Metoprolol Tartrate 100 mg/1
Metoprolol Tartrate · TABLET, FILM COATED · A-S Medication Solutions
Metoprolol tartrate is a beta-blocker medication taken by mouth that is used to treat high blood pressure and heart conditions. It works by slowing your heart rate and reducing the workload on your heart.
Key Facts
- Brand Name
- Metoprolol Tartrate
- Generic Name
- Metoprolol Tartrate
- NDC Code (Product)
50090-6764- Manufacturer
- A-S Medication Solutions
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA200981
- Marketing Start
- 12/01/2018
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD22845_1, EXP: 4/30/2014; LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD73525_49, EXP: 5/30/2014.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
RemedyRepack Inc.
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Aidapak Services, LLC
Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD76675_1, EXP: 6/3/2014.
Aidapak Services, LLC
Labeling:Label Mixup; METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68022_1, EXP: 5/28/2014; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 57664050652, Pedigree: AD68010_14, EXP: 5/28/2014.
Aurobindo Pharma USA Inc.
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Aidapak Services, LLC
Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: METOPROLOL TARTRATE, Tablet, 25 mg, NDC 57664050652, Pedigree: W003843, EXP: 6/27/2014; ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 60505257909, Pedigree: W003846, EXP: 6/27/2014; OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: W003898, EXP: 6/27/2014.
Teva Pharmaceuticals USA, Inc.
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Aidapak Services, LLC
Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 25 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003826, EXP: 6/27/2014; amLODIPine BESYLATE, Tablet, 5 mg, NDC 00093716798, Pedigree: W002840, EXP: 6/7/2014.
Baxter Healthcare Corporation
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Angina Pectoris. ( 1.2 ) Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3 ) 1.1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sod…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer once daily with food or after a meal. Titrate at weekly or longer intervals as needed and tolerated. ( 2 ) Hypertension: Recommended starting dosage is 100 mg daily, in single or divided doses. ( 2.1 ) Angina Pectoris: Recommended starting dosage is 100 mg daily, given as two divided doses. ( 2.2 ) Myocardial Infarction: The starting dosage depends upon tolerance of intravenous metoprolol, see full prescribing information. ( 2.3 ) 2.1 Hypertension Individualize the dosage of metoprolol tartrate tablets. Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage is 100 mg daily in single or divided doses. Adjust 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 1 week of therapy. The effective dosage range of metoprolol tartrate tablets is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing 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 th…
Contraindications
4 CONTRAINDICATIONS Metoprolol tartrate tablets are 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. Known hypersensitivity to product components. ( 4 ) Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. ( 4 ) Cardiogenic shock or decompensated heart failure. ( 4 )
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 ) 7.1 Catecholamine Depleting Drugs Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents. Observe patients treated with metoprolol plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. 7.2 Epinephrine While taking beta-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge and may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction. 7.…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: Worsening angina or myocardial infarction [see Warnings and Precautions (5) ] Worsening heart failure [see Warnings and Precautions (5) ]. Worsening AV block [see Contraindications (4) ]. Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypertension and Angina Most adverse effects have been mild and transient. Central Nervous System: Tiredness and dizziness have occurred in about 10% of 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 rep…
Frequently Asked Questions
What is Metoprolol Tartrate used for?
Metoprolol tartrate is a beta-blocker medication taken by mouth that is used to treat high blood pressure and heart conditions. It works by slowing your heart rate and reducing the workload on your heart.
Is Metoprolol Tartrate a controlled substance?
Metoprolol Tartrate is not classified as a controlled substance by the DEA.
What is the generic name for Metoprolol Tartrate?
The generic name for Metoprolol Tartrate is Metoprolol Tartrate. There are 6 other brand versions of Metoprolol Tartrate.
What is the NDC code for Metoprolol Tartrate 100 mg/1?
The NDC (National Drug Code) for Metoprolol Tartrate 100 mg/1 is 50090-6764, listed by A-S Medication Solutions.