Medication info
Nebivolol/Rosuvastatin Tablets 2.5/5 mg

Nebivolol/Rosuvastatin Tablets 2.5/5 mg

Prescription medicationTablet경구
Ingredient · strength
Nebivolol Hydrochloride›5.45mg / 1 tabletRosuvastatin Calcium Micronized›20.8mg / 1 tablet
Manufacturer / importer
에리슨제약(주)
Appearance
White to almost white round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202006004 · Approved 2020.08.25 · Insurance code 620500340

Summary

Main use
Treatment for hypertension and heart failure improvement, reduction of risk of hypercholesterolemia and cardiovascular diseases
Who takes it
Adults
Adult dose
This medication is taken as a single tablet once daily for the convenience of patients who are receiving both nebivolol and rosuvastatin.

Ingredients

Manufacturer
에리슨제약(주)

Efficacy & effects

Treatment for hypertension and heart failure improvement, reduction of risk of hypercholesterolemia and cardiovascular diseases

  • Essential hypertension
  • chronic heart failure
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as a substitution therapy for patients receiving both nebivolol and rosuvastatin. Nebivolol is used as an adjunct treatment for essential hypertension and mild to moderate chronic stable heart failure in elderly patients aged 70 years and over. Rosuvastatin is used as an adjunct to diet in patients with hypercholesterolemia and familial hypercholesterolemia that cannot be controlled with diet and exercise, as well as in mixed dyslipidemia patients. It also aids in the treatment of homozygous familial hypercholesterolemia or dysbetalipoproteinemia. This medication helps lower total cholesterol and LDL cholesterol to normal levels, delay the progression of atherosclerosis, and reduce the risk of cardiovascular diseases (such as stroke, myocardial infarction, and post-angioplasty risk). Therefore, it is used for the reduction of hypertension and heart failure, hyperlipidemia, and the risk of cardiovascular diseases.

How to take

Adult dose

This medication is taken as a single tablet once daily for the convenience of patients who are receiving both nebivolol and rosuvastatin.

Precautions

This medication should not be used in patients who are allergic to specific components. It should also not be administered to patients with active liver disease or severe liver function impairment. It is contraindicated in patients with bradycardia or heart conduction disorders, as well as those with acute heart failure or uncontrolled heart failure. Patients with hypotension, severe peripheral circulation disorders, or a history of bronchial asthma should not take this medication. Use is restricted in pregnant or breastfeeding women, and in women of childbearing age without adequate contraceptive measures, and can only be used when the possibility of pregnancy is low and the risks have been thoroughly explained. High-dose administration is contraindicated for patients with a history of muscle diseases or risk factors for myopathy, and care should be taken with muscle-related adverse reactions. Patients with genetic metabolic issues such as lactose intolerance should also avoid this medication. Patients with chronic lung diseases, congestive heart failure, or diabetes should be administered this drug cautiously, and any symptoms of myalgia or muscle weakness should be reported to a healthcare professional immediately. Periodic testing of liver and muscle enzyme levels is important to check for the occurrence of side effects. As this medication may interact with other drugs, patients should inform their healthcare provider of any medications they are currently taking. Pregnant or breastfeeding women should not take this medication, and fertile women should exercise caution regarding pregnancy prevention. Elderly patients should start with a low dosage and be closely monitored. In case of overdose, patients should visit a healthcare facility immediately for appropriate treatment and monitor blood pressure and heart rate as necessary based on symptoms. This medication may cause dizziness when operating a vehicle or machinery, so caution is required. Keep out of reach of children, and store the medication in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Eye discharge
  • upper abdominal discomfort
  • gastritis
  • gastroesophageal reflux disease
  • chest pain
  • nasopharyngitis
  • flu
  • increased CK
  • increased ALT
  • increased AST
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  • increased blood potassium
  • hyperkalemia
  • musculoskeletal chest pain
  • musculoskeletal pain
  • musculoskeletal stiffness
  • headache
  • dizziness
  • hematuria
  • hematoma
  • rash
  • itching
  • diarrhea
  • constipation
  • nausea
  • dyspepsia
  • vomiting
  • erectile dysfunction
  • fatigue
  • increased serum creatinine
  • tinnitus
  • dizziness
  • tremors
  • neuromuscular disease
  • gastroesophageal reflux

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and it is advisable to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a long time.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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.