Medication info
Candesartan Cilexetil and Rosuvastatin Tablets 5/16 mg

Candesartan Cilexetil and Rosuvastatin Tablets 5/16 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletCandesartan Cilexetil›16mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/box [10 tablets/PTPX3]
Approval status
Active

MFDS item code 202107089 · Approved 2021.10.25 · Insurance code 694003650

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 starting and maintenance dose is 8 to 16 mg orally once daily. - If blood pressure remains uncontrolled after 4 weeks of treatment at 16 mg once daily, it can be increased to a maximum of 32 mg once daily. - In patients with decreased effective blood volume or renal impairment, the initial dose is 4 mg. - In patients with mild to moderate liver impairment, the initial dose is 2 mg once daily. 2. Heart Failure
Child dose
The safety and efficacy in adolescents and children under 18 years have not been established.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

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

  • Essential hypertension
  • heart failure
  • hypercholesterolemia
  • dyslipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • stroke risk
  • myocardial infarction risk
  • revascularization procedure risk
View approved original text

This medication is suitable for patients using both Candesartan Cilexetil and Rosuvastatin simultaneously. Candesartan Cilexetil is used for the treatment of essential hypertension and in patients with heart failure with impaired left ventricular function who require additional treatment with ACE inhibitors or who cannot tolerate them. Rosuvastatin is mainly administered as an adjunct to diet for patients with hypercholesterolemia (including primary and familial) and combined dyslipidemia, and is also effective in patients with homozygous familial hypercholesterolemia and dysbetalipoproteinemia. Additionally, it lowers blood cholesterol levels, delaying the progression of atherosclerosis, and reduces the risk of stroke, myocardial infarction, and revascularization procedures in patients at high risk for cardiovascular diseases. Therefore, this medication improves the management of hypertension, heart failure, and cardiovascular diseases associated with complex dyslipidemia.

How to take

Adult dose

Candesartan Cilexetil 1. Essential Hypertension - The recommended starting and maintenance dose is 8 to 16 mg orally once daily. - If blood pressure remains uncontrolled after 4 weeks of treatment at 16 mg once daily, it can be increased to a maximum of 32 mg once daily. - In patients with decreased effective blood volume or renal impairment, the initial dose is 4 mg. - In patients with mild to moderate liver impairment, the initial dose is 2 mg once daily. 2. Heart Failure

Child dose

The safety and efficacy in adolescents and children under 18 years have not been established.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters; therefore, if pregnancy is confirmed, it should be discontinued immediately. This medication should not be given to patients with certain liver diseases, severely impaired kidney function, muscle disease history, and genetically induced lactose intolerance. Caution should be exercised in the elderly, patients with hyperkalemia, and those with compromised liver function while using this medication, and regular blood tests should be conducted to monitor their condition if necessary. If symptoms such as muscle pain or weakness occur, consult a doctor immediately; if blood markers indicating muscle damage increase along with these symptoms, the medication should be stopped. This medication may affect liver function; therefore, liver enzyme levels should be checked before and during administration, and if abnormalities are found, treatment should be discontinued. There is a risk of excessively low blood pressure or worsening kidney function, so especially in patients with heart failure or renal impairment, blood pressure and kidney function should be monitored regularly during administration. There may be interactions with other medications, so if you are taking any other medications, you must inform your doctor or pharmacist. Women of childbearing potential should use appropriate contraceptive methods while taking this medication, and breastfeeding women should avoid taking it or discontinue breastfeeding. The safety and efficacy of this medication have not been established in children and is not recommended. In case of overdose, appropriate treatment is required depending on the symptoms, and as there is no specific antidote, symptom management and monitoring are crucial. Dizziness or lethargy may occur while taking this medication; therefore, caution is advised when driving or operating machinery. Keep this medication out of reach of children and do not transfer it to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, shock, syncope, loss of consciousness, rash, Stevens-Johnson syndrome, eosinophilia and systemic symptoms drug reaction syndrome (DRESS), jaundice, hepatitis, acute renal failure, increased serum creatinine, thrombocytopenia, cerebrovascular accident, inflammatory spinal cord disease, pneumonia, unstable angina, idiopathic pulmonary fibrosis, worsening hypertension, vertigo, postural vertigo, adrenal insufficiency, blood pressure increase

Mild side effects

  • Headache
  • dizziness
  • positional dizziness
  • nasopharyngitis
  • papules
  • local infections
  • periodontitis
  • chest discomfort
  • fatigue
  • inflammation
Show 27 more
  • foreign body sensation
  • generalized pruritus
  • dermatitis
  • itching
  • arthralgia
  • musculoskeletal pain
  • neck pain
  • limb pain
  • cataract
  • glare
  • dyspepsia
  • nausea
  • increased blood sugar
  • decreased serum sodium
  • hand fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • tooth extraction
  • nausea
  • constipation
  • abdominal pain
  • diarrhea
  • anorexia
  • abdominal distention
  • syncope
  • generalized pain

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 exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTPX3]

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.