Medication info
Rosumedi Tablet 10mg (Rosuvastatin Calcium)

Rosumedi Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)텔콘알에프제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets/PPT [(15 tablets/PTP x 2)]
Approval status
Active

MFDS item code 201908417 · Approved 2019.12.14 · Insurance code 625501120

Summary

Main use
Treatment of high cholesterol and familial hypercholesterolemia (improvement of lipid levels), reduction of cardiovascular disease risk (stroke, myocardial infarction, etc.)
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time during the day, regardless of meals. The initial dose is 5mg once daily, and the maintenance dose is 10mg once daily. The dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20mg per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is administered once daily between 5mg and 20mg, with adjustments made according to individual treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)텔콘알에프제약

Efficacy & effects

Treatment of high cholesterol and familial hypercholesterolemia (improvement of lipid levels), reduction of cardiovascular disease risk (stroke, myocardial infarction, etc.)

  • High cholesterol
  • hyperlipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunct for patients with primary hypercholesterolemia and mixed hyperlipidemia who have difficulty controlling their condition with diet and exercise alone. It is also beneficial for patients with homozygous familial hypercholesterolemia in combination with dietary therapy or other lipid-lowering therapies. Additionally, it lowers total cholesterol and LDL cholesterol levels in patients with high cholesterol, effectively delaying the progression of atherosclerosis. It is used as an adjunct to dietary therapy in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia and is also administered as an adjunct treatment for patients with primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization procedures in middle-aged or older patients with high levels of high-sensitivity C-reactive protein, indicating a high risk of cardiovascular disease. Thus, this medication is effective for cholesterol management and cardiovascular disease prevention.

Dosage and Administration

Adult dosage

This medication can be taken at any time during the day, regardless of meals. The initial dose is 5mg once daily, and the maintenance dose is 10mg once daily. The dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20mg per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is administered once daily between 5mg and 20mg, with adjustments made according to individual treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients allergic to this medicine, those with severe liver dysfunction, muscle disorders, severely impaired kidney function, pregnant or breastfeeding women, and those taking certain medications should not use this medication. Additionally, liver function and muscle condition should be regularly monitored while using this medication. Caution is particularly needed for patients who consume large amounts of alcohol or have a history of liver disease, hypothyroidism, and elderly patients. If symptoms of muscle pain or weakness occur, they should immediately inform their physician, and discontinuation of the medication may be necessary. This medication may increase blood sugar levels in some patients, raising the risk of diabetes; therefore, patients at risk for diabetes should have regular blood sugar-related tests. This medication may interact with other drugs, so if other medications are being taken, it is essential to inform the physician or pharmacist. In particular, concomitant use with certain antiviral agents, immunosuppressants, antibiotics, and fibrate drugs may increase the risk of muscle toxicity. Women who are pregnant or planning to become pregnant should not take this medication and should use appropriate contraceptive methods. In the case of overdose, there is no specific antidote, so one should seek appropriate treatment at a hospital immediately and monitor liver function and muscle enzyme levels. Rarely, side effects such as skin rash, itching, headache, dizziness, indigestion, muscle pain, weakness, hematuria, diarrhea, fatigue, numbness, abnormal sensations, chest discomfort, loss of appetite, abdominal distension, syncope, body ache, muscle cramps, gout, erectile dysfunction, memory loss, peripheral neuropathy, cough, thrombocytopenia, hepatitis, increased transaminase levels, eosinophilia, and drug reaction with eosinophilia and systemic symptoms syndrome may occur; thus, it is important to inform healthcare personnel of any unusual symptoms. Lastly, this medication does not significantly affect driving or operating machinery, but caution should be exercised due to the possibility of dizziness.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory problems accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning headache, seizure, altered consciousness, visual disturbances, paralysis, urination issues.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, muscle pain, weakness, hematuria, diarrhea, fatigue, numbness, altered sensation, chest discomfort, loss of appetite, abdominal bloating, syncope, body pain, muscle cramps, gout, erectile dysfunction, memory loss, peripheral neuropathy, cough, thrombocytopenia, hepatitis, increased transaminase levels, eosinophilia, and drug reaction with eosinophilia and systemic symptoms syndrome, drug rash resembling psoriasis.

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/PPT [(15 tablets/PTP x 2)]

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.