Medication info
Rosuvastatin Calcium 20 mg Tablets

Rosuvastatin Calcium 20 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 100 tablets/box[(10 tablets/PTP*10)]
Approval status
Active

MFDS item code 201400419 · Approved 2014.01.29 · Insurance code 651204040

Summary

Main use
Treatment for improving hypercholesterolemia and dyslipidemia, and reducing the risk of cardiovascular diseases.
Who takes it
Adults
Adult dose
This medication can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once a day, which may be adjusted to the maintenance dose if needed. The maintenance dose is generally 10 mg once a day, and most patients will be managed at this dose. The maintenance dose should be adjusted appropriately, at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum dose of 20 mg per day.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Treatment for improving hypercholesterolemia and dyslipidemia, and reducing the risk of cardiovascular diseases.

  • Hypercholesterolemia
  • hyperlipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease risk factors
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
  • risk of stroke
  • risk of myocardial infarction.
View approved original text

This medicine is used primarily as an adjunct therapy for patients with primary hypercholesterolemia and mixed dyslipidemia, who find it difficult to control their condition through diet and exercise alone. It can also be used as an adjunct to diet or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. It helps reduce the total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It also serves as an adjunct to diet for patients with primary dysbetalipoproteinemia. Furthermore, it improves cardiovascular health by reducing the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 years old and women over 60 years old with elevated high-sensitivity C-reactive protein and cardiovascular risk factors.

How to take

Adult dose

This medication can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once a day, which may be adjusted to the maintenance dose if needed. The maintenance dose is generally 10 mg once a day, and most patients will be managed at this dose. The maintenance dose should be adjusted appropriately, at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum dose of 20 mg per day.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to any of the ingredients, have severe liver impairment, have muscle disorders, or have severe renal impairment. Additionally, women who are pregnant or breastfeeding, as well as fertile women not using effective contraception, should not take this medication. This medication can cause muscle problems, so special caution is needed for patients with a history of muscle disorders, moderate to severe renal impairment, hypothyroidism, alcoholics, and those taking certain concurrent medications. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. This medication can affect liver health, so patients with a history of liver disease or who excessively consume alcohol should regularly undergo liver function tests before and during treatment. If muscle pain, weakness, or cramps occur, contact a doctor immediately for necessary tests. Especially at high doses, kidney function tests might also be necessary. Rarely, side effects such as headaches, dizziness, dyspepsia, itching, rash, muscle pain, fatigue, pallor, numbness, and abnormal sensations may occur while taking this medication. Serious reactions like rash, liver damage, or muscle damage can sometimes occur, so if these symptoms appear, consult medical professionals immediately. This medication may interact with other drugs, so if you are taking other medications, you must inform your healthcare provider. Be especially cautious when taken concurrently with certain antiviral medications, immunosuppressants, select antibiotics, and fibrate drugs, as it may increase the risk of muscle damage. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraceptive methods. In case of overdose, there is no specific antidote, so treatment should be based on symptoms, and liver and muscle function tests are necessary. Caution should be exercised as dizziness may occur while driving or operating machinery. Lastly, this medication may show higher systemic concentrations in Asians, so dosage adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe swelling, chest tightness, difficulty breathing, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severely abnormal skin reactions, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden and extremely severe headaches, thunderclap headaches, seizures.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
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  • chest discomfort
  • cold sweat
  • pallor
  • fatigue
  • numbness
  • abnormal sensation
  • nausea
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized body pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve its effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 100 tablets/box[(10 tablets/PTP*10)]

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.