TOPROL XL 25 mg/1

Metoprolol succinate · TABLET, EXTENDED RELEASE · Aphena Pharma Solutions - Tennessee, LLC

No Recall HistoryCurrently in Shortage

Plain English

TOPROL XL is a tablet, extended release containing metoprolol succinate at 25 mg/1, taken oral. Manufactured by Aphena Pharma Solutions - Tennessee, LLC.

Key Facts

Brand Name: TOPROL XL
Generic Name: Metoprolol succinate
NDC Code (Product): 71610-035
Manufacturer: Aphena Pharma Solutions - Tennessee, LLC
Strength: 25 mg/1
Dosage Form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA019962
Marketing Start: 01/01/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue6,277 reports

diarrhoea5,121 reports

nausea4,890 reports

dyspnoea4,779 reports

drug ineffective4,147 reports

off label use4,128 reports

dizziness4,075 reports

headache3,720 reports

death3,461 reports

asthenia3,196 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE TOPROL-XL, 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 TOPROL-XL is 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 p…

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 to 100 mg. ( 2.1 ) Angina Pectoris: Starting dose is 100 mg. ( 2.2 ) Heart Failure: Starting dose is 12.5 or 25 mg. ( 2.3 ) Switching from immediate-release metoprolol to TOPROL-XL: use the same total daily dose of TOPROL-XL. ( 2 ) 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: The recommended starting dose of TOPROL-XL 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) ]. TOPROL-XL has not been studied in pediatric patients < 6 years of a…

Contraindications

4 CONTRAINDICATIONS TOPROL-XL is 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 TOPROL-XL 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…

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 Melinta Therapeutics at 1-844-633-6568 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, depression, dia…

Frequently Asked Questions

What is TOPROL XL used for?

TOPROL XL contains Metoprolol succinate. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is TOPROL XL a controlled substance?

TOPROL XL is not classified as a controlled substance by the DEA.

What is the generic name for TOPROL XL?

The generic name for TOPROL XL is Metoprolol succinate. There are 12 other brand versions of Metoprolol succinate.

What is the NDC code for TOPROL XL 25 mg/1?

The NDC (National Drug Code) for TOPROL XL 25 mg/1 is 71610-035, listed by Aphena Pharma Solutions - Tennessee, LLC.

Product NDC

71610-035

Package NDC

71610-035-45

Other Metoprolol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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