Medication info
Rosetive Tablets 10/10 mg

Rosetive Tablets 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
알보젠코리아(주)
Appearance
Yellow rectangular film-coated tablet
Packaging
PTP - 30 tablets/PTP [(10 tablets/PTP X 3)], bottle - 30 tablets/bottle, bottle - 100 tablets/bottle
Approval status
Active

MFDS item code 201506784 · Approved 2015.09.24 · Insurance code 652604920

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary and mixed) and prevention of atherosclerotic vascular disease risk
Who takes it
Adults
Adult dose
This medication is administered once daily with or without meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg daily. The initial recommended dose is 10/5 mg daily. For patients requiring greater LDL cholesterol reduction, the dose may be adjusted. After starting the treatment or adjusting the dose, lipid levels should be checked at intervals of 4 weeks or more to adjust the dose accordingly.

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary and mixed) and prevention of atherosclerotic vascular disease risk

  • 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 lower total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial types, as well as mixed dyslipidemia, while increasing levels of 'good' HDL cholesterol. It is effectively used to control blood lipid concentrations mainly in conjunction with dietary measures, and reduces the risk of atherosclerotic vascular disease. During treatment, it is essential to identify secondary causes such as diabetes and hypothyroidism, and treat them if necessary. Additionally, the patient's condition should be closely monitored through lipid tests to plan appropriate therapy. This medication is used in conjunction with dietary management and is administered at the appropriate times for the improvement of blood lipids and prevention of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily with or without meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg daily. The initial recommended dose is 10/5 mg daily. For patients requiring greater LDL cholesterol reduction, the dose may be adjusted. After starting the treatment or adjusting the dose, lipid levels should be checked at intervals of 4 weeks or more to adjust the dose accordingly.

Precautions

This medication may cause serious muscular problems, so if you experience sudden muscle pain or weakness, you should inform your doctor immediately. Patients at risk of impaired kidney function due to severe infections, hypotension, major surgery, trauma, or metabolic disorders should temporarily discontinue or stop taking this medication. This medication should not be administered to certain patients, including those allergic to the active ingredients or other components, those with active liver disease or persistently elevated liver enzyme levels without a known cause, those with muscular disorders, those receiving specific immunosuppressants, patients with severe renal impairment, pregnant women or those who might become pregnant, and nursing mothers. Caution is advised when administering this medication to patients at high risk for myopathy or rhabdomyolysis, as well as in patients with a history of alcohol abuse, liver dysfunction, elderly patients, and those with hypothyroidism. If this medication is taken with certain lipid-lowering drugs or other medications, the risk of muscle damage may increase, so it is important to consult with a doctor. During treatment, liver function and muscle enzyme levels should be regularly monitored, and if any abnormal signs are detected, treatment should be adjusted immediately. If liver enzymes significantly rise or muscle enzymes increase to over five times the normal upper limit, the use of this medication should be discontinued. This medication may be harmful to a fetus when taken during pregnancy, so women who are pregnant or planning to become pregnant must consult their doctor and use appropriate contraception. It is also advisable for nursing mothers to avoid taking this medication. Safety has not been adequately established for children or adolescents, so its use is not recommended. Additionally, this medication should be used with caution in patients with a history of excessive alcohol use or liver disease, and patients should be cautious when driving or operating machinery as dizziness and other symptoms may occur. There may be interactions with other medications; therefore, if you are taking other medications, you must inform your doctor or pharmacist. Particularly, the risk of muscle damage may increase when taken with specific antifungals, antibiotics, immunosuppressants, and lipid-lowering agents. Finally, this medication should be kept out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blisters, skin peeling, painful mucosa of the mouth/eyes, severe skin abnormal reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues paired with cough and fever, skin or eye jaundice (yellowing), extreme lethargy, liver abnormalities (jaundice), sudden and very severe headache

Mild side effects

  • Pharyngitis
  • dyspepsia
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • dry mouth
  • increased blood sugar
  • itching
Show 28 more
  • rash
  • muscle pain
  • weakness
  • fatigue
  • paresthesia
  • chest discomfort
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • back pain
  • cough
  • upper respiratory infection
  • pharyngitis
  • sinusitis
  • sputum
  • runny nose
  • dermatitis
  • skin burning sensation
  • alopecia
  • urticaria
  • hyperhidrosis
  • xerostomia

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

Storage

This medication must be stored in a tightly sealed container to protect it from exposure to air and moisture. It is also safe to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow rectangular film-coated tablet

Package unit

PTP - 30 tablets/PTP [(10 tablets/PTP X 3)], bottle - 30 tablets/bottle, 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

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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.