Medication info

Rosumax Tablet 5 Milligrams (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
정우신약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets (15 tablets/PTP x 2 packs)
Approval status
Expired

MFDS item code 201903290 · Approved 2019.05.21

This product's status changed to Expired on 2024.05.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 milligrams once daily at any time of the day, regardless of meals. If further reductions in LDL-cholesterol are needed, adjust to a maintenance dose, which is typically 10 milligrams once daily for most patients. Dose adjustments should be made at intervals of 4 weeks or more based on LDL-cholesterol levels, therapeutic goals, and patient response, and the dose may be increased up to a maximum of 20 milligrams per day.
Children's dosage
For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, the dose is administered once daily at 5 milligrams to 20 milligrams. The dosage should be adjusted according to the therapeutic goals of individual patients at intervals of 4 weeks or more.

Ingredients

Manufacturer
정우신약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunct when diet and exercise alone are not sufficient for patients with primary hypercholesterolemia and mixed hyperlipidemia. It can be used in conjunction with diet or other treatments to lower cholesterol levels in patients with homozygous familial hypercholesterolemia. Additionally, it reduces total cholesterol and LDL-cholesterol to target levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It is also effective as an adjunct to diet in adolescents (ages 10 to 17) with high LDL-cholesterol levels. It can be used in patients with primary dysbetalipoproteinemia and helps reduce the risk of cardiovascular disease. This drug contributes to the reduction of risks associated with stroke, myocardial infarction, and arterial revascularization, thereby improving overall cardiovascular health.

Dosage and Administration

Adult dosage

Administer 5 milligrams once daily at any time of the day, regardless of meals. If further reductions in LDL-cholesterol are needed, adjust to a maintenance dose, which is typically 10 milligrams once daily for most patients. Dose adjustments should be made at intervals of 4 weeks or more based on LDL-cholesterol levels, therapeutic goals, and patient response, and the dose may be increased up to a maximum of 20 milligrams per day.

Children's dosage

For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, the dose is administered once daily at 5 milligrams to 20 milligrams. The dosage should be adjusted according to the therapeutic goals of individual patients at intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For instance, it is contraindicated in patients with allergies to this medication, severe liver impairment, or muscle disorders. Additionally, women who are pregnant, breastfeeding, or planning to become pregnant should not use this drug. Liver function and muscle condition should be monitored closely while using this medication. In particular, patients with a history of liver disease or excessive alcohol consumption should consult their doctor immediately if they experience muscle pain or weakness. This drug may raise blood sugar levels in some patients, so those at risk for diabetes should regularly monitor their blood sugar. Furthermore, this medication may interact with other drugs, so it is essential to inform healthcare providers of any current medications. Special caution is needed when taken with certain antiviral agents, immunosuppressants, and fibrate drugs. This drug may rarely cause severe skin reactions or liver damage, so if severe rash or jaundice develops, it should be discontinued immediately and medical attention sought. In the case of overdose, there is no specific antidote, and appropriate treatment and monitoring of liver function and muscle enzymes should be conducted. Lastly, while taking this medication, patients may experience dizziness when driving or operating machinery, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, hepatitis, jaundice, severe muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, hematuria, edema, liver failure, severe allergic reactions, severe skin adverse reactions, dyspnea, respiratory issues, serious neurological symptoms, severe edema or urinary abnormalities

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • thrombocytopenia
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  • diarrhea
  • lichenoid drug eruption
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • myalgia
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness
  • amnesia
  • memory impairment
  • confusion

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best stored at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets (15 tablets/PTP x 2 packs)

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.