Medication info
Candesartan and Rosuvastatin Tablets 5/8 mg

Candesartan and Rosuvastatin Tablets 5/8 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletCandesartan Cilexetil›8mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Pink circular film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP X 3)]
Approval status
Active

MFDS item code 202008721 · Approved 2020.12.11 · Insurance code 649105090

Summary

Main use
(Hypertension, heart failure) improvement and (hyperlipidemia, cardiovascular disease risk) inhibition effect
Who takes it
Adults · Children
Adult dose
Candesartan Cilexetil for essential hypertension: The recommended oral dose is 8 to 16 mg once daily. After 4 weeks of administering 16 mg, if blood pressure is not controlled, the dose may be increased to a maximum of 32 mg once daily. For heart failure: An initial dose of 4 mg once daily is recommended, and the dose may be doubled at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. For Rosuvastatin for primary hyperlipidemia: Start with 5 mg once daily.
Child dose
The safety and efficacy in adolescents and children under 18 years of age have not been established.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

(Hypertension, heart failure) improvement and (hyperlipidemia, cardiovascular disease risk) inhibition effect

  • Essential hypertension
  • heart failure
  • reduced left ventricular systolic function
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hyperlipidemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
View approved original text

This medication is used for patients who need to take both components, Candesartan Cilexetil and Rosuvastatin. Candesartan Cilexetil is primarily used in patients with essential hypertension or heart failure with reduced left ventricular function when additional treatment with ACE inhibitors is needed or not tolerated. Rosuvastatin is used in combination with diet for patients with hyperlipidemia, particularly familial hypercholesterolemia and mixed hyperlipidemia, and as an adjunctive treatment for patients with homozygous familial hypercholesterolemia. Furthermore, it helps improve hyperlipidemia to slow the progression of atherosclerosis and aids in the treatment of dysbetalipoproteinemia. Additionally, it contributes to reducing the risk of stroke, myocardial infarction, and associated vascular revascularization in patients at high risk for cardiovascular disease. Therefore, this medication is used for the treatment of hypertension and heart failure, cholesterol regulation, and risk reduction for cardiovascular disease.

How to take

Adult dose

Candesartan Cilexetil for essential hypertension: The recommended oral dose is 8 to 16 mg once daily. After 4 weeks of administering 16 mg, if blood pressure is not controlled, the dose may be increased to a maximum of 32 mg once daily. For heart failure: An initial dose of 4 mg once daily is recommended, and the dose may be doubled at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. For Rosuvastatin for primary hyperlipidemia: Start with 5 mg once daily.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to this medication, severely compromised liver function, pregnant or breastfeeding women, and those with muscle disorders should not take this medication. Elderly patients, those with compromised liver function, or patients with hyperkalemia should take this medication with special caution, and regular blood tests and physical status checks are recommended. Symptoms such as muscle aches, weakness, headaches, dyspepsia may appear during treatment, and if these symptoms are severe or persistent, a physician should be consulted immediately. This medication may interact with other drugs, so if you are taking other medications, it is essential to inform your doctor or pharmacist. Women who may become pregnant should use appropriate contraceptive methods, and breastfeeding women should avoid taking this medication. In cases of overdose, hypotension and dizziness may occur, and immediate medical attention is required. Be cautious when driving or operating machinery as dizziness due to lowered blood pressure may occur. Store out of reach of children and do not transfer medications to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest discomfort, difficulty breathing, cold sweats, paleness, severe rash with fever, blistering, skin peeling, oral/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice of the skin or eyes, systemic malaise, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, vision changes, paralysis, decreased urine output, systemic heart failure

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • localized infection
  • periodontitis
  • fatigue
  • inflammation
  • foreign body sensation
  • itching
  • joint stiffness
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  • limb pain
  • glare
  • dyspepsia
  • nausea
  • increased blood sugar
  • decreased serum sodium
  • bone fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • tooth extraction
  • orthostatic dizziness
  • hives
  • rash
  • weakness
  • muscle pain
  • joint pain
  • muscle cramps
  • abdominal pain
  • diarrhea
  • decreased appetite
  • abdominal distension
  • increased appetite
  • sleep disturbances
  • decreased libido
  • memory loss
  • altered taste

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. It is best stored at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink circular film-coated tablets

Package unit

30 tablets/box [(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.