Drug Catalog - Product Detail
CARVEDILOL 3.125MG TB 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-3631-01 | MYLAN | 100 | 3.125MG | TABLET |
PACKAGE FILES
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Description
11 DESCRIPTION Carvedilol is a nonselective β-adrenergic blocking agent with α 1 -blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure: Carvedilol Carvedilol tablets, USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. In addition, the 3.125 mg tablets contain FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24 H 26 N 2 O 4 . 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). Carvedilol Tablets, USP meet USP Dissolution Test 2. Carvedilol Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Carvedilol Tablets, USP are available containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol, USP. The 3.125 mg tablets are blue film-coated, round, unscored tablets debossed with M on one side of the tablet and C31 on the other side. They are available as follows: NDC 0378-3631-28 bottles of 28 tablets NDC 0378-3631-91 bottles of 60 tablets NDC 0378-3631-01 bottles of 100 tablets NDC 0378-3631-05 bottles of 500 tablets The 6.25 mg tablets are white film-coated, round, unscored tablets debossed with M on one side of the tablet and C32 on the other side. They are available as follows: NDC 0378-3632-28 bottles of 28 tablets NDC 0378-3632-91 bottles of 60 tablets NDC 0378-3632-01 bottles of 100 tablets NDC 0378-3632-05 bottles of 500 tablets The 12.5 mg tablets are white film-coated, round, unscored tablets debossed with M on one side of the tablet and C33 on the other side. They are available as follows: NDC 0378-3633-28 bottles of 28 tablets NDC 0378-3633-91 bottles of 60 tablets NDC 0378-3633-01 bottles of 100 tablets NDC 0378-3633-05 bottles of 500 tablets The 25 mg tablets are white film-coated, round, unscored tablets debossed with M on one side of the tablet and C34 on the other side. They are available as follows: NDC 0378-3634-28 bottles of 28 tablets NDC 0378-3634-91 bottles of 60 tablets NDC 0378-3634-01 bottles of 100 tablets NDC 0378-3634-05 bottles of 500 tablets 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 as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
Indications & Usage
1 INDICATIONS AND USAGE Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: • Left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2 ) • Hypertension. ( 1.3 ) 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 ≤ 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) ] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Carvedilol tablets should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects. Take with food. Individualize dosage and monitor during up-titration. ( 2 ) • Left ventricular dysfunction following myocardial infarction: Start at 6.25 mg twice daily and increase to 12.5 mg then 25 mg twice daily after intervals of 3 to 10 days. A lower starting dose or slower titration may be used. ( 2.2 ) • Hypertension: Start at 6.25 mg twice daily and increase if needed for blood pressure control to 12.5 mg then 25 mg twice daily over intervals of 1 to 2 weeks. ( 2.3 ) 2.2 Left Ventricular Dysfunction Following Myocardial Infarction DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction. 2.3 Hypertension DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about one hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol is seen within 7 to 14 days. Total daily dose should not exceed 50 mg. Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action. 2.4 Hepatic Impairment Carvedilol tablets should not be given to patients with severe hepatic impairment [see Contraindications (4) ] .