Metoprolol Tartrate and Hydrochlorothiazide

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE- metoprolol tartrate and hydrochlorothiazide tablet
Bryant Ranch Prepack

metoprololhydrochlorothiazide

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, 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 (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Limitation of Use

Metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS

Metoprolol tartrate and hydrochlorothiazide tablets, USP are supplied in the following strengths:

50 mg/25 mg: Tablets are white to off-white colored, round shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one side of score line and “230” on another side of score line and plain on other side.

100 mg/25 mg: Tablets are white to off-white colored, oval shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one side of score line and “232” on another side of score line and plain on other side.

100 mg/50 mg: Tablets are white to off-white colored, capsule shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one side of score line and “231” on another side of score line and plain on other side.

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.

5 WARNINGS AND PRECAUTIONS

5.1 Abrupt Cessation of Therapy

Following abrupt cessation of therapy with beta adrenergic blockers, exacerbations of angina pectoris and myocardial infarction may occur. When discontinuing chronically administered metoprolol tartrate and hydrochlorothiazide, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, promptly resume therapy and take measures appropriate for the management of unstable angina. Warn patients not to interrupt therapy without their physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abruptly discontinuing metoprolol tartrate in patients treated only for hypertension.

5.2 Heart Failure

Worsening cardiac failure may occur during up-titration of beta-blockers. If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of metoprolol. It may be necessary to lower the dose of metoprolol tartrate or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of metoprolol tartrate.

5.3 Bronchospastic Disease

Beta adrenergic blockers can cause bronchospasm. Patients with bronchospastic diseases should, in general, not receive beta-blockers. Because of its relative beta1 cardio-selectivity, however, metoprolol tartrate 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 have bronchodilators (e.g., beta2-agonists) readily available or administered concomitantly.

5.4 Bradycardia

Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of metoprolol tartrate and hydrochlorothiazide. Patients with first-degree atrioventricular block, sinus node dysfunction, conduction disorders (including Wolff-Parkinson-White) or on concomitant drugs [see Drug Interactions (7)] that cause bradycardia may be at increased risk. Monitor heart rate in patients receiving metoprolol tartrate and hydrochlorothiazide. If severe bradycardia develops, reduce or stop metoprolol tartrate and hydrochlorothiazide.

5.5 Major Surgery

Avoid initiation of high-dose regimen of metoprolol tartrate and hydrochlorothiazide in patients with cardiovascular risk factors undergoing non-cardiac surgery, since use in such patients has been associated with bradycardia, hypotension, stroke and death.

Chronically administered beta adrenergic blockers 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 [see Warnings and Precautions (5.1)].

5.6 Masked Symptoms of Hypoglycemia

Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.

5.7 Electrolyte and Metabolic Effects

Metoprolol tartrate and hydrochlorothiazide contains hydrochlorothiazide which can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hydrochlorothiazide reduces clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.

Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels.