Medication info

Carvedilol 25 mg Tablet

Prescription medicationApproval withdrawn
Ingredient · strength
Carvedilol›Strength being verified
Manufacturer / importer
COSMAX Pharma Co., Ltd.
Appearance
White round tablet
Packaging
90 tablets (10 tablets/PTP × 9) - 90 tablets/PTP[10 tablets/PTP × 9]
Approval status
Approval withdrawn

MFDS item code 201804268 · Approved 2018.10.29

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of essential hypertension and chronic stable angina
Who uses it
Adults
Adult dosage
Do not increase the dose or stop taking this medicine without a doctor's instructions. 1. Essential hypertension 1) Adults (1) For the first 2 days, administer 12.5 mg of carvedilol orally once daily, followed by 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 provide a sufficient effect. 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 twice daily, followed by 25 mg 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.

Ingredients

Manufacturer
COSMAX Pharma Co., Ltd.

Efficacy & effects

Treatment of essential hypertension and chronic stable angina

  • Essential hypertension
  • chronic stable angina
View approved original text

Used for essential hypertension and chronic stable angina.

Dosage and Administration

Adult dosage

Do not increase the dose or stop taking this medicine without a doctor's instructions. 1. Essential hypertension 1) Adults (1) For the first 2 days, administer 12.5 mg of carvedilol orally once daily, followed by 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 provide a sufficient effect. 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 twice daily, followed by 25 mg 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.

Precautions

This medication should not be used by certain patients. For example, it must not be administered to patients who have allergies to this medication or its components, are experiencing cardiogenic shock, have extremely slow heart rates or conduction problems, have cor pulmonale, have metabolic disorders due to diabetes, have severely impaired cardiac function, have asthma or chronic pulmonary diseases, or are pregnant or nursing. Additionally, patients with diabetes, severe allergic reactions, impaired kidney or liver function, elderly patients, and patients with low blood pressure should use this medication with special caution. This medication can affect heart function, so it is essential to regularly monitor heart condition, and if symptoms worsen, consult a physician immediately. Side effects such as dizziness, fatigue, headache, decreased heart rate, lowered blood pressure, dyspepsia, and skin rash may occur while taking this medication. Especially if heart-related adverse reactions arise, treatment should be stopped immediately or dosage adjusted. Discontinuing this medication suddenly can worsen heart symptoms; therefore, the dosage should be gradually reduced according to a physician's instruction, and discontinuation should not be done arbitrarily. Additionally, caution should be exercised while driving or operating dangerous machinery as dizziness or drowsiness may occur. Due to interactions with other medications, patients should inform healthcare providers if they are taking other drugs, especially when used in conjunction with antihypertensives, antidiabetics, antidepressants, sedatives, or calcium channel blockers. Pregnant or nursing women should not use this medication, and safety for children or adolescents has not been established, so it is not recommended.

Side effects

  • Dizziness
  • headache
  • fatigue
  • weakness
  • hallucinations
  • confusion
  • depression
  • sleep disturbances
  • nightmares
  • psychosis
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  • severe bradycardia
  • shock
  • complete heart block
  • heart failure
  • cardiac arrest
  • significant hypotension
  • loss of consciousness
  • decreased pulse rate
  • peripheral coldness
  • edema
  • asystole
  • worsening of renal function
  • renal failure
  • increased airway resistance
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • constipation
  • hives
  • itching
  • lichen planus-like reaction
  • sweating
  • allergic rash
  • thrombocytopenia
  • leukopenia
  • hypoglycemia
  • masked hyperthyroidism
  • hyperglycemia
  • weight gain
  • increased serum cholesterol
  • bradycardia
  • hypotension
  • shortness of breath
  • hypertension in angina
  • liver dysfunction
  • jaundice
  • limb pain
  • reduced tear production
  • sensory disturbances
  • visual disturbances
  • eye irritation
  • dry mouth
  • urinary dysfunction
  • sexual dysfunction
  • allergic reactions
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • marked hypotension
  • bradycardia
  • myocardial weakness
  • asystole
  • dyspnea
  • bronchospasm
  • vomiting
  • altered consciousness
  • generalized seizures

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

Storage

This medication is sensitive to light, so it must be stored in a dark container that prevents light from entering. Additionally, it is important to store it in a cool room temperature, between 1 to 30 degrees Celsius, to maintain its efficacy.

Appearance and packaging

Appearance

White round tablet

Package unit

90 tablets (10 tablets/PTP × 9) - 90 tablets/PTP[10 tablets/PTP × 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.

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.