Carvedilol Phosphate
Generic Name: carvedilol phosphate
Brand Names:
Carvedilol Phosphate
11 DESCRIPTION Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha 1 -blocking activity. It is (2 RS )-1-(9 H -Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure: Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C 24 H 26 N 2 O 4 •H 3 PO 4 •1/2 EtOH.
Overview
11 DESCRIPTION Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha 1 -blocking activity. It is (2 RS )-1-(9 H -Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure: Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C 24 H 26 N 2 O 4 •H 3 PO 4 •1/2 EtOH.
Uses
1 INDICATIONS AND USAGE Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure. ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2 ) hypertension ( 1.3 ) 1.1 Heart Failure Carvedilol phosphate extended-release capsules 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) ].
Dosage
2 DOSAGE AND ADMINISTRATION Carvedilol phosphate extended-release capsules are intended for once-daily administration. Patients controlled with immediate-release carvedilol tablets alone or in combination with other medications may be switched to carvedilol phosphate extended-release capsules based on the total daily doses shown in Table 1. Table 1.
Side Effects
6 ADVERSE REACTIONS The safety profile of carvedilol phosphate extended-release capsules were similar to that observed for immediate-release carvedilol. Most common adverse events seen with immediate-release carvedilol. ( 6.1 ): Heart failure and left ventricular dysfunction following myocardial infarction (greater than or equal to 10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase. Hypertension (greater than or equal to 5%): Dizziness. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS CYP P450 2D6 enzyme inhibitors may increase and rifampin may decrease carvedilol levels. ( 7.1 , 7.5 ) Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia. ( 7.2 ) Cyclosporine or digoxin levels may increase. ( 7.3 , 7.4 ) Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. ( 7.4 ) Amiodarone may increase carvedilol levels resulting in further slowing of the heart rate or cardiac conduction. ( 7.6 ) Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure. ( 7.7 ) Insulin and oral hypoglycemics action may be enhanced.
Warnings
5 WARNINGS AND PRECAUTIONS In clinical trials of extended-release carvedilol phosphate capsules in subjects with hypertension (338 subjects) and in subjects with left ventricular dysfunction following a myocardial infarction or heart failure (187 subjects), the profile of adverse events observed with carvedilol phosphate was generally similar to that observed with the administration of immediate-release carvedilol. Therefore, the information included within this section is based on data from controlled clinical trials with extended-release carvedilol phosphate capsules as well as immediate-release carvedilol. Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. 4 CONTRAINDICATIONS Carvedilol phosphate extended-release capsules are contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release carvedilol. Second- or third-degree AV block. Sick sinus syndrome. Severe bradycardia (unless a permanent pacemaker is in place).
Pregnancy
8.1 Pregnancy Risk Summary Available data regarding use of carvedilol phosphate extended-release capsules in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate [see Clinical Considerations ] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING The hard gelatin extended-release capsules are available in the following strengths: 10 mg – capsules with white opaque body imprinted with “H31” in black ink and dark green opaque cap. Bottles of 30: NDC 42291-479-30 20 mg – capsules with white opaque body imprinted with “H32” in black ink and bright orange opaque cap.
Frequently Asked Questions
What is Carvedilol Phosphate used for?▼
1 INDICATIONS AND USAGE Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure. ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2 ) hypertension ( 1.3 ) 1.1 Heart Failure Carvedilol phosphate extended-release capsules 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) ].
What are the side effects of Carvedilol Phosphate?▼
6 ADVERSE REACTIONS The safety profile of carvedilol phosphate extended-release capsules were similar to that observed for immediate-release carvedilol. Most common adverse events seen with immediate-release carvedilol. ( 6.1 ): Heart failure and left ventricular dysfunction following myocardial infarction (greater than or equal to 10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase. Hypertension (greater than or equal to 5%): Dizziness. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Carvedilol Phosphate during pregnancy?▼
8.1 Pregnancy Risk Summary Available data regarding use of carvedilol phosphate extended-release capsules in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate [see Clinical Considerations ] .
What are the important warnings for Carvedilol Phosphate?▼
5 WARNINGS AND PRECAUTIONS In clinical trials of extended-release carvedilol phosphate capsules in subjects with hypertension (338 subjects) and in subjects with left ventricular dysfunction following a myocardial infarction or heart failure (187 subjects), the profile of adverse events observed with carvedilol phosphate was generally similar to that observed with the administration of immediate-release carvedilol. Therefore, the information included within this section is based on data from controlled clinical trials with extended-release carvedilol phosphate capsules as well as immediate-release carvedilol. Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. 4 CONTRAINDICATIONS Carvedilol phosphate extended-release capsules are contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release carvedilol. Second- or third-degree AV block. Sick sinus syndrome. Severe bradycardia (unless a permanent pacemaker is in place).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.