Medication info
Rosurod Tablets 20 Milligrams (Rosuvastatin Calcium)

Rosurod Tablets 20 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Pink round film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle
Approval status
Active

MFDS item code 201000963 · Approved 2010.01.28 · Insurance code 643305700

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer once daily at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is usually adjusted at 10 milligrams once daily, which is sufficient for most patients. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and the patient's response, with a maximum increase of 20 milligrams per day.
Child dose
Pediatric patients aged 10 to 17 years are administered 5 milligrams to 20 milligrams once daily. The dosage should be individually adjusted according to the recommended treatment goals and should be modified at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

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

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

This medication is used to effectively lower cholesterol levels in several types of hypercholesterolemia, particularly primary hypercholesterolemia and familial hypercholesterolemia. If dietary and exercise modifications are inadequate, it can be used to reduce total cholesterol and LDL cholesterol to target levels, thereby slowing the progression of atherosclerosis. Additionally, it is used in conjunction with diet for managing cholesterol levels in children aged 10 years and older with familial hypercholesterolemia. It is also used as a dietary adjunct in patients with primary dysbetalipoproteinemia. In patients at high risk of cardiovascular disease, it contributes to reducing the risk of stroke, myocardial infarction, and arterial revascularization. Thus, this drug is used to improve cardiovascular health in various conditions associated with hyperlipidemia.

How to take

Adult dose

Administer once daily at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is usually adjusted at 10 milligrams once daily, which is sufficient for most patients. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and the patient's response, with a maximum increase of 20 milligrams per day.

Child dose

Pediatric patients aged 10 to 17 years are administered 5 milligrams to 20 milligrams once daily. The dosage should be individually adjusted according to the recommended treatment goals and should be modified at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients with an allergy to any of its components, severely impaired liver function, muscle disorders, or severe kidney dysfunction. Pregnant or breastfeeding women, as well as women of childbearing potential, must consult a physician before using this medication and should use appropriate contraceptive methods. In particular, high-dose administration of this medication is contraindicated in patients at high risk of muscle disorders. While using this medication, liver function and muscle condition should be periodically monitored, and any symptoms such as muscle pain or weakness should be promptly reported to healthcare professionals. Additionally, it is important to address any existing renal dysfunction or hypothyroidism before using this medication. Caution is needed for those with a history of excessive alcohol consumption or liver disease, and regular liver enzyme tests should be conducted. This medication may increase blood levels when used in combination with certain drugs, thereby raising the risk of muscle-related adverse reactions; thus, patients should consult their physician or pharmacist if they are taking other medications. This drug contains lactose, so it should not be used by patients with lactose intolerance, and serious skin reactions, liver damage, or muscle rupture may occur infrequently; if any such symptoms arise, treatment should be stopped immediately, and medical advice should be sought. Reported side effects from clinical trials and post-marketing surveillance include headache, dizziness, muscle pain, dyspepsia, and elevated liver enzyme levels, most of which are mild and transient. Caution should be exercised due to potential dizziness when driving or operating machinery during treatment. In cases of overdose, there is no specific antidote, and management should be focused on symptomatic treatment and monitoring liver function and muscle enzyme levels. Overall, this medication requires caution in patients with specific conditions or when used with other drugs, and it should only be taken under medical supervision with regular monitoring for safety.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, eosinophilia alongside systemic symptoms, jaundice, hepatitis, acute kidney failure, oliguria, chest tightness, difficulty breathing, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • thrombocytopenia
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  • diarrhea
  • ocular muscle weakness
  • hematuria
  • edema
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness
  • amnesia
  • cognitive impairment
  • confusion
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is best kept at room temperature between 1 degrees Celsius and 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3], 30 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.

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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.