RAVILDO 25/MG FC TAB 30/FC TAB

Indications

Approved Uses

Heart failure with reduced ejection fraction, Hypertension, Left ventricular dysfunction following myocardial infarction.

Dosage & Administration

Dosing by Condition

Heart Failure: Start 3.125mg twice daily, titrate every 2 weeks to 6.25mg, 12.5mg, then 25mg twice daily as tolerated. Max 50mg twice daily in patients >85kg. Hypertension: Start 6.25mg twice daily, titrate after 7-14 days to 12.5mg then 25mg twice daily as needed. Max 50mg total daily dose. Left Ventricular Dysfunction Post-MI: Start 6.25mg twice daily, titrate after 3-10 days to 12.5mg then 25mg twice daily as tolerated.

Initial Dose

Hypertension: 6.25 mg twice daily. Heart Failure: 3.125 mg twice daily.

Maintenance Dose

Hypertension: 12.5-25 mg twice daily; Heart failure: 25 mg twice daily (up to 50 mg twice daily if >85 kg)

Maximum Dose

Hypertension: max 50 mg/day; Heart failure: max 25 mg twice daily (50 mg/day) if ≤85 kg, or 50 mg twice daily (100 mg/day) if >85 kg.

Dose Adjustment Notes

Titrate gradually (typically every ≥2 weeks in heart failure) and avoid up‑titration if symptomatic hypotension, bradycardia, or worsening heart failure occurs; reduce dose if clinically significant bradycardia occurs. Severe hepatic impairment: contraindicated. Renal impairment: generally no initial dose adjustment, but monitor renal function in heart failure or hypotension.

How to Take

Oral: swallow the film‑coated tablet with water; take with food. Usual administration is twice daily for immediate‑release carvedilol (e.g., morning and evening) when used for heart failure or hypertension per standard dosing; follow the prescriber’s regimen.

Side Effects

Common Side Effects

Dizziness, fatigue/asthenia, hypotension/orthostatic hypotension, bradycardia, diarrhea, nausea, weight gain, edema/fluid retention, headache; may worsen glycemic control or mask hypoglycemia in diabetics.

Safety & Warnings

Contraindications

Bronchial asthma/bronchospastic disease; second- or third-degree AV block; sick sinus syndrome (unless pacemaker); severe bradycardia; cardiogenic shock; decompensated heart failure requiring IV inotropes; severe hepatic impairment; hypersensitivity to carvedilol.

Warnings & Precautions

Do not stop abruptly; monitor for worsening HF/fluid retention during initiation/titration; may cause bradycardia/hypotension; can mask hypoglycemia and thyrotoxicosis; caution in diabetes, peripheral vascular disease, bronchospastic disease, and during major surgery; pheochromocytoma requires alpha-blockade first.

Age Restriction

Not established/Not routinely recommended in patients <18 years (use only under specialist direction).

Drug Interactions

Interaction Severity

MAJOR: Verapamil/diltiazem (additive bradycardia/AV block), other strong negative chronotropes/AV‑nodal blockers; clonidine (risk of rebound hypertension if clonidine is stopped-taper beta‑blocker first). MODERATE: Digoxin (↑ digoxin levels and additive bradycardia), amiodarone (additive bradycardia/AV block), CYP2D6 inhibitors such as fluoxetine/paroxetine (↑ carvedilol exposure), insulin/oral antidiabetics (masks hypoglycemia; may affect glycemic control), cyclosporine (↑ cyclosporine levels). MINOR: NSAIDs (may blunt antihypertensive effect), rifampin (↓ carvedilol levels).

Food Interaction

Take with food; food slows absorption and reduces the risk of orthostatic hypotension (especially in heart failure).

Special Populations

Breastfeeding

Consult Doctor

Liver Impairment

Contraindicated in severe hepatic impairment; mild-moderate impairment: use with caution and consider lower doses/slow titration.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not double the dose

Stopping the Medicine

Do not stop abruptly-taper gradually over ~1-2 weeks under medical supervision.

Patient Counseling

Take with food; rise slowly to reduce dizziness/orthostatic hypotension; do not stop abruptly-taper under medical supervision; monitor BP/HR as advised; in diabetes, monitor glucose more closely because symptoms of hypoglycemia may be masked; report worsening shortness of breath, rapid weight gain, swelling, fainting, or very slow pulse; inform clinicians before surgery/anesthesia.

Monitoring Requirements

Monitor blood pressure and heart rate; in heart failure monitor weight/edema and symptoms of congestion; monitor renal function and electrolytes in heart failure or if hypotension/volume depletion occurs; monitor blood glucose in diabetics; consider liver function tests if hepatic injury symptoms occur.

Pharmacology

Mechanism of Action

Nonselective β‑adrenergic blockade (β1 and β2) plus α1‑adrenergic blockade: decreases heart rate and contractility and suppresses renin release, while α1 blockade causes peripheral vasodilation, lowering systemic vascular resistance and blood pressure.

Duration of Effect

Approximately 12 hours for the immediate‑release formulation (supporting twice‑daily dosing).

Bioavailability

Approximately 25-35% oral bioavailability (extensive first‑pass hepatic metabolism).

Metabolism

Extensive hepatic metabolism, primarily via CYP2D6 and CYP2C9 (with additional pathways), with stereoselective first‑pass metabolism.

Protein Binding

>98% (highly protein bound, ~98-99%)

Product Information

Composition per Dose

Each film-coated tablet: 25 mg carvedilol

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Beta-blocker

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