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Metoprolol Succinate ER

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Overview

What is Metoprolol Succinate ER?

Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:

structure

Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol.

Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol 6000, prosolv, sodium stearyl fumarate, talc and titanium dioxide.



What does Metoprolol Succinate ER look like?



What are the available doses of Metoprolol Succinate ER?

100 mg tablets: white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side.

200 mg tablets: white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side.

Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71c1d33e-be6f-6d59-b715-45075445891a

What should I talk to my health care provider before I take Metoprolol Succinate ER?

8.1 Pregnancy

Pregnancy Category C

Metoprolol tartrate has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 22 times, on a mg/m2 basis, the daily dose of 200 mg in a 60 kg patient. Distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. These studies have revealed no evidence of impaired fertility or teratogenicity. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, use this drug during pregnancy only if clearly needed.

8.3 Nursing Mothers

Metoprolol is excreted in breast milk in very small quantities. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Consider possible infant exposure when metoprolol succinate extended-release is administered to a nursing woman.

8.4 Pediatric Use

One hundred forty-four hypertensive pediatric patients aged 6 to 16 years were randomized to placebo or to one of three dose levels of metoprolol succinate extended-release (0.2, 1 or 2 mg/kg once daily) and followed for 4 weeks. The study did not meet its primary endpoint (dose response for reduction in SBP). Some pre-specified secondary endpoints demonstrated effectiveness including:

Dose-response for reduction in DBP, 1 mg/kg vs. placebo for change in SBP, and 2 mg/kg vs. placebo for change in SBP and DBP. The mean placebo corrected reductions in SBP ranged from 3 to 6 mmHg, and DBP from 1 to 5 mmHg. Mean reduction in heart rate ranged from 5 to 7 bpm but considerably greater reductions were seen in some individuals [see Dosage and Administration (2.1)]. No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of metoprolol succinate extended-release have not been established in patients
8.5 Geriatric Use

Clinical studies of metoprolol succinate extended-release in hypertension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in hypertensive patients has not identified differences in responses between elderly and younger patients. Of the 1,990 patients with heart failure randomized to metoprolol succinate extended-release in the MERIT-HF trial, 50% (990) were 65 years of age and older and 12% (238) were 75 years of age and older. There were no notable differences in efficacy or the rate of adverse reactions between older and younger patients.

In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Hepatic Impairment

No studies have been performed with metoprolol succinate extended-release in patients with hepatic impairment. Because metoprolol succinate extended-release is metabolized by the liver, metoprolol blood levels are likely to increase substantially with poor hepatic function. Therefore, initiate therapy at doses lower than those recommended for a given indication; and increase doses gradually in patients with impaired hepatic function.

8.7 Renal Impairment

The systemic availability and half-life of metoprolol in patients with renal failure do not differ to a clinically significant degree from those in normal subjects. No reduction in dosage is needed in patients with chronic renal failure [see Clinical Pharmacology (12.3)].

Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71c1d33e-be6f-6d59-b715-45075445891a

How should I use Metoprolol Succinate ER?

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 be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Metoprolol succinate extended-release tablets may be administered with other antihypertensive agents.

1.2 Angina Pectoris

Metoprolol succinate extended-release tablets are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.

1.3 Heart Failure

Metoprolol succinate extended-release tablets are indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, metoprolol succinate extended-release tablets decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.

Metoprolol succinate extended-release tablets intended for once daily administration. For treatment of hypertension and angina, when switching from immediate release metoprolol to metoprolol succinate extended-release, use the same total daily dose of metoprolol succinate extended-release tablets. Individualize the dosage of metoprolol succinate extended-release tablets. Titration may be needed in some patients.

Metoprolol succinate extended-release tablets are scored and can be divided; however, do not crush or chew the whole or half tablet.

2.1 Hypertension

Adults: The usual initial dosage is 25 mg to 100 mg daily in a single dose. The dosage may be increased 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 is 1 mg/kg once daily, but the maximum initial dose should not exceed 50 mg once daily. Dosage should be adjusted 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 Clinical Pharmacology (12.3)].

Metoprolol succinate extended-release is not recommended in pediatric patients
2.2 Angina Pectoris

Individualize the dosage of metoprolol succinate extended-release tablets. The usual initial dosage is 100 mg daily, given in a single dose. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 to 2 weeks [see Warnings and Precautions (5)].

2.3 Heart Failure

Dosage must be individualized and closely monitored during up-titration. Prior to initiation of metoprolol succinate extended-release tablets, stabilize the dose of other heart failure drug therapy. The recommended starting dose of metoprolol succinate extended-release tablets is 25 mg once daily for two weeks in patients with NYHA Class II heart failure and 12.5 mg once daily in patients with more severe heart failure. Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of metoprolol succinate extended-release. Initial difficulty with titration should not preclude later attempts to introduce metoprolol succinate extended-release. If patients experience symptomatic bradycardia, reduce the dose of metoprolol succinate extended-release. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of metoprolol succinate extended-release tablets or temporarily discontinuing it. The dose of metoprolol succinate extended-release tablets should not be increased until symptoms of worsening heart failure have been stabilized.


What interacts with Metoprolol Succinate ER?

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What are the warnings of Metoprolol Succinate ER?

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What are the precautions of Metoprolol Succinate ER?

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What are the side effects of Metoprolol Succinate ER?

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What should I look out for while using Metoprolol Succinate ER?

Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.

Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71c1d33e-be6f-6d59-b715-45075445891a


What might happen if I take too much Metoprolol Succinate ER?

Signs and Symptoms - Overdosage of metoprolol succinate extended-release may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include: atrioventricular block, heart failure, bronchospasm, hypoxia, impairment of consciousness/coma, nausea and vomiting.

Treatment – Consider treating the patient with intensive care. Patients with myocardial infarction or heart failure may be prone to significant hemodynamic instability. Seek consultation with a regional poison control center and a medical toxicologist as needed. Beta-blocker overdose may result in significant resistance to resuscitation with adrenergic agents, including beta-agonists. On the basis of the pharmacologic actions of metoprolol, employ the following measures.

There is very limited experience with the use of hemodialysis to remove metoprolol, however metoprolol is not highly protein bound.

Bradycardia: Administer intravenous atropine; repeat to effect. If the response is inadequate, consider intravenous isoproterenol or other positive chronotropic agents. Evaluate the need for transvenous pacemaker insertion.

Hypotension: Treat underlying bradycardia. Consider intravenous vasopressor infusion, such as dopamine or norepinephrine.

Bronchospasm: Administer a beta2-agonist, including albuterol inhalation, or an oral theophylline derivative.

Cardiac Failure: Administer diuretics or digoxin for congestive heart failure. For cardiogenic shock, consider IV dobutamine, isoproterenol, or glucagon.


How should I store and handle Metoprolol Succinate ER?

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-468-30Bottles of 60 NDC 55111-468-60Bottles of 100 NDC 55111-468-01Bottles of 500 NDC 55111-468-05Unit dose packages of 100 (10x10) NDC 55111-468-78 Metoprolol succinate extended-release tablets USP, 200 mg are white to off-white, oval shaped film-coated tablets, debossed with “M” and “4” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10).Bottles of 30 NDC 55111-469-30Bottles of 60 NDC 55111-469-60Bottles of 100 NDC 55111-469-01Bottles of 500 NDC 55111-469-05Unit dose packages of 100 (10x10) NDC 55111-469-78Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]


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Clinical Information

Chemical Structure

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Clinical Pharmacology

12.1 Mechanism of Action

Hypertension: The mechanism of the antihypertensive effects of beta-blocking agents has not been elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity.

Heart Failure: The precise mechanism for the beneficial effects of beta-blockers in heart failure has not been elucidated.

12.2 Pharmacodynamics

Clinical pharmacology studies have confirmed the beta-blocking activity of metoprolol in man, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia.

Metoprolol is a beta1-selective (cardioselective) adrenergic receptor blocking agent. This preferential effect is not absolute, however, and at higher plasma concentrations, metoprolol also inhibits beta2-adrenoreceptors, chiefly located in the bronchial and vascular musculature. Metoprolol has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at plasma concentrations much greater than required for beta-blockade. Animal and human experiments indicate that metoprolol slows the sinus rate and decreases AV nodal conduction.

The relative beta1-selectivity of metoprolol has been confirmed by the following: (1) In normal subjects, metoprolol is unable to reverse the beta2-mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective beta-blockers, which completely reverse the vasodilating effects of epinephrine. (2) In asthmatic patients, metoprolol reduces FEV1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta1-receptor blocking doses.

The relationship between plasma metoprolol levels and reduction in exercise heart rate is independent of the pharmaceutical formulation. Using an Emax model, the maximum effect is a 30% reduction in exercise heart rate, which is attributed to beta1-blockade. Beta1-blocking effects in the range of 30 to 80% of the maximal effect (approximately 8 to 23% reduction in exercise heart rate) correspond to metoprolol plasma concentrations from 30 to 540 nmol/L. The relative beta1-selectivity of metoprolol diminishes and blockade of beta2-adrenoceptors increases at plasma concentration above 300 nmol/L.

Although beta-adrenergic receptor blockade is useful in the treatment of angina, hypertension, and heart failure there are situations in which sympathetic stimulation is vital. In patients with severely damaged hearts, adequate ventricular function may depend on sympathetic drive. In the presence of AV block, beta-blockade may prevent the necessary facilitating effect of sympathetic activity on conduction. Beta2-adrenergic blockade results in passive bronchial constriction by interfering with endogenous adrenergic bronchodilator activity in patients subject to bronchospasm and may also interfere with exogenous bronchodilators in such patients.

In other studies, treatment with metoprolol succinate extended-release produced an improvement in left ventricular ejection fraction. Metoprolol succinate extended-release was also shown to delay the increase in left ventricular end-systolic and end-diastolic volumes after 6 months of treatment.

12.3 Pharmacokinetics

Adults: In man, absorption of metoprolol is rapid and complete. Plasma levels following oral administration of conventional metoprolol tablets, however, approximate 50% of levels following intravenous administration, indicating about 50% first-pass metabolism. metoprolol crosses the blood-brain barrier and has been reported in the CSF in a concentration 78% of the simultaneous plasma concentration.

Plasma levels achieved are highly variable after oral administration. Only a small fraction of the drug (about 12%) is bound to human serum albumin. Metoprolol is a racemic mixture of R- and S- enantiomers, and is primarily metabolized by CYP2D6. When administered orally, it exhibits stereoselective metabolism that is dependent on oxidation phenotype. Elimination is mainly by biotransformation in the liver, and the plasma half-life ranges from approximately 3 to 7 hours. Less than 5% of an oral dose of metoprolol is recovered unchanged in the urine; the rest is excreted by the kidneys as metabolites that appear to have no beta-blocking activity.

Following intravenous administration of metoprolol, the urinary recovery of unchanged drug is approximately 10%. The systemic availability and half-life of metoprolol in patients with renal failure do not differ to a clinically significant degree from those in normal subjects. Consequently, no reduction in metoprolol succinate dosage is usually needed in patients with chronic renal failure.

Metoprolol is metabolized predominantly by CYP2D6, an enzyme that is absent in about 8% of Caucasians (poor metabolizers) and about 2% of most other populations. CYP2D6 can be inhibited by a number of drugs. Poor metabolizers and extensive metabolizers who concomitantly use CYP2D6 inhibiting drugs will have increased (several-fold) metoprolol blood levels, decreasing metoprolol's cardioselectivity [see Drug Interactions (7.2)].

In comparison to conventional metoprolol, the plasma metoprolol levels following administration of metoprolol succinate extended-release are characterized by lower peaks, longer time to peak and significantly lower peak to trough variation. The peak plasma levels following once-daily administration of metoprolol succinate extended-release tablets average one-fourth to one-half the peak plasma levels obtained following a corresponding dose of conventional metoprolol, administered once daily or in divided doses. At steady state the average bioavailability of metoprolol following administration of metoprolol succinate extended-release, across the dosage range of 50 to 400 mg once daily, was 77% relative to the corresponding single or divided doses of conventional metoprolol. Nevertheless, over the 24-hour dosing interval, β1-blockade is comparable and dose-related [see Clinical Pharmacology (12)]. The bioavailability of metoprolol shows a dose-related, although not directly proportional, increase with dose and is not significantly affected by food following metoprolol succinate extended-release administration.

Pediatrics: The pharmacokinetic profile of metoprolol succinate extended-release was studied in 120 pediatric hypertensive patients (6 to 17 years of age) receiving doses ranging from 12.5 to 200 mg once daily. The pharmacokinetics of metoprolol were similar to those described previously in adults. Age, gender, race, and ideal body weight had no significant effects on metoprolol pharmacokinetics. Metoprolol apparent oral clearance (CL/F) increased linearly with body weight. Metoprolol pharmacokinetics have not been investigated in patients

Non-Clinical Toxicology
Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.

Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71c1d33e-be6f-6d59-b715-45075445891a

See .

5.1 Ischemic Heart Disease

Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol succinate extended-release, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, promptly reinstate metoprolol succinate extended-release, and take measures appropriate for the management of unstable angina. Warn patients not to interrupt therapy without their physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abruptly discontinuing metoprolol succinate extended-release in patients treated only for hypertension.

5.2 Heart Failure

Worsening cardiac failure may occur during up-titration of metoprolol succinate extended-release. If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of metoprolol succinate extended-release [see Dosage and Administration (2)]. It may be necessary to lower the dose of metoprolol succinate extended-release or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of metoprolol succinate extended-release.

5.3 Bronchospastic Disease

PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta1 cardio-selectivity, however, metoprolol succinate extended-release may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta1-selectivity is not absolute, use the lowest possible dose of metoprolol succinate extended-release. Bronchodilators, including beta2-agonists, should be readily available or administered concomitantly, [see Dosage and Administration (2)].

5.4 Pheochromocytoma

If metoprolol succinate extended-release is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.

5.5 Major Surgery

Avoid initiation of a high-dose regimen of extended release metoprolol in patients undergoing non-cardiac surgery, since such use in patients with cardiovascular risk factors has been associated with bradycardia, hypotension, stroke and death.

Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

5.6 Diabetes and Hypoglycemia

Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.

5.7 Hepatic Impairment

Consider initiating metoprolol succinate extended-release therapy at doses lower than those recommended for a given indication; gradually increase dosage to optimize therapy, while monitoring closely for adverse events.

5.8 Thyrotoxicosis

Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may precipitate a thyroid storm.

5.9 Anaphylactic Reaction

While taking beta-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge and may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction.

5.10 Peripheral Vascular Disease

Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.

5.11 Calcium Channel Blockers

Because of significant inotropic and chronotropic effects in patients treated with beta-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be exercised in patients treated with these agents concomitantly.

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 extended-release patients discontinued for adverse reactions vs. 12.2% of placebo patients.

The table below lists adverse reactions in the MERIT-HF study that occurred at an incidence of ≥ 1% in the metoprolol succinate extended-release group and greater than placebo by more than 0.5%, regardless of the assessment of causality.

Adverse Reactions Occurring in the MERIT-HF Study at an Incidence ≥ 1 % in the Metoprolol Succinate Extended-Release Tablets Group and Greater Than Placebo by More Than 0.5 % Metoprolol Succinate Extended-Release Tablets n=1990 % of patients Placebo n=2001 % of patients Dizziness/vertigo 1.8 1 Bradycardia 1.5 0.4 Accident and/or injury 1.4 0.8

Post-operative Adverse Events:In a randomized, double-blind, placebo-controlled trial of 8351 patients with or at risk for atherosclerotic disease undergoing non-vascular surgery and who were not taking beta–blocker therapy, metoprolol succinate extended-release tablets 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Metoprolol succinate extended-release use was associated with a higher incidence of bradycardia (6.6% vs. 2.4% ; HR 2.74; 95% CI 2.19,3.43), hypotension (15% vs. 9.7%; HR 1.55 95% CI 1.37,1.74), stroke (1% vs 0.5%; HR 2.17; 95% CI 1.26,3.74) and death (3.1% vs 2.3%; HR 1.33; 95% CI 1.03, 1.74) compared to placebo.

6.2 Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of metoprolol succinate extended-release or immediate-release metoprolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Cold extremities, arterial insufficiency (usually of the Raynaud type), palpitations, peripheral edema, syncope, chest pain and hypotension.

Respiratory: Wheezing (bronchospasm), dyspnea.

Central Nervous System: Confusion, short-term memory loss, headache, somnolence, nightmares, insomnia. anxiety/nervousness, hallucinations, paresthesia.

Gastrointestinal: Nausea, dry mouth, constipation, flatulence, heartburn, hepatitis, vomiting.

Hypersensitive Reactions: Pruritus.

Miscellaneous: Musculoskeletal pain, arthralgia, blurred vision, decreased libido, male impotence, tinnitus, reversible alopecia, agranulocytosis, dry eyes, worsening of psoriasis, Peyronie’s disease, sweating, photosensitivity, taste disturbance.

Potential Adverse Reactions: In addition, there are adverse reactions not listed above that have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol succinate extended-release.

Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, clouded sensorium, and decreased performance on neuropsychometrics.

Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.

Hypersensitive Reactions: Laryngospasm, respiratory distress.

6.3 Laboratory Test Findings

Clinical laboratory findings may include elevated levels of serum transaminase, alkaline phosphatase, and lactate dehydrogenase.

Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71c1d33e-be6f-6d59-b715-45075445891a

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).