Medication info
Rosuva Tablet 10 Milligrams (Rosuvastatin Calcium)

Rosuva Tablet 10 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Pink round film-coated tablets
Packaging
For domestic use: 28 tablets (14 tablets/PTP X 2), for export: 56 tablets (14 tablets/PTP X 4)
Approval status
Active

MFDS item code 201007499 · Approved 2010.12.16 · Insurance code 663604300

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For adult patients with primary hypercholesterolemia, this medication can be taken at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, and if necessary, it can be adjusted to a maintenance dose of 10 milligrams once daily. The maintenance dose should be adjusted based on patient condition at intervals of at least 4 weeks, up to a maximum of 20 milligrams per day.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is administered once daily ranging from 5 milligrams to 20 milligrams. The dosage should be adjusted individually based on therapeutic goals at intervals of at least 4 weeks.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of premature coronary heart disease
  • stroke risk
View approved original text

This medication is primarily used as an adjunct to diet in patients with primary hypercholesterolemia and heterozygous familial hypercholesterolemia, and combined hyperlipidemia. It effectively lowers LDL-cholesterol and total cholesterol levels within the target range, delaying the progression of atherosclerosis. It is particularly prescribed for pediatric patients aged 10 to 17 years who have elevated LDL-cholesterol levels that cannot be controlled by diet alone. It is also used as an adjunct in the treatment of patients with primary dysbetalipoproteinemia. In middle-aged and older men and women at risk for cardiovascular disease, it helps to reduce the risk of stroke, myocardial infarction, and vascular revascularization, thereby maintaining cardiovascular health. Therefore, it is used for various forms of hyperlipidemia and risk reduction for cardiovascular diseases.

How to take

Adult dose

For adult patients with primary hypercholesterolemia, this medication can be taken at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, and if necessary, it can be adjusted to a maintenance dose of 10 milligrams once daily. The maintenance dose should be adjusted based on patient condition at intervals of at least 4 weeks, up to a maximum of 20 milligrams per day.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is administered once daily ranging from 5 milligrams to 20 milligrams. The dosage should be adjusted individually based on therapeutic goals at intervals of at least 4 weeks.

Precautions

This medication should not be used in certain patients. For example, patients with an allergy to any components of this drug, unexplained elevation of liver enzymes, patients with muscle diseases, those with severe renal impairment, and women who are pregnant or breastfeeding should not take this medication. Additionally, high-dose use of this medication is prohibited in patients at high risk of muscle-related diseases. Such patients include those with moderate to severe renal impairment, hypothyroidism, a family history of muscle disease, and alcohol dependence. This medication contains lactose; therefore, it should not be administered to patients with lactose intolerance or related genetic disorders. When administering this drug, caution is necessary for those with excessive alcohol consumption or a history of liver disease, and repeated liver function tests are recommended before and during treatment. If symptoms of muscle pain or weakness occur, inform a physician immediately and check for muscle damage through blood tests. Particularly, if muscle enzyme levels rise significantly, the medication should be discontinued. It is safe to stop taking this medication during acute severe illness or post-surgical conditions. This medication may interact with other drugs; therefore, it is essential to inform about any other medications being taken, especially when combined with those that may increase the risk of muscle toxicity. Women who may become pregnant should use appropriate contraception and should not take this medication during pregnancy. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle enzyme tests are needed. This medication does not significantly affect driving or operating machinery, but dizziness may occur; caution is advised. Finally, if symptoms such as skin rash, itching, severe muscle pain, or jaundice occur during treatment, consult medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), liver abnormalities (jaundice), acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, severe muscle weakness, ocular muscle weakness, rhabdomyolysis, severe skin reactions, severe allergic reactions, respiratory problems, severe neurological symptoms, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • hives
  • muscle pain
  • weakness
Show 27 more
  • thrombocytopenia
  • diarrhea
  • ocular muscle weakness
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hematuria
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • memory disturbance
  • confusion

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the drug's efficacy and safety over time.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

For domestic use: 28 tablets (14 tablets/PTP X 2), for export: 56 tablets (14 tablets/PTP X 4)

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.