Medication info
Robitan 20 mg (Rosuvastatin Calcium)

Robitan 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
삼일제약(주)
Appearance
Pink round film-coated tablet
Packaging
14 tablets/blister X 2
Approval status
Active

MFDS item code 201001006 · Approved 2010.01.28 · Insurance code 643902820

Summary

Main use
Treatment of hypercholesterolemia and reduced risk of cardiovascular disease
Who takes it
Adults · Children
Adult dose
Can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is required, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, which is suitable for most patients. The maintenance dose should be adjusted 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 individual patients. The dosage should be adjusted at intervals of 4 weeks or longer.

Ingredients

Manufacturer
삼일제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduced risk of cardiovascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • familial combined hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as an adjunctive treatment when dietary changes and exercise alone are insufficient to control primary hypercholesterolemia and mixed dyslipidemia in patients. It also aids in the treatment of patients with homozygous familial hypercholesterolemia and lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It can be safely used in pediatric patients aged 10 to 17 with familial hypercholesterolemia and serves as an adjunctive therapy for patients with dysbetalipoproteinemia. Moreover, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged adults with high levels of high-sensitivity C-reactive protein and additional cardiovascular risk factors. This medication is used to improve various dyslipidemia and cardiovascular risk conditions.

How to take

Adult dose

Can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is required, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, which is suitable for most patients. The maintenance dose should be adjusted 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 individual patients. The dosage should be adjusted at intervals of 4 weeks or longer.

Precautions

This medication should not be used by certain patients. For example, patients with allergies to any ingredient of this medication, those with severely impaired liver function, and those with muscle diseases should not take it. Additionally, patients with severely impaired kidney function or women who are pregnant or breastfeeding also should not use this medication. Women of childbearing age may take this drug only when the possibility of pregnancy is low. Patients who are prone to muscle-related problems, such as those with moderate or severe kidney function impairment, hypothyroidism, family history of muscle disease, alcoholics, and those taking certain concurrent medications should be especially cautious. As this medication contains lactose, individuals with lactose intolerance or related genetic disorders should not take it. Patients who drink alcohol excessively or have a history of liver disease should have regular liver function tests before and during use of this medication. In cases of hypothyroidism or nephrotic syndrome, the underlying conditions should be treated first. This drug can cause muscle-related side effects, such as myalgia or muscle weakness, so immediate medical attention should be sought if symptoms such as myalgia, muscle weakness, or cramps occur. Patients at high risk of muscle damage are advised to have muscle enzyme tests before and during treatment. This medication should be discontinued in situations where acute severe illness or renal failure worsens. This drug can rarely induce or worsen severe muscle weakness or ophthalmoplegia, and use should be discontinued if such symptoms occur. The risk of muscle-related side effects may increase when combined with certain other medications, so it is necessary to consult a healthcare professional regarding concurrent medications. High-dose use may impact kidney function, so kidney function tests should be considered. In Asians, drug concentration may be higher, necessitating dosage adjustments. For children and adolescents, caution is required due to limited data on effects on growth and sexual development. This medication contains specific dyes, so patients allergic to these components should be cautious. While taking this drug, there have been reports of liver function abnormalities, elevated blood sugar, and increased risk of diabetes, so blood sugar and liver function should be monitored regularly. Severe allergic skin reactions may occur rarely, so if rashes or severe allergic symptoms develop, the medication should be immediately discontinued, and medical advice should be sought. This medication can interact with multiple drugs, so patients should inform their healthcare provider of any other medications they are taking. Women who are pregnant or breastfeeding should not take this medication, and appropriate contraceptive methods should be used if planning to become pregnant. In case of overdose, there is no specific antidote, so treatment should be symptomatic, with monitoring of liver function and muscle enzyme levels.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, severe muscle weakness, dyspnea, ophthalmoplegia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia and systemic symptom drug reaction syndrome (DRESS), immune-mediated necrotizing myopathy, edema, acute renal failure, oliguria, increased serum creatinine, fatal and non-fatal liver failure

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • general pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • sensory disturbances
  • cough
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 to 30 degrees Celsius. Proper storage will prolong the effectiveness of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

14 tablets/blister X 2

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.