Medication info

Canderova Tablet 5/16 mg

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

MFDS item code 202008712 · Approved 2020.12.11

Summary

Main use
(Hypertension, heart failure) improvement and (hypercholesterolemia, cardiovascular disease risk) inhibition
Who takes it
Adults · Children
Adult dose
Candesartan Cilexetil 1. Essential Hypertension - Initial and maintenance dosage: Recommended oral administration of 8 to 16 mg once daily. - If blood pressure control is insufficient, dosage may be increased to a maximum of 32 mg once daily. - In patients with reduced intravascular effective blood volume: Initial dose of 4 mg. - In patients with kidney impairment: Initial dose of 4 mg, adjusted based on patient response. - In patients with liver impairment: For mild to moderate liver impairment, initial dose is 2 mg once daily, adjusted based on response. Rosuvastatin 1. Primary Hypercholesterolemia (including heterozygous familial hypercholesterolemia, type IIa), Mixed Hyperlipidemia (type IIb), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia Patients receiving this medication must follow a standard cholesterol-lowering diet, which should be continued throughout treatment. It can be administered at any time during the day, regardless of meals. The initial dose is 5 mg once daily, with maintenance doses adjusted based on the need for further LDL cholesterol reduction. The maintenance dose is typically 10 mg once daily for most patients, and should be appropriately adjusted at least every 4 weeks based on LDL cholesterol levels, treatment goals, and patient response, with a maximum increase of up to 20 mg once daily. 2. Elderly: No dose adjustment is necessary. 3. Patients with renal insufficiency: No dose adjustment is necessary for mild and moderate renal impairment. It is contraindicated in severe renal insufficiency. Caution is required when administering 20 mg to patients with moderate renal impairment. 4. Hepatic impairment: No significant increase in overall exposure was observed in patients with Child-Pugh scores of 7 or lower, but there was an increase in those with scores of 8 or 9. Renal function tests should be considered in these patients. There is no experience with patients having a Child-Pugh score exceeding 9, and this medication is not to be administered in cases of active liver disease.
Child dose
Safety and efficacy in patients under 18 years of age have not been established.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

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

  • Essential hypertension
  • impaired left ventricular systolic function
  • intolerance to ACE inhibitors
  • primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is used for patients who need to take both Candesartan Cilexetil and Rosuvastatin simultaneously. Candesartan Cilexetil is used for the treatment of essential hypertension and in heart failure patients with impaired left ventricular function who require additional treatment or cannot tolerate ACE inhibitors. Rosuvastatin is used as an adjunct in the treatment of primary hypercholesterolemia, familial hypercholesterolemia, and mixed hyperlipidemia, reducing total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. It also helps reduce the risk of stroke, myocardial infarction, and vascular reconstruction procedures in high-risk cardiovascular patients. This drug is used to improve cardiovascular health through the management of blood pressure and cholesterol.

How to take

Adult dose

Candesartan Cilexetil 1. Essential Hypertension - Initial and maintenance dosage: Recommended oral administration of 8 to 16 mg once daily. - If blood pressure control is insufficient, dosage may be increased to a maximum of 32 mg once daily. - In patients with reduced intravascular effective blood volume: Initial dose of 4 mg. - In patients with kidney impairment: Initial dose of 4 mg, adjusted based on patient response. - In patients with liver impairment: For mild to moderate liver impairment, initial dose is 2 mg once daily, adjusted based on response. Rosuvastatin 1. Primary Hypercholesterolemia (including heterozygous familial hypercholesterolemia, type IIa), Mixed Hyperlipidemia (type IIb), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia Patients receiving this medication must follow a standard cholesterol-lowering diet, which should be continued throughout treatment. It can be administered at any time during the day, regardless of meals. The initial dose is 5 mg once daily, with maintenance doses adjusted based on the need for further LDL cholesterol reduction. The maintenance dose is typically 10 mg once daily for most patients, and should be appropriately adjusted at least every 4 weeks based on LDL cholesterol levels, treatment goals, and patient response, with a maximum increase of up to 20 mg once daily. 2. Elderly: No dose adjustment is necessary. 3. Patients with renal insufficiency: No dose adjustment is necessary for mild and moderate renal impairment. It is contraindicated in severe renal insufficiency. Caution is required when administering 20 mg to patients with moderate renal impairment. 4. Hepatic impairment: No significant increase in overall exposure was observed in patients with Child-Pugh scores of 7 or lower, but there was an increase in those with scores of 8 or 9. Renal function tests should be considered in these patients. There is no experience with patients having a Child-Pugh score exceeding 9, and this medication is not to be administered in cases of active liver disease.

Child dose

Safety and efficacy in patients under 18 years of age have not been established.

Precautions

This medication can cause serious risks to the fetus and newborn during pregnancy, and should be discontinued immediately if pregnancy is confirmed. This drug is contraindicated in certain patients with severe liver disease, significantly impaired kidney function, hereditary angioedema, and others. Elderly patients, those with impaired liver function, and patients with high potassium levels should be monitored more carefully while using this drug. If symptoms such as muscle pain or weakness occur, consult a physician immediately, and in severe cases, it may be necessary to discontinue the medication. This drug may interact with other medications, so patients must inform healthcare providers of any other drugs they are taking. Pregnant or breastfeeding women are advised not to take this medication, and women of childbearing age should use appropriate contraception. Safety and efficacy in pediatric patients have not been established, and thus this medication is not recommended for children. In cases of overdose, appropriate treatment is required depending on the symptoms, as this medication is not removed by dialysis. Care should be taken when driving or operating machinery, as dizziness or fatigue may occur. This medication should be stored out of the reach of children, and it is not recommended to transfer it from the original container to another.

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, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, decreased urine output

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • local infection
  • gingivitis
  • itching
  • generalized itching
  • dermatitis
  • joint stiffness
  • limb pain
Show 27 more
  • glare
  • dyspepsia
  • increased blood sugar
  • decreased sodium in the blood
  • hand fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • nausea
  • fever
  • fatigue
  • weakness
  • constipation
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abnormal liver function tests
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thirst
  • sleep disturbances
  • reduced libido
  • forgetfulness
  • increased appetite
  • itch

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, at room temperature between 1 degree and 30 degrees Celsius. Proper storage will ensure the drug's effect is safely maintained.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3) - 30 tablets/PTP [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.

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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.