Medication info
Rosuvastatin Calcium Tablet 20 mg (Unformulated)

Rosuvastatin Calcium Tablet 20 mg (Unformulated)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›20.8mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Active

MFDS item code 201400452 · Approved 2014.01.29 · Insurance code 657202680

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia and reduction of the risk of cardiovascular disease
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, with most patients controlled on this dose. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20 mg per day as needed.
Child dose
The usual dosage range for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 5 mg to 20 mg once daily. The dosing should be adjusted on an individual basis according to the recommended treatment goals for each patient.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia and reduction of the risk of cardiovascular disease

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

This medication is used as an adjunct when dietary control and exercise are insufficient in patients with various forms of hyperlipidemia, including primary hypercholesterolemia and mixed hyperlipidemia, as well as familial hypercholesterolemia. It helps lower total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It is particularly effective in controlling cholesterol levels in adolescent patients with heterozygous familial hypercholesterolemia. Additionally, it is used as an adjunct in patients with primary dysbetalipoproteinemia. Furthermore, in men over 50 years and women over 60 years with additional risk factors such as hypertension, low HDL, and smoking, it also aids in the reduction of risks for stroke, myocardial infarction, and arterial revascularization. This medication is used to reduce the risk of cardiovascular disease and improve heart health.

How to take

Adult dose

The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, with most patients controlled on this dose. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20 mg per day as needed.

Child dose

The usual dosage range for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 5 mg to 20 mg once daily. The dosing should be adjusted on an individual basis according to the recommended treatment goals for each patient.

Precautions

This medication should not be used in certain patients, such as those with allergies to this medication, severe liver dysfunction, muscle disorders, those taking certain drugs, severely impaired renal function, or women who are pregnant or nursing. Additionally, this medication should be used with caution in patients with a history of significant alcohol consumption or liver disease, and regular liver function tests should be conducted during treatment. If symptoms such as muscle pain or weakness occur, the doctor should be notified immediately, and in severe cases, discontinuation of the medication may be necessary. This medication may raise blood sugar levels in some patients, so those at risk of diabetes should closely manage their blood sugar. Furthermore, genetic factors may influence the drug's effects or side effects, so the dosage should be adjusted according to a doctor’s instructions. It is rare for severe skin reactions or liver damage to occur during medication use, so if symptoms such as skin rash, jaundice, or severe fatigue arise, immediate consultation with healthcare professionals is advised. This medication may interact with other drugs, so if there are other medications being taken, healthcare professionals should be informed, especially since muscle-related side effect risks may increase when taken with specific antivirals, immunosuppressants, antifungals, and antibiotics. Women who are pregnant or planning to become pregnant should not take this medication, and if pregnancy is confirmed during treatment, it should be discontinued immediately and a doctor consulted. It is also advisable to avoid this medication while nursing. In case of overdose, there are no specific antidotes, and treatment should be based on symptoms while regularly checking liver function and muscle enzyme levels. Caution is advised when driving or operating machinery due to the potential for dizziness from this medication. Finally, this medication contains lactose, so patients with lactose intolerance should not use it.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe allergic reactions, serious skin abnormalities, severe edema or urinary disturbances, acute renal failure, difficulty breathing and dyspnea, severe liver damage and hyperbilirubinemia or jaundice, severe kidney

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, diarrhea, chest discomfort, loss of appetite, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, fatigue, numbness, paresthesia, hematuria, thrombocytopenia, memory loss, peripheral neuropathy, cough, increased serum creatinine, sexual dysfunction, gynecomastia, depression, sleep disturbances (including insomnia and nightmares), cognitive disturbances (such as memory impairment, forgetfulness

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3)

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.