Medication info
Rosetive Tablet 10/20 mg

Rosetive Tablet 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
알보젠코리아(주)
Appearance
Pink oval 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 201506785 · Approved 2015.09.24 · Insurance code 652604930

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed) and inhibition of atherosclerotic vascular disease risk
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg per day. The recommended initial dosage is 10/5 mg per day. The dosage may be adjusted for patients requiring a greater reduction in LDL cholesterol. After starting medication or adjusting dosage, blood lipid levels should be checked at intervals of more than 4 weeks, and the dosage should be adjusted accordingly, with a maximum daily dose of 10/20 mg.

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

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

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

This medication helps lower total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, such as familial or non-familial hypercholesterolemia, and mixed dyslipidemia. It is used in conjunction with an appropriate diet and is administered as an adjunct when dietary control is insufficient. Additionally, in managing the risk of atherosclerotic vascular disease due to hypercholesterolemia, multiple risk factors should be considered in the treatment with lipid-modifying therapy. It is important to check for other secondary causes and provide appropriate treatments, with regular monitoring of cholesterol and triglyceride levels before and during treatment. This medication is effective for improving the patient's blood lipid status and contributes to reducing the risk of atherosclerotic vascular disease.

How to take

Adult dose

This medication is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg per day. The recommended initial dosage is 10/5 mg per day. The dosage may be adjusted for patients requiring a greater reduction in LDL cholesterol. After starting medication or adjusting dosage, blood lipid levels should be checked at intervals of more than 4 weeks, and the dosage should be adjusted accordingly, with a maximum daily dose of 10/20 mg.

Precautions

This medication may cause serious problems with muscles, so if sudden muscle pain or weakness occurs, inform your doctor immediately. In particular, it may be necessary to temporarily discontinue or stop taking this medication if there are risk factors such as severe infections, hypotension, major surgeries, trauma, or endocrine disorders. This medication should not be taken by those with allergies to it or liver or muscle disorders. Furthermore, patients with severe renal impairment, women who are pregnant or may become pregnant, and nursing mothers should not use this medication. Patients at high risk of myopathy, such as those with moderate renal impairment, hypothyroidism, a family history of muscle disease, alcoholics, and Asian patients, should use this medication with caution. Careful administration is also required for patients with poor liver function, those who consume large amounts of alcohol, the elderly, and those taking certain other medications. This medication may cause side effects such as liver dysfunction, dyspepsia, myalgia, headache, and edema, so consult your doctor if you experience unusual symptoms. It should be absolutely avoided during pregnancy due to potential harm to the fetus, and women of childbearing potential should be on appropriate contraception during treatment. Its safety and efficacy have not been established in children and adolescents, so it is not recommended. Regular liver and muscle function tests should be performed during treatment, and inform your healthcare provider about any medications you are currently taking due to potential interactions. There is no specific antidote for overdose, so symptomatic treatment and appropriate supportive care are necessary. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe edema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, decreased urine output

Mild side effects

  • Headache
  • dizziness
  • dyspepsia
  • edema
  • myalgia
  • dry mouth
  • elevated liver enzymes
  • abnormal liver function tests
  • increased serum lactate dehydrogenase
  • pruritus
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  • elevated blood sugar
  • chest discomfort
  • cough
  • diarrhea
  • itching
  • cold sweat
  • dermatitis
  • skin disorders
  • alopecia
  • nausea
  • abdominal pain
  • fatigue
  • numbness
  • paresthesia
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • diabetes
  • constipation
  • joint pain
  • low back pain

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

Storage

This medication is sensitive to air and humidity, so it must be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature to ensure the safety of the medication's effectiveness.

Appearance and packaging

Appearance

Pink oval 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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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.