METOPROLOL SUCCINATE 100 mg Tablet, Extended Release, 30-count
Other active recalls for Metoprolol Succinate (different manufacturers) — 5 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the beta-Adrenergic Blocker class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Metoprolol is used to treat high blood pressure, angina (chest pain) and heart failure. Metoprolol also is used to improve survival after a heart attack . Metoprolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.
Read the full MedlinePlus article ↗- That depends on why you were prescribed it. Metoprolol is a beta-blocker, which means it slows your heart rate and reduces the workload on your heart. Depending on your formulation...
- What exactly is metoprolol supposed to do for me?
- Please don't stop suddenly — this is one of the most important things to know about this drug. Stopping metoprolol abruptly, especially if you have any heart disease, can cause you...
- Can I stop taking metoprolol if I feel fine or if it makes me tired?
Patient education
Supplement & herbal interactions
Metoprolol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 0ZBX0N59RZ
A plasticizer derived from citric acid that is added to tablet coatings and film formulations. It increases flexibility and durability of the coating layer, helping the tablet withstand handling and moisture without cracking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 3DYK7UYZ62
Ethylcellulose is a plant-fiber derivative used as a binder and film-coating agent in tablets and capsules. It helps hold ingredients together and can create a protective coating that controls how quickly the medicine dissolves.
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UNII Z82Y2C65EA
Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 588X2YUY0A
Methylene chloride is a volatile organic solvent used in pharmaceutical manufacturing to dissolve and process active ingredients and other substances. It evaporates during production, helping create tablets, capsules, or coatings with uniform quality.
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UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.0707 | $2.12 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metoprolol Succinate 100 mg 68001-0358-00 | BluePoint | 100 tablets | $0.082 | AB | FDA listed | — |
| Metoprolol succinate 100 mg 70436-0166-01 | Slate | 100 tablets | $0.086 | AB | Availability likely | — |
| Metoprolol succinate 100 mg 00904-6324-61 | Major | 1 tablet | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 27808-0304-01 | Cranbury | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 31722-0591-01 | Camber | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol succinate 100 mg 42806-0726-01 | Epic | 100 tablets | $0.091 | AB | Availability likely | — |
| metoprolol succinate 100 mg 45963-0677-11 | Actavis | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol succinate 100 mg 50268-0542-15 | AvPAK | 1 tablet | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 50742-0617-01 | Ingenus | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol succinate 100 mg 55111-0468-01 | Dr. | 100 tablets | $0.091 | — | Availability likely | — |
| Metoprolol Succinate 100 mg 60687-0413-01 | American | 1 tablet | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 67877-0592-01 | Ascend | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 68001-0470-00 | BluePoint | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 68001-0502-00 | BluePoint | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 68001-0686-00 | BluePoint | 100 tablets | $0.091 | AB | Availability likely | — |
| metoprolol succinate 100 mg 68382-0566-01 | Zydus | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 70010-0782-01 | Granules | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 72516-0032-01 | Oryza | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol succinate 100 mg 72603-0144-01 | Northstar | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol succinate 100 mg 75907-0345-01 | Dr. | 100 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol succinate 100 mg 82009-0115-05 | Quallent | 500 tablets | $0.091 | AB | Availability likely | — |
| Metoprolol Succinate 100 mg 75834-0292-00 | Nivagen | 1000 tablets | $0.097 | — | Discontinued | — |
| Toprol Xl 100 mg 70842-0112-02 | Melinta | 100 tablets | $2.079 | AB | Availability likely | — |
| Metoprolol succinate 100 mg 00615-7825-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 43063-0841-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| metoprolol succinate 100 mg 50090-5411-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 50090-5720-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 50090-5721-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 50090-6260-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 50090-7069-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 50090-7070-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 51407-0405-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| metoprolol succinate 100 mg 51655-0193-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 51655-0888-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 53401-0014-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 55154-4347-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 55154-7279-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| metoprolol succinate 100 mg 60760-0663-90 | St. | 90 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 60760-0994-90 | ST. | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mgthis 61919-0334-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 62207-0131-49 | Granules | 1000 tablets | — | — | FDA listed | — |
| Metoprolol succinate 100 mg 63187-0768-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 63629-8865-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 63629-9171-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 63629-9172-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 68001-0119-00 | BluePoint | 100 tablets | — | AB | FDA listed | — |
| metoprolol succinate 100 mg 68071-2651-01 | NuCare | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 68071-5282-01 | NuCare | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 68788-8448-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 69097-0408-02 | Cipla | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 70518-2080-01 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| metoprolol succinate 100 mg 70518-3122-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 70518-4190-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 70518-4407-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 70518-4456-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 70518-4533-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| metoprolol succinate 100 mg 70771-1340-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 71205-0336-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 71205-0683-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| metoprolol succinate 100 mg 71205-0801-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 71335-0167-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| metoprolol succinate 100 mg 71335-1951-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 71335-2945-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 71335-9706-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 71610-0484-45 | Aphena | 45 tablets | — | AB | Discontinued | — |
| Metoprolol Succinate 100 mg 71610-0558-45 | Aphena | 45 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 71765-0007-01 | Zhejiang | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 72162-1858-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 72516-0027-01 | Oryza | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 82804-0279-90 | Proficient | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 82868-0079-30 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Succinate 100 mg 67046-1686-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 71335-3167-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol succinate 100 mg 67296-2321-03 | Redpharm | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61919-0334-30 You're viewing this | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-334-30) | 2021-01-19 | Active |
| 61919-0334-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-334-90) | 2021-01-19 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 61919-0334-30?
What is the difference between NDC 61919-0334-30 and NDC 61919-0334-90?
What NDC number is used to bill for this package of METOPROLOL SUCCINATE 100 mg Tablet, Extended Release?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol tartrate. Oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy, or alternatively, oral treatment can begin within 3 to 10 days of acute event(see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS).
⏱️ Dosage and Administration ▾
Hypertension The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage of Metoprolol tartrate tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic.
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. The effective dosage range of Metoprolol tartrate tablets is 100 to 450 mg per day.
Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day.
Beta selectivity diminishes as the dose of metoprolol is increased. Angina Pectoris The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.
The usual initial dosage of Metoprolol tartrate tablets is 100 mg daily, given in two divided doses. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Metoprolol tartrate tablets is 100 to 400 mg per day.
Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1 to 2 weeks (see WARNINGS). Myocardial Infarction Early Treatment: During the early phase of definite or suspected acute myocardial infarction, treatment with metoprolol tartrate can be initiated as soon as possible after the patient’s arrival in the hospital.
Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2-minute intervals. During the intravenous administration of metoprolol, blood pressure, heart rate,and electrocardiogram should be carefully monitored.In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours.
Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below). Patients who appear not to tolerate the full intravenous dose should be started on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, treatment with metoprolol should be discontinued (see WARNINGS).
Late Treatment: Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued for at least 3 months. Although the efficacy of metoprolol beyond 3 months has not been conclusively established, data from studies with other beta blockers suggest that treatment should be continued for 1 to 3 years.
Special populations Pediatric patients: No pediatric studies have been performed. The safety and efficacy of Metoprolol Tartrate in pedi…
⛔ Contraindications ▾
Hypertension and Angina Metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS). Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross sensitivity between beta-blockers can occur). Sick-sinus syndrome.
Severe peripheral arterial circulatory disorders. Myocardial Infarction Metoprolol is contraindicated in patients with a heart rate < 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval ³ 0.24 sec); systolic blood pressure < 100 mmHg; or moderate-to-severe cardiac failure (see WARNINGS).
⚠️ Warnings ▾
Heart Failure Beta blockers, like Metoprolol tartrate, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of Metoprolol tartrate tablets or to discontinue it.
Ischemic Heart Disease Do not abruptly discontinue Metoprolol tartrate therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with beta-blockers. When discontinuing chronically administered metoprolol tartrate, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored.
If angina markedly worsens or acute coronary insufficiency develops, metoprolol tartrate administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol tartrate therapy abruptly even in patients treated only for hypertension.
Use During Major Surgery: 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. Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of metoprolol tartrate. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk.
Monitor heart rate and rhythm in patients receiving metoprolol tartrate. If severe bradycardia develops, reduce or stop metoprolol tartrate. Exacerbation of Bronchospastic Disease Patients with bronchospastic disease should, in general, not receive beta blockers, including metoprolol tartrate.
Because of its relative beta1 selectivity, however, metoprolol tartrate 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 tartrate and consider administering metoprolol tartrate in smaller doses three times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval (see DOSAGE AND ADMINISTRATION).Bronchodilators, including beta2 agonists, should be readily available or administered concomitantly.
Diabetes and Hypoglycemia:Beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Pheochromocytoma: If metoprolol 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.
Thyrotoxicosis: Metoprolol tartrate may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta blockade, which might precipitate a thyroid storm.
🤒 Adverse Reactions ▾
Hypertension and Angina Most adverse effects have been mild and transient. Central Nervous System: Tiredness and dizziness have occurred in about 10 of 100 patients. Depression has been reported in about 5 of 100 patients.
Mental confusion and short-term memory loss have been reported. Headache, nightmares, and insomnia have also been reported. Cardiovascular: Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients.
Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; and hypotension have been reported in about 1 of 100 patients. Gangrene in patients with pre-existing severe peripheral circulatory disorders has also been reported very rarely. see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS.) Respiratory: Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS). Rhinitis has also been reported.
Gastrointestinal: Diarrhea has occurred in about 5 of 100 patients. Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1 of 100 patients. Vomiting was a common occurrence.
Post-marketing experience reveals very rare reports of hepatitis, jaundice and non-specific hepatic dysfunction. Isolated cases of transaminase, alkaline phosphatase and lactic dehydrogenase elevations have also been reported. Hypersensitive Reactions: Pruritus or rash have occurred in about 5 of 100 patients.
Very rarely, photosensitivity and worsening of psoriasis has been reported. Miscellaneous: Peyronie’s disease has been reported in fewer than 1 of 100,000 patients. Musculoskeletal pain, blurred vision, and tinnitus have also been reported.
There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to metoprolol tartrate has not been definitely established).
The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with metoprolol tartrate. Myocardial Infarction Central Nervous System: Tiredness has been reported in about 1 of 100 patients. Vertigo, sleep disturbances, hallucinations, headache, dizziness, visual disturbances, confusion, and reduced libido have also been reported, but a drug relationship is not clear. .
Cardiovascular: In the randomized comparison of metoprolol and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported: [Table] Respiratory: Dyspnea of pulmonary origin has been reported in fewer than 1 of 100 patients. Gastrointestinal: Nausea and abdominal pain have been reported in fewer than 1 of 100 patients. Dermatologic: Rash and worsened psoriasis have been reported, but a drug relationship is not clear.
Miscellaneous: Unstable diabetes and claudication have been reported, but a drug relationship is not clear. Potential Adverse Reactions A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol tartrate. 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, slightly clouded sensorium, and decreased performance on neuropsychometrics.
Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS). Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura. Hypersensitive Reactions: Fever combined with aching and sore throat, laryngospasm, and respiratory distress.
Postmarketing Experience The following adverse reactions have been reported during postapproval use of metoprolol tartrate: confusional state, an increase in blood triglycerides and a decre…
🆘 Overdosage ▾
Acute Toxicity Several cases of overdosage have been reported, some leading to death. Oral LD50’s (mg/kg): mice, 1158 to 2460; rats, 3090 to 4670. Signs and Symptoms Potential signs and symptoms associated with overdosage with metoprolol are bradycardia, hypotension, bronchospasm, myocardial infarction, cardiac failure and death.
Management There is no specific antidote. In general, patients with acute or recent myocardial infarction may be more hemodynamically unstable than other patients and should be treated accordingly (see WARNINGS, Myocardial Infarction). On the basis of the pharmacologic actions of metoprolol tartrate, the following general measures should be employed: Elimination of the Drug: Gastric lavage should be performed.
Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care. Hypotension: A vasopressor should be administered, e.g., levarterenol or dopamine. Bronchospasm: A beta -stimulating agent and/or a theophylline derivative should be 2 administered.
Cardiac Failure: A digitalis glycoside and diuretic should be administered. In shock resulting from inadequate cardiac contractility, administration of dobutamine, isoproterenol, or glucagon may be considered.
🧬 Clinical Pharmacology ▾
Mechanism of Action: Metoprolol Tartrate is a beta1-selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, Metoprolol Tartrate also inhibits beta2-adrenoreceptors, chiefly located in the bronchial and vascular musculature. Clinical pharmacology studies have demonstrated the beta-blocking activity of metoprolol, 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.
Hypertension The mechanism of the antihypertensive effects of beta-blocking agents has not been fully 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 Tartrate 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.
Myocardial Infarction The precise mechanism of action of Metoprolol Tartrate in patients with suspected or definite myocardial infarction is not known. Pharmacodynamics Relative beta1 selectivity is demonstrated by the following: (1) In healthy subjects, Metoprolol Tartrate is unable to reverse the beta2-mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective (beta1 plus beta2) beta blockers, which completely reverse the vasodilating effects of epinephrine.
(2) In asthmatic patients, Metoprolol Tartrate reduces FEV1 and FVC significantly less than a nonselective beta blocker, propranolol, at equivalent beta1-receptor blocking doses. Metoprolol Tartrate has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at doses much greater than required for beta blockade. Animal and human experiments indicate that Metoprolol Tartrate slows the sinus rate and decreases AV nodal conduction.
Significant beta-blocking effect (as measured by reduction of exercise heart rate) occurs within 1 hour after oral administration, and its duration is dose-related. For example, a 50% reduction of the maximum effect after single oral doses of 20, 50, and 100 mg occurred at 3.3, 5.0, and 6.4 hours, respectively, in normal subjects. After repeated oral dosages of 100 mg twice daily, a significant reduction in exercise systolic blood pressure was evident at 12 hours.
When the drug was infused over a 10-minute period, in normal volunteers, maximum beta blockade was achieved at approximately 20 minutes. Equivalent maximal beta-blocking effect is achieved with oral and intravenous doses in the ratio of approximately 2.5:1. There is a linear relationship between the log of plasma levels and reduction of exercise heart rate.
However, antihypertensive activity does not appear to be related to plasma levels. Because of variable plasma levels attained with a given dose and lack of a consistent relationship of antihypertensive activity to dose, selection of proper dosage requires individual titration. In several studies of patients with acute myocardial infarction, intravenous followed by oral administration of Metoprolol Tartrate caused a reduction in heart rate, systolic blood pressure and cardiac output.
Stroke volume, diastolic blood pressure and pulmonary artery end diastolic pressure remained unchanged. In patients with angina pectoris, plasma concentration measured at 1 hour is linearly related to the oral dose within the range of 50-400 mg. Exercise heart rate and systolic blood pressure are reduced in relation to…
📦 How Supplied / Storage and Handling ▾
Metoprolol Tartrate Tablets USP, 25 mg - White, circular, film coated tablets debossed with "1" on one side and plain on the other side Bottles of 30 .................. Bottles of 90 ................. Bottles of 100 ................
Bottles of 1000 .............. Metoprolol Tartrate Tablets USP, 50 mg - Round, white film coated tablets with "477" debossed on one side and scored on the other side Bottles of 100 ................ Bottles of 1000...............
Metoprolol Tartrate Tablets USP, 50 mg - Capsule-shaped, biconvex, white, scored (debossed 166) Bottles of 100 ................ Bottles of 1000 .............. Metoprolol Tartrate Tablets USP, 100 mg - Round-shaped, film coated, white colored tablets debossed with '162' on one side and 'scored' on the other side.
Bottles of 90 ................... Bottles of 100 ................. Bottles of 1000 ...............
Metoprolol Tartrate Tablets USP, 100 mg - Capsule-shaped, biconvex, white, scored (debossed 167) Bottles of 90.................... Bottles of 100 ................. Bottles of 1000 ...............
Samples, when available, are identified by the word SAMPLE appearing on each bottle.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Protect from Moisture.
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No.
259/15, Dadra-396 191, (U.T. of D & NH), India. 5094T89 Iss: 07/15
📋 Description ▾
Metoprolol tartrate, USP is a selective beta1 -adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is: [Structure] Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.
Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.