Medication info

Carvedilol 12.5 mg Tablet

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Carvedilol›12.5mg / 1 tablet
Manufacturer / importer
Cosmax Pharma Co., Ltd.
Appearance
Dark reddish-brown round tablets
Packaging
90 tablets (10 tablets/PTP X 9)
Approval status
Approval withdrawn

MFDS item code 201907561 · Approved 2019.10.30

This product's status changed to Approval withdrawn on 2024.01.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunctive treatment of congestive heart failure; treatment of essential hypertension and chronic stable angina
Who takes it
Adults
Adult dose
Do not increase the dose or discontinue use without consulting a physician. 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 an increase is necessary, increase the dose to 25 mg twice daily. The maximum dose per administration is 25 mg, and the maximum daily dose is 50 mg. 2) Elderly patients Some elderly patients may achieve adequate efficacy with 12.5 mg once daily. 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 an increase is necessary (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 should be stable on the standard treatment regimen already being administered (conventional treatment for chronic heart failure with an ACE inhibitor, a diuretic, and usually a digitalis preparation). Fluid retention should also be minimized before starting treatment with this medicine. 1) Generally, the initial dose 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) Increase the dose gradually after taking each dose for at least 2 weeks, up to the dose the patient can tolerate. 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 the rate of absorption and may reduce the incidence of orthostatic hypotension.

Ingredients

Manufacturer
Cosmax Pharma Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat essential hypertension, chronic stable angina, and congestive heart failure. It is particularly helpful when used as an adjunct to diuretics, digitalis preparations, ACE inhibitors, and other vasodilators to improve heart and vascular health.

How to take

Adult dose

Do not increase the dose or discontinue use without consulting a physician. 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 an increase is necessary, increase the dose to 25 mg twice daily. The maximum dose per administration is 25 mg, and the maximum daily dose is 50 mg. 2) Elderly patients Some elderly patients may achieve adequate efficacy with 12.5 mg once daily. 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 an increase is necessary (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 should be stable on the standard treatment regimen already being administered (conventional treatment for chronic heart failure with an ACE inhibitor, a diuretic, and usually a digitalis preparation). Fluid retention should also be minimized before starting treatment with this medicine. 1) Generally, the initial dose 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) Increase the dose gradually after taking each dose for at least 2 weeks, up to the dose the patient can tolerate. 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 the rate of absorption and may reduce the incidence of orthostatic hypotension.

Precautions

This medication should not be administered to certain patients. For instance, individuals with a history of allergy to this medication or its components, those with severely weakened heart function, very slow heart rates, lung problems, metabolic disturbances due to diabetes, severe heart failure, patients with asthma or chronic obstructive pulmonary disease may be at risk if used. Additionally, pregnant or breastfeeding women should not take this medication, and individuals with certain genetic issues such as lactose intolerance should avoid it. This medication may affect blood sugar control in diabetic patients, so it should be used cautiously, and patients with weak heart or kidney function should also use it carefully. Elderly patients or those with very low blood pressure should be particularly careful when starting the medication. During treatment, symptoms such as dizziness, fatigue, and headaches may occur, and in severe cases, the heart rate may slow down or blood pressure may drop too low, necessitating regular checks of heart function and blood pressure. Also, this medication may interact with several other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. Special caution is needed when used with blood pressure medications, diabetes medications, heart medicines, sedatives, or antidepressants. Abruptly stopping this medication can worsen heart issues or angina symptoms, so dosage should be gradually decreased under a doctor’s guidance. This medication is sensitive to light, so it should be stored in a dark, closed container and kept out of reach of children. In case of overdose, serious symptoms such as low blood pressure, decreased heart rate, and difficulty breathing may occur, and medical personnel should be contacted immediately.

Side effects

  • Dizziness
  • headache
  • fatigue
  • weakness
  • hallucinations
  • confusion
  • depression
  • sleep disturbances
  • nightmares
  • psychosis
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  • severe bradycardia
  • shock
  • complete atrioventricular block
  • heart failure
  • cardiac arrest
  • significantly lowered blood pressure
  • loss of consciousness
  • decreased pulse rate
  • limb coldness
  • edema
  • cardiac arrest
  • worsening renal function
  • renal failure
  • increased airway resistance
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • constipation
  • urticaria
  • itching
  • lichenoid reactions
  • sweating
  • allergic rash
  • thrombocytopenia
  • leukopenia
  • hypoglycemia
  • concealed hyperthyroidism
  • hyperglycemia
  • weight gain
  • increased blood cholesterol
  • bradycardia
  • hypotension
  • shortness of breath
  • hypertension in angina
  • liver dysfunction
  • jaundice
  • limb pain
  • reduced tears
  • sensory disturbances
  • visual disturbances
  • eye irritation
  • dry mouth
  • urinary disorders
  • sexual dysfunction
  • allergic reactions
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • marked drop in blood pressure
  • slowed heart rate
  • cardiac weakness
  • cardiac arrest
  • respiratory distress
  • bronchospasm
  • vomiting
  • consciousness disturbance
  • generalized seizures

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

Storage

This medication is sensitive to light, so it should be stored in a container that blocks light. Additionally, it is important to keep the temperature between 1°C and 30°C during storage to maintain its effectiveness and prevent degradation.

Appearance and packaging

Appearance

Dark reddish-brown round tablets

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.