Medication info
Nebivolol and Rosuvastatin Tablets 5/20 mg (Nebivolol, Rosuvastatin)

Nebivolol and Rosuvastatin Tablets 5/20 mg (Nebivolol, Rosuvastatin)

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 tablets
Packaging
30 tablets/bottle, 100 tablets/bottle, 30 tablets/box [10 tablets/PTP*3]
Approval status
Active

MFDS item code 201906183 · Approved 2019.08.30 · Insurance code 620500300

Summary

Main use
Improvement of hypertension and hyperlipidemia, reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
Patients taking both nebivolol and rosuvastatin should take this medication once daily, 1 tablet.

Ingredients

Manufacturer
에리슨제약(주)

Efficacy & effects

Improvement of hypertension and hyperlipidemia, reduction of cardiovascular disease risk

  • Essential hypertension
  • chronic heart failure
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dyslipidemia
  • coronary artery disease risk factors
  • stroke risk
  • myocardial infarction risk
  • arterial revascularization risk
View approved original text

This medication is used as an alternative treatment for patients taking both of the two components, nebivolol and rosuvastatin, simultaneously. Nebivolol is mainly used to treat essential hypertension and as an adjunct in the treatment of chronic stable heart failure in patients aged 70 years and older. Rosuvastatin is additionally administered to patients with various forms of hyperlipidemia, particularly primary hypercholesterolemia and familial hypercholesterolemia, when dietary therapy and exercise are ineffective. Moreover, rosuvastatin lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and is also used to support treatment in patients with dyslipidemia. Additionally, it helps reduce the risks of stroke, myocardial infarction, and arterial revascularization in middle-aged and older patients at high risk of cardiovascular disease. This medication is widely used in treatments aimed at improving cardiovascular health.

How to take

Adult dose

Patients taking both nebivolol and rosuvastatin should take this medication once daily, 1 tablet.

Precautions

This medication should not be taken by certain patients. For example, those allergic to any components of this medication, severely impaired liver function, bradycardia, uncontrolled heart failure, hypotension, severe renal impairment, bronchial asthma patients, pregnant or nursing women may be at risk if they take this medication. Caution is also needed if there is a history of muscle disorders or if certain drugs are taken concurrently. This medication should be used with caution in patients with chronic pulmonary disease, heart failure, peripheral circulation disorders, thyroid disorders, and diabetes, and regular monitoring of liver function and muscle status is necessary. If experiencing symptoms like myalgia, muscle weakness, fatigue, or dizziness, consult a physician immediately. Women of childbearing potential should use appropriate contraception and should not take this medication during pregnancy. It is also safe for nursing mothers not to take this medication. Elderly patients should start at a low dose and be carefully monitored. When used in combination with other medications, potential interactions should be reported to a physician or pharmacist, especially when taken with antihypertensives, diabetes medications, antiarrhythmics, certain antibiotics, and antifungals. In case of overdose, severe bradycardia, hypotension, and respiratory distress may occur, and immediate medical attention should be sought. Regular liver function tests and muscle-related examinations are required during this medication, and consultations should be sought for any abnormal symptoms. This medication is not recommended for children as safety has not been established. Store this medication out of reach of children and in its original container. Caution is required when driving or operating machinery as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • paleness
  • severe rash with high fever
  • blisters
  • peeling skin
  • pain in oral/ocular mucosa
Show 12 more
  • breathlessness or difficulty breathing
  • asthma attacks
  • unusual breathing with cough + fever
  • yellowing of skin or eyes (jaundice)
  • profound lethargy
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • confusional state
  • visual disturbances
  • paralysis
  • urination

Mild side effects

  • Eye discharge
  • upper abdominal discomfort
  • gastritis
  • gastroesophageal reflux disease
  • chest pain
  • nasopharyngitis
  • influenza
  • increased CK
  • increased ALT
  • increased AST
Show 26 more
  • elevated blood potassium
  • hyperkalemia
  • musculoskeletal chest pain
  • musculoskeletal pain
  • musculoskeletal stiffness
  • headache
  • dizziness
  • hematuria
  • hematoma
  • rash
  • vision impairment
  • bradycardia
  • AV block
  • AV conduction delay
  • hypotension
  • heart failure
  • intermittent claudication
  • depression
  • nightmares
  • syncope
  • diarrhea
  • constipation
  • nausea
  • dyspepsia
  • bloating
  • vomiting

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 30 tablets/box [10 tablets/PTP*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.