Medication info
Nebivolol and Rosuvastatin Tablets 2.5/20 Milligrams (Nebivolol, Rosuvastatin)

Nebivolol and Rosuvastatin Tablets 2.5/20 Milligrams (Nebivolol, Rosuvastatin)

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

MFDS item code 202202181 · Approved 2022.05.23 · Insurance code 620500390

Summary

Main use
Treatment for improvement of hypertension and heart failure, and reduction of risk for hyperlipidemia and cardiovascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily as one tablet for patients taking both nebivolol and rosuvastatin concurrently for convenience, transitioning to this combined formulation containing the same dosage as the individual agents.

Ingredients

Manufacturer
에리슨제약(주)

Efficacy & effects

Treatment for improvement of hypertension and heart failure, and reduction of risk for hyperlipidemia and cardiovascular disease

  • Essential hypertension
  • chronic heart failure
  • primary hyperlipidemia
  • familial combined hyperlipidemia
  • mixed dyslipidemia
  • familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
View approved original text

This medication is used as an alternative treatment for patients taking nebivolol and rosuvastatin simultaneously. Nebivolol is used as an adjunct to standard treatment in elderly patients aged 70 years and above with essential hypertension and mild to moderate chronic heart failure. Rosuvastatin is used as an adjunct to diet in patients with primary hyperlipidemia and mixed dyslipidemia, and it helps lower blood cholesterol levels and delay the progression of atherosclerosis. Additionally, it serves as an adjunct to diet for patients with dysbetalipoproteinemia and is also effective in reducing the risk of cardiovascular diseases, which helps lower the risks of stroke, myocardial infarction, and arterial revascularization procedures, thereby improving the patient's health status. Therefore, this medication is used for hypertension, heart failure, hyperlipidemia, and reduction of cardiovascular disease risk.

How to take

Adult dose

This medication is administered once daily as one tablet for patients taking both nebivolol and rosuvastatin concurrently for convenience, transitioning to this combined formulation containing the same dosage as the individual agents.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to the components of this medication, have severely impaired liver function, have a very slow heart rate, or those with acute heart failure may be at risk if they take this medication. Additionally, this medication should not be administered to pregnant or breastfeeding women, or to fertile women who are not using adequate contraceptive methods. This medication should be used cautiously in patients with specific diseases, such as chronic lung disease, heart failure, peripheral circulation disorders, and diabetes, and those at high risk for muscle-related side effects need particular attention. If muscle pain or weakness occurs during treatment, healthcare professionals should be notified immediately. It is important to regularly monitor liver function and muscle health while taking this medication. This medication can interact with other drugs, so if you are taking other medications, you must inform your healthcare professionals. Special caution is required when taking it concurrently with calcium channel blockers, antiarrhythmics, antihypertensives, or antidepressants. Women who are pregnant or planning to become pregnant should consult with a doctor before taking this medication, and it should be avoided during breastfeeding. The safety of this medication for children and the elderly has not been adequately established, so careful management is necessary if taken. In case of overdose, severe bradycardia, hypotension, and respiratory distress may occur, prompting an immediate visit to a medical institution for proper treatment. This medication may cause dizziness when driving or operating machinery, so caution is advised during such activities. Finally, this medication should be kept out of reach of children and stored in its original container.

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 of the skin, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory problems with cough+fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, vision changes, paralysis, urination issues

Mild side effects

  • Dizziness
  • headache
  • constipation
  • nausea
  • indigestion
  • vomiting
  • insomnia
  • palpitations
  • hematuria
  • hematoma
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  • itching
  • erythematous rash
  • worsening of psoriasis
  • fatigue
  • erectile dysfunction
  • diarrhea
  • chest pain
  • weakness
  • weight loss
  • cough
  • cold
  • dry cough
  • loss of appetite
  • anxiety
  • back pain
  • tinnitus
  • dizziness
  • tremors
  • neuromyopathy
  • gastroesophageal reflux
  • irritable bowel syndrome
  • thirst
  • gastric ulcer
  • gastrointestinal disturbances
  • general weakness
  • generalized edema
  • upper respiratory infection

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature to ensure the efficacy and safety of the medication for a longer time.

Appearance and packaging

Appearance

Pale yellow 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.