Carvista 12.5 mg Tablet

What is Carvista?

Carvista is a brand of Carvedilol manufactured by Incepta Pharmaceuticals Ltd. Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of beta-adrenergic receptors, with appreciable alpha-adrenergic antagonistic activity. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

Indications

Carvista is indicated for the treatment of mild, moderate or severe heart failure of ischemic or cardiomyopathic origin, in conjunction with digitalis, diuretics and an ACE inhibitor, to reduce the progression of disease as evidenced by cardiovascular death, cardiovascular hospitalization, or the need to adjust other heart failure medications. Carvista may be used in patients unable to tolerate an ACE inhibitor, and in patients not receiving digitalis, hydralazine or nitrate therapy.

Pharmacology

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of beta-adrenergic receptors but which also possesses appreciable alpha-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals.

Dosage & Administration

In hypertension: Initially 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to a maximum of 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: Recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days, thereafter 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: Initially 3.125 mg twice daily (with food), increased at intervals of at least 2 weeks to 6.25 mg twice daily, then 12.5 mg twice daily, then 25 mg twice daily, to the highest dose tolerated (maximum 25 mg twice daily in patients under 85 kg, 50 mg twice daily in patients over 85 kg).

Interaction

Digoxin: Co-administration resulted in significantly increased digoxin levels; increased monitoring is recommended.
Rifampin: Pretreatment resulted in a 60% decrease in Cmax and AUC.
Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.
Clonidine: Beta-blockers potentiate the pressor reaction that may follow sudden withdrawal of clonidine.

Contraindications

Contraindicated in patients with 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 or severe bradycardia.

Side Effects

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms; rarely 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

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Safety and efficacy in children have not been established.

Precautions & Warnings

Use caution in hepatic impairment. In heart failure, monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing the dose, ensure that renal function and heart failure are not deteriorating.

Therapeutic Class

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Storage Conditions

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