Metoprolol Tartrate And Hydrochlorothiazide

1 INDICATIONS AND USAGE Metoprolol tartrate and hydrochlorothiazide tablets is 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.

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 Ajanta Pharma USA Inc. at 1-855-664-7744 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 tablets.

8.1 Pregnancy Risk Summary Untreated hypertension during pregnancy can lead to adverse outcomes for the mother and the fetus ( see Clinical Considerations ). Available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with metoprolol use during pregnancy. However, there are inconsistent reports of intrauterine growth restriction, preterm birth, and perinatal mortality with maternal use of beta blockers, including metoprolol, during pregnancy ( see Data ).

5 WARNINGS AND PRECAUTIONS Abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) May worsen congestive heart failure. ( 5.2 ) Bronchospasm: Avoid beta-blockers. ( 5.3 ) Bradycardia. ( 5.4 ) Avoid discontinuing therapy prior to major surgery. ( 5.5 ) Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor. ( 5.6 ) Monitor serum electrolytes and creatinine periodically. ( 5.7 ) Peripheral vascular disease: Can aggravate symptoms of arterial insufficiency. ( 5.9 ) Pheochromocytoma: First initiate therapy with an alpha blocker. ( 5.10 ) Abrupt withdrawal in thyrotoxicosis might precipitate a thyroid storm. ( 5.11 ) Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. 4 CONTRAINDICATIONS Metoprolol tartrate and hydrochlorothiazide tablets 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 tartrate or hydrochlorothiazide or to other sulfonamide- derived drugs.