Medication info
Nebilet M Tablet 5 mg (Nebivolol Hydrochloride)

Nebilet M Tablet 5 mg (Nebivolol Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Nebivolol Hydrochloride›5.45mg / 1 tablet
Manufacturer / importer
광동제약(주)
Appearance
White round tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202006680 · Approved 2020.09.28

Summary

Main use
Adjuvant treatment for essential hypertension and chronic heart failure
Who takes it
Adults
Adult dose
1. Essential Hypertension (1) Adults Nebivolol 5 mg is administered orally once daily at the same time each day. Can be taken with food. (2) Patients with Renal Impairment The initial dose is 2.5 mg of Nebivolol taken orally once daily. If needed, the daily dose may be increased to 5 mg. (3) Elderly Patients The initial dose for elderly patients aged 65 and older is 2.5 mg of Nebivolol taken orally once daily. If necessary, the daily dose can be increased to 5 mg. (2.5 mg of Nebivolol is given once daily for patients aged 75 and older due to insufficient clinical experience with this demographic, requiring careful observation). 2. Chronic Heart Failure (1) Elderly patients aged 70 and older This medication should be administered to chronic stable heart failure patients without an acute heart failure history for the past six weeks, and the dosages of diuretics, digoxin, ACE inhibitors, and angiotensin II receptor antagonists should have stabilized at least two weeks prior to administration. The dose should be increased gradually in 1-2 week intervals to reach the optimal dosage for each individual patient, beginning with 1.25 mg of Nebivolol taken orally once daily. If required, it may be increased to 2.5 mg once daily, 5 mg once daily, or 10 mg once daily. The maximum daily dosage is 10 mg. Can be taken with food. (2) Patients with Renal Impairment Dosing adjustments to the maximum tolerable dose should be tailored to each individual patient, thus dose adjustments are not generally needed for patients with mild to moderate renal impairment. There is no experience in using this medication in patients with severe renal impairment (serum creatinine ≥ 250 μmol/L), so it should not be administered.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Adjuvant treatment for essential hypertension and chronic heart failure

  • Essential hypertension
  • chronic heart failure
View approved original text

This medication is used as an adjunct to existing standard treatment in patients with essential hypertension and mild to moderate chronic stable heart failure in individuals aged 70 and older. It helps in controlling blood pressure and alleviating heart failure symptoms, thereby improving the patient's condition.

How to take

Adult dose

1. Essential Hypertension (1) Adults Nebivolol 5 mg is administered orally once daily at the same time each day. Can be taken with food. (2) Patients with Renal Impairment The initial dose is 2.5 mg of Nebivolol taken orally once daily. If needed, the daily dose may be increased to 5 mg. (3) Elderly Patients The initial dose for elderly patients aged 65 and older is 2.5 mg of Nebivolol taken orally once daily. If necessary, the daily dose can be increased to 5 mg. (2.5 mg of Nebivolol is given once daily for patients aged 75 and older due to insufficient clinical experience with this demographic, requiring careful observation). 2. Chronic Heart Failure (1) Elderly patients aged 70 and older This medication should be administered to chronic stable heart failure patients without an acute heart failure history for the past six weeks, and the dosages of diuretics, digoxin, ACE inhibitors, and angiotensin II receptor antagonists should have stabilized at least two weeks prior to administration. The dose should be increased gradually in 1-2 week intervals to reach the optimal dosage for each individual patient, beginning with 1.25 mg of Nebivolol taken orally once daily. If required, it may be increased to 2.5 mg once daily, 5 mg once daily, or 10 mg once daily. The maximum daily dosage is 10 mg. Can be taken with food. (2) Patients with Renal Impairment Dosing adjustments to the maximum tolerable dose should be tailored to each individual patient, thus dose adjustments are not generally needed for patients with mild to moderate renal impairment. There is no experience in using this medication in patients with severe renal impairment (serum creatinine ≥ 250 μmol/L), so it should not be administered.

Precautions

This medication should not be used in patients with specific conditions. For instance, it is contraindicated in patients who are allergic to this drug, have respiratory conditions like bronchial asthma, have an excessively slow heart rate, or have acute heart failure. Additionally, it is not recommended for pregnant or breastfeeding women, or patients with severe liver or kidney dysfunction. Patients with genetic issues like lactose intolerance should also avoid taking this medication. Patients with chronic pulmonary diseases, untreated heart failure, diabetes, or elderly individuals should use this drug cautiously and consult a doctor before taking it. During treatment with this medication, side effects such as headaches, dizziness, dyspepsia, shortness of breath, and skin rashes may occur, and if symptoms worsen, immediate consultation with healthcare professionals is recommended. Patients scheduled for surgery should discontinue the use of this drug at least 24 hours prior, and dosage adjustment may be necessary if bradycardia or symptoms of hypotension occur. This drug may interact with other medications, particularly calcium channel blockers, antiarrhythmics, central nervous system medications, and diabetes medications, so caution is advised when taking it with these drugs. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication, and it is not recommended for children due to safety concerns. Elderly individuals should start with a low dose and closely monitor conditions, as overdose may lead to severe cardiac and respiratory problems, necessitating immediate treatment.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • bronchospasm
  • shortness of breath
  • bradycardia
  • worsening of heart failure
  • cerebrovascular disease
  • chest pain
  • chronic myeloid leukemia

Mild side effects

  • Rash
  • vision impairment
  • bradycardia
  • AV block
  • AV conduction delay
  • hypotension
  • heart failure
  • intermittent claudication
  • headache
  • dizziness
Show 26 more
  • paresthesia
  • depression
  • nightmares
  • fainting
  • diarrhea
  • constipation
  • nausea
  • dyspepsia
  • bloating
  • vomiting
  • shortness of breath
  • bronchospasm
  • pruritus
  • erythema
  • exacerbation of psoriasis
  • edema
  • fatigue
  • erectile dysfunction
  • angioedema
  • hallucinations
  • psychosis
  • confusion
  • cyanosis of limbs
  • dry eyes
  • Raynaud's phenomenon
  • orthostatic hypotension

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. The recommended storage temperature is at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White round tablet

Package unit

30 tablets/bottle, 300 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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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.