Medication info
Combirocan Tablet 5/16 mg

Combirocan Tablet 5/16 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletCandesartan Cilexetil›16mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201803502 · Approved 2018.08.28 · Insurance code 657203350

Summary

Main use
(Hypertension, heart failure) improvement and (hyperlipidemia, cardiovascular disease risk) reduction effect
Who takes it
Adults · Children
Adult dose
For the treatment of essential hypertension with Candesartan Cilexetil, the recommended dose for adults is 8-16 mg orally once a day. If blood pressure control is insufficient, the dose may be increased to a maximum of 32 mg once daily. For heart failure, the initial dose is 4 mg once daily, and the dose can be doubled at intervals of 2 weeks up to a maximum of 32 mg once daily. Rosuvastatin should be started at an initial dose of 5 mg once daily, and if necessary,
Child dose
The safety and efficacy in adolescents and children under 18 years have not been established. Therefore, it should not be administered to children.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

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

  • Essential hypertension
  • impaired left ventricular systolic function
  • hyperlipidemia
  • familial hypercholesterolemia
  • abnormal beta-lipoproteinemia
  • risk factors for coronary heart disease
  • risk of stroke
  • risk of myocardial infarction
  • risk of arterial revascularization
View approved original text

This medication is used for patients who need to be treated with the two components, Candesartan Cilexetil and Rosuvastatin. Candesartan Cilexetil is effective for patients with essential hypertension and those with heart failure with impaired left ventricular systolic function, especially when an additional ACE inhibitor is needed or if there is poor tolerance. Rosuvastatin is mainly used to treat hyperlipidemia that is not controlled by diet and exercise or familial dyslipidemia. Additionally, it is used as an adjunct to dietary therapy to delay the progression of atherosclerosis and helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in high-risk cardiovascular disease patients. This medication is used for the improvement of health in patients who require control of hypertension and blood cholesterol.

How to take

Adult dose

For the treatment of essential hypertension with Candesartan Cilexetil, the recommended dose for adults is 8-16 mg orally once a day. If blood pressure control is insufficient, the dose may be increased to a maximum of 32 mg once daily. For heart failure, the initial dose is 4 mg once daily, and the dose can be doubled at intervals of 2 weeks up to a maximum of 32 mg once daily. Rosuvastatin should be started at an initial dose of 5 mg once daily, and if necessary,

Child dose

The safety and efficacy in adolescents and children under 18 years have not been established. Therefore, it should not be administered to children.

Precautions

This medication can cause serious harm to the fetus, especially during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. People with an allergy to this medication or its components, those with liver disease or pregnant women, patients with severe liver impairment, and those with myopathy should not use this medication. Elderly patients, those with hyperkalemia, patients with mild to moderate liver disease, etc., should use it with caution and should have liver function and muscle health status checked periodically. This medication may cause serious muscle-related side effects such as muscle pain, myopathy, and rarely rhabdomyolysis, so if there is any pain or weakness in the muscles, consult a doctor immediately. Liver enzyme levels should be checked before and during treatment as abnormal liver function may occur, and if abnormalities are found, the medication should be discontinued. This medication can also affect renal function, so patients with kidney disease or kidney transplant patients should use it cautiously according to their doctor's advice. When taken with other antihypertensive drugs or diuretics, potassium supplements may increase blood potassium levels, so regular blood tests are necessary. This medication may interact with other drugs, so if you are taking any other medications, be sure to inform your doctor or pharmacist. Caution is needed when driving or operating machinery as dizziness or fatigue may occur.

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 fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • hordeolum
  • local infection
  • periodontitis
  • chest discomfort
  • fatigue
  • inflammation
  • foreign body sensation
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  • generalized pruritus
  • dermatitis
  • itching
  • joint stiffness
  • limb pain
  • photophobia
  • dyspepsia
  • hand fractures
  • increased blood sugar
  • decreased blood sodium
  • nausea
  • hypoglycemia
  • renal stones
  • cough
  • extraction
  • orthostatic dizziness
  • muscle pain
  • throat pain
  • musculoskeletal pain
  • cataract
  • increased blood pressure
  • elevated blood creatinine
  • thirst
  • sleep disorders
  • sexual

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 air and moisture, and it is safe to store at a temperature between 1 degree and 30 degrees Celsius (room temperature). Storing it this way will help maintain the efficacy of the medication for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablet

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.