Category : CARDIOVASCULAR

Name : CARDIOL® (CARVEDILOL)     Type & Dosage : SCORED F.C. Tab. ; 6.25 mg Package : 30

Pharmacologic Category Beta – adrenergic blocker ( nonselective ) ; Antihypertensive . Mechanism Of Action Carvedilol is a nonselective beta – adrenergic blocking agent with alpha - adrenergic blocking activity and no intrinsic sympathomimetic activity . The exact mechanism of the antihypertensive effect produced by beta – adrenergic blockade is not known , but may involve suppression of renin production . The mechanism by which carvedilol produces a beneficial effect in congestive heart failure is not known , but may be attributable to beta – adrenergic blockade and vasodilation . Indications Congestive heart failure ( treatment adjunct ) Carvedilol is indicated , in conjunction with digitals , diuretics , and / or ACE inhibitors , for the treatment of mild or moderate ( class II or III ) heart failure of ischemic or cardiomyopathic origin . Hypertension ( treatment ) Carvedilol is indicated , either alone or in combination with other antihypertensive agents in the treatment of essential hypertension . Side Adverse Effects a – Those indicating need for medical attention : Bradycardia ; Chest pain ; Dizziness ; Dyspnea ; Generalized edema ; Peripheral edema ; Hypotension ; Pain ; Syncope ; Weight increase ; Fever ; Hematuria; Hepatic injury ; Mental depression ; Thrombocytopenia . b – Those indicating need for medical attention only if continue or are bothersome : Back pain ; Diarrhea ; Fatigue ; Paresthesia ; Abdominal pain ; Arthralgia ; Blurred vision ; Headache ; Insomnia ; Decreased lacrimation ; Myalgia ; Nausea ; Pharyngitis ; Rhinitis ; Increased sweating ; Vomiting . Contraindications Bronchial asthma or related bronchospastic conditions ; Second or third degree atrioventricular block , sick sinus syndrome , and severe bradycardia ( except in patients with a functioning artificial pacemaker ) ; Cardiogenic shock ; Severe decompensated cardiac failure ( class IV ) requiring intravenous inotropic therapy ; Severe hepatic function impairment ; Hypersensitivity to carvedilol or any component of the formulation . Warnings Precautions Risk benefit should be considered when the following medical problems exist : History of severe anaphylactic reaction to a variety of allergens , Prinzmetal's angina , Nonallergic bronchospastic conditions such as chronic bronchitis and emphysema , Congestive heart failure if accompanied by hypotension (systolic blood pressure < 100 mm Hg) or ischemic heart disease or renal insufficiency or diffuse vascular disease , Diabetes or hypoglycemia , Hyperthyroidism , Peripheral vascular disease , Pheochromocytoma , Renal function impairment . Pregnancy FDA Pregnancy Category C . Use during pregnancy only if the potential benefit justifies the risk . Breast Feeding It is not known whether carvedilol is distributed into breast milk . Because of the potential for a serious reaction in nursing infants from beta – adrenergic blockade ( bradycardia ) , a decision should be made about whether to discontinue nursing or to discontinue carvedilol . Drug Interactions Concurrent use of general anesthetics such as cyclopropane , ether and trichloroethylene with carvedilol may further depress myocardial function . Concurrent use with carvedilol may increase the serum glucose – lowering effects of insulin and sulfonylurea antidiabetic agents ; regular monitoring of blood glucose is recommended . Concurrent use of carvedilol with calcium channel blocking agents , especially diltiazem or verapamil has resulted in isolated cases of conduction disturbances . Concurrent use of carvedilol with drugs that can deplete catecholamines may cause hypotension and bradycardia . Concurrent use of clonidine with carvedilol may have additive blood pressure – and heart rate – lowering effects . Carvedilol may increase the serum level of digoxin . Hepatic enzyme inducers such as rifampin may increase the metabolism of carvedilol . Hepatic enzyme inhibitors such as cimetidine , fluoxetine , paroxetine , propafenone , quinidine , fluconazole , NSAIDs and sulfonamides may increase carvedilol serum levels . Concurrent use of carvedilol with alpha – blockers( prazosin , terazosin ) may increase risk of orthostasis . Calcium channel blockers may enhance hypotensive effects of carvedilol . NSAIDs ( ibuprofen , indomethacin , naproxen , piroxicam ) may reduce the antihypertensive effects of carvedilol . Monitoring Parameters Standing systolic blood pressure determinations ; Blood glucose concentrations ( for diabetic patients ) ; ECG determinations ( when carvedilol is used concurrently with calcium channel blocking agents ) ; Hepatic and renal function determinations ( especially in patients with congestive heart failure during dosage increases ) . Dietary Considerations Taking carvedilol with food may slow the rate of absorption and minimize the risk of orthostatic hypotension . Administration And Dosage Usual adult dose : Congestive heart failure – Initial : Oral , 3.125 mg two times a day for two weeks , taken with food . If tolerated , the dose may be increased to 6.25 mg two times a day . The dosage may then be doubled every two weeks to the highest dose tolerated by the patient . Hypertension – Initial : Oral , 6.25 mg two times a day , taken with food . Dose should be maintained for 7 to 14 days and then increased to 12.5 mg two times a day, if tolerated , if blood pressure is not adequately controlled . If after the new dose is maintained for 7 to 14 days blood pressure is still not controlled , the dose may be increased to 25 mg two times a day , if tolerated . Maintenance : Oral , 6.25 to 25 mg two times a day .The full antihypertensive effect occurs within 7 – 14 days . Usual adult prescribing limits : Congestive heart failure – 25 mg two times a day in patients weighing less than 85 kg and 50 mg two times a day in patients weighing more than 85 kg . Hypertension – 25 mg two times a day . Usual pediatric dose : Children younger than 18 years of age – Safety and efficacy have not been established. How Supplied Tablet , 6.25 and 12.5 mg . Storage Store between 15 and C ( 59 and F ) in a tight , light – resistant container . Protect from moisture . References - USP DI , 2004 - Up To Date , 13.3 ( 2005 ) - Martindale , The Complete Drug Reference , 34 th edition , 2005