Medication info
Crestin Tablet 10 mg (Rosuvastatin Calcium)

Crestin Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP*2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201401921 · Approved 2014.04.18 · Insurance code 693901310

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The medication can be administered at any time of the day regardless of meals. The initial dosage is 5 mg once daily, and if greater reductions in LDL cholesterol are needed, the maintenance dosage can be adjusted accordingly. The maintenance dosage is typically 10 mg once daily, and most patients will be managed at this dosage. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer.
Child dose
The usual dosage range is 5 mg to 20 mg once daily. The dosage should be individually adjusted based on the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or longer.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • coronary heart disease risk factors
  • stroke risk factors
  • myocardial infarction risk factors
  • artery revascularization risk factors
View approved original text

This drug is primarily used as an adjunct in patients with primary hypercholesterolemia and mixed hyperlipidemia when diet and exercise alone do not adequately control their condition. It is also used in conjunction with diet or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia to lower cholesterol levels. Additionally, it helps lower total cholesterol and bad cholesterol (LDL) to target levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. In pediatric patients with familial hypercholesterolemia, it is also used as a dietary adjunct to reduce cholesterol and related indicators. Furthermore, it may assist in treating patients with dysbetalipoproteinemia and is effective in reducing the risk of stroke, myocardial infarction, and artery revascularization in adults at high risk for cardiovascular disease. Therefore, this drug is used for various types of lipid issues related to hypercholesterolemia and for reducing the risk of cardiovascular diseases.

How to take

Adult dose

The medication can be administered at any time of the day regardless of meals. The initial dosage is 5 mg once daily, and if greater reductions in LDL cholesterol are needed, the maintenance dosage can be adjusted accordingly. The maintenance dosage is typically 10 mg once daily, and most patients will be managed at this dosage. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The dosage should be individually adjusted based on the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or longer.

Precautions

This medication should not be used in certain patients. For example, it is contraindicated in patients with an allergy to this drug, severe liver dysfunction, or muscle disorders. Additionally, patients with significantly impaired kidney function, pregnant or breastfeeding women should not use this medication. It contains lactose, so caution is needed for patients with lactose intolerance. Patients who consume excessive alcohol or have a history of liver disease should undergo liver function tests before starting this medication and should have their liver function monitored regularly during treatment. If symptoms of myalgia or myopathy occur, patients should inform their healthcare provider immediately, and if severe muscle-related adverse symptoms appear, the discontinuation of the medication may be necessary. This drug may interact with other medications; therefore, it's essential to inform your healthcare provider about any medications being taken. Special caution is required when co-administering with certain antivirals, immunosuppressants, or fibrate drugs. Women of childbearing potential should use appropriate contraception, and this medication should not be used during pregnancy. In cases of overdose, there is no specific antidote, so symptomatic treatment and liver and muscle function testing are required. Caution is advised when driving or operating machinery as dizziness may occur. This medication can rarely cause severe skin reactions, liver damage, or muscle damage in some patients, and if symptoms occur, one should consult a physician immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, severe muscle weakness, critical myopathy, ocular muscle weakness, hepatitis, jaundice, liver failure, acute renal failure, oliguria, chest tightness, difficulty breathing, dyspnea, severe skin adverse reactions, severe liver abnormalities, severe allergic reactions, severe swelling or urination abnormalities, severe renal

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function test results
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • increased transaminases
  • ocular muscle weakness
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1°C and 30°C to preserve the efficacy and safety of the drug.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP*2), 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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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.