Medication info
Rotimib Tablets 10/20 Milligrams

Rotimib Tablets 10/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium Micronized›20.8mg / 1 tablet
Manufacturer / importer
현대약품(주)
Appearance
Pink, oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201601198 · Approved 2016.02.29 · Insurance code 642003780

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. The dosage range is 10/5mg to 10/20mg daily, with an initial recommended dose of 10/5mg per day. For patients requiring greater reduction in LDL-cholesterol, the dose may be adjusted. After starting treatment or adjusting the dosage, blood lipid levels should be checked after an interval of no less than 4 weeks to adjust the dose, with a maximum daily dose of up to 10/20mg.

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL-cholesterol
  • raised Apo B levels
  • elevated triglycerides
  • increased non-HDL-cholesterol
View approved original text

This medication helps to reduce total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol while increasing HDL-cholesterol in patients with primary hypercholesterolemia, heterozygous familial and non-familial hypercholesterolemia, and mixed dyslipidemia. It is particularly recommended for use in conjunction with dietary therapy in patients at high risk for atherosclerotic vascular disease due to hypercholesterolemia. This medication is used when there is insufficient response to appropriate dietary modification and other non-pharmacological treatments, such as restrictions on saturated fat and cholesterol intake. Before administering this medication, any secondary causes of dyslipidemia, such as diabetes, hypothyroidism, liver disease, and renal failure, should be identified and treated if necessary. During treatment, total cholesterol, LDL, HDL, and triglyceride levels should be monitored periodically; particularly, if triglyceride levels are elevated, further testing may be required. This medication is used to improve blood lipid levels and lower the risk of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily regardless of meals. The dosage range is 10/5mg to 10/20mg daily, with an initial recommended dose of 10/5mg per day. For patients requiring greater reduction in LDL-cholesterol, the dose may be adjusted. After starting treatment or adjusting the dosage, blood lipid levels should be checked after an interval of no less than 4 weeks to adjust the dose, with a maximum daily dose of up to 10/20mg.

Precautions

This medication can affect the muscles and, although rare, may cause a serious muscle disorder known as rhabdomyolysis. Patients with risk factors such as severe infections, hypotension, or surgical procedures should temporarily discontinue or stop using this medication. Patients with an allergy to the active ingredients or components of this medication, those with liver disease, muscle disorders, severe renal impairment, and women who are pregnant or breastfeeding should not be administered this medication. Additionally, careful use is recommended in cases where there is a history of muscle disease in the family, concurrent use with specific medications, or in patients with hypothyroidism, alcohol dependence, or those at high risk for myopathy. This medication contains lactose and is not suitable for patients with lactose intolerance or related genetic conditions. During administration, if symptoms relating to muscles such as myalgia, muscle weakness, or fever occur, it is important to notify a doctor immediately, and if needed, blood tests should be performed to check for muscle damage. Liver function abnormalities may occur, so liver function tests should be conducted before beginning treatment and during treatment; if liver enzyme levels rise, dosage adjustments or discontinuation should be considered. This medication may slightly increase blood glucose levels; however, its preventive effect against cardiovascular diseases is more significant, so patients requiring blood glucose management should regularly monitor their blood glucose levels. There could be interactions with other medications, so caution is needed, particularly when used in conjunction with anticoagulants, fibrates, certain antibiotics, and antifungals. Women who are pregnant or planning to become pregnant should consult a physician and use appropriate contraceptive methods, and breastfeeding women should avoid use. Safety and efficacy in children and the elderly have not been sufficiently established, so caution must be exercised in administration. In cases of overdose, there is no specific antidote, so treatment will be based on symptoms, and liver function and muscle enzyme levels should be regularly checked. This medication should be stored out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, significantly reduced urine output

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • dizziness
  • upper respiratory tract infection
  • fatigue
  • abdominal pain
  • diarrhea
  • constipation
  • nausea
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  • itching
  • alopecia
  • chest discomfort
  • appetite loss
  • abdominal distension
  • myalgia
  • weakness
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • sensory disturbances
  • fainting
  • vomiting
  • gastric inflammation
  • dry mouth
  • epigastric discomfort
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • cough
  • sputum

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain storage at room temperature, specifically between 1 to 30 degrees Celsius. This will help ensure that the medication's efficacy is preserved and it can be used safely.

Appearance and packaging

Appearance

Pink, oval film-coated tablets

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.