Medication info
Rovatin Tablet 5 Milligrams (Rosuvastatin Calcium)

Rovatin Tablet 5 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201310588 · Approved 2013.12.09 · Insurance code 642904990

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) improvement and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time during the day regardless of meals. The initial dose is 5 milligrams once a day, and if more reduction in LDL cholesterol is needed, it can be titrated to a maintenance dose. The maintenance dose is usually 10 milligrams once a day, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment objectives, and patient response at intervals of 4 weeks or longer.
Child dose
The usual dosage range is 5 milligrams to 20 milligrams once a day. The dose should be adjusted for individual patients according to the recommended treatment target. Dosing should occur at intervals of 4 weeks or longer.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atypical familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is mainly used in patients with hypercholesterolemia and combined hyperlipidemia when not controlled by diet and exercise. It is also used as an adjunct to diet and lipid-lowering therapy in patients with homozygous familial hypercholesterolemia and helps lower total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. In children aged between 10 and 17 years with familial hypercholesterolemia, it is also used as a dietary adjunct. It is beneficial for patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged and older patients with elevated high-sensitivity C-reactive protein levels. Overall, this medication is used for reducing the risk of cardiovascular disease and improving blood lipid levels.

How to take

Adult dose

This medication can be taken at any time during the day regardless of meals. The initial dose is 5 milligrams once a day, and if more reduction in LDL cholesterol is needed, it can be titrated to a maintenance dose. The maintenance dose is usually 10 milligrams once a day, and most patients are managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment objectives, and patient response at intervals of 4 weeks or longer.

Child dose

The usual dosage range is 5 milligrams to 20 milligrams once a day. The dose should be adjusted for individual patients according to the recommended treatment target. Dosing should occur at intervals of 4 weeks or longer.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients allergic to any of the ingredients, those with liver function issues, muscle disorders, or severely impaired kidney function. Additionally, it is advisable to avoid use in pregnant or lactating women, as well as in fertile women who do not use proper contraception. This medication can cause muscle-related side effects, so if symptoms of muscle pain or weakness occur, you should notify your physician immediately. Particular caution is advised when using this medication in patients with poor kidney function, hypothyroidism, alcohol abuse, or older patients. Regular liver function tests and muscle enzyme tests are required, and the medication should be discontinued if liver function worsens or muscle damage is suspected. This medication can have increased blood levels and a heightened risk of side effects when taken with certain drugs, so it is essential to consult your physician or pharmacist if you are taking other medications. It should not be used during pregnancy or lactation, and women of childbearing potential should use proper contraception. In case of overdose, as there is no specific antidote, treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Caution is necessary as symptoms like dizziness may occur while driving or operating machinery. This medication contains lactose, so patients with lactose intolerance should avoid using it. If you experience sudden skin rashes, fever, or difficulty breathing, indicating a severe allergic reaction while taking this medication, you should immediately stop treatment and inform healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, breathlessness or difficulty in breathing, asthma attacks, cough with fever and respiratory disturbances, yellowing of the skin or eyes (jaundice), profound fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hematuria
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • polyneuropathy
  • thrombocytopenia
  • ocular muscle weakness
  • sleep disorders
  • depression
  • sexual dysfunction
  • gynecomastia
  • cognition

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture and is best kept at room temperature between 1 and 30 degrees Celsius. Maintaining this storage will help preserve the medication's effectiveness.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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.