METOPROLOL SUCCINATE 50 mg/1
metoprolol succinate · TABLET, EXTENDED RELEASE · A-S Medication Solutions
METOPROLOL SUCCINATE is a tablet, extended release containing metoprolol succinate at 50 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- METOPROLOL SUCCINATE
- Generic Name
- metoprolol succinate
- NDC Code (Product)
50090-6663- Manufacturer
- A-S Medication Solutions
- Strength
- 50 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207465
- Marketing Start
- 03/25/2019
Recall History
Wockhardt Usa Inc.
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Ascend Laboratories, LLC
Failed Dissolution Specification
Ascend Laboratories, LLC
Failed Dissolution Specification
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specification; 12-Month stability interval.
Wockhardt Usa Inc.
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Wockhardt Usa Inc.
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
American Health Packaging
Failed Dissolution Specifications
Teva Pharmaceuticals USA
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
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 Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Angina Pectoris. ( 1.2 ) • Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3 ) 1.1 Hypertension Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advic…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Administer once daily. Titrate at weekly or longer intervals as needed and tolerated. ( 2 ) • Hypertension: Starting dose is 25 mg to 100 mg. ( 2.1 ) • Angina Pectoris: Starting dose is 100 mg. ( 2.2 ) • Heart Failure: Starting dose is 12.5 mg or 25 mg. ( 2.3 ) • Switching from immediate-release metoprolol to metoprolol succinate extended-release tablets: use the same total daily dose of metoprolol succinate extended-release tablets. ( 2 ) 2.1 Hypertension Adults: The usual initial dosage is 25 mg to 100 mg daily in a single dose. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. Dosages above 400 mg per day have not been studied. Pediatric Hypertensive Patients ≥ 6 Years of age: The recommended starting dose of metoprolol succinate extended-release tablets are 1 mg/kg once daily, but the maximum initial dose should not exceed 50 mg once daily. Adjust dosage according to blood pressure response. Doses above 2 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients [see Use in Sp…
Contraindications
4 CONTRAINDICATIONS Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second- or third- degree heart block, cardiogenic shock, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. • Known hypersensitivity to product components. ( 4 ) • Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. ( 4 ) • Cardiogenic shock or decompensated heart failure. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. ( 7.1 ) • CYP2D6 Inhibitors are likely to increase metoprolol concentration. ( 7.2 ) • Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. ( 7.3 ) 7.1 Catecholamine Depleting Drugs Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents. Observe patients treated with metoprolol succinate extended-release tablets plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. 7.2 CYP2D6 Inhibitors Drugs that are strong inhibitors of CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone were shown to double metoprolol concentrations. While there is no information about moderate or weak inhibitors, these too are likely to increase metoprolol concentration. Increases in plasma concentration decrease the cardioselectivity of metoprolol [ see Clinical Pharmacology (12.3) ]. Monitor patients closely when the combination canno…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: • Worsening angina or myocardial infarction [see Warnings and Precautions (5) ] • Worsening heart failure [see Warnings and Precautions (5) ]. • Worsening AV block [see Contraindications (4) ]. • Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension and Angina : Most adverse reactions have been mild and transient. The most common (>2%) adverse reactions are tiredness, dizziness, de…
Frequently Asked Questions
What is METOPROLOL SUCCINATE used for?
METOPROLOL SUCCINATE contains metoprolol succinate. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is METOPROLOL SUCCINATE a controlled substance?
METOPROLOL SUCCINATE is not classified as a controlled substance by the DEA.
What is the generic name for METOPROLOL SUCCINATE?
The generic name for METOPROLOL SUCCINATE is metoprolol succinate. There are 10 other brand versions of metoprolol succinate.
What is the NDC code for METOPROLOL SUCCINATE 50 mg/1?
The NDC (National Drug Code) for METOPROLOL SUCCINATE 50 mg/1 is 50090-6663, listed by A-S Medication Solutions.
Other METOPROLOL SUCCINATE Dosages
Other Metoprolol Brands
See all →- Metoprolol Succinate ER50 mg/172189-547
- Metoprolol succinate50 mg/10904-6323
- Metoprolol succinate25 mg/142806-724
- Metoprolol Succinate25 mg/150090-6488
- Metoprolol succinate100 mg/150090-7070
- Metoprolol Succinate100 mg/151407-405
- Metoprolol Succinate200 mg/151407-406
- Metoprolol Succinate25 mg/155154-4698
- metoprolol succinate100 mg/160760-663
- Metoprolol succinate100 mg/160760-994
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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