Metoprolol Tartrate 12.5 mg Tablet, 30-count
Other active recalls for Metoprolol Tartrate (different manufacturers) — 1 · tap to view
🆔 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
- 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.
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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 2S42T2808B
A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
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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 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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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.
10 inactive ingredients listed in the exact product block matched to this NDC.
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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 |
|---|---|---|---|---|---|---|
| Lopressor 12.5 mg 30698-0460-01 | VALIDUS | 60 tablets | — | — | Discontinued | — |
| Metoprolol Tartrate 12.5 mgthis 72888-0197-30 | Advagen | 30 tablets | — | — | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 72888-0197-00 | 1000 TABLET in 1 BOTTLE (72888-197-00) | — | — | 2025-08-28 | Active |
| 72888-0197-03 | 60 TABLET in 1 BOTTLE (72888-197-03) | $2.84 / ea | $170.47 | 2026-01-25 | Active |
| 72888-0197-30 You're viewing this | 30 TABLET in 1 BOTTLE (72888-197-30) | — | — | 2025-08-28 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 72888-0197-30?
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Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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 ▾
1. INDICATIONS AND USAGE Metoprolol Tartrate Tablets is a beta-adrenergic blocker indicated in the treatment of hemodynamically stable adult patients with myocardial infarction, to reduce the risk of cardiovascular mortality. ( 1.1 )
1.1Myocardial Infarction Metoprolol Tartrate Tablets is indicated in the treatment of hemodynamically stable adult patients with myocardial infarction (MI) to reduce cardiovascular mortality.
⏱️ Dosage and Administration ▾
2. DOSAGE AND ADMINISTRATION Myocardial Infarction: The recommended starting dosage is 50 mg orally every 6 hours. Maintenance dosage depends upon hemodynamic tolerance, see full prescribing information. ( 2.1 )
2.1Myocardial Infarction The recommended starting dose in hemodynamically stable patients is 50 mg orally every 6 hours. In case of intolerance, reduce the starting dose to 25 mg orally every 6 hours and administer for 48 hours. Titrate dosage based on tolerability and hemodynamic parameters (i.e., heart rate, blood pressure).
Metoprolol Tartrate Tablets should preferably be administered with or following meals. The maximum daily maintenance dosage is 100 mg orally twice daily.
💊 Dosage Forms and Strengths ▾
3. DOSAGE FORMS AND STRENGTHS Metoprolol Tartrate Tablets is supplied as a 12.5 mg tablet that is pink-colored, film coated, round, biconvex, debossed with “˄E” on one side, and plain on the other side. Tablets: 12.5 mg. of metoprolol tartrate ( 3 )
⛔ Contraindications ▾
4. CONTRAINDICATIONS Metoprolol Tartrate Tablets is contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, systolic blood pressure <100, 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. Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker.
( 4 ) Cardiogenic shock or decompensated heart failure. ( 4 ) Known hypersensitivity to product components. ( 4 )
⚠️ Warnings and Cautions ▾
5. WARNINGS AND PRECAUTIONS Abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) Heart Failure: Worsening cardiac failure may occur.
( 5.2 ) Bronchospastic Disease: Avoid beta-blockers. ( 5.3 ) Pheochromocytoma: Initiate therapy with an alpha blocker. ( 5.4 ) Major Surgery: Avoid initiation of high-dose metoprolol in patients undergoing non-cardiac surgery.
Do not routinely withdraw chronic beta-blocker therapy prior to surgery. ( 5.5 , 6.1 ) Diabetes: May mask symptoms of hypoglycemia. ( 5.6 ) Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm.
( 5.7 ) Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. ( 5.9 )
5.1Abrupt 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 Tartrate Tablets, gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient. Warn patients not to interrupt therapy without their physician’s advice.
5.2Heart Failure Worsening cardiac failure may occur during up-titration of Metoprolol Tartrate Tablets. If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of Metoprolol Tartrate Tablets [see Dosage and Administration (2) ]. It may be necessary to lower the dose of Metoprolol Tartrate Tablets or temporarily discontinue it.
Such episodes do not preclude subsequent successful titration of Metoprolol Tartrate Tablets.
5.3Bronchospastic Disease Patients with bronchospastic disease, should in general, not receive beta-blockers, including Metoprolol Tartrate Tablets. Because of its relative beta 1 cardio-selectivity, however, Metoprolol Tartrate Tablets 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 Tablets.
Bronchodilators, including beta 2 -agonists, should be readily available or administered concomitantly [see Dosage and Administration (2) ].
5.4Pheochromocytoma If Metoprolol Tartrate Tablets 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.
5.5Major Surgery Avoid initiation of a high-dose regimen of beta blocker therapy 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.
5.6Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment.
5.7Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may precipitate a thyroid storm.
5.8Risk of Anaphylactic Reactions While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients m…
🤒 Adverse Reactions ▾
6. ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: Worsening Ischemia with Abrupt Discontinuation [see Warnings and Precautions (5) ] Worsening heart failure [see Warnings and Precautions (5) ]. Worsening atrioventricular (AV) block [see Contraindications (4) ].
Most common adverse reactions in the setting of treatment of myocardial infarction are hypotension and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at +1 (866)-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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. Myocardial Infarction In a randomized comparison of Metoprolol Tartrate Tablets and placebo in the setting of acute MI [see Clinical studies 14.1 ] the following adverse reactions were reported: Adverse Reaction Metoprolol Tartrate Tablets N=698 % Placebo N=697 % 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%
6.2Post-Marketing Experience The following adverse reactions have been reported during post-approval use of Metoprolol Tartrate Tablets. 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. 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 cognitive performance.
Cardiovascular: Worsening AV block [see Contraindications (4) ]. Hematologic: Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura. Hypersensitive Reactions: Fever combined with aching and sore throat, laryngospasm and respiratory distress.
Laboratory Findings: Increase in blood triglycerides, elevated transaminase and decrease in high-density lipoprotein (HDL)
🔄 Drug Interactions ▾
7. 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 )
7.1Catecholamine Depleting Drugs Observe patients treated with Metoprolol Tartrate Tablets plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents.
7.2Epinephrine The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as metoprolol. Higher doses of epinephrine might be necessary for patients taking metoprolol.
7.3CYP2D6 Inhibitors Monitor patients closely when the combination use of CYP2D6 inhibitor and metoprolol cannot be avoided. 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 may also increase metoprolol concentration.
Increases in plasma concentration decrease the beta 1 cardioselectivity of metoprolol [see Clinical Pharmacology (12.3) ] .
7.4Negative Chronotropes If clonidine and metoprolol are coadministered, withdraw the beta-blocker several days before the gradual withdrawal of clonidine because metoprolol may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. If replacing clonidine with metoprolol, delay the introduction of metoprolol for several days after clonidine discontinuation. Digitalis glycosides, clonidine, diltiazem, and verapamil slow atrioventricular conduction and decrease heart rate.
Concomitant use with beta blockers can increase the risk of bradycardia.
👥 Use in Specific Populations ▾
8. USE IN SPECIFIC POPULATIONS Hepatic Impairment: Consider initiating Metoprolol Tartrate Tablets therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events. ( 8.6 )
8.1Pregnancy 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 myocardial infarction 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 11 times the daily dose of 450 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 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 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 definitively 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. 11 times, on a mg/m 2 basis, the daily dose of 450 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. 4 times, the daily dose of 400mg in a 60-kg patient.
8.2Lactation 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 ranges 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…
🆘 Overdosage ▾
10. OVERDOSAGE Signs and Symptoms - Overdosage of Metoprolol Tartrate Tablets may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include AV 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. Hemodialysis is unlikely to make a useful contribution to metoprolol elimination [see Clinical Pharmacology (12.3) ] . 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
🧬 Clinical Pharmacology ▾
12. CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics Clinical pharmacology studies have confirmed the beta-blocking activity of metoprolol in humans, 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. The relationship between plasma metoprolol levels and reduction in exercise heart rate is independent of the pharmaceutical formulation. Beta 1 -blocking effects in the range of 30-80% of the maximal effect (approximately 8 to 23% reduction in exercise heart rate) correspond to metoprolol plasma concentrations from 30 to 540 nmol/L.
The relative beta 1 -selectivity of metoprolol diminishes, and blockade of beta 2 -adrenoceptors increases at plasma concentration above 300 nmol/L.
12.3Pharmacokinetics Absorption: The estimated oral bioavailability of immediate release metoprolol is about 50% because of pre- systemic metabolism which is saturable leading to non-proportionate increase in the exposure with increased dose. Distribution: Metoprolol is extensively distributed with a reported volume of distribution of 3.2 to
5.6L/kg. About 10% of metoprolol in plasma is bound to serum albumin. Metoprolol is known to cross the placenta and is found in breast milk.
Metoprolol is also known to cross the blood brain barrier following oral administration and cerebrospinal fluid (CSF) concentrations close to that observed in plasma have been reported. Metoprolol is not a significant P-glycoprotein substrate. Elimination: Elimination of Metoprolol Tartrate Tablets is mainly by biotransformation in the liver.
The mean elimination half-life of metoprolol is 3 to 4 hours; in poor CYP2D6 metabolizers the half-life may be 7 to 9 hours. Metabolism: Metoprolol Tartrate Tablets is primarily metabolized by CYP2D6. Metoprolol is a racemic mixture of R- and S- enantiomers, and when administered orally, it exhibits stereoselective metabolism that is dependent on oxidation phenotype.
CYP2D6 is absent (poor metabolizers) in about 8% of Caucasians and about 2% of most other populations. Poor CYP2D6 metabolizers exhibit several-fold higher plasma concentrations of Metoprolol tartrate than extensive metabolizers with normal CYP2D6 activity thereby decreasing Metoprolol tartrate’s cardioselectivity. Excretion: Approximately 95% of the dose can be recovered in urine.
In most subjects (extensive metabolizers), less than 5% of an oral dose and the rest is excreted by the kidneys as metabolites that appear to have no beta-blocking activity. The renal clearance of the stereoisomers does not exhibit stereo-selectivity in renal excretion. Specific populations Geriatric patients : The geriatric population may show slightly higher plasma concentrations of metoprolol as a combined result of a decreased meta…
📦 How Supplied / Storage and Handling ▾
16. HOW SUPPLIED/STORAGE AND HANDLING Metoprolol Tartrate Tablets Tablets 12.5 mg - pink colored film coated, round, biconvex tablets debossed with “˄E” on one side and plain on the other side. They are available as follows: Bottles of 30..................NDC 72888-197-30 Bottles of 60..................NDC 72888-197-03 Bottles of 1,000.............NDC 72888-197-00 Storage: Store at 20°C to 25°C (68°F 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.
📋 Description ▾
11. DESCRIPTION Metoprolol Tartrate Tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol.
It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol Tartrate Tablets is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients : Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide. Metoprolol tartrate Tablet Structure
💬 Information for Patients ▾
17. PATIENT COUNSELING INFORMATION Advise patients to take Metoprolol Tartrate Tablets regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it).
Patients should not interrupt or discontinue Metoprolol Tartrate Tablets 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 Tartrate Tablets 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 Tartrate Tablets. Inform patients or caregivers that there is a risk of hypoglycemia when Metoprolol Tartrate Tablets is given to patients who are fasting or who are vomiting.
Instruct patients or caregivers how to monitor for signs of hypoglycemia [see Warnings and Precautions (5.6) ]. Distributed by: Advagen Pharma Ltd East Windsor, NJ 08520, USA. Manufactured by: Rubicon Research Limited Thane, 421506 India.
Rev: 01, 11/2025