Medication info

Starova Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)비씨월드제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets/box [30 tablets (15 tablets/PTP (AluAlu) × 2)]
Approval status
Approval withdrawn

MFDS item code 201907231 · Approved 2019.10.15

This product's status changed to Approval withdrawn on 2024.11.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily at any time of day without regard to meals. The maintenance dose can be adjusted as needed, generally to 10 mg once daily. Maintenance doses should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg once daily.
Children's dosage
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer a dose of 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual therapy goals of each patient.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia patients
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunct to dietary changes and exercise in patients with primary hypercholesterolemia and mixed dyslipidemia who do not achieve adequate control. It also helps patients with homozygous familial hypercholesterolemia in conjunction with diet or other therapies. It effectively lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It can also be used as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, and in those meeting specific criteria, it reduces cholesterol levels and decreases the risk of cardiovascular disease. It is also utilized as an adjunct in patients with primary dysbetalipoproteinemia. Additionally, it helps reduce the risk of stroke, myocardial infarction, and revascularization in middle-aged patients with elevated high-sensitivity C-reactive protein levels and cardiovascular disease risk factors.

Dosage and Administration

Adult dosage

Administer 5 mg once daily at any time of day without regard to meals. The maintenance dose can be adjusted as needed, generally to 10 mg once daily. Maintenance doses should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg once daily.

Children's dosage

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer a dose of 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual therapy goals of each patient.

Precautions

This medication should not be used in certain patients. For instance, it should not be administered to patients with an allergy to any of its components, severely impaired liver function, muscle disorders, or significantly reduced kidney function. Women who are pregnant or breastfeeding, as well as women who may become pregnant, must utilize appropriate contraception to reduce pregnancy risk before using this medication, and caution is advised due to potential risks to the fetus. Patients at high risk of muscle-related disorders, such as those with moderately to severely impaired kidney function, reduced thyroid function, a family history of muscle disorders, previous muscle toxicity, alcoholics, and individuals of Asian descent, should avoid high doses of this medication or use it carefully. This medication contains lactose, so patients with lactose intolerance or related genetic conditions should not take it. It is essential to undergo regular liver function tests and muscle function tests while taking this medication. Particular caution is warranted for patients with a history of liver disease or those consuming alcohol excessively; any symptoms such as muscle pain, weakness, or cramps should be reported to healthcare professionals immediately. Furthermore, this medication can interact with other drugs, so patients should inform their healthcare providers of any concomitant medications. The combination with certain drugs may increase the blood concentration of this medication, raising the risk of muscle disorders. Pregnant or breastfeeding patients should not use this medication, and those planning to become pregnant should consult before use. In case of overdose, since there is no specific antidote, symptomatic treatment and monitoring of liver and muscle function is required. Finally, this medication may cause side effects such as dizziness, so caution is advised while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, breathing difficulties, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, polyneuropathy, severe muscle weakness, ocular myasthenia, acute kidney injury, oliguria, worsening of renal failure due to acute critical condition, rhabdomyolysis, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • hematuria
Show 21 more
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [30 tablets (15 tablets/PTP (AluAlu) × 2)]

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.