Rovedilol 12.5 mg (Tablet)

Indications

• Treatment of mild, moderate or severe heart failure
• Treatment of heart failure of ischemic or cardiomyopathic origin
• May be used in conjunction with digitalis, diuretics, and ACE inhibitor
• Reduction of cardiovascular death progression
• Reduction of cardiovascular hospitalization progression
• Reduction of the need to adjust other heart failure medications

Pharmacology

• Non-selective antagonism of β-adrenergic receptors
• Appreciable a-adrenergic antagonistic activity
• Antiproliferative properties
• Scavenger of reactive free oxidant radicals
• Treatment of hypertension
• Treatment of angina pectoris
• Treatment of congestive heart failure

Dosage & Administration

• Initial dose of 12.5 mg once daily for hypertension
• Usual dose of 25 mg once daily for hypertension
• Maximum dose of 50 mg daily for hypertension
• Recommended initial dose of 12.5 mg twice daily for angina pectoris
• Recommended dosage of 25 mg twice daily for angina pectoris
• Maximum daily dose of 50 mg for angina pectoris
• Initial dose of 3.125 mg twice daily for heart failure
• Maximum dose of 25 mg twice daily for heart failure in patients less than 85 kg body-weight
• Maximum dose of 50 mg twice daily for heart failure in patients over 85 kg

Interaction

• Increased levels of digoxin when taken together
• Decrease in Cmax and AUC when pretreated with rifampin
• No alteration in the in vitro plasma protein binding of warfarin
• Potential potentiation of the pressor reaction with clonidine withdrawal

Contraindications

• Decompensated heart failure requiring intravenous inotropic therapy
• Bronchial asthma or related bronchospastic conditions
• Second or third-degree AV block
• Sick sinus syndrome (unless a permanent pacemaker is in place)
• Cardiogenic shock
• Severe bradycardia

Side Effects

• Postural hypotension
• Dizziness
• Headache
• Fatigue
• Gastro-intestinal disturbances
• Bradycardia
• Peripheral circulation disturbances
• Peripheral oedema and painful extremities
• Dry mouth
• Dry eyes
• Eye irritation or disturbed vision
• Impotence
• Disturbances of micturition
• Influenza-like symptoms
• Angina
• AV block
• Exacerbation of intermittent claudication or Raynaud's phenomenon
• Allergic skin reactions
• Exacerbation of psoriasis
• Nasal stuffiness
• Wheezing
• Depressed mood
• Sleep disturbances
• Paresthesia
• Heart failure
• Changes in liver enzymes
• Thrombocytopenia
• Leukopenia

Pregnancy & Lactation

• Not to be used during breastfeeding
• Excretion in breast milk
• Safety and efficacy not established in children
• Crosses the placental barrier

Precautions & Warnings

• Caution in hepatic impairment
• Monitoring clinical status in heart failure
• Monitoring clinical status in renal function
• Monitoring clinical status after increasing each dose

Therapeutic Class

• Alpha adrenoceptor blocking drugs
• Beta-adrenoceptor blocking drugs
• Beta-blockers

Storage Conditions

• Keep below 30°C temperature
• Keep away from light & moisture
• Keep out of the reach of children

Related Brands

• Carvista 3.125 mg (Tablet) - incepta-pharmaceuticals-ltd