Medication info

Krestin Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
대한약품공업(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets PTP
Approval status
Expired

MFDS item code 201000996 · Approved 2010.01.28

This product's status changed to Expired on 2024.10.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
It can be administered at any time during the day regardless of meals. The initial dose is 5 mg once daily, and it can be adjusted to a maintenance dose. The maintenance dose is usually adjusted to 10 mg once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol level, treatment goals, and patient response at intervals of 4 weeks or more, and can be increased up to a maximum of 20 mg per day.
Children's dosage
The usual dosage range is 5 mg to 20 mg once daily. The administration dose should be adjusted according to the therapeutic goal of each individual patient and can be modified at intervals of 4 weeks or more. For children under 10 years old, the safety and efficacy have not been established.

Ingredients

Manufacturer
대한약품공업(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
View approved original text

This medicine is used in patients with primary hypercholesterolemia and mixed dyslipidemia who cannot control their cholesterol levels with diet and exercise alone. It is also used as an adjunctive therapy for patients with homozygous familial hypercholesterolemia. This medication lowers total cholesterol and LDL-cholesterol levels, delays the progression of atherosclerosis, and is effective for children and adolescents with familial hypercholesterolemia. Additionally, it is used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged patients at high risk for cardiovascular disease. Therefore, this medication is effectively used for hyperlipidemia and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

It can be administered at any time during the day regardless of meals. The initial dose is 5 mg once daily, and it can be adjusted to a maintenance dose. The maintenance dose is usually adjusted to 10 mg once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol level, treatment goals, and patient response at intervals of 4 weeks or more, and can be increased up to a maximum of 20 mg per day.

Children's dosage

The usual dosage range is 5 mg to 20 mg once daily. The administration dose should be adjusted according to the therapeutic goal of each individual patient and can be modified at intervals of 4 weeks or more. For children under 10 years old, the safety and efficacy have not been established.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to it, patients with severely impaired liver function, patients with muscle disorders, patients taking certain medications, and patients with severe kidney dysfunction. Additionally, it should be used cautiously in pregnant or breastfeeding women, and in fertile women who are not using adequate contraception. Patients at high risk for muscle-related side effects, such as those with hypothyroidism or a history of genetic muscle disorders, should be monitored closely, particularly at high doses. This medication contains lactose, so it should not be administered to patients with lactose intolerance or related genetic conditions. It is important to regularly monitor liver function and muscle condition during treatment with this medication. If symptoms such as myalgia, muscle weakness, fatigue, or fever occur, patients should immediately inform their healthcare provider, and if necessary, discontinue use. Patients who consume alcohol excessively or have a history of liver disease should undergo liver function testing before taking this medication and be monitored closely. This medication may interact with other drugs, so it is essential to inform the healthcare provider of any other medications being taken. Pregnant or breastfeeding women should avoid using this medication as it may pose risks to the fetus or baby, so they should ensure contraception or refrain from use. In the event of an overdose, there is no specific antidote, so treatment should be tailored to symptoms, and liver function and muscle enzyme levels should be monitored. Dizziness may occur while taking this medication, so caution is advised when driving or operating machinery. Finally, if serious skin reactions occur while taking this medication, it should be discontinued immediately, and the healthcare provider should be consulted.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, muscle disorders, rhabdomyolysis, severe muscle weakness, oculomotor muscle weakness, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute kidney failure, oliguria, chest tightness, shortness of breath, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
Show 16 more
  • diarrhea
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • joint pain
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough

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. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets PTP

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.