Medication info
Cratin Tablet 10 mg (Rosuvastatin Calcium)

Cratin Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201602575 · Approved 2016.05.10 · Insurance code 694001070

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dosage is 5 mg once daily and can be adjusted to a maintenance dose if greater LDL cholesterol reduction is needed. The maintenance dose is usually 10 mg once daily, and most patients are managed at this dose. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, at an interval of four weeks or more, with a maximum dose of 20 mg per day.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The administered dosage should be adjusted according to the recommended treatment goals for each individual patient.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • increased total cholesterol
  • increased LDL cholesterol
  • increased Apo-B protein level
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol level
View approved original text

This drug is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia who are inadequately controlled with diet and exercise alone. It also aids patients with homozygous familial hypercholesterolemia as an adjunct to diet or other lipid-lowering therapies. This drug lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It may be used as an adjunct to diet in pediatric patients aged 10 to 17 years who meet specific criteria for heterozygous familial hypercholesterolemia. It is also effective as an adjunct to diet in patients with primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization interventions in men over 50 years and women over 60 years with elevated high-sensitivity C-reactive protein levels in high cardiovascular risk groups. In summary, this drug is used to improve cholesterol levels and reduce cardiovascular disease risk in various forms of hypercholesterolemia and high-risk cardiovascular groups.

Dosage and Administration

Adult dosage

The initial dosage is 5 mg once daily and can be adjusted to a maintenance dose if greater LDL cholesterol reduction is needed. The maintenance dose is usually 10 mg once daily, and most patients are managed at this dose. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, at an interval of four weeks or more, with a maximum dose of 20 mg per day.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The administered dosage should be adjusted according to the recommended treatment goals for each individual patient.

Precautions

This drug should not be used in patients with known allergies to any of its components. It should not be administered to patients with active liver disease or significantly elevated liver enzyme levels. This drug is contraindicated in patients with muscle-related diseases or severely impaired kidney function. Pregnant or nursing women, and women of childbearing age who are not using appropriate contraception, should not take this drug, and it should only be administered if they have a low risk of pregnancy and understand the risks to the fetus. High-dose use is prohibited in patients at high risk of muscle disorders. This drug contains lactose; patients with lactose intolerance or related genetic diseases should not take it. Patients who excessively consume alcohol or have a history of liver disease should undergo regular liver function tests while using this drug. Muscle-related side effects, such as myalgia, myopathy, and rhabdomyolysis, can occur; therefore, if any unusual muscle symptoms develop, the patient should consult a doctor immediately. Older patients, those with renal impairment, hypothyroidism, a history of genetic muscle disease, and the elderly are at increased risk of muscle side effects and require caution. In cases of severe acute illness or postoperative states, this drug should be discontinued. As with other statins, severe myopathy or ocular muscle weakness can occur; therefore, dosing should be discontinued upon symptom manifestation. Certain drug interactions may increase this drug's serum concentration, raising the risk of muscle side effects; patients should discuss any concomitant medication with their healthcare provider. Temporary proteinuria may occur with high-dose use, necessitating kidney function tests. Asian patients may exhibit higher drug exposure, necessitating dose adjustment. For pediatric and adolescent patients, limited reports of impacts on growth and sexual development necessitate careful observation. Interstitial lung disease, severe liver injury, and severe skin reactions (such as Stevens-Johnson syndrome) may develop while taking this drug; patients should inform their medical team immediately of any unusual symptoms. Blood glucose levels may increase, so patients at high risk of diabetes should manage their blood sugar carefully. In the case of overdose, there is no specific antidote; symptomatic treatment and monitoring of liver function and muscle enzymes should be performed. Caution is advised when driving or operating machinery due to the possibility of dizziness.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy, rhabdomyolysis, polyneuropathy, peripheral neuropathy, severe myopathy, dyspnea, ocular muscle weakness, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute renal failure, oliguria, increased blood pressure, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • cough
  • diarrhea
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  • thrombocytopenia
  • increased transaminases
  • hematuria
  • fatigue
  • numbness
  • dysesthesia
  • chest discomfort
  • poor appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive impairment
  • confusion

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

Storage

This drug should be stored in a tightly sealed container to avoid exposure to air or moisture and should be kept at room temperature between 1 to 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained, and degradation can be prevented.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.

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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.