Medication info
Intrac 12.5 mg (Carvedilol)

Intrac 12.5 mg (Carvedilol)

Prescription medicationTabletOral
Ingredient · strength
Carvedilol›12.5mg / 1 tablet
Manufacturer / importer
Samjin Pharmaceutical Co., Ltd.
Appearance
Brownish-red round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 100 tablets/box (10 tablets/PTP*10)
Approval status
Active

MFDS item code 200702202 · Notified 2007.02.20 · Insurance code 647802000

Summary

Main use
Treatment of essential hypertension and chronic stable angina; adjunctive treatment of congestive heart failure
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 dosage is 25 mg orally once daily for 2 weeks. If an increase is needed, increase to 25 mg per dose twice daily. The maximum dose per administration is 25 mg, and the maximum daily dose is 50 mg. 2) Older adults In some older adults, 12.5 mg once daily may be sufficient to produce an adequate effect. However, the dose may be increased if the effect is insufficient after 2 weeks of administration. 2. Chronic stable angina 1) For the first 2 days, administer 12.5 mg of this medicine per dose twice daily orally, then administer 25 mg per dose twice daily orally. 2) The usual dosage is 25 mg per dose twice daily for 2 weeks. If an increase is needed (excluding older adults), the dose may be increased to 50 mg per dose twice daily. 3. Congestive heart failure Before starting treatment with this medicine, the patient's existing standard treatment regimen (conventional treatment for chronic heart failure with an ACE inhibitor, a diuretic, and usually a digitalis preparation) must be stable. Fluid retention should also be minimized before starting treatment with this medicine. 1) The usual initial dosage is 3.125 mg of this medicine per dose twice daily orally for 2 weeks. If the patient tolerates this treatment well, increase the dose to 6.25 mg per dose twice daily for 2 weeks, then to 12.5 mg per dose twice daily for 2 weeks, and then to 25 mg per dose twice daily. 2) After taking each dose for at least 2 weeks, gradually increase the dose to the highest dose the patient can tolerate. 3) The minimum effective dose is 6.25 mg per dose twice daily. The maximum dose is 25 mg per dose twice daily for patients weighing 85 kg or less, and 50 mg per dose twice daily for patients weighing more than 85 kg. 4) To control the rate of absorption, it is recommended that the medicine be taken 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
Samjin Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for cardiovascular diseases such as essential hypertension, chronic stable angina, and congestive heart failure. It provides adjunctive therapeutic effects, especially when combined with diuretics, digitalis preparations, ACE inhibitors, and other vasodilators. This medication helps control blood pressure and reduce the burden on the heart, thereby improving blood circulation. Through these actions, it supports heart function and alleviates symptoms, improving overall cardiovascular health. In summary, it is used adjunctively for the treatment of essential hypertension, angina, and congestive heart failure.

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 dosage is 25 mg orally once daily for 2 weeks. If an increase is needed, increase to 25 mg per dose twice daily. The maximum dose per administration is 25 mg, and the maximum daily dose is 50 mg. 2) Older adults In some older adults, 12.5 mg once daily may be sufficient to produce an adequate effect. However, the dose may be increased if the effect is insufficient after 2 weeks of administration. 2. Chronic stable angina 1) For the first 2 days, administer 12.5 mg of this medicine per dose twice daily orally, then administer 25 mg per dose twice daily orally. 2) The usual dosage is 25 mg per dose twice daily for 2 weeks. If an increase is needed (excluding older adults), the dose may be increased to 50 mg per dose twice daily. 3. Congestive heart failure Before starting treatment with this medicine, the patient's existing standard treatment regimen (conventional treatment for chronic heart failure with an ACE inhibitor, a diuretic, and usually a digitalis preparation) must be stable. Fluid retention should also be minimized before starting treatment with this medicine. 1) The usual initial dosage is 3.125 mg of this medicine per dose twice daily orally for 2 weeks. If the patient tolerates this treatment well, increase the dose to 6.25 mg per dose twice daily for 2 weeks, then to 12.5 mg per dose twice daily for 2 weeks, and then to 25 mg per dose twice daily. 2) After taking each dose for at least 2 weeks, gradually increase the dose to the highest dose the patient can tolerate. 3) The minimum effective dose is 6.25 mg per dose twice daily. The maximum dose is 25 mg per dose twice daily for patients weighing 85 kg or less, and 50 mg per dose twice daily for patients weighing more than 85 kg. 4) To control the rate of absorption, it is recommended that the medicine be taken 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 drug should not be administered to certain patients. For instance, patients who are allergic to this drug or its components, those in a state of cardiogenic shock, and individuals with significantly slow heart rates or conduction issues should not take this medication. It is also not administered to patients with cor pulmonale or metabolic abnormalities due to diabetes, patients with very poor heart function, or those with respiratory diseases such as asthma or chronic lung disease. Pregnant or nursing women should not take this medication, and caution is necessary for patients with certain genetic lactose intolerance. This medication should be used cautiously in patients with diabetes, allergic hypersensitivity, weakened cardiac function, impaired renal function, and the elderly. Particular attention is required if cardiovascular symptoms are unstable or if there are other cardiovascular diseases, and when taking this medication along with certain other drugs. Mild symptoms such as dizziness, headaches, and fatigue may occur. Rarely, severe heart problems or mental abnormalities may arise. Heart rate may slow down too much or blood pressure may drop excessively, so regular cardiac function monitoring is essential. Additionally, periodic assessments are necessary as liver or kidney function may become compromised. When taking this medication for a prolonged period, cardiac function and blood pressure should be checked regularly according to the physician's instructions, and discontinuation should be gradual to avoid exacerbating heart symptoms. Caution is advised when driving or operating machinery due to possible dizziness or drowsiness. This medication has many drug interactions; therefore, consulting a physician is mandatory when taking other antihypertensive medications, diabetes drugs, antidepressants, antiarrhythmics, etc. Caution is particularly important when taken with certain antibiotics, analgesics, or alcohol as it may influence blood pressure or the heart. Pregnant women or nursing mothers should avoid this medication as it could be harmful to the fetus or newborn, and safety has not been established in children or adolescents under 18 years old, thus it is not recommended. Elderly patients may have increased drug concentration due to impaired liver function; hence, it is crucial to start with a lower dose and to use caution. In cases of overdose, dangerous symptoms such as blood pressure drop, reduced heart rate, decreased cardiac function, shock, and respiratory distress may occur, requiring immediate medical treatment; this medication is not removed by dialysis. This medication may discolor when exposed to light, so it should be stored in a light-resistant container and kept out of reach of children. Caution should be taken as transferring it to another container is not suitable for maintaining quality.

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
  • hypotension
  • loss of consciousness
  • decreased pulse rate
  • cold extremities
  • edema
  • asystole
  • worsening renal function
  • renal failure
  • increased respiratory tract resistance
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • constipation
  • urticaria
  • itching
  • lichenoid reaction
  • hyperhidrosis
  • allergic rash
  • changes in serum amino transferases
  • thrombocytopenia
  • leukopenia
  • hypoglycemia
  • concealment of hyperthyroidism
  • hyperglycemia
  • weight gain
  • increased blood cholesterol
  • bradycardia
  • hypotension
  • shortness of breath
  • hypertension in angina
  • hepatic dysfunction
  • jaundice
  • limb pain
  • reduced tear production
  • sensory disturbance
  • visual impairment
  • eye irritation
  • dry mouth
  • urinary disorders
  • sexual dysfunction
  • allergic reactions
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • blood pressure reduction
  • decreased heart rate
  • myocardial depression
  • cardiogenic shock
  • asystole
  • cardiac arrest
  • dyspnea
  • bronchospasm
  • vomiting
  • cognitive disturbance
  • generalized seizure

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

Storage

This medication may be sensitive to light and should be stored in a light-protective container. Furthermore, it is important to maintain a room temperature between 1 and 30 degrees Celsius when storing the medication. Proper storage in this manner ensures the medication's efficacy and safety.

Appearance and packaging

Appearance

Brownish-red round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 100 tablets/box (10 tablets/PTP*10)

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.