Finished product reference
Carvedilol
Tablet · Oral · 12.5 mg
- List code
- 1924
- Pharmacologic class
- alpha-Adrenergic Blocker · beta-Adrenergic Blocker
What it is and how it works
Mechanism of Action Carvedilol is a racemic mixture in which nonselective β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α 1 -adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. Carvedilol has no intrinsic sympathomimetic activity.
Mechanism class: Adrenergic alpha-Antagonists · Adrenergic beta1-Antagonists · Adrenergic beta2-Antagonists
Indications
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure left ventricular dysfunction following myocardial infarction in clinically stable patients hypertension Heart Failure Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization . Left Ventricular Dysfunction following Myocardial Infarction Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) . Hypertension Carvedilol tablets are indicated for the management of essential hypertension . It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics .
Dosage and administration (summary)
Take with food. Individualize dosage and monitor during up-titration. Heart failure: Start at 3.125 mg twice daily and increase to 6.25, 12.5, and then 25 mg twice daily over intervals of at least 2 weeks. Maintain lower doses if higher doses are not tolerated. Left ventricular dysfunction following myocardial infarction: Start at 6.25 mg twice daily and increase to 12.5 mg then 25 mg twice daily after intervals of 3 to 10 days. A lower starting dose or slower titration may be used. Hypertension: Start at 6.25 mg twice daily and increase if needed for blood pressure control to 12.5 mg and then 25 mg twice daily over intervals of 1 to 2 weeks.
Contraindications
Bronchial asthma or related bronchospastic conditions. Second- or third-degree AV block. Sick sinus syndrome. Severe bradycardia (unless permanent pacemaker in place). Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy. Severe hepatic impairment.
Warnings and precautions
Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Reduce the dose as needed. ( 5.2 , 5.3 , 5.4 ) Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid β-blockers. However, if deemed necessary, use with caution and at lowest effective dose. Diabetes: May mask symptoms of hypoglycemia and alter glucose levels.
Pregnancy
Pregnancy Risk Summary Available data regarding use of carvedilol in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy.
Storage and supply
Carvedilol Tablets USP, 3.125 mg are white to off-white, round, biconvex, film-coated tablets debossed with 'Z' on one side and '1' on other side and are supplied as follows: NDC-42708-181-60 in bottles of 60 tablets Storage Store at 20°C to 25°C (68°F to 77°F) . Protect from moisture. Dispense in a tight, light-resistant container.
Source: Carvedilol (Carvedilol) — US FDA prescribing information, 2026-05-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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