Medication info
Roitimib Tablets 10/5 mg

Roitimib Tablets 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
현대약품(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201601200 · Approved 2016.02.29 · Insurance code 642003770

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and suppression of the risk for atherosclerotic vascular disease
Who takes it
Adults
Adult dose
Take this medication once daily regardless of meals. The dosage range is between 10/5 mg to 10/20 mg per day. A starting dose of 10/5 mg per day is recommended. In patients who require a greater reduction in LDL-cholesterol, the dosage can be adjusted accordingly. After starting treatment or after adjusting the dose, lipid levels in the blood should be checked at intervals of more than 4 weeks, and the dosage should be adjusted accordingly. Maximum daily dose is 1

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and suppression of the risk for atherosclerotic vascular disease

  • 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 caused by hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used to improve cholesterol and related lipid levels in patients with primary hypercholesterolemia, heterozygous familial and non-familial, and mixed dyslipidemia. Specifically, it lowers total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and non-HDL-cholesterol while increasing HDL-cholesterol. This medication is used in conjunction with non-pharmacological treatments such as dietary therapy when dietary therapy alone is not effective enough. Additionally, a more cautious approach is necessary in cases where there is a high risk of atherosclerotic vascular disease due to hypercholesterolemia. Prior to administration, secondary causes such as diabetes and hypothyroidism should be identified and treated, and treatment efficacy should be evaluated through lipid testing. Treatment should be initiated at an appropriate time based on the patient's condition to effectively manage lipid levels.

How to take

Adult dose

Take this medication once daily regardless of meals. The dosage range is between 10/5 mg to 10/20 mg per day. A starting dose of 10/5 mg per day is recommended. In patients who require a greater reduction in LDL-cholesterol, the dosage can be adjusted accordingly. After starting treatment or after adjusting the dose, lipid levels in the blood should be checked at intervals of more than 4 weeks, and the dosage should be adjusted accordingly. Maximum daily dose is 1

Precautions

This medication can cause a rare side effect that affects the muscles known as rhabdomyolysis; thus, if serious muscle pain or weakness symptoms occur, it is essential to inform a doctor immediately. Before taking this medication, liver function tests and muscle enzyme levels should be checked, and if abnormalities are found, treatment may need to be adjusted or discontinued. This medication should not be administered to patients with active liver disease or persistent unexplained elevation of liver enzymes. In patients with severe renal impairment, a history of muscle disease, or when used in combination with certain drugs, careful administration or avoidance of this medication is recommended. Pregnant women or those likely to become pregnant, as well as nursing mothers, should not use this medication, and women of childbearing age should use appropriate contraceptive methods while on this medication. This medication contains lactose, so patients with lactose intolerance should avoid it. Patients with a history of alcohol addiction or liver disease, the elderly, and those with hypothyroidism should exercise caution when taking this medication. There may be interactions with other medications, particularly when used in conjunction with anticoagulants, fibric acid derivatives, and certain antibiotics; consultation with a physician is advised in such cases. During the use of this medication, if symptoms such as muscle pain, fatigue, or fever occur, it is crucial to inform healthcare professionals immediately and undergo testing. There may be central nervous system symptoms such as dizziness or headaches, so caution is advised when driving or operating machinery. This medication is not recommended for children, and in the elderly, it should be administered cautiously without dose adjustment. In cases of overdose, there is no specific antidote, and appropriate treatment and supportive care should be provided based on symptoms while periodically monitoring liver function and muscle enzyme levels. This medication should be kept out of reach of children, and it should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, edema, chest tightness, shortness of breath, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, breathlessness or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice of the skin or eyes, generalized malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, significantly reduced urine output, elevated blood pressure, blood disorders

Mild side effects

  • Pharyngitis
  • arthralgia
  • headache
  • elevated ALT
  • elevated AST
  • myalgia
  • edema
  • elevated bilirubin levels
  • acneiform dermatitis
  • pruritus
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  • dizziness
  • upper respiratory infection
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • diabetes
  • impaired glucose tolerance
  • depression
  • bronchitis
  • rhinitis
  • cystitis
  • onychomycosis

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The recommended storage temperature is room temperature, between 1 to 30 degrees Celsius. This helps to maintain the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Pale yellow rectangular 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.