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Coreg 12.5 Mg Tabs 100 By Glaxo Smithkline.

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Coreg 12.5 Mg Tabs 100 By Glaxo Smithkline.

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Coreg 12.5 Mg Tabs 100 By Glaxo Smithkline. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD2557478/RXB10051942/RXA323231
Size : 100
Selling UoM : EA
NDC: 00007-4141-20
UPC Barcode : 300074141204Supplier: 0050003878 GLAXOSMITHKLINE/KDC
Supplier Material : 414120
Generic Code : 022233 CARVEDILOL ORAL TABLET 12.5 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

SB 4141, SB 4141
tablet , film-coated , white , oval oblong

Carvedilol is a nonselective β-adrenergic blocking agent with ⓫-blocking activity.

COREG is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 6.25 mg, 12.5 mg, and 25 mg tablets are TILTAB? tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sucrose, and titanium dioxide.

Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide soluble in methylene chloride and methanol sparingly soluble in 95% ethanol and isopropanol slightly soluble in ethyl ether and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).

INDICATIONS
Heart Failure

COREG is 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 and Clinical Studies].
Left Ventricular Dysfunction Following Myocardial Infarction

COREG is 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 ≤ 40% (with or without symptomatic heart failure) [see Clinical Studies].
Hypertension

COREG is indicated for the management of essential hypertension [see Clinical Studies]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics

SIDE EFFECTS
Clinical Studies Experience

COREG has been evaluated for safety in patients with heart failure (mild, moderate, and severe), in patients with left ventricular dysfunction following myocardial infarction and in hypertensive patients. The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials. Adverse events reported for each of these patient populations are provided below. Excluded are adverse events considered too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. Rates of adverse events were generally similar across demographic subsets (men and women, elderly and non-elderly, blacks and non-blacks).
Heart Failure

COREG has been evaluated for safety in heart failure in more than 4,500 patients worldwide of whom more than 2,100 participated in placebo-controlled clinical trials. Approximately 60% of the total treated population in placebo-controlled clinical trials received COREG for at least 6 months and 30% received COREG for at least 12 months. In the COMET trial, 1,511 patients with mild-to-moderate heart failure were treated with COREG for up to 5.9 years (mean 4.8 years). Both in US clinical trials in mild-to-moderate heart failure that compared COREG in daily doses up to 100 mg (n = 765) to placebo (n = 437), and in a multinational clinical trial in severe heart failure (COPERNICUS) that compared COREG in daily doses up to 50 mg (n = 1,156) with placebo (n = 1,133), discontinuation rates for adverse experiences were similar in carvedilol and placebo patients. In placebo-controlled clinical trials, the only cause of discontinuation > 1%, and occurring more often on carvedilol was dizziness (1.3% on carvedilol, 0.6% on placebo in the COPERNICUS trial).

Table 1 shows adverse events reported in patients with mild-to-moderate heart failure enrolled in US placebo-controlled clinical trials, and with severe heart failure enrolled in the COPERNICUS trial. Shown are adverse events that occurred more frequently in drug-treated patients than placebo-treated patients with an incidence of > 3% in patients treated with carvedilol regardless of causality. Median study medication exposure was 6.3 months for both carvedilol and placebo patients in the trials of mild-to-moderate heart failure, and 10.4 months in the trial of severe heart failure patients. The adverse event profile of COREG observed in the long-term COMET study was generally similar to that observed in the US Heart Failure Trials.