Medication info
Kratin Tablet 20mg (Rosuvastatin Calcium)

Kratin Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201602574 · Approved 2016.05.10 · Insurance code 694001080

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For the treatment of primary hypercholesterolemia and mixed hyperlipidemia, administer 5 mg once daily at any time of the day, regardless of meals. If more reduction in LDL-cholesterol is needed, adjust the maintenance dose to 10 mg once daily and may increase to a maximum of 20 mg daily according to treatment goals and patient response at intervals of at least 4 weeks.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), doses of 5 mg to 20 mg are administered once daily. The dosage should be adjusted based on individual treatment goals at intervals of at least 4 weeks.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • excess total cholesterol
  • excess LDL-cholesterol
  • excess Apo-B protein levels
  • risk factors for coronary heart disease
  • excess high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
View approved original text

This medication is used in those patients with primary hypercholesterolemia and mixed hyperlipidemia who are not adequately controlled with a diet and exercise. It is also used as an adjunct to diet in patients with homozygous familial hypercholesterolemia and helps to lower total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis. In some pediatric patients with heterozygous familial hypercholesterolemia, it is used as an adjunct to diet to reduce cholesterol and Apo-B protein levels. It can also assist patients with primary dysbetalipoproteinemia. Particularly, in men over the age of 50 and women over the age of 60 with certain cardiovascular disease risk factors, it contributes to risk reduction for stroke, myocardial infarction, and arterial revascularization. This medication is used primarily for the treatment of hyperlipidemia and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

For the treatment of primary hypercholesterolemia and mixed hyperlipidemia, administer 5 mg once daily at any time of the day, regardless of meals. If more reduction in LDL-cholesterol is needed, adjust the maintenance dose to 10 mg once daily and may increase to a maximum of 20 mg daily according to treatment goals and patient response at intervals of at least 4 weeks.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), doses of 5 mg to 20 mg are administered once daily. The dosage should be adjusted based on individual treatment goals at intervals of at least 4 weeks.

Precautions

This medication should not be used in certain patients. For instance, it should not be given to patients with an allergy to its components, those with severely impaired liver function, patients with muscle disorders, those taking cyclosporine, patients with severe renal impairment, and women who are pregnant or breastfeeding. Additionally, high-dose use is prohibited in patients at high risk for muscle disorders. As this medication contains lactose, it should not be administered to patients with certain genetic lactose intolerance. This medication can affect liver function; therefore, patients who consume alcohol excessively or have a history of liver disease should undergo repeat liver function tests before administration. Muscle-related side effects such as myalgia or myopathy may occur, so any symptoms of muscle pain or weakness should be reported to healthcare professionals immediately. Patients with renal impairment, hypothyroidism, or a history of genetic muscle disorders should be especially cautious. This medication may rarely cause serious skin reactions or liver damage; therefore, administration should be stopped immediately if symptoms such as rash or jaundice occur. Drug interactions may occur when used concurrently with other medications, so if you are taking other drugs, you must inform your healthcare provider. In particular, some antiviral agents, immunosuppressants, and antifungal drugs may increase the blood levels of this medication, raising the risk of muscle side effects. Women who are pregnant or of childbearing potential should employ appropriate contraception and should not use this medication during pregnancy. Breastfeeding should also be avoided while using this medication. In case of overdose, since there is no specific antidote, management is based on symptoms and monitoring liver function and muscle enzyme levels. Caution is advised as dizziness may occur while driving or operating machinery. This medication may show higher blood levels in Asians, therefore dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular myasthenia, rhabdomyolysis, immune-mediated necrotizing myopathy, edema, difficulty breathing, thrombocytopenia, acute renal failure, oliguria, serious adverse drug reactions (muscle pain, joint pain)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paraesthesia
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius to safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablet

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.

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.