CARVEDILOL TABLETS

/CARVEDILOL TABLETS
CARVEDILOL TABLETS2018-09-06T09:12:40+00:00

Prescription Drug Name:

CARVEDILOL TABLETS

ID:

3FD99144-3C4D-9DBB-E6D6-C75688CA8B1C

Code:

45129-4

2 DOSAGE AND ADMINISTRATION


id: 3EABB629-0FE2-CB37-FC0E-C98A5BDD2135
displayName: DOSAGE AND ADMINISTRATION SECTION
FDA Article Code: 34068-7

Carvedilol should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.

3 DOSAGE FORMS AND STRENGTHS


id: ACE60CD5-893E-EEC6-0978-7EDDE341EE28
displayName: DOSAGE FORMS AND STRENGTHS SECTION
FDA Article Code: 43678-2

3.125 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX4’, on one side and plain on the other side. 6.25 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘RX’, on one side and ‘824’ on the other side. 12.5 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘RX825’ on one side and plain on the other side. 25 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘RX826’ on one side and plain on the other side.

4 CONTRAINDICATIONS


id: 5BBC2E44-1A4B-E1C4-3FE8-C44FC862F17C
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Carvedilol is contraindicated in the following conditions:Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of carvedilol.Second- or third-degree AV blockSick sinus syndromeSevere bradycardia (unless a permanent pacemaker is in place)Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating carvedilolPatients with clinical manifest hepatic impairmentPatients with a history of a serious hypersensitivity reaction to carvedilol (e.g. Stevens-Johnson syndrome)

10 OVERDOSAGE


id: 37E3F50E-72D0-7EEC-4864-D85AB85EDD81
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, and cardiac arrest. Respiratory problems, bronchospasms, vomiting, lapses of consciousness, and generalized seizures may also occur.The patient should be placed in a supine position and, where necessary, kept under observation and treated under intensive-care conditions. Gastric lavage or pharmacologically induced emesis may be used shortly after ingestion. The following agents may be administered:for excessive bradycardia: Atropine, 2 mg IV.to support cardiovascular function: glucagon, 5 to 10 mg IV rapidly over 30 seconds, followed by a continuous infusion of 5 mg/hour; sympathomimetics (dobutamine, isoprenaline, adrenaline) at doses according to body weight and effect.If peripheral vasodilation dominates, it may be necessary to administer adrenaline or noradrenaline with continuous monitoring of circulatory conditions. For therapy-resistant bradycardia, pacemaker therapy should be performed. For bronchospasm, β-sympathomimetics (as aerosol or IV) or aminophylline IV should be given. In the event of seizures, slow IV injection of diazepam or clonazepam is recommended.NOTE: In the event of severe intoxication where there are symptoms of shock, treatment with antidotes must be continued for a sufficiently long period of time consistent with the 7- to 10-hour half-life of carvedilol.Cases of overdosage with carvedilol alone or in combination with other drugs have been reported. Quantities ingested in some cases exceeded 1,000 milligrams. Symptoms experienced included low blood pressure and heart rate. Standard supportive treatment was provided and individuals recovered.

11 DESCRIPTION


id: B039C4BA-C0BC-0ABF-AC0D-830CAA975FBA
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 is a white to off-white, oval-shaped, biconvex, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients: consist of colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polysorbate 80, povidone, propylene glycol, sucrose, talc and titanium dioxide.Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H26N2O4. 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).

16 HOW SUPPLIED/STORAGE AND HANDLING


id: 7CF8432B-E7E7-E641-D68B-911924371A00
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Carvedilol tablets are supplied as:3.125 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX4’ , on one side and plain on the other side.NDC 63304-823-30 Bottles of 30NDC 63304-823-10 Bottles of 10006.25 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX’ on one side and ‘824’ on the other side.NDC 63304-824-30 Bottles of 30NDC 63304-824-10 Bottles of 100012.5 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX825’ on one side and plain on the other side.NDC 63304-825-30 Bottles of 30NDC 63304-825-10 Bottles of 100025 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX826’ on one side and plain on the other side.NDC 63304-826-30 Bottles of 30NDC 63304-826-10 Bottles of 1000Store at 20 – 25°C (68 – 77°F). (See USP Controlled Room Temperature).Protect from moisture. Dispense in a tight, light-resistant container.