Metoprolol Succinate ER 50 mg/1
Metoprolol Succinate ER · TABLET, EXTENDED RELEASE · Direct_Rx
Metoprolol Succinate ER is a tablet, extended release containing metoprolol succinate er at 50 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Metoprolol Succinate ER
- Generic Name
- Metoprolol Succinate ER
- NDC Code (Product)
72189-547- Manufacturer
- Direct_Rx
- Strength
- 50 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203894
- Marketing Start
- 04/11/2024
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; METOPROLOL SUCCINATE ER, Tablet, 200 mg may be potentially mislabeled as Pedigree: AD73652_13, EXP: 5/30/2014.
Full Prescribing Information
Indications & Usage
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 advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can b…
Dosage & Administration
2.1 Hypertension Adults: The usual initial dosage is 25 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: A pediatric clinical hypertension study in patients 6 to 16 years of age did not meet its primary endpoint (dose response for reduction in SBP); however some other endpoints demonstrated effectiveness [see USE IN SPECIFIC POPULATIONS (8.4)]. If selected for treatment, the recommended starting dose of metoprolol succinate extended-release tablets is 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 SPECIFIC POPULATIONS (8.4) and CLINICAL PHARMACOLOGY (12.3)]. Metoprolol succinate extended-release tablets has not been studied in pediatric patients < 6 years of age [see USE IN SPECIFIC POPULATIONS (8.4)]. 2.…
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.
Drug Interactions
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 cannot be avoided. 7.3 Digitalis, Clonidine, and Calcium Channel Blockers Digitalis glycosides, clonidine, diltiazem, and verapamil slow atrioventricular conduction and decrease heart rate. Concomitant use with beta-blockers can increase the risk of bradycardia. If clonidine and a beta blocker, such as metoprolol are co-administered, with…
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)]. 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, depression, diarrhea, shortness of breath, bradycardia, and rash. Heart Failure: In the MERIT-HF study comparing metoprolol succinate extended-release tablets in daily doses up to 200 mg (mean dose 159 mg once-daily; n=1990) to placebo (n=2001), 10.3% of metoprolol succinate patients discontinued for adverse reactions…
Frequently Asked Questions
What is Metoprolol Succinate ER used for?
Metoprolol Succinate ER contains Metoprolol Succinate ER. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Metoprolol Succinate ER a controlled substance?
Metoprolol Succinate ER is not classified as a controlled substance by the DEA.
What is the generic name for Metoprolol Succinate ER?
The generic name for Metoprolol Succinate ER is Metoprolol Succinate ER. There are 11 other brand versions of Metoprolol Succinate ER.
What is the NDC code for Metoprolol Succinate ER 50 mg/1?
The NDC (National Drug Code) for Metoprolol Succinate ER 50 mg/1 is 72189-547, listed by Direct_Rx.
Other Metoprolol Brands
See all →- Metoprolol Succinate25 mg/163629-9168
- Metoprolol Succinate100 mg/163629-9171
- Metoprolol Succinate25 mg/171335-2834
- Metoprolol Succinate100 mg/150090-5721
- Metoprolol Succinate50 mg/172162-1857
- Metoprolol Succinate50 mg/163629-9170
- Metoprolol Succinate200 mg/163629-9173
- Metoprolol Succinate50 mg/167877-591
- Metoprolol Succinate200 mg/167877-593
- Metoprolol Succinate50 mg/168001-501
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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