Medication info
Astrotin Tablets 20 mg (Rosuvastatin Calcium)

Astrotin Tablets 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
에스케이케미칼(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201001030 · Approved 2010.01.29 · Insurance code 644703340

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Start at 5 mg once daily, and adjust the dose at intervals of more than 4 weeks based on treatment goals and patient response. The maintenance dose is 10 mg once daily, and it can be increased up to a maximum of 20 mg per day. It can be administered at any time of day, regardless of meals.
Child dose
For pediatric patients aged 10 to 17 years, administer 5 mg to 20 mg once daily. The dosage should be adjusted at intervals of more than 4 weeks based on the treatment goals of individual patients. 10 years

Ingredients

Manufacturer
에스케이케미칼(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • excess LDL cholesterol
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • hypertension
  • low HDL cholesterol
  • smoking
View approved original text

This medication is used as an adjunct when diet and exercise alone do not adequately control primary hypercholesterolemia and mixed dyslipidemia patients. It is also used as an adjunct therapy in patients with homozygous familial hypercholesterolemia along with dietary therapy or LDL apheresis. This medication lowers total cholesterol and LDL cholesterol levels in hypercholesterolemic patients to the target range, delaying the progression of atherosclerosis. It may also be used as an adjunct to dietary therapy in pediatric patients aged 10 to 17 years who meet specific criteria for heterozygous familial hypercholesterolemia. It also serves as an adjunct to dietary therapy for patients with primary dysbetalipoproteinemia. Furthermore, it helps to improve cardiovascular health by reducing the risk of stroke, myocardial infarction, and coronary revascularization in adult patients at high risk for cardiovascular disease.

How to take

Adult dose

Start at 5 mg once daily, and adjust the dose at intervals of more than 4 weeks based on treatment goals and patient response. The maintenance dose is 10 mg once daily, and it can be increased up to a maximum of 20 mg per day. It can be administered at any time of day, regardless of meals.

Child dose

For pediatric patients aged 10 to 17 years, administer 5 mg to 20 mg once daily. The dosage should be adjusted at intervals of more than 4 weeks based on the treatment goals of individual patients. 10 years

Precautions

This drug should not be administered to certain patients. For example, patients who are allergic to this drug or have liver dysfunction, muscular disorders, severe renal impairment, or women who are pregnant or breastfeeding should not use it. Additionally, this medication may affect muscles, and symptoms such as myalgia or muscle weakness may occur, so caution is required. Patients with renal impairment, hypothyroidism, a history of genetic muscular disorders, the elderly, and alcohol abusers should consult a healthcare professional before taking this medication. Regular liver function tests must be performed while taking this drug, and if symptoms such as myalgia, fatigue, or fever occur, immediate medical advice should be sought. Furthermore, muscle damage markers may not be accurate after strenuous exercise, so caution is advised. This medication may interact with other drugs, so it is essential to inform your healthcare provider of any current medications. Co-administration with certain medications may increase the blood concentration of this drug, raising the risk of muscle damage. Women planning to become pregnant or those who may become pregnant should use appropriate contraceptive methods and discontinue the drug immediately if pregnancy occurs. It is also safer for breastfeeding women not to take this medication. There is no specific antidote for overdose; therefore, symptomatic treatment should be received while monitoring liver function and muscle enzyme levels. Lastly, this medication may rarely cause various side effects such as liver dysfunction, neurological abnormalities, and skin rashes, so it is important to consult a healthcare provider immediately if any abnormal symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, jaundice, hepatitis, acute renal failure, oliguria, severe muscle weakness, ocular muscle weakness, rhabdomyolysis, severe edema, increased serum creatinine

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • myalgia
  • arthralgia
  • fatigue
  • numbness
  • sensory disturbances
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • hepatitis
  • increased transaminase levels
  • lichenoid drug rash
  • lupus-like syndrome
  • muscle pain

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

Storage

This medication should be stored in a tightly sealed container to protect it from air or moisture. Additionally, it is best to store the medication at room temperature between 1 to 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

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.

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.