 mg to 10/20 mg daily. The initial dose of 10/5 mg daily is recommended. Patients requiring more significant LDL cholesterol reduction may adjust the dose, and after starting treatment or adjusting the dose, blood lipid levels should be monitored at intervals of at least 4 weeks.

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Effect of reducing total cholesterol and LDL-C, and increasing HDL-C in the treatment of hypercholesterolemia (primary and mixed types)

  • 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 to reduce elevated total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol, while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. Since these lipid abnormalities may increase the risk of atherosclerotic vascular diseases, it is used in conjunction with dietary therapy to manage lipid levels in the body. Prior to using this medication, secondary causes such as diabetes and hypothyroidism should be verified and treated, and lipid levels should be monitored as necessary. It is particularly important to assess lipid levels at hospitalization for patients with acute coronary events to establish appropriate treatment plans. This medication is used to reduce cardiovascular disease risk through effective lipid improvement.

How to take

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosing range is from 10/5 mg to 10/20 mg daily. The initial dose of 10/5 mg daily is recommended. Patients requiring more significant LDL cholesterol reduction may adjust the dose, and after starting treatment or adjusting the dose, blood lipid levels should be monitored at intervals of at least 4 weeks.

Precautions

This medication has been reported to have a rare side effect known as rhabdomyolysis, which can cause serious muscle damage. If severe muscle pain or weakness occurs, consult a doctor immediately. Additionally, patients with renal impairment, serious infections, major surgery, trauma, or metabolic abnormalities may need to temporarily suspend or discontinue this medication. This medication should not be used in individuals with allergies to the active or inactive ingredients, severely impaired liver function, muscle disorders, or in women who are pregnant or breastfeeding. Also, it is contraindicated in patients with significantly impaired renal function or when used in conjunction with certain medications. Patients at high risk for muscle-related side effects, such as those with a history of alcohol dependence or liver disease, the elderly, and those with hypothyroidism, should be treated with caution, and the condition of the muscles should be closely monitored before and during treatment. Regular liver function tests and muscle enzyme tests should be performed to determine if there are any abnormal signs, and if abnormalities are found, treatment should be adjusted or discontinued immediately. Women of childbearing potential should use adequate contraception while taking this medication, and should discontinue it immediately if pregnancy is confirmed. This medication is not recommended for children as safety and efficacy have not been sufficiently established. Also, this medication may interact with several other drugs, so if taking other medications, be sure to inform healthcare professionals. Dizziness or headache may occur during treatment, so caution is needed when driving or operating machinery. When storing this medication, it is important to keep it out of reach of children and not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, facial edema, chest tightness, chest pain, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory problems, jaundice (yellowing of skin or eyes), systemic malaise, liver abnormalities (jaundice), sudden and

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • increased ALT
  • increased AST
  • myalgia
  • elevated bilirubin levels
  • acneiform dermatitis
  • pruritus
  • dizziness
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  • upper respiratory tract infection
  • cough
  • diarrhea
  • constipation
  • nausea
  • abdominal pain
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • somnolence
  • neurodegenerative disorders
  • orthostatic dizziness
  • migraine
  • diabetes
  • depression

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 sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. This helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pale 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.