Rafildo 12.5 mg 30 tablets

Product Description:

• Rivaldo (carvedilol) is a multi-acting adrenergic receptor antagonist with α1, β1, and β2 adrenergic receptor blocking properties.
• Carvedilol has been shown to have an organ-protective effect.
• Carvedilol inhibits the renin-angiotensin-aldosterone system through an ß-blockade,
• Which reduces the secretion of renin, making fluid retention rare.
• Carvedilol reduces peripheral vascular resistance by selective blockade of alpha 1 receptors.
• Carvedilol has no negative effect on the lipid profile. The normal ratio of high-density lipoproteins to low-density lipoproteins (HDL/LDL) is maintained.

Features :

• Absorption: Carvedilol is rapidly absorbed after oral administration. Maximum plasma concentration
• Peak plasma levels are reached after approximately 1 to 2 hours. There is a pronounced first-phase metabolism, and absolute bioavailability is approximately 25% (12–49%).
• Distribution: Steady-state volume of distribution (VDss) is about 2 L/kg.
• Carvedilol is 98% bound to plasma proteins.
• Metabolism: Carvedilol is almost completely broken down into compounds that are eliminated primarily via the
• Biliary tract. Carvedilol is primarily metabolized in the liver.
• Elimination: The half-life of carvedilol after oral administration is approximately 6–10 hours. Plasma clearance
• 590 ml/min. Elimination is predominantly biliary. The primary route of elimination is via feces. Less than 2% of the unchanged substance is excreted in the urine, and approximately 15% is excreted as metabolites.

indication:

Rivaldo is used in the following cases:

• Treatment of essential (mild to moderate) hypertension and chronic angina to prevent attacks.
• Treatment of mild to severe stable heart failure (NYHA class II-IV) due to ischemic cardiomyopathy
• As an adjunct to standard therapy (diuretics, digoxin, ACE inhibitors).

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Directions for use:

Essential hypertension:

• For adults: The initial dose of Rafildo is 12.5 mg given once daily for the first two days. Thereafter, a dose of 25 mg is given once daily for the first two days.
• One mg once daily is recommended. If the effect is insufficient, the daily dose may be increased after at least two weeks to 50 mg, taken as one or two doses of Rivaldo. The maximum daily dose for hypertension is 50 mg.
• Elderly patients: Initially, a dose of 12.5 mg of Rafildo is given once a day.
• In some patients, the dose of Raveldo is sufficient to achieve adequate blood pressure control. If the effect is insufficient, the daily dose may be gradually increased over intervals of at least two weeks to a maximum of 50 mg, taken as a single dose or two single doses.
• Angina pectoris:
• The initial dose of Rafildo is 12.5 mg twice daily for the first two days. Thereafter, the dose is increased to 25 mg twice daily.
• Daily is recommended. If the effect is insufficient, the dose can be increased gradually at intervals of at least
• Two weeks up to a maximum daily dose of 100 mg taken as two single doses.
• Elderly patients: In general, a dose of 25 mg of Rafildo twice daily should not be exceeded.
• Treatment of mild acute heart failure (NYHA class II-IV):
• The dose of Rivaldo should be determined individually and the patient should be closely monitored during titration.
• The dose of digitalis, diuretics, and ACE inhibitors should be stabilized before starting Rivaldo.
• The recommended starting dose is 3.125 mg of Rafildo taken twice daily.
• The dose is increased to 12.5 mg twice daily and then to 25 mg twice daily. The dose should be titrated to the highest level tolerated by the patient.
• The maximum recommended dose is 25 mg twice daily for patients up to 85 kg and 50 mg
• Twice daily for patients weighing more than 85 kg.
• Before each dose increase, the physician should examine the patient for signs and symptoms of worsening heart failure, vasodilation (low blood pressure, dizziness), or bradycardia. Transient worsening
• Heart failure or fluid retention should be treated with increasing doses of diuretics, although it may sometimes be necessary to reduce the dose of Raveldo or temporarily discontinue treatment.
• If treatment with Raveldo is discontinued for more than two weeks, it should be restarted at a dose of 3.125 mg;
• This dose should then be increased at two-week intervals, as described above.
• Signs and symptoms of vasodilation should be treated initially by reducing the dose of the diuretic.
• The dose of the ACE inhibitor should be reduced, and then the dose of Raveldo should be reduced.
• Under these conditions, the dose of Raveldo should not be increased until signs and symptoms of worsening heart failure or vasodilation improve.
• The safety and effectiveness of Raveldo in patients under 18 years of age have not been investigated.
• Patients with renal impairment: No initial dose reduction is required in patients with renal impairment.
• Patients with hepatic failure: Careful dose titration is required in hepatic failure.
• Rivaldo tablets should be taken with plenty of liquid.
• Patients with heart failure should take Raveldo tablets with food to slow the rate of absorption and reduce the occurrence of orthostatic effects.
• Treatment with Raveldo is generally long-term. It should not be stopped abruptly, but should be tapered over several days (for example, by halving the dose every three days). This is particularly important in patients who also have coronary artery disease.

Warnings and Precautions:

Contraindications:

• Hypersensitivity to the active substance or any of the excipients.
• NYHA Class II and IV decompensated chronic heart failure in patients requiring intravenous inotropic support.
• chronic obstructive pulmonary disease.
• Bronchial asthma.
• Allergic rhinitis.
• Glottic edema.
• cor pulmonale.
• Sick sinus syndrome (including sinoatrial block).
• Second and third degree AV block.
• Severe bradycardia (less than 45-50 beats/minute at rest).
• Cardiogenic shock.
• Myocardial infarction with complications.
• Clinically manifests as liver failure.
• Metabolic acidosis.
• Concomitant administration of MAO inhibitors (except MAO-B inhibitors).
• Slow receptors of debrisoquine and

Precautions:

• Patients with pheochromocytoma can be treated with carvedilol only in conjunction with an effective alpha-blocker.
• Carvedilol should be used with caution in patients with uncompensated heart failure concomitant with digitalis, diuretics, and/or ACE inhibitors, because digitalis and carvedilol may prolong AV conduction and carvedilol may increase digitalis levels.
• Because of insufficient therapeutic experience, carvedilol should not be used in children.
• Secondary hypertension, unstable angina, complete bundle branch block, end-stage peripheral arterial disease
• Coronary artery disease, as beta blockers may cause or worsen signs and symptoms of coronary artery insufficiency.
• These patients: recent myocardial infarction, tendency to orthostatic hypotension, or concomitant use of certain antihypertensive agents (alpha 1 receptor antagonists).
• Beta-blocker treatment may increase sensitivity to allergens and the risk of severe anaphylactic reactions.
• Patients with a history of serious hypersensitivity reactions and those undergoing desensitization treatments.
• Therefore, caution should be exercised in these patients. Patients with psoriasis or a family history of psoriasis should be given medications with beta-blocking properties, including carvedilol, only after careful risk-benefit analysis.
• Carvedilol should be discontinued in hypertensive patients who also suffer from coronary heart disease; it is recommended to reduce the dose gradually, as in the case of other drugs with beta-blocking properties.
• Bradycardia occurred in 2% of hypertensive patients and 9% of heart failure patients in clinical studies. If
• If the heart rate is less than 55 beats/minute, the dose should be reduced. Hypotension and syncope occurred in 9.7% of patients.
• 4% of heart failure patients treated with carvedilol develop these effects. The risk of these effects is greatest during the first 30 days of treatment, i.e., during the dose titration phase. Careful monitoring of blood pressure and ECG parameters is required during concomitant treatment with calcium antagonists such as verapamil, diltiazem, or other antiarrhythmics.
• In elderly patients, the first dose of carvedilol may be followed by an excessive drop in blood pressure.
• It can be hypothesized that by causing beta-blockers, carvedilol may mask signs and symptoms of hyperthyroidism, such as tachycardia. Abrupt discontinuation of beta-blockers may be followed by worsening symptoms.
• Signs and symptoms of hyperthyroidism.
• Close medical supervision is particularly required in patients with diabetes. Diabetics should be informed that carvedilol may mask or mitigate the signs and symptoms of hypoglycemia, particularly tachycardia. Serum glucose levels are affected by non-selective beta-blockers. Regular monitoring of blood glucose is required, and the dosage of insulin or oral antidiabetic agents may need to be adjusted.
• Symptoms may be exacerbated in patients with intermittent claudication or Raynaud's phenomenon.
• Contact lens wearers should be aware of the possibility of reducing tearing.
• Patients with heart failure may experience worsening heart failure or fluid retention during the dose titration phase of carvedilol treatment.
• If such effects occur, the dose of the diuretic should be increased and the dose of carvedilol should not be increased until the patient's condition stabilizes.
• From time to time it may be necessary to reduce the dose of carvedilol or discontinue treatment.
• Reversible deterioration in renal function has been observed in association with carvedilol in patients with
• Decompensated heart failure, hypotension (systolic blood pressure <100 mmHg), coronary heart disease

, or other vascular diseases, and/or with renal impairment.

• Rivaldo tablets should be taken with plenty of liquid.
• Patients with heart failure should take Raveldo tablets with food to slow the rate of absorption and reduce the occurrence of orthostatic effects.
• Treatment with Raveldo is generally long-term. It should not be stopped abruptly, but should be tapered over several days (for example, by halving the dose every three days). This is particularly important in patients who also have coronary artery disease.

the components:

• Rivaldo 25: Each film-coated tablet contains Carvedilol 25 mg in packs of 30 tablets.