Medication info

Starova Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)비씨월드제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets (15 tablets/PTP (AluAlu) × 2)
Approval status
Approval withdrawn

MFDS item code 201907232 · 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This product's status changed to Approval withdrawn on 2024.11.13.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 for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg as an initial dose once daily at any time regardless of meals. The maintenance dose is 10 mg once daily, and should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer. The dose can be increased up to a maximum of 20 mg once daily.
Children's dosage
Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia are administered 5 mg to 20 mg once daily. The dosage is adjusted according to the individual patient's treatment goals, with adjustments made every 4 weeks.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is primarily used as an adjunct for patients with hypercholesterolemia and mixed dyslipidemia when diet or exercise is not sufficient. It is particularly beneficial for patients with primary hypercholesterolemia, familial hypercholesterolemia, and dysbetalipoproteinemia. It helps lower total cholesterol and LDL cholesterol levels to slow the progression of atherosclerosis. It is also used in pediatric patients aged 10 to 17 years with familial hypercholesterolemia. For men over 50 years and women over 60 years with high sensitivity C-reactive protein levels and cardiovascular risk factors, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization procedures. This medication is used to improve cardiovascular health and reduce the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

Administer 5 mg as an initial dose once daily at any time regardless of meals. The maintenance dose is 10 mg once daily, and should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer. The dose can be increased up to a maximum of 20 mg once daily.

Children's dosage

Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia are administered 5 mg to 20 mg once daily. The dosage is adjusted according to the individual patient's treatment goals, with adjustments made every 4 weeks.

Precautions

This medication should not be used in certain patients. Firstly, individuals allergic to this medication should avoid it. Patients with severely impaired liver function or active liver disease should not use this medication. It should also not be administered to patients with muscle disorders or those experiencing muscle problems. Additionally, patients taking the immunosuppressant cyclosporine should not use this medication. Patients with very poor kidney function, pregnant or nursing women, and women of childbearing age who are uncertain about pregnancy should also avoid this medication. High doses (40 mg) are contraindicated, especially in patients at high risk for muscle problems. Patients with genetic metabolic disorders such as lactose intolerance should not take this medication. This medication should be used with caution in patients who consume alcohol excessively or have a history of liver disease, and liver function tests should be performed regularly before and during administration. Patients with conditions such as hypothyroidism or nephrotic syndrome should first have those conditions treated before using this medication. If symptoms such as muscle pain or weakness occur, the physician should be informed immediately, and if necessary, the medication should be discontinued. This medication can rarely cause severe adverse reactions such as serious skin reactions, liver damage, or muscle damage, so if such symptoms occur, treatment should be stopped immediately and medical consultation sought. Furthermore, this medication may interact with other drugs, so if taking any other medications, patients should inform their doctor or pharmacist. In particular, the risk of muscle damage may increase when used in conjunction with certain antivirals, immunosuppressants, antibiotics, or fibrate drugs. Pregnant or nursing women should not use this medication, and women who are capable of becoming pregnant should use appropriate contraception. In the event of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Dizziness may occur when driving or operating machinery, so caution is advised. It is important to have regular check-ups as advised by a physician during the course of this medication, and to consult a healthcare provider immediately if abnormal symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues with cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination changes

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • diabetes
  • itching
  • myalgia
  • weakness
  • hematuria
Show 25 more
  • diarrhea
  • rash
  • thrombocytopenia
  • immune-mediated myopathy
  • memory loss
  • peripheral neuropathy
  • cough
  • muscle weakness
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature to maintain the drug's efficacy and safety over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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.