Metoprolol Succinate
Tablet, Extended Release · Oral
Uses
Metoprolol succinate extended-release capsules are beta 1 -selective adrenoceptor blocking agent 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 hospitalization in patients with heart failure. (1.3) 1.1 Hypertension Metoprolol succinate extended-release capsules 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 capsules may be administered with other antihypertensive agents. 1.2 Angina Pectoris Metoprolol succinate extended-release capsules 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 capsules are indicated to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure.
Dosage and administration
• Adult Hypertension: Usual initial dosage is 25 to 100 mg once daily. Titrate weekly (or longer) to optimal blood pressure. (2.1)
• Pediatric Hypertension 6 years of age and older: The recommended starting dose is 1 mg/kg, once daily and titrate to response. Do not exceed a maximum initial dose of 50 mg once daily. (2.1)
• Angina Pectoris: Usual initial dosage is 100 mg once daily. Titrate weekly based on clinical response. (2.2)
• Heart Failure: The recommended starting dose is 25 mg doubled every two weeks to the highest dose tolerated or up to 200 mg. (2.3) 2.1 Hypertension Adults: The usual initial dosage is 25 mg to 100 mg once daily in a single dose. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. Dosages above 400 mg per day have not been studied. Pediatric Hypertensive Patients 6 Years of age or older: The recommended starting dose of metoprolol succinate extended-release capsules is 1 mg/kg once daily, 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 Clinical Pharmacology (12.3)]. Metoprolol succinate extended-release capsules has not been studied in pediatric patients less than 6 years of age [see Use in Specific Populations (8.4)] . 2.2 Angina Pectoris Individualize the dosage of metoprolol succinate extended-release capsules. The usual initial dosage is 100 mg once 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 Prior to initiation of metoprolol succinate extended-release capsules, stabilize the dose of other heart failure drug therapy and ensure that the patient is not fluid overloaded. The recommended starting dose of metoprolol succinate extended-release capsules is 25 mg once daily for two weeks. Metoprolol succinate extended-release capsules are not suitable for initial therapy in patients who are expected to require a starting dose less than 25 mg daily. Dosage must be individualized and closely monitored during up-titration. 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 capsules. If a patient experiences symptomatic bradycardia, reduce the dose of metoprolol succinate extended-release capsules. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of metoprolol succinate extended-release capsules or temporarily discontinuing it. The dose of metoprolol succinate extended-release capsules should not be increased until symptoms of worsening heart failure have been stabilized. Initial difficulty with titration should not preclude later attempts to introduce metoprolol succinate extended-release capsules. For patients who are taking metoprolol succinate extended-release tablets at a dose of 25 mg to 200 mg once daily, substitute metoprolol succinate extended-release capsules for metoprolol succinate extended-release tablets, using the same total daily dose of metoprolol succinate in mg. 2.4 Administration Metoprolol succinate extended-release capsules should be swallowed whole. For patients unable to swallow an intact capsule, alternative administration options are available. Directions for use with soft food (applesauce, pudding, or yogurt) For patients with swallowing difficulty, Metoprolol succinate extended-release capsules can be opened and contents can be sprinkled over soft food. The contents of the capsules should be swallowed along with a small amount (teaspoonful) of soft food (such as applesauce, pudding, or yogurt). The drug/food mixture should be swallowed within 60 minutes and not stored for future use. Nasogastric tube administration Open and add content of capsule to an all plastic oral tip syringe and add 15 mL of water. Gently shake the syringe for approx. 10 sec to help suspend the granules and promptly deliver through a 12 French or larger nasogastric tube. No granules should be left in the syringe, rinse as required.
Dosage forms and strengths
25 mg capsule: Light yellow opaque cap and white opaque body both imprinted with ‘ RL14 ’ in black ink containing white to off-white pellets. 50 mg capsule: Dark yellow opaque cap and white opaque body both imprinted with ‘ RL15 ’ in black ink containing white to off-white pellets. 100 mg capsule: White opaque cap and white opaque body both imprinted with ‘ RL16 ’ in black ink containing white to off-white pellets. 200 mg capsule: Yellow opaque cap and yellow opaque body both imprinted with ‘ RL17’ in black ink containing white to off-white pellets.
• Metoprolol succinate extended-release capsules: 25 mg, 50 mg, 100 mg and 200 mg. (3)
Contraindications
Metoprolol succinate 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)
Warnings and precautions
• Abrupt cessation may exacerbate myocardial ischemia. (5.1)
• Worsening cardiac failure may occur. (5.2)
• Bronchospastic Disease: Avoid beta blockers. (5.3)
• Pheochromocytoma: First initiate therapy with an alpha blocker. (5.4)
• Avoid initiation of high-dose extended-release metoprolol and do not routinely withdraw chronic beta blocker therapy prior to surgery. (5.5, 6.1)
• May mask tachycardia occurring with hypoglycemia. (5.6)
• Abrupt withdrawal in thyrotoxicosis might precipitate a thyroid storm. (5.7)
• May aggravate symptoms of arterial insufficiency. (5.8) 5.1 Abrupt Cessation of Therapy 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, 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, 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 in patients treated only for hypertension. 5.2 Heart Failure Worsening cardiac failure may occur during up-titration of metoprolol succinate. If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of metoprolol succinate [see Dosage and Administration (2)]. It may be necessary to lower the dose of metoprolol succinate or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of metoprolol succinate. 5.3 Bronchospastic Disease PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta 1 cardio-selectivity, however, metoprolol succinate may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta 1 -selectivity is not absolute, use the lowest possible dose of metoprolol succinate. Bronchodilators, including beta 2 -agonists, should be readily available or administered concomitantly [see Dosage and Administration (2)]. 5.4 Pheochromocytoma If metoprolol succinate 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 Masked Symptoms of Hypoglycemia Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. 5.7 Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may precipitate a thyroid storm. 5.8 Peripheral Vascular Disease Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
Side effects
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 Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 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, diarrhea, shortness of breath, bradycardia, and rash. Heart Failure: In the MERIT-HF study comparing metoprolol succinate 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 events 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 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 Group and Greater Than Placebo by More Than 0.5% Metoprolol Succinate n = 1990 % of patients Placebo n = 2001 % of patients Dizziness/vertigo 1.8 1 Bradycardia 1.5 0.4 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 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Metoprolol succinate 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 extended-release metoprolol 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. 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.
Drug interactions
• Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. (7.1)
• Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. (7.2)
• CYP2D6 Inhibitors are likely to increase metoprolol concentration. (7.3)
• Concomitant use of glycosides, clonidine, and diltiazem and verapamil with beta-blockers can increase the risk of bradycardia. (7.4)
• Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. (7.4)
• Alcohol interferes with the extended release properties of this product. (7.5) 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 plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. 7.2 Epinephrine 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. 7.3 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. 7.4 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 coadministered, withdraw the beta-blocker several days before the gradual withdrawal of clonidine because beta-blockers may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, delay the introduction of beta-blockers for several days after clonidine administration has stopped . 7.5 Alcohol Metoprolol succinate is released faster from metoprolol succinate extended-release capsules in the presence of alcohol. This may increase the risk for adverse events associated with metoprolol succinate extended-release capsules. Avoid alcohol consumption when taking metoprolol succinate extended-release capsules [see Clinical Pharmacology (12.3)].
Use in specific populations
• Hepatic Impairment: Consider initiating metoprolol succinate therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events. (8.6) 8.1 Pregnancy Risk Summary Available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during pregnancy ( see Data). Untreated hypertension and heart failure during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations). In animal reproduction studies, metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, approximately 24 times the daily dose of 200 mg in a 60-kg patient on a mg/m 2 basis. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical consideration Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. There is a risk for preterm birth with pregnant women with chronic heart failure in 3 rd trimester of pregnancy. Fetal/Neonatal adverse reactions Metoprolol crosses the placenta. Neonates born to mothers who are receiving metoprolol during pregnancy, may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression. Observe neonates for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage accordingly. Data Human Data Data from published observational studies did not demonstrate an association of major congenital malformations and use of metoprolol in pregnancy. The published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth and perinatal mortality with maternal use of metoprolol during pregnancy; however, these studies have methodological limitations hindering interpretation. Methodological limitations include retrospective design, concomitant use of other medications, and other unadjusted confounders that may account for the study findings including the underlying disease in the mother. These observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. Animal Data Metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, i.e. 24 times, on a mg/m 2 basis, the daily dose of 200 mg in a 60-kg patient. No fetal abnormalities were observed when pregnant rats received metoprolol orally up to a dose of 200 mg/kg/day, i.e. 10 times, the daily dose of 200 mg in a 60-kg patient. 8.2 Lactation Risk Summary Limited available data from published literature report that metoprolol is present in human milk. The estimated daily infant dose of metoprolol received from breastmilk range from 0.05 mg to less than 1 mg. The estimated relative infant dosage was 0.5% to 2% of the mother's weight-adjusted dosage (see Data). No adverse reactions of metoprolol on the breastfed infant have been identified. There is no information regarding the effects of metoprolol on milk production. Clinical consideration Monitoring for adverse reactions For a lactating woman who is a slow metabolizer of metoprolol, monitor the breastfed infant for bradycardia and other symptoms of beta blockade such as dry mouth, skin or eyes, diarrhea or constipation. In a report of 6 mothers taking metoprolol, none reported adverse effects in her breastfed infant. Data Limited published cases estimate the infant daily dose of metoprolol received from breast milk range from 0.05 mg to less than 1 mg. In 2 women who were taking unspecified amount of metoprolol, milk samples were taken after one dose of metoprolol. The estimated amount of metoprolol and alpha-hydroxymetoprolol in breast milk is reported to be less than 2% of the mother's weight-adjusted dosage. In a small study, breast milk was collected every 2 to 3 hours over one dosage interval, in three mothers (at least 3 months postpartum) who took metoprolol of unspecified amount. The average amount of metoprolol present in breast milk was 71.5 mcg/day (range 17.0 to 158.7). The average relative infant dosage was 0.5% of the mother's weight-adjusted dosage. 8.3 Females and Males of Reproductive Potential Risk Summary Based on the published literature, beta blockers (including metoprolol) may cause erectile dysfunction and inhibit sperm motility. In animal fertility studies, metoprolol has been associated with reversible adverse effects on spermatogenesis starting at oral dose level of 3.5 mg/kg in rats, which would correspond to a dose of 34 mg/day in humans in mg/m 2 equivalent, although other studies have shown no effect of metoprolol on reproductive performance in male rats. No evidence of impaired fertility due to metoprolol was observed in rats [see Nonclinical Toxicology (13.1)] . 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 (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).
Pregnancy
8.1 Pregnancy Risk Summary Available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during pregnancy ( see Data). Untreated hypertension and heart failure during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations). In animal reproduction studies, metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, approximately 24 times the daily dose of 200 mg in a 60-kg patient on a mg/m 2 basis. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical consideration Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. There is a risk for preterm birth with pregnant women with chronic heart failure in 3 rd trimester of pregnancy. Fetal/Neonatal adverse reactions Metoprolol crosses the placenta. Neonates born to mothers who are receiving metoprolol during pregnancy, may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression. Observe neonates for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage accordingly. Data Human Data Data from published observational studies did not demonstrate an association of major congenital malformations and use of metoprolol in pregnancy. The published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth and perinatal mortality with maternal use of metoprolol during pregnancy; however, these studies have methodological limitations hindering interpretation. Methodological limitations include retrospective design, concomitant use of other medications, and other unadjusted confounders that may account for the study findings including the underlying disease in the mother. These observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. Animal Data Metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, i.e. 24 times, on a mg/m 2 basis, the daily dose of 200 mg in a 60-kg patient. No fetal abnormalities were observed when pregnant rats received metoprolol orally up to a dose of 200 mg/kg/day, i.e. 10 times, the daily dose of 200 mg in a 60-kg patient.
Pediatric use
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 (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 have not been established in patients < 6 years of age.
Geriatric use
8.5 Geriatric Use Clinical studies of metoprolol succinate 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 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.
Overdosage
Signs and Symptoms - Overdosage of metoprolol succinate 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. 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: Evaluate the need for atropine, adrenergic-stimulating drugs or pacemaker to treat bradycardia and conduction disorders. Hypotension: Treat underlying bradycardia. Consider intravenous vasopressor infusion, such as dopamine or norepinephrine. Heart failure and shock: May be treated when appropriate with suitable volume expansion, injection of glucagon (if necessary, followed by an intravenous infusion of glucagon), intravenous administration of adrenergic drugs such as dobutamine, with α 1 receptor agonistic drugs added in presence of vasodilation. Bronchospasm: Can usually be reversed by bronchodilators.
Description
Metoprolol succinate, is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules 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 extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 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: Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide. structure
Mechanism of action
12.1 Mechanism of Action Metoprolol is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent. This preferential effect is not absolute, however, and at higher plasma concentrations, metoprolol also inhibits beta 2 -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 beta 1 -selectivity of metoprolol has been confirmed by the following: (1) In normal subjects, metoprolol is unable to reverse the beta 2 -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 FEV 1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta 1 -receptor blocking doses. 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. Angina Pectoris: By blocking catecholamine-induced increases in heart rate, in velocity and extent of myocardial contraction, and in blood pressure, metoprolol reduces the oxygen requirements of the heart at any given level of effort, thus making it useful in the long-term management of angina pectoris. Heart Failure: The precise mechanism for the beneficial effects of beta-blockers in heart failure has not been elucidated.
How supplied
Each extended-release capsule contains 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP respectively and are supplied as follows: 25 mg capsule: Light yellow opaque cap and white opaque body both imprinted with ‘ RL14 ’ in black ink containing white to off-white pellets. NDC 10631-008-30 Bottle of 30 50 mg capsule: Dark yellow opaque cap and white opaque body both imprinted with ‘ RL15 ’ in black ink containing white to off-white pellets. NDC 10631-009-30 Bottles of 30 100 mg capsule: White opaque cap and white opaque body both imprinted with ‘ RL16 ’ in black ink containing white to off-white pellets. NDC 10631-010-30 Bottles of 30 200 mg capsule: Yellow opaque cap and yellow opaque body both imprinted with ‘ RL17’ in black ink containing white to off-white pellets. NDC 10631-011-30 Bottles of 30 Store at 20° C - 25° C (68° F - 77° F). [See USP Controlled Room Temperature].
Patient information
Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. Advise patients if a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue metoprolol succinate extended-release capsules without consulting the physician. Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with metoprolol succinate extended-release capsules has been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking metoprolol succinate extended-release capsules. Advise patients who are breastfeeding to monitor the infant for bradycardia, dry mouth, skin or eyes, and diarrhea or constipation. [see Use in Specific Population (8.2)]. PLENDIL ® and TOPROL-XL ® are trademarks of the AstraZeneca group of companies. Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 FDA-05
Label text from the FDA structured product label by Sun Pharmaceutical Industries Inc. (revised Feb 7, 2018). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Metoprolol Succinate in 237 products
- Metoprolol Tartrate in 14 products
Metoprolol Succinate NDC products (251)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6260 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7118 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5411 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5418 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5720 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5721 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5722 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5723 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5733 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7117 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6448 | Metoprolol Tartrate 50 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6488 | Metoprolol Tartrate 25 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6489 | Metoprolol Tartrate 25 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6662 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6663 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7069 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7070 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7239 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7238 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7590 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7591 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 45963-676 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Actavis Pharma, Inc. | ANDA |
| 45963-677 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Actavis Pharma, Inc. | ANDA |
| 45963-678 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Actavis Pharma, Inc. | ANDA |
| 45963-709 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Actavis Pharma, Inc. | ANDA |
| 60687-413 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | American Health Packaging | ANDA |
| 60687-402 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | American Health Packaging | ANDA |
| 60687-390 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | American Health Packaging | ANDA |
| 53401-014 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 53401-010 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-555 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 53401-009 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-558 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-573 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-642 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 67877-592 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-591 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-590 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-593 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Ascend Laboratories, LLC | ANDA |
| 50268-540 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | AvPAK | ANDA |
| 50268-541 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | AvPAK | ANDA |
| 50268-542 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | AvPAK | ANDA |
| 50268-543 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | AvPAK | ANDA |
| 68001-501 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | BluePoint Laboratories | ANDA |
| 68001-687 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-686 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-119 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-120 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-356 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-358 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-360 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-470 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-471 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-685 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-684 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-503 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | BluePoint Laboratories | ANDA |
| 68001-469 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-500 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | BluePoint Laboratories | ANDA |
| 68001-502 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | BluePoint Laboratories | ANDA |
| 71335-9706 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9173 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1951 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2592 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2811 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2834 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2835 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9413 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-3167 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-3134 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-3069 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-3052 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2945 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-3286 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-8863 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-8864 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-8865 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-8866 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9167 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9168 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9169 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9170 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9171 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9172 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-9753 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-0149 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-0158 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-0167 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1875 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1878 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1856 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1857 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1858 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1859 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-9749 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 31722-592 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-589 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-590 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-591 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-2642 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 55154-4347 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 55154-4698 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 55154-6886 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 55154-7279 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 55154-7280 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 69097-409 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Cipla USA Inc. | ANDA |
| 69097-408 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Cipla USA Inc. | ANDA |
| 69097-407 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Cipla USA Inc. | ANDA |
| 67046-0883 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Coupler LLC | ANDA |
| 67046-1650 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Coupler LLC | ANDA |
| 67046-1685 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Coupler LLC | ANDA |
| 67046-1686 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Coupler LLC | ANDA |
| 27808-302 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Cranbury Pharmaceuticals, LLC | ANDA |
| 27808-303 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Cranbury Pharmaceuticals, LLC | ANDA |
| 27808-304 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Cranbury Pharmaceuticals, LLC | ANDA |
| 27808-305 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Cranbury Pharmaceuticals, LLC | ANDA |
| 61919-754 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Direct_Rx | ANDA |
| 61919-334 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Direct_Rx | ANDA |
| 75907-344 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Dr. Reddy's Laboratories Inc | ANDA |
| 75907-345 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Dr. Reddy's Laboratories Inc | ANDA |
| 75907-346 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Dr. Reddy's Laboratories Inc | ANDA |
| 75907-347 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Dr. Reddy's Laboratories Inc | ANDA |
| 55111-466 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-467 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-468 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-469 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Dr. Reddy's Laboratories Limited | ANDA |
| 42806-724 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 42806-725 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 42806-726 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 42806-727 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 51407-403 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-404 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-405 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-406 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 62207-133 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-130 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-131 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-132 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 70010-780 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Granules Pharmaceuticals Inc. | ANDA |
| 70010-781 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Granules Pharmaceuticals Inc. | ANDA |
| 70010-782 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Granules Pharmaceuticals Inc. | ANDA |
| 70010-783 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Granules Pharmaceuticals Inc. | ANDA |
| 50742-615 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-616 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-617 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-618 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 0904-6322 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-6323 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-6324 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0615-7824 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-7823 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-7825 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 72603-142 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Northstar Rx LLC | ANDA |
| 72603-143 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Northstar Rx LLC | ANDA |
| 72603-144 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Northstar Rx LLC | ANDA |
| 72603-145 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Northstar Rx LLC | ANDA |
| 82868-087 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-193 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-203 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-239 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-519 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-888 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-919 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-934 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Northwind Health Company, LLC | ANDA |
| 82868-079 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Northwind Health Company, LLC | ANDA |
| 82868-083 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 82868-084 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Northwind Health Company, LLC | ANDA |
| 68071-3828 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | NuCare Pharmaceutcals, Inc. | ANDA |
| 68071-3965 | Metoprolol Tartrate 50 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3943 | Metoprolol Tartrate 50 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-2522 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2651 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3963 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5282 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 72516-028 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Oryza pharmaceuticals Inc. | ANDA |
| 72516-027 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Oryza pharmaceuticals Inc. | ANDA |
| 72516-026 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Oryza pharmaceuticals Inc. | ANDA |
| 72516-025 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Oryza pharmaceuticals Inc. | ANDA |
| 72516-030 | Metoprolol Tartrate 25 mg/1 Tablet, Extended Release | Oryza Pharmaceuticals, Inc | ANDA |
| 72516-031 | Metoprolol Tartrate 50 mg/1 Tablet, Extended Release | Oryza Pharmaceuticals, Inc | ANDA |
| 72516-032 | Metoprolol Tartrate 100 mg/1 Tablet, Extended Release | Oryza Pharmaceuticals, Inc | ANDA |
| 72516-033 | Metoprolol Tartrate 200 mg/1 Tablet, Extended Release | Oryza Pharmaceuticals, Inc | ANDA |
| 72789-010 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-284 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-497 | Metoprolol Tartrate 50 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-576 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-841 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-624 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8448 | Metoprolol Tartrate 100 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals Inc | ANDA |
| 68788-8312 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8869 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4022 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Preferred Pharmaceuticals Inc. | ANDA |
| 71205-800 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 82804-301 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 82804-279 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 82804-262 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 82804-252 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 82804-198 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 82804-014 | Metoprolol Tartrate 50 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-179 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-336 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-350 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 63187-768 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-801 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 71205-724 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 71205-683 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 71205-368 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 82009-116 | Metoprolol Succinate 200 mg/1 Tablet, Film Coated, Extended Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-113 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-114 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-115 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 67296-2125 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Redpharm Drug | ANDA |
| 67296-1902 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Redpharm Drug | ANDA |
| 67296-2301 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | Redpharm Drug | ANDA |
| 67296-2321 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | Redpharm Drug | ANDA |
| 67296-2325 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | Redpharm Drug | ANDA |
| 70518-3164 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-2080 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-3122 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-3143 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-3680 | Metoprolol Succinate 50 mg/1 Tablet, Film Coated, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4090 | Metoprolol Tartrate 25 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4190 | Metoprolol Tartrate 100 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4407 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4456 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4531 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4198 | Metoprolol Succinate 25 mg/1 Tablet, Film Coated, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4533 | Metoprolol Succinate 100 mg/1 Tablet, Film Coated, Extended Release | REMEDYREPACK INC. | ANDA |
| 70436-202 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-183 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-167 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-166 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Slate Run Pharmaceuticals, LLC | ANDA |
| 60760-634 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | St Mary's Medical Park Pharmacy | ANDA |
| 60760-994 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | ST. MARY'S MEDICAL PARK PHARMACY | ANDA |
| 60760-993 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | ST. MARY'S MEDICAL PARK PHARMACY | ANDA |
| 60760-663 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | St. Mary's Medical Park Pharmacy | ANDA |
| 71765-008 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Zhejiang Jutai Pharamceutical Co., Ltd | ANDA |
| 71765-007 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Zhejiang Jutai Pharamceutical Co., Ltd | ANDA |
| 71765-006 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Zhejiang Jutai Pharamceutical Co., Ltd | ANDA |
| 70771-1340 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1341 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1339 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1338 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 68382-565 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-566 | Metoprolol Succinate 100 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-564 | Metoprolol Succinate 25 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-567 | Metoprolol Succinate 200 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 63304-011 | Metoprolol Succinate 200 mg/1 Capsule, Extended Release | Sun Pharmaceutical Industries Inc. | NDA |
| 63304-010 | Metoprolol Succinate 100 mg/1 Capsule, Extended Release | Sun Pharmaceutical Industries Inc. | NDA |
| 63304-009 | Metoprolol Succinate 50 mg/1 Capsule, Extended Release | Sun Pharmaceutical Industries Inc. | NDA |
| 63304-008 | Metoprolol Succinate 25 mg/1 Capsule, Extended Release | Sun Pharmaceutical Industries Inc. | NDA |
| 71205-162 | Metoprolol Succinate 50 mg/1 Tablet, Extended Release | Proficient Rx LP | NDA AUTHORIZED GENERIC |
Metoprolol Succinate recalls
- D-0547-2026 May 20, 2026 · Class II · Ongoing
Failed Dissolution Specifications - D-0354-2026 Mar 11, 2026 · Class II · Ongoing
Failed Dissolution Specifications - D-0355-2026 Mar 11, 2026 · Class II · Ongoing
Failed Dissolution Specifications - D-0356-2026 Mar 11, 2026 · Class II · Ongoing
Failed Dissolution Specifications - D-0357-2026 Mar 11, 2026 · Class II · Ongoing
Failed Dissolution Specifications - D-0510-2025 Jul 9, 2025 · Class II · Ongoing
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. - D-0191-2024 Jan 3, 2024 · Class II · Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - D-0269-2023 Feb 22, 2023 · Class II · Terminated
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories. - D-0169-2023 Feb 1, 2023 · Class II · Terminated
Failed Dissolution Specification - D-0170-2023 Feb 1, 2023 · Class II · Terminated
Failed Dissolution Specification - D-0171-2023 Feb 1, 2023 · Class II · Terminated
Failed Dissolution Specification - D-0393-2022 Feb 2, 2022 · Class II · Terminated
Failed Dissolution Specifications. - D-0451-2022 Feb 2, 2022 · Class II · Terminated
Failed Dissolution Specifications - D-0727-2018 May 16, 2018 · Class II · Terminated
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets. - D-1381-2014 Jun 18, 2014 · Class II · Terminated
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. - D-1080-2014 Feb 12, 2014 · Class II · Terminated
Failed Dissolution Specification; 12-Month stability interval.
Frequently asked questions
What is Metoprolol Succinate used for?
Metoprolol succinate extended-release capsules are beta 1 -selective adrenoceptor blocking agent 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…
What are the side effects of Metoprolol Succinate?
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,… See the full label for the complete list.
Who makes Metoprolol Succinate?
Metoprolol Succinate is listed by 45 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., American Health Packaging, Aphena Pharma Solutions - Tennessee, LLC.
Has Metoprolol Succinate been recalled?
The FDA enforcement database lists 16 recalls for Metoprolol Succinate, most recently D-0547-2026 (class ii): Failed Dissolution Specifications