Medication info

Carvedilol Tablets 25 mg (Carvedilol)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Carvedilol›25mg / 1 tablet
Manufacturer / importer
Poongrim Pharmaceutical Co., Ltd.
Appearance
White round tablet
Packaging
90 tablets (10 tablets/PTP X 9)
Approval status
Approval withdrawn

MFDS item code 201908435 · Approved 2019.12.16

This product's status changed to Approval withdrawn on 2024.03.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunctive treatment of congestive heart failure, and treatment of essential hypertension and chronic stable angina
Who takes it
Adults
Adult dose
Do not increase the dose or stop taking this medicine without your doctor’s instructions. 1. Essential hypertension 1) Adults (1) For the first 2 days, administer 12.5 mg of carvedilol orally once daily, then administer 25 mg orally once daily. (2) The usual dose is 25 mg orally once daily for 2 weeks. If a dose increase is needed, increase to 25 mg twice daily. The maximum dose per administration is 25 mg, and the maximum daily dose is 50 mg. 2) Elderly patients In some elderly patients, 12.5 mg once daily may be sufficiently effective. However, the dose may be increased if the effect is insufficient after 2 weeks of treatment. 2. Chronic stable angina 1) For the first 2 days, administer 12.5 mg of this medicine orally twice daily, then administer 25 mg orally twice daily. 2) The usual dose is 25 mg twice daily for 2 weeks. If a dose increase is needed (excluding elderly patients), the dose may be increased to 50 mg twice daily. 3. Congestive heart failure Before starting treatment with this medicine, the patient’s existing standard treatment regimen (the conventional treatment regimen for chronic heart failure, consisting of an ACE inhibitor, a diuretic, and usually a digitalis preparation) should be stable. Fluid retention should also be minimized before starting treatment with this medicine. 1) The usual initial treatment is 3.125 mg of this medicine orally twice daily for 2 weeks. If the patient tolerates this treatment well, increase the dose to 6.25 mg twice daily for 2 weeks, then to 12.5 mg twice daily for 2 weeks, and then to 25 mg twice daily. 2) After taking each dose for at least 2 weeks, increase the dose gradually to the dose tolerated by the patient. 3) The minimum effective dose is 6.25 mg twice daily. The maximum dose is 25 mg twice daily for patients weighing 85 kg or less, and 50 mg twice daily for patients weighing more than 85 kg. 4) To control the rate of absorption, it is recommended to take the medicine with meals in the morning and evening. Taking it with meals slows absorption and may reduce the incidence of orthostatic hypotension.

Ingredients

Manufacturer
Poongrim Pharmaceutical Co., Ltd.

Efficacy & effects

Adjunctive treatment of congestive heart failure, and treatment of essential hypertension and chronic stable angina

  • Essential hypertension
  • chronic stable angina
  • congestive heart failure
View approved original text

This drug is used in the treatment of cardiovascular diseases such as essential hypertension, chronic stable angina, and congestive heart failure. In particular, it helps enhance therapeutic efficacy when administered as an adjunct to diuretics, digoxin, ACE inhibitors, and other vasodilators. This combination therapy is used to reduce the burden on the heart and improve symptoms.

How to take

Adult dose

Do not increase the dose or stop taking this medicine without your doctor’s instructions. 1. Essential hypertension 1) Adults (1) For the first 2 days, administer 12.5 mg of carvedilol orally once daily, then administer 25 mg orally once daily. (2) The usual dose is 25 mg orally once daily for 2 weeks. If a dose increase is needed, increase to 25 mg twice daily. The maximum dose per administration is 25 mg, and the maximum daily dose is 50 mg. 2) Elderly patients In some elderly patients, 12.5 mg once daily may be sufficiently effective. However, the dose may be increased if the effect is insufficient after 2 weeks of treatment. 2. Chronic stable angina 1) For the first 2 days, administer 12.5 mg of this medicine orally twice daily, then administer 25 mg orally twice daily. 2) The usual dose is 25 mg twice daily for 2 weeks. If a dose increase is needed (excluding elderly patients), the dose may be increased to 50 mg twice daily. 3. Congestive heart failure Before starting treatment with this medicine, the patient’s existing standard treatment regimen (the conventional treatment regimen for chronic heart failure, consisting of an ACE inhibitor, a diuretic, and usually a digitalis preparation) should be stable. Fluid retention should also be minimized before starting treatment with this medicine. 1) The usual initial treatment is 3.125 mg of this medicine orally twice daily for 2 weeks. If the patient tolerates this treatment well, increase the dose to 6.25 mg twice daily for 2 weeks, then to 12.5 mg twice daily for 2 weeks, and then to 25 mg twice daily. 2) After taking each dose for at least 2 weeks, increase the dose gradually to the dose tolerated by the patient. 3) The minimum effective dose is 6.25 mg twice daily. The maximum dose is 25 mg twice daily for patients weighing 85 kg or less, and 50 mg twice daily for patients weighing more than 85 kg. 4) To control the rate of absorption, it is recommended to take the medicine with meals in the morning and evening. Taking it with meals slows absorption and may reduce the incidence of orthostatic hypotension.

Precautions

This drug should not be used in patients with certain diseases or conditions. For example, it may be dangerous for patients with allergies to this drug or its components, cardiac shock, severe bradycardia, or cardiac conduction disorders. It should also not be administered to patients with cor pulmonale, diabetic ketoacidosis, severely weakened heart function, or respiratory diseases such as asthma or chronic obstructive pulmonary disease. Pregnant or breastfeeding women, patients with severe liver dysfunction, and patients with peripheral circulation disorders should also preferably not use this drug. Careful use is required in patients with diabetes, a history of hypersensitivity, heart diseases, or impaired kidney function. Symptoms such as dizziness, headache, and fatigue may occur during treatment, and it may cause a slow heart rate or low blood pressure, so regular cardiac function tests should be conducted. Additionally, liver or kidney function abnormalities may arise, requiring periodic testing, and if severe side effects occur, medical consultation should be sought immediately. This drug may interact with other medications; therefore, it is essential to inform healthcare providers of any other medications being taken. Particular caution is needed when used in conjunction with antihypertensives, antiarrhythmics, antidiabetic medications, and some antidepressants. Pregnant or breastfeeding women should not take this medication, and safety has not been established for children or adolescents under 18 years of age. Older adults may experience increased drug concentrations due to decreased liver function, and there is a risk of excessive blood pressure reduction leading to stroke, so treatment should start at a lower dose and be administered cautiously. In cases of overdose, symptoms such as bradycardia, hypotension, respiratory distress, or consciousness disorder may appear, necessitating immediate medical attention. This drug is sensitive to light and should be stored in a light-resistant container, out of the reach of children. Additionally, users must not arbitrarily discontinue or adjust the dosage and should follow their doctor's instructions.

Side effects

  • Dizziness
  • headache
  • fatigue
  • weakness
  • hallucination
  • confusion
  • depression
  • sleep disorders
  • nightmares
  • psychosis
Show 61 more
  • severe bradycardia
  • shock
  • complete atrioventricular block
  • heart failure
  • cardiac arrest
  • significant drop in blood pressure
  • loss of consciousness
  • decreased pulse rate
  • limb coldness
  • edema
  • worsening of heart failure
  • asystole
  • worsening of renal function
  • renal failure
  • increased respiratory tract resistance
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • constipation
  • urticaria
  • itching
  • lichen planus-like reaction
  • hyperhidrosis
  • allergic rash
  • serum aminotransferase elevation
  • thrombocytopenia
  • leukopenia
  • hypoglycemia
  • masked hyperthyroidism
  • hyperglycemia
  • weight gain
  • increased blood cholesterol
  • bradycardia
  • hypotension
  • shortness of breath
  • hypertension in angina patients
  • liver function impairment
  • jaundice
  • limb pain
  • reduced tear production
  • sensory disturbances
  • visual impairment
  • eye irritation
  • dry mouth
  • urination disorders
  • sexual dysfunction
  • allergic reactions
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • marked drop in blood pressure
  • slowed heart rate
  • cardiac weakening
  • cardiogenic shock
  • asystole
  • cardiac arrest
  • dyspnea
  • bronchospasm
  • vomiting
  • altered consciousness
  • generalized seizure

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

Storage

This drug is sensitive to light and should be stored in a special container that prevents exposure to light. It is also crucial to store it at room temperature, between 1 and 30 degrees Celsius, to maintain its efficacy.

Appearance and packaging

Appearance

White round tablet

Package unit

90 tablets (10 tablets/PTP X 9)

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.