Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)
Direct_Rx
ORAL
PRESCRIPTION DRUG
1.1 Heart Failure Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies (14.1)]. 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)]. 1.3 Hypertension Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)]. Carvedilol tablets are contraindicated
Carvedilol Tablets USP, 3.125 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1,000 Carvedilol Tablets USP, 6.25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘02’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1,000 Carvedilol Tablets USP, 12.5 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘03’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1,000 Carvedilol Tablets USP, 25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘04’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1,000 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
CARVEDILOL- CARVEDILOL TABLET, FILM COATED DIRECT_RX ---------- CARVEDIDOL 1.1 Heart Failure Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies (14.1)]. 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)]. 1.3 Hypertension Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)]. Carvedilol tablets should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects. 2.1 Heart Failure DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of carvedilol tablets, it is recommended that fluid retention be minimized. The recommended starting dose of carvedilol tablets is 3.125 mg twice daily for 2 weeks. If tolerated, patients may have their dose increased to 6.25 mg, 12.5 mg and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated. A maximum dose of 50 mg twice daily has been administered to patients with mild-to- moderate heart failure weighing over 85 kg (187 lbs). Patients should be advised that initiation of treatment and (to a lesser extent) dosage increases may be associated with transient symptoms of dizziness or lightheadedness (and rarely syncope) within the first h Olvassa el a teljes dokumentumot