Medication info

Rosumax Tablet 20 Milligrams (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
정우신약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (15 tablets/PTP x 2 packs)
Approval status
Expired

MFDS item code 201903288 · 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 of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Can be taken once daily at any time of the day, regardless of meals. The initial dosage is 5 milligrams once daily, and the maintenance dosage is 10 milligrams once daily, with most patients adjusting to this dosage. The maintenance dosage should be appropriately adjusted every 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response and can be increased up to a maximum of 20 milligrams per day.
Children's dosage
For pediatric patients aged 10 to 17 years, administer 5 to 20 milligrams once daily. Dosage should be adjusted every 4 weeks or more based on individual treatment goals. For those under 10 years of age

Ingredients

Manufacturer
정우신약(주)

Efficacy & effects

Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and reduction of cardiovascular disease risk

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

This medicine is used as an adjunct therapy in patients with primary hypercholesterolemia and mixed hyperlipidemia when diet and exercise do not adequately control these conditions. It is also helpful as an adjunct to lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. It effectively lowers total cholesterol and LDL-cholesterol levels, limiting the progression of atherosclerosis. Furthermore, it is used as an adjunct to diet in pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia that meets specific criteria. It is beneficial for patients with primary dysbetalipoproteinemia; while there is no clinical evidence for the risk of coronary artery disease, it is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged patients with cardiovascular disease risk factors. This medication effectively improves dyslipidemia and the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

Can be taken once daily at any time of the day, regardless of meals. The initial dosage is 5 milligrams once daily, and the maintenance dosage is 10 milligrams once daily, with most patients adjusting to this dosage. The maintenance dosage should be appropriately adjusted every 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response and can be increased up to a maximum of 20 milligrams per day.

Children's dosage

For pediatric patients aged 10 to 17 years, administer 5 to 20 milligrams once daily. Dosage should be adjusted every 4 weeks or more based on individual treatment goals. For those under 10 years of age

Precautions

This medication should not be used in patients with known allergies to specific ingredients. Patients with active liver disease or abnormally high liver enzyme levels should not take this medication. Patients with muscular disorders or myopathy should avoid this medication, and those taking cyclosporine should not use it concurrently. Patients with severe renal impairment and pregnant or breastfeeding women, as well as women of childbearing potential who are not using appropriate contraception, should not use this medication. The 40-milligram dosage is contraindicated for patients at high risk of muscle disorders, including those with moderate renal impairment, hypothyroidism, a history of hereditary muscular diseases, and alcohol abuse. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic disorders. Patients with high alcohol consumption or a history of liver disease should have regular liver function tests before and during treatment. If symptoms of myalgia or myopathy occur, immediate medical consultation and necessary testing should occur, and drug cessation may be required. If acute severe conditions or serious physical ailments are present, this medication should be discontinued. This medication may rarely trigger severe myasthenia gravis or ophthalmoplegic myasthenia; if such symptoms occur, discontinue use. The risk of muscular toxicity may increase when taken with certain other medications, so concomitant use must be checked. Renal function tests may be required for high-dose administration. Asian patients may have higher drug exposure, so dosages may need to be adjusted. This medication can also be used in children and adolescents, but growth and secondary sexual characteristics need to be monitored. Severe skin reactions may occur infrequently; if skin abnormality symptoms appear, medication use should be stopped immediately. This medication can interact with other drugs, so consult with healthcare providers if currently taking any other medications. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential should practice appropriate contraception. In case of overdose, as there are no specific antidotes, treatment should be symptomatic along with liver function and muscle enzyme testing.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • chest tightness
  • difficulty breathing
  • Stevens-Johnson syndrome
  • dyspnea
  • jaundice
  • hepatitis
  • severe myasthenia gravis
  • ophthalmoplegic myasthenia
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  • myopathy
  • rhabdomyolysis
  • acute renal failure
  • oliguria
  • severe edema
  • severe skin adverse reactions
  • severe allergic reactions
  • severe skin abnormal reactions
  • serious neurological symptoms

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, hematuria, diarrhea, fatigue, numbness, paresthesia, chest discomfort, anorexia, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, memory loss, peripheral neuropathy, thrombocytopenia, hepatitis, elevated transaminases, eosinophilia, and drug reaction with eosinophilia and systemic symptoms syndrome, lupus-like syndrome, muscle rupture

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

Storage

Store this medication in a tightly sealed container to avoid exposure to air or moisture. It is best to keep the storage temperature between 1 to 30 degrees Celsius. This will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Pink 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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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.