Medication info
Rotacan Tablet 20/32 Milligrams

Rotacan Tablet 20/32 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletCandesartan Cilexetil›32mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Pink round film-coated tablets
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201702408 · Approved 2017.05.16 · Insurance code 643605420

Summary

Main use
Improvement of (hypertension, heart failure) and suppression of (hypercholesterolemia, cardiovascular disease risk)
Who takes it
Adults · Children
Adult dose
Candesartan Cilexetil 1. Essential Hypertension - The recommended initial and maintenance dose is 8–16 mg orally once daily. - After 4 weeks of treatment at 16 mg, if blood pressure is not controlled, it may be increased to a maximum of 32 mg once daily. - For patients with decreased intravascular effective blood volume, the initial dose is 4 mg. - For patients with renal impairment, the initial dose is 4 mg, and for those with liver impairment, the initial dose is 2 mg. 2. Heart Failure - The initial dose is recommended at 4 mg once daily.
Child dose
The safety and efficacy of Candesartan Cilexetil in the pediatric population under 18 years old have not been established. Therefore, it is not recommended for dosing in children.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Improvement of (hypertension, heart failure) and suppression of (hypercholesterolemia, cardiovascular disease risk)

  • Essential hypertension
  • left ventricular systolic dysfunction
  • primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used for patients who need to take Candesartan Cilexetil and Rosuvastatin together. Candesartan Cilexetil is effective for patients with essential hypertension or those with heart failure and impaired left ventricular function when additional treatment with ACE inhibitors is needed or if there is poor tolerance. Rosuvastatin helps with hypercholesterolemia and familial hypercholesterolemia that cannot be controlled by diet and exercise, slows the progression of atherosclerosis, and reduces cardiovascular disease risk. It is particularly used in patients with high-sensitive C-reactive protein levels and other additional cardiovascular risk factors to lower the risk of stroke, myocardial infarction, and vascular revascularization. These two medications help improve cardiovascular health by controlling blood pressure and cholesterol levels.

How to take

Adult dose

Candesartan Cilexetil 1. Essential Hypertension - The recommended initial and maintenance dose is 8–16 mg orally once daily. - After 4 weeks of treatment at 16 mg, if blood pressure is not controlled, it may be increased to a maximum of 32 mg once daily. - For patients with decreased intravascular effective blood volume, the initial dose is 4 mg. - For patients with renal impairment, the initial dose is 4 mg, and for those with liver impairment, the initial dose is 2 mg. 2. Heart Failure - The initial dose is recommended at 4 mg once daily.

Child dose

The safety and efficacy of Candesartan Cilexetil in the pediatric population under 18 years old have not been established. Therefore, it is not recommended for dosing in children.

Precautions

This medication can cause severe harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it must be discontinued immediately if pregnancy is confirmed. Patients with allergies to this drug or its components, those with active liver disease, women who are pregnant or breastfeeding, patients with severe liver impairment, those with myopathy, hereditary angioedema patients, those with severe kidney failure, and patients on certain other medications should not take this medicine. Elderly patients, those with hyperkalemia, mild to moderate liver impairment, and patients with heart or kidney-related diseases should take this medication with caution, requiring regular blood tests and monitoring of physical condition during treatment. This medication can cause serious muscle-related side effects such as myalgia, myopathy, and rarely rhabdomyolysis, so if symptoms of muscle pain or weakness occur, immediate consultation with a doctor is required. Possible liver function abnormalities may arise; therefore, liver function tests should be performed periodically before and during treatment, and if liver enzyme levels rise significantly, treatment should be discontinued. This medication may interact with other drugs, so it is crucial to inform the doctor or pharmacist of any other medications being taken, especially if combined with potassium-sparing diuretics, certain antibiotics, antifungals, immunosuppressants, etc. Women who are pregnant or breastfeeding should not use this medication, and those planning pregnancy should use appropriate contraceptive methods. The safety and efficacy of this medication have not been established in children, so it is not recommended for pediatric use. In case of overdose, symptoms such as hypotension, dizziness, and tachycardia may occur, requiring immediate treatment. During treatment, dizziness or fatigue may occur due to blood pressure lowering, so caution is advised while driving or operating machinery. Lastly, this medication should be kept out of reach of children and is safest when stored in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, confusion of consciousness, vision disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • maculopapular rash
  • local infection
  • periodontitis
  • fatigue
  • inflammation
  • foreign body sensation
  • itching
Show 28 more
  • dermatitis
  • joint stiffness
  • limb pain
  • photophobia
  • dyspepsia
  • nausea
  • increased blood sugar
  • decreased sodium in the blood
  • hand fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • dental extraction
  • constipation
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • weakness
  • joint pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • sensory disturbances
  • chest discomfort
  • syncope
  • generalized pain
  • muscle pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, with a storage temperature maintained between 1 to 30 degrees Celsius. It is important to avoid direct sunlight or high temperatures, and to keep it in a place out of reach of children.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets (10 tablets/PTP X 3)

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

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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.