Medication info
VIVACO Tablets 10 mg (Rosuvastatin Calcium)

VIVACO Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201400434 · Approved 2014.01.29 · Insurance code 640006740

Summary

Main use
Treatment for hypercholesterolemia and cardiovascular disease risk reduction
Who takes it
Adults · Children
Adult dose
Administer an initial dose of 5 mg once daily at any time of the day, regardless of meals. If greater reduction in LDL cholesterol is needed, the maintenance dose can be administered as 10 mg once daily, adjusting based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. The dose may be increased up to a maximum of 20 mg per day.
Child dose
For pediatric patients aged 10 to 17 years, the recommended dosage is 5 mg to 20 mg once a day, adjusted individually according to the recommended treatment goals. Dosage adjustments should be made at intervals of 4 weeks or more.

Ingredients

Importer
에이치케이이노엔(주)

Efficacy & effects

Treatment for hypercholesterolemia and cardiovascular disease risk reduction

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dysbetalipoproteinemia
  • primary dyslipidemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as an adjunct to diet for the treatment of primary hypercholesterolemia and mixed dyslipidemia, particularly when diet and exercise alone do not achieve adequate control. It also enhances the treatment effect in patients with homozygous familial hypercholesterolemia when used in combination with other lipid-lowering therapies. It helps lower total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is used to reduce cholesterol levels in children and adolescents aged 10 years and older with heterozygous familial hypercholesterolemia when diet alone is insufficient for improvement. It also acts as an adjunct to diet in patients with primary dysbetalipoproteinemia, and helps to reduce the risk of stroke, myocardial infarction, and arterial revascularization in high-risk patients with cardiovascular disease risk factors. This medication effectively improves cholesterol management and reduces the risk of cardiovascular diseases.

How to take

Adult dose

Administer an initial dose of 5 mg once daily at any time of the day, regardless of meals. If greater reduction in LDL cholesterol is needed, the maintenance dose can be administered as 10 mg once daily, adjusting based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. The dose may be increased up to a maximum of 20 mg per day.

Child dose

For pediatric patients aged 10 to 17 years, the recommended dosage is 5 mg to 20 mg once a day, adjusted individually according to the recommended treatment goals. Dosage adjustments should be made at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, patients with an allergy to any component of this medication, those with severely impaired liver function, those with muscle diseases, those taking certain medications, those with severe renal impairment, pregnant or nursing women, and women of childbearing age who do not use adequate contraceptive measures should not take this medication. This medication should be used with caution in patients at high risk of muscle diseases. If symptoms of muscle pain or weakness occur, consultation with a physician should be sought immediately, and regular blood tests are necessary to check for muscle damage during treatment. Since this medication can affect liver function, patients with a history of liver disease should consult their physician before taking it and should regularly monitor liver function during use. Patients who consume excessive alcohol or have hypothyroidism should be cautious when taking this medication, and it is important to treat these underlying conditions first. This medication can interact with other drugs, so if patients are currently taking other medications, they must inform their physician. In particular, the risk of muscle damage may increase when taken with certain antivirals, immunosuppressants, antibiotics, and fibrate drugs. Women who are pregnant or planning to become pregnant should consult their physician before taking this medication and use appropriate contraceptive methods. Nursing women should also avoid taking this medication. In case of overdose, there is no specific antidote, so patients should visit a medical institution immediately for treatment based on symptoms, and liver function and muscle damage should be monitored. This medication can rarely cause serious skin reactions or liver damage, so if symptoms such as skin rash or jaundice occur, the medication should be stopped immediately, and medical attention should be sought. Dizziness or headache may occur, so caution is advised when driving or operating machinery. Finally, this medication can also be used in children and adolescents, but it should be taken carefully as it can affect growth and development of secondary sexual characteristics, following the instructions of healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguric renal failure, thrombocytopenia, increased serum creatinine, severe muscle weakness, ocular muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, severe skin reactions, liver abnormalities (jaundice), respiratory problems

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • cough
Show 22 more
  • diarrhea
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • cognitive dysfunction
  • confusion

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius.

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.

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.