Carvedilol Phosphate 80 mg/1
Carvedilol Phosphate · CAPSULE, EXTENDED RELEASE · Bryant Ranch Prepack
Carvedilol phosphate is a prescription medication taken by mouth as an extended-release capsule that belongs to a class of drugs called beta-blockers, commonly used to treat high blood pressure and heart failure. Your doctor will determine the appropriate dose for your condition.
Key Facts
- Brand Name
- Carvedilol Phosphate
- Generic Name
- Carvedilol Phosphate
- NDC Code (Product)
63629-9635- Manufacturer
- Bryant Ranch Prepack
- Strength
- 80 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090132
- Marketing Start
- 11/08/2017
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: CARVEDILOL PHOSPHATE ER, Capsule, 20 mg may be potentially mislabeled as the following drug: BUMETANIDE, Tablet, 1 mg, NDC 00093423301, Pedigree: W003224, EXP: 6/17/2014.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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) ]. 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol phosphate extended-release capsules 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 phosphate extended-release capsules are indicated for the management of essential hyp…
Dosage & Administration
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. Dosing Conversion Daily Dose of Immediate-Release Carvedilol Tablets Daily Dose of Carvedilol Phosphate Extended-Release Capsules* 6.25 mg (3.125 mg twice daily) 10 mg once daily 12.5 mg (6.25 mg twice daily) 20 mg once daily 25 mg (12.5 mg twice daily) 40 mg once daily 50 mg (25 mg twice daily) 80 mg once daily * When switching from carvedilol 12.5 mg or 25 mg twice daily, a starting dose of carvedilol phosphate extended-release capsules 20 mg or 40 mg once daily, respectively, may be warranted for elderly patients or those at increased risk of hypotension, dizziness, or syncope. Subsequent titration to higher doses should, as appropriate, be made after an interval of at least 2 weeks. Carvedilol phosphate extended-release capsules should be taken once daily in the morning with food. Carvedilol phosphate extended-release capsules shoul…
Contraindications
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). 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 carvedilol phosphate extended-release capsules. Patients with severe hepatic impairment. Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of carvedilol phosphate extended-release capsules. Bronchial asthma or related bronchospastic conditions. ( 4 ) Second- or third-degree AV block. ( 4 ) Sick sinus syndrome. ( 4 ) Severe bradycardia (unless permanent pacemaker in place). ( 4 ) Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic ther…
Drug 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. ( 7.8 ) 7.1 CYP2D6 Inhibitors and Poor Metabolizers Interactions of carvedilol with potent inhibitors of CYP2D6 isoenzyme (such as quinidine, fluoxetine, paroxetine, and propafenone) have not been studied, but these drugs would be expected to increase blood levels of the R(+) enantiomer of carvedilol [see Clinical Pharmacology (12.3) ] . Retrospective analysis of side effects in clinical trials showed that poor 2D6 metabolizers had a highe…
Adverse Reactions
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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Carvedilol has been evaluated for safety in subjects with heart failure (mild, moderate, and severe), in subjects with left ventricular dysfunction following myocardial infarction, and in hypertensive subjects. The observed adverse event profile was consistent with the pharmacology of th…
Frequently Asked Questions
What is Carvedilol Phosphate used for?
Carvedilol phosphate is a prescription medication taken by mouth as an extended-release capsule that belongs to a class of drugs called beta-blockers, commonly used to treat high blood pressure and heart failure. Your doctor will determine the appropriate dose for your condition.
Is Carvedilol Phosphate a controlled substance?
Carvedilol Phosphate is not classified as a controlled substance by the DEA.
What is the generic name for Carvedilol Phosphate?
The generic name for Carvedilol Phosphate is Carvedilol Phosphate. There are 3 other brand versions of Carvedilol Phosphate.
What is the NDC code for Carvedilol Phosphate 80 mg/1?
The NDC (National Drug Code) for Carvedilol Phosphate 80 mg/1 is 63629-9635, listed by Bryant Ranch Prepack.
Other Carvedilol Phosphate Dosages
- Carvedilol Phosphate40 mg/151407-052
- Carvedilol Phosphate20 mg/169238-2578
- Carvedilol Phosphate10 mg/10115-1248
- Carvedilol Phosphate80 mg/157664-666
- Carvedilol Phosphate10 mg/167046-1551
- Carvedilol Phosphate40 mg/163629-9634
- Carvedilol Phosphate40 mg/169238-2579
- Carvedilol Phosphate10 mg/171335-0308
- Carvedilol Phosphate40 mg/10115-1250
Other Carvedilol Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)