Metoprolol Succinate and Hydrochlorothiazide

Name: Metoprolol Succinate and Hydrochlorothiazide

Indications and Usage for Metoprolol Succinate and Hydrochlorothiazide

Metoprolol Succinate Extended Release/Hydrochlorothiazide is a combination tablet of metoprolol succinate, a beta adrenoceptor blocking agent and hydrochlorothiazide, a diuretic. Metoprolol Succinate Extended Release/Hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure.  Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol and hydrochlorothiazide.

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, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Metoprolol Succinate Extended Release/Hydrochlorothiazide may be administered with other antihypertensive agents.

Metoprolol Succinate and Hydrochlorothiazide Dosage and Administration

Dosing Information

The recommended starting dose of Metoprolol Succinate Extended Release/Hydrochlorothiazide is 25 mg/12.5 mg taken orally once daily with or without food. Depending on the blood pressure response, the dose may be titrated at intervals of 2 weeks to a maximum recommended dose of 200 mg/25 mg (two Metoprolol Succinate Extended Release/Hydrochlorothiazide 100 mg/12.5 mg tablets) once daily [see Clinical Studies (14)].

For specific advice on blood pressure goals, 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).

Use with and Switching from other Anti-Hypertensive Drugs

Metoprolol Succinate Extended Release/Hydrochlorothiazide may be administered with other antihypertensive drugs. Patients titrated to the individual components (Metoprolol Succinate and Hydrochlorothiazide) may instead receive the corresponding dose of Metoprolol Succinate Extended Release/Hydrochlorothiazide.

A patient whose blood pressure is inadequately controlled by metoprolol succinate alone or hydrochlorothiazide alone may be switched to Metoprolol Succinate Extended Release/Hydrochlorothiazide.

Dosage Forms and Strengths

25/12.5 mg tablets: Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side.

50/12.5 mg tablets: Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side.

100/12.5 mg tablets: Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side.

Contraindications

Metoprolol Succinate Extended Release/Hydrochlorothiazide is 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 succinate or hydrochlorothiazide or to other sulfonamide-derived drugs.

Overdosage

Signs and Symptoms

The most frequently observed signs expected with overdosage of a beta adrenergic blocker are bradycardia and bradyarrhythmia, hypotension, heart failure, cardiac conduction disturbances and bronchospasm.

With thiazide diuretics, acute intoxication is rare. The most prominent feature of overdose is acute loss of fluid, electrolytes and magnesium. Signs and symptoms of overdose may include hypotension, dizziness, muscle cramps, renal impairment or failure, and sedation/ impairment of consciousness. Altered laboratory findings can also occur (e.g. hypokalemia, hypomagnesaemia, hyponatremia, hypochloremia, alkalosis, increased BUN).

Management

Care should be provided at a facility that can provide appropriate supporting measures, monitoring and supervision as treatment is symptomatic and supportive and there is no specific antidote. Limited data suggest that neither metoprolol nor hydrochlorothiazide is dialyzable. If justified, gastric lavage and/or activated charcoal can be administered.

Based on the expected pharmacologic actions and recommendations for other beta adrenergic blockers and hydrochlorothiazide, the following measures should be considered when clinically warranted.

Bradycardia and conduction disturbances: Use atropine, adrenergic-stimulating drugs or pacemaker.

Hypotension, acute heart failure, and shock: Treat 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 α1 receptor agonistic drugs added in the presence of vasodilation.

Bronchospasm: Can usually be reversed by bronchodilators.

PRINCIPAL DISPLAY PANEL – 50/12.5 mg BOTTLE

50/12.5 mg Bottle

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