Medication info
VIVACO Tablet 20 mg (Rosuvastatin Calcium)

VIVACO Tablet 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201400433 · Approved 2014.01.29 · Insurance code 640006750

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The medication can be taken once daily at any time of the day, regardless of meals. The initial dose is 5 mg once a day, and if more LDL cholesterol reduction is needed, it can be adjusted to the maintenance dose. The maintenance dose is usually adjusted to 10 mg once a day, with most patients controlled at this dose. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or more based on the LDL cholesterol level, treatment goals, and patient response.
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dose is 5 mg to 20 mg once daily. The dose should be adjusted individually according to the recommended treatment goals.

Ingredients

Importer
에이치케이이노엔(주)

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • coronary artery disease risk factors
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • early family history of coronary artery disease
View approved original text

This medication is used as an adjunct when diet and exercise are insufficient to control primary hypercholesterolemia and mixed dyslipidemia. It is also suitable as a dietary therapy adjunct for patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. Additionally, it lowers total cholesterol and LDL cholesterol in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and has an effect of reducing LDL cholesterol and apo-B protein levels in certain pediatric patients. In high-risk patients with cardiovascular disease risk factors, it helps to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures. Therefore, it is used to improve cardiovascular health and prevent related diseases.

How to take

Adult dose

The medication can be taken once daily at any time of the day, regardless of meals. The initial dose is 5 mg once a day, and if more LDL cholesterol reduction is needed, it can be adjusted to the maintenance dose. The maintenance dose is usually adjusted to 10 mg once a day, with most patients controlled at this dose. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or more based on the LDL cholesterol level, treatment goals, and patient response.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dose is 5 mg to 20 mg once daily. The dose should be adjusted individually according to the recommended treatment goals.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any component of this medication, have liver dysfunction, have muscle disorders, have severe renal impairment, or are pregnant or breastfeeding should not take this medication. In addition, this medication carries a risk of muscle-related side effects, so patients who are prone to myopathy or rhabdomyolysis should be particularly cautious. Risk factors include renal impairment, hypothyroidism, family history or genetic muscle disorders, and alcohol abuse. This medication contains lactose, so patients with lactose intolerance or related genetic conditions should not take it. It is important to regularly check liver function and muscle condition while taking this medication. Special caution should be taken if one drinks alcohol excessively or has a history of liver disease, and if symptoms such as muscle pain, weakness, or fatigue occur, one should consult a doctor immediately. This medication may interact with other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Taking this medication with certain medications may increase its blood concentration and the risk of side effects. Women who could become pregnant should use appropriate contraception before taking this medication, and should avoid taking it during pregnancy or while breastfeeding. There is no specific antidote for overdose, so treatment should be based on symptoms, and liver function and muscle condition should be monitored. Caution is needed when driving or operating machinery as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myopathy, jaundice, hepatitis, liver failure, polyneuropathy, severe muscle weakness, dyspnea, interstitial lung disease, thrombocytopenia, acute renal failure, oliguria

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, hematuria, diarrhea, chest pain, cough, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal bloating, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, thrombocytopenia, amnesia, peripheral neuropathy, cough, sexual dysfunction, gynecomastia, depression, sleep disturbances (including insomnia and nightmares)

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication’s efficacy over a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 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.

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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.