Medication info
Rositiv Tablets 10/5 milligrams

Rositiv Tablets 10/5 milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
알보젠코리아(주)
Appearance
Pink, oblong film-coated tablet
Packaging
30 tablets (10 tablets/PTP × 3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201506783 · Approved 2015.09.24 · Insurance code 652604910

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily, irrespective of meals. The dosage range is 10/5mg to 10/20mg per day. The recommended initial dose is 10/5mg once daily. For patients requiring more significant LDL cholesterol reduction, the dose can be adjusted. After starting treatment or adjusting the dose, lipid levels should be checked after an interval of more than 4 weeks, and the dose should be adjusted accordingly, with a maximum daily dose of 10/20mg.

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

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

  • 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
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is primarily used to improve blood cholesterol and lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It effectively reduces elevated lipid levels such as LDL cholesterol, total cholesterol, triglycerides, and apo B protein while increasing HDL cholesterol, protecting vascular health. It is used in conjunction with a proper diet when there is a risk of atherosclerotic vascular disease due to hypercholesterolemia and when dietary measures alone are insufficient. It is also important to identify and appropriately manage secondary causes such as diabetes or hypothyroidism before treatment. Additionally, during treatment, blood lipid levels, including total cholesterol, LDL, HDL, and triglycerides, should be regularly monitored to evaluate treatment efficacy. This medication is used to control lipid levels in patients with dyslipidemia to reduce the risk of cardiovascular disease and improve health.

How to take

Adult dose

This medication is administered once daily, irrespective of meals. The dosage range is 10/5mg to 10/20mg per day. The recommended initial dose is 10/5mg once daily. For patients requiring more significant LDL cholesterol reduction, the dose can be adjusted. After starting treatment or adjusting the dose, lipid levels should be checked after an interval of more than 4 weeks, and the dose should be adjusted accordingly, with a maximum daily dose of 10/20mg.

Precautions

This medication carries a risk of rhabdomyolysis, a rare side effect that can affect the muscles. It may lead to acute renal failure, so if symptoms such as muscle pain or weakness occur, consult a physician immediately. Furthermore, this medication may affect liver function; therefore, liver function tests should be performed before starting treatment, and liver function should be regularly monitored during treatment. It is not to be administered to patients with active liver disease or elevated liver enzyme levels of unknown cause. Patients with severe renal impairment should also avoid using this medication. This medication should not be used during pregnancy or in nursing mothers. Patients with a history of alcoholism or liver disease, the elderly, and those with hypothyroidism should use this medication with caution and undergo immediate examination if muscle-related abnormal symptoms arise. This medication may interact with other drugs, so if other medications are being taken, it is crucial to inform the physician or pharmacist. It is not recommended for children, as safety and efficacy have not been established. Dizziness may occur during treatment, so caution is advised when driving or operating machinery. Severe skin reactions may occur; if symptoms such as rash, urticaria, or edema develop, treatment should be discontinued immediately, and medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

Nasopharyngitis, dyspepsia, headache, myalgia, dizziness, constipation, nausea, abdominal pain, dry mouth, elevated liver enzymes, abnormal liver function tests, increased serum lactate dehydrogenase levels, pruritus, itching, dermatitis, skin burning sensations, skin disorders, alopecia, cough, diarrhea, thrombocytopenia, dry mouth, epigastric discomfort, belching, gastrointestinal disturbances, gastroesophageal reflux disease, tongue disorders, depression, palpitations, congestive heart failure, myocardial ischemia,

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

Storage

This medication is sensitive to air and humidity, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink, oblong film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3), 30 tablets/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

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.