METOPROLOL TARTRATE 25 mg Tablet, 500-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the beta-Adrenergic Blocker class.
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🏭 Manufacturer & labeler
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🩺 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
Some supplements/herbs that may interact with Metoprolol — tap one for details:
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 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 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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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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 G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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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 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.
9 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
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💲 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metoprolol Tartrate 25 mg 00378-0018-01 | Mylan | 100 tablets | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 51079-0255-20 | Mylan | 1 tablet | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 52817-0250-00 | TRUPHARMA | 1000 tablets | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 52817-0360-00 | TruPharma | 1000 tablets | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 57237-0100-01 | Rising | 100 tablets | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 62584-0265-01 | American | 1 tablet | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 65862-0062-01 | Aurobindo | 100 tablets | $0.016 | — | Availability likely | — |
| Metoprolol Tartrate 25 mg 72888-0004-00 | Advagen | 1000 tablets | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 72888-0208-00 | Advagen | 1000 tablets | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 76282-0794-01 | Exelan | 100 tablets | $0.016 | AB | Availability likely | — |
| Metoprolol Tartrate 25 mg 00615-8421-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 42708-0110-60 | QPharma | 60 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 43063-0927-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mgthis 46708-0290-71 | Alembic | 500 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 48433-0073-20 | Safecor | 1 tablet | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 50090-2207-00 | A-S | 180 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 50090-5070-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 50090-7362-00 | A-S | 180 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 50090-7363-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 50090-7567-00 | A-S | 180 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 50090-7568-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 50090-7738-00 | A-S | 180 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 50090-7739-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 51407-0109-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 51655-0534-25 | Northwind | 60 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 53401-0011-53 | Aphena | 60 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 53401-0015-53 | Aphena | 60 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 55154-4752-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 55154-5356-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 55289-0382-14 | PD-Rx | 14 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 62332-0112-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 63187-0600-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 67046-1561-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 67046-1592-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 67296-1903-03 | RedPharm | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 67296-2216-01 | Redpharm | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 68071-3723-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 68071-5236-01 | NuCare | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 68788-8509-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 68788-8840-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 70518-2615-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 70518-3291-00 | REMEDYREPACK | 60 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 70518-3506-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 70518-3950-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 70518-4308-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 70882-0132-60 | Cambridge | 60 tablets | — | AB | Discontinued | — |
| Metoprolol Tartrate 25 mg 71205-0003-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 71335-0192-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 71335-0743-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 71335-1142-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 71335-2789-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 71335-9745-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 71610-0137-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 71610-0184-53 | Aphena | 60 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 71610-0556-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 72189-0640-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 76420-0054-20 | Asclemed | 20 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 82868-0037-20 | Northwind | 20 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 87063-0184-01 | ASCLEMED | 100 tablets | — | AB | FDA listed | — |
| Metoprolol Tartrate 25 mg 67296-2323-06 | Redpharm | 60 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)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0290-10 | 100 TABLET in 1 CARTON (46708-290-10) | 2013-07-22 | Active |
| 46708-0290-30 | 30 TABLET in 1 BOTTLE (46708-290-30) | 2013-07-22 | Active |
| 46708-0290-31 | 100 TABLET in 1 BOTTLE (46708-290-31) | 2013-07-22 | Active |
| 46708-0290-71 You're viewing this | 500 TABLET in 1 BOTTLE (46708-290-71) | 2013-07-22 | Active |
| 46708-0290-91 | 1000 TABLET in 1 BOTTLE (46708-290-91) | 2013-07-22 | Active |
Pack size FAQ
What quantity is in NDC 46708-0290-71?
What is the difference between NDC 46708-0290-71 and NDC 46708-0290-30?
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🧭 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. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & 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. Oral metoprolol therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION Hypertension Individualize the dosage of metoprolol tablets. 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.
Increase the dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after one 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.
Beta1 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. 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, gradually decrease the dosage 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 tablets 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.
Begin 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, monitor blood pressure, heart rate, and electrocardiogram. In patients who tolerate the full intravenous dose (15 mg), initiate metoprolol tartrate tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours.
Thereafter, the maintenance dosage is 100 mg twice daily (see Late Treatment below). Start patients who appear not to tolerate the full intravenous dose on metoprolol 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, discontinue metoprolol(see WARNINGS).
Late Treatment: Start 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 on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy 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 in pediatric patients have not been established. Renal impairment: No dose adjustment of metoprolol is required in patients with renal impairment.
Hepatic…
⛔ Contraindications ▾
CONTRAINDICATIONS Hypertension and Angina Metoprolol tartrate tablets are 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 (crosssensitivity 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 ≥ 0.24 sec); systolic blood pressure < 100 mmHg; or moderate to severe cardiac failure (see WARNINGS).
⚠️ Warnings ▾
WARNINGS Heart Failure Beta blockers, like metoprolol, 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 or to discontinue it.
Ischemic Heart Disease Do not abruptly discontinue metoprolol 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, 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 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 physicians advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol 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. 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. If severe bradycardia develops, reduce or stop metoprolol. Exacerbation of Bronchospastic Diseases Patients with bronchospastic diseases, should, in general, not receive beta blockers, including metoprolol.
Because of its relative beta1 selectivity, however, metoprolol 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 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 tablets may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta-blockade, which might precipitate a thyroid storm.
🤒 Adverse Reactions ▾
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 nonspecific 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 have 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 has not been definitely established). The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with metoprolol. 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: Metoprolol Placebo Hypotension (systolic BP <90 mm Hg) 27.4% 23.2% Bradycardia (heart rate <40 beats/min) 15.9% 6.7% Second- or third-degree heart block 4.7% 4.7% First-degree heart block (P-R ≥0.26 sec) 5.3% 1.9% Heart failure 27.5% 29.6% 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 has been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol. 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 and thrombocytopenic purpura. Hypersensitive Reactions: Fever combined with aching and sore throat, laryn…
🔄 Drug Interactions ▾
DRUG INTERACTIONS Catecholamine-depleting drugs: Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents or monoamine oxidase (MAO) inhibitors. Observe patients treated with metoprolol plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. In addition, possibly significant hypertension may theoretically occur up to 14 days following discontinuation of the concomitant administration with an irreversible MAO inhibitor.
Digitalis glycosides and beta blockers: Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Monitor heart rate and PR interval.
Calcium channel blockers: Concomitant administration of a beta-adrenergic antagonist with a calcium channel blocker may produce an additive reduction in myocardial contractility because of negative chronotropic and inotropic effects. CYP2D6 Inhibitors: Potent inhibitors of the CYP2D6 enzyme may increase the plasma concentration of metoprolol which would mimic the pharmacokinetics of CYP2D6 poormetabolizer (see Pharmacokinetics section). Increase in plasma concentrations of metoprolol would decrease the cardioselectivity of metoprolol.
Known clinically significant potent inhibitors of CYP2D6 are antidepressants such as fluvoxamine, fluoxetine, paroxetine, sertraline, bupropion, clomipramine, and desipramine; antipsychotics such as chlorpromazine, fluphenazine, haloperidol, and thioridazine; antiarrhythmics such as quinidine or propafenone; antiretrovirals such as ritonavir; antihistamines such as diphenhydramine; antimalarials such as hydroxychloroquine or quinidine; antifungals such as terbinafine. Hydralazine: Concomitant administration of hydralazine may inhibit presystemic metabolism of metoprolol leading to increased concentrations of metoprolol.
Alpha-adrenergic agents: Antihypertensive effect of alpha-adrenergic blockers such as guanethidine, betanidine, reserpine, alpha-methyldopa or clonidine may be potentiated by beta-blockers including metoprolol. Beta-adrenergic blockers may also potentiate the postural hypotensive effect of the first dose of prazosin, probably by preventing reflex tachycardia. On the contrary, beta adrenergic blockers may also potentiate the hypertensive response to withdrawal of clonidine in patients receiving concomitant clonidine and beta-adrenergic blocker.
If a patient is treated with clonidine and metoprolol concurrently, and clonidine treatment is to be discontinued, stop metoprolol several days before clonidine is withdrawn. Rebound hypertension that can follow withdrawal of clonidine may be increased in patients receiving concurrent beta-blocker treatment. Ergot alkaloid: Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.
Dipyridamole: In general, administration of a beta-blocker should be withheld before dipyridamole testing, with careful monitoring of heart rate following the dipyridamole injection.
🤰 Pregnancy ▾
Pregnancy Category C Upon confirming the diagnosis of pregnancy, women should immediately inform the doctor. Metoprolol has been shown to increase postimplantation loss and decrease neonatal survival in rats at doses up to 11 times the maximum daily human dose of 450 mg, when based on surface area. Distribution studies in mice confirm exposure of the fetus when metoprolol is administered to the pregnant animal.
These limited animal studies do not indicate direct or indirect harmful effects with respect to teratogenicity (see Carcinogenesis, Mutagenesis, Impairment of Fertility). There are no adequate and well-controlled studies in pregnant women. The amount of data on the use of metoprolol in pregnant women is limited.
The risk to the fetus/mother is unknown. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical trials of metoprolol in hypertension did not include sufficient numbers of elderly patients to determine whether patients over 65 years of age differ from younger subjects in their response to metoprolol. Other reported clinical experience in elderly hypertensive patients has not identified any difference in response from younger patients. In worldwide clinical trials of metoprolol in myocardial infarction, where approximately 478 patients were over 65 years of age (0 over 75 years of age), no age-related differences in safety and effectiveness were found.
Other reported clinical experience in myocardial infarction has not identified differences in response between the elderly and younger patients. However, greater sensitivity of some elderly individuals taking metoprolol cannot be categorically ruled out. Therefore, in general, it is recommended that dosing proceed with caution in this population.
🆘 Overdosage ▾
OVERDOSAGE Acute Toxicity Several cases of overdosage have been reported, some leading to death. Oral LD50’s (mg/kg): mice, 1,158 to 2,460; rats, 3,090 to 4,670. 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, 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: Administer a vasopressor, e.g.,levarterenol or dopamine. Bronchospasm: Administer a beta2-stimulating agent and/or a theophylline derivative.
Cardiac Failure: Administer digitalis glycoside and diuretic. In shock resulting from inadequate cardiac contractility, consider administration of dobutamine, isoproterenol or glucagon.
🧬 Clinical Pharmacology ▾
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 also inhibits beta2- adrenoreceptors, chiefly located in the bronchial and vascular musculature. Clinical pharmacology studies have confirmed the beta-blocking activity of metoprolol in man, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia.
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, leadingto 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.
Myocardial Infarction The precise mechanism of action of metolrolol 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 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 reduces FEV1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta1-receptor blocking doses. Metoprolol 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 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, 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 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 to 400 mg. Exercise heart rate and systolic blood pressure are reduced in relation to the logarithm of the oral dose of metoprolol…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate, USP. The 25 mg tablets are white to off white film coated, round, biconvex tablets debossed with ‘L150’ on one side and breakline on other side. They are available as follows: NDC 46708-290-30 bottles of 30 tablets NDC 46708-290-31 bottles of 100 tablets NDC 46708-290-71 bottles of 500 tablets NDC 46708-290-91 bottles of 1000 tablets NDC 46708-290-10 100 (10 x 10) Tablets Unit-dose blisters The 50 mg tablets are pink, film coated, round, biconvex tablets debossed with ‘L151’ on one side and breakline on other side.
They are available as follows: NDC 46708-291-30 bottles of 30 tablets NDC 46708-291-31 bottles of 100 tablets NDC 46708-291-91 bottles of 1000 tablets NDC 46708-291-10 100 (10 x 10) Tablets Unit-dose blisters The 100 mg tablets are blue, film coated, round, biconvex tablets debossed with ‘L152’ on one side and breakline on other side. They are available as follows: NDC 46708-292-30 bottles of 30 tablets NDC 46708-292-31 bottles of 100 tablets NDC 46708-292-91 bottles of 1000 tablets NDC 46708-292-10 100 (10 x 10) Tablets Unit-dose blisters Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Alembic Pharmaceuticals Limited Manufactured in India Revised: 03/2023
📋 Description ▾
DESCRIPTION Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, its structural formula is: 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.
Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No.
2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents. Structure
💬 Information for Patients ▾
Information for patients Advise patients to take metoprolol regularly and continuously, as directed, with or immediately following meals. If a dose should be missed, the patient should take only the next scheduled dose (without doubling it). Patients should not discontinue metoprolol 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 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.