Drugplain

Metoprolol Tartrate and Hydrochlorothiazide 50 mg/1

metoprolol tartrate and hydrochlorothiazide · TABLET · Mylan Pharmaceuticals Inc.

1 Recall on RecordCurrently in Shortage
Plain English

Metoprolol Tartrate and Hydrochlorothiazide is a tablet containing metoprolol tartrate and hydrochlorothiazide at 50 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..

Key Facts

Brand Name
Metoprolol Tartrate and Hydrochlorothiazide
Generic Name
metoprolol tartrate and hydrochlorothiazide
NDC Code (Product)
0378-0445
Manufacturer
Mylan Pharmaceuticals Inc.
Strength
50 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA076792
Drug Class
Thiazide Diuretic [EPC]
Marketing Start
08/20/2004

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea15 reports
fatigue13 reports
death11 reports
dyspnoea11 reports
renal failure acute11 reports
diarrhoea10 reports
anaemia9 reports
asthenia9 reports
dizziness9 reports
pain8 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality,…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Usual dose range: Hydrochlorothiazide 12.5 to 25 mg and metoprolol tartrate 100 mg dosed once daily. (2.1) 2.1 Recommended Dosage Titrate doses of individual components before switching to metoprolol tartrate and hydrochlorothiazide tablets. Administer metoprolol tartrate and hydrochlorothiazide tablets with or immediately following meals. Hydrochlorothiazide is usually given at a dosage of 12.5 mg to 50 mg per day. The usual initial dosage of metoprolol is 100 mg daily in single or divided doses. Dosage may be increased gradually until optimum blood pressure control is achieved. Once daily dosing may not maintain the full effect for the entire dosing period, particularly at lower doses. In such patients, consider administration in divided doses. Dosing regimens that exceed 50 mg of hydrochlorothiazide per day are not recommended.

Contraindications

4 CONTRAINDICATIONS Metoprolol tartrate and hydrochlorothiazide tablets are contraindicated in patients with: Cardiogenic shock or decompensated heart failure. Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place. Anuria Hypersensitivity to metoprolol tartrate or hydrochlorothiazide or to other sulfonamide derived drugs. Hypersensitivity to metoprolol tartrate or hydrochlorothiazide or other sulfonamide-derived drugs. (4) Cardiogenic shock or decompensated heart failure. (4) Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place. (4) Anuria. (4)

Drug Interactions

7 DRUG INTERACTIONS Catecholamine-depleting drugs (e.g., MAO inhibitors): Hypotension, bradycardia. (7.1) CYP2D6 inhibitors: Increased metoprolol concentration. (12.3) Digitalis glycosides, clonidine, diltiazem and verapamil: Bradycardia. (5.4, 7.1) Clonidine: Rebound hypertension following clonidine withdrawal. (7.1) Antidiabetic drugs: Dosage adjustment may be required. (7.2) Cholestyramine and colestipol: Reduced absorption of thiazides. (7.2) Lithium: Risk of lithium toxicity. (7.2) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects of diuretics. (7.2) 7.1 Drug Interactions with Metoprolol Catecholamine Depleting Drugs: The concomitant use of catecholamine-depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) with beta adrenergic blockers may have an additive affect and increase the risk of hypotension or bradycardia. CYP2D6 Inhibitors: Drugs that are strong inhibitors of CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone were shown to double metoprolol concentrations. While there is no information about moderate or weak inhibitors, these too are likely to increase metoprolol concentration. …

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described in more detail elsewhere in the label; Worsening angina or myocardial infarction [see Warnings and Precautions (5)] Worsening heart failure [see Warnings and Precautions (5)] Worsening AV block [see Contraindications (4)] To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.2 Post-Marketing Experience The following adverse reactions have been reported in postmarketing experience: adverse reactions have been identified during post approval use of metoprolol tartrate and hydrochlorothiazide. 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. Metoprolol Confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL). 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. Hydrochlorothiazide Digestive: P…

Frequently Asked Questions

What is Metoprolol Tartrate and Hydrochlorothiazide used for?

Metoprolol Tartrate and Hydrochlorothiazide contains metoprolol tartrate and hydrochlorothiazide. It is a tablet taken oral. Consult your doctor for specific uses.

Is Metoprolol Tartrate and Hydrochlorothiazide a controlled substance?

Metoprolol Tartrate and Hydrochlorothiazide is not classified as a controlled substance by the DEA.

What is the generic name for Metoprolol Tartrate and Hydrochlorothiazide?

The generic name for Metoprolol Tartrate and Hydrochlorothiazide is metoprolol tartrate and hydrochlorothiazide. There are 1 other brand versions of metoprolol tartrate and hydrochlorothiazide.

What is the NDC code for Metoprolol Tartrate and Hydrochlorothiazide 50 mg/1?

The NDC (National Drug Code) for Metoprolol Tartrate and Hydrochlorothiazide 50 mg/1 is 0378-0445, listed by Mylan Pharmaceuticals Inc..

Product NDC

0378-0445

Package NDC

0378-0445-01

Other Metoprolol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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