NOTICE TO PATIENTS AND HEALTH CARE PROFESSIONALS: Validus is no longer manufacturing or distributing this product. This website is maintained solely for reference purposes. Patients — Validus recommends that you talk to your Health Care Professional about alternative therapies.

WHY IS THIS MEDICATION PRESCRIBED?

Lopressor HCT® (metoprolol tartrate and hydrochlorothiazide) Tablets are a combination beta-blocker and diuretic used to treat high blood pressure.

WHAT CONDITIONS ARE TREATED WITH LOPRESSOR HCT?

Lopressor HCT combines hydrochlorothiazide and metoprolol to treat high blood pressure (hypertension). Hydrochlorothiazide is a thiazide diuretic (water pill) that prevents your body from absorbing too much salt which can cause fluid retention. Metoprolol is a beta-blocker which works by lowering heart rate, blood pressure and strain on the heart. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems.

This is a fixed combination drug that is not indicated for initial therapy of high blood pressure. It is a more convenient means to take your medication if the dosages in the fixed combination represent the dosages for your particular needs as determined by your doctor.

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IMPORTANT SAFETY INFORMATION

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LOPRESSOR HCT® (metoprolol tartrate and hydrochlorothiazide)

CONTRAINDICATIONS

Individuals with sinus bradycardia, heart block greater than firth degree, cardiogenic shock, overt cardiac failure, sick-sinus syndrome, and severe arterial circulatory disorders should not use Lopressor HCT® (metoprolol tartrate and hydrochlorothiazide) Tablets.

Individuals with hypersensitivity to Lopressor HCT and related derivatives, or to any of the excipients, or hypersensitivity to any other beta blockers should not take Lopressor HCT.

Individuals with anuria or hypersensitivity to sulfamide-derived drugs should not take hydrochlorothiazide.

WARNINGS

Lopressor

Cardiac Failure: If you are hypertensive and have congestive heart failure controlled by digitalis and diuretics, Lopressor HCT should be administered cautiously.

In Patients Without a History of Cardiac Failure: At the first sign of impending cardiac failure, you should be given digitalis and/or a diuretic and, if cardiac failure continues, Lopressor HCT should be withdrawn.

Ischemic Heart Disease: Abrupt cessation of Lopressor HCT therapy can cause exacerbation of angina pectoris and in some cases, myocardial infarction. Even in the absence of angina pectoris and myocardial infarction, Lopressor HCT should never be withdrawn abruptly.

Bronchospastic Disease: IF YOU HAVE BRONCHOSPASTIC DISEASE, YOU SHOULD NOT RECEIVE ANY BETA-BLOCKER THERAPY INCLUDING LOPRESSOR HCT. IF YOU HAVE BRONCHOSPASTIC DISEASE, THERE MAY BE SELECTIVE INSTANCES WHERE YOUR DOCTOR MAY PRESCRIBE LOPRESSOR HCT.

Major Surgery: You should NOT discontinue Lopressor HCT therapy prior to major surgery, but be sure to tell your surgeon that you are taking Lopressor HCT prior to any surgery.

Diabetes: If you have diabetes, Lopressor HCT should be taken with caution as the use of Lopressor HCT may mask tachycardia occurring with hypoglycemia.

Pheochromocytoma: If you have pheochromocytoma you should only use Lopressor HCT in combination with an alpha blocker, and only after the alpha blocker has been initiated.

Thyrotoxicosis: If your doctor thinks that you may be at risk of developing thyrotoxocosis, your doctor should manage your Lopressor HCT use carefully to avoid abrupt withdrawal of the beta blockade.

Hydrochlorothiazide

If you have severe renal disease, impaired hepatic function or progressive liver disease, you should use Lopressor HCT with caution. Similarly, thiazides may add to the action of other antihypertensive drugs.

Hydrochlorothiazide can cause acute transient myopia and acute angle-closure glaucoma, particularly for those individuals with a history of allergy to sulfonamide or penicillin.

PRECAUTIONS

Lopressor HCT should be used with caution if you have impaired hepatic function.

If you are taking Lopressor HCT, you should be observed for fluid or electrolyte imbalance, hypokalemia (especially in cases of brisk diuresis or severe cirrhosis or interference with adequate oral intake of electrolytes). Individuals with problems with low blood salt content and edema in hot weather may require water restriction, or in severe cases, salt administration. This should be monitored by your doctor.

Thiazides may also cause hyperuricemia, latent diabetes, and enhanced antihypertensive effects in postsympathectomy patients. If you have progressive renal impairment, withholding or discontinuing diuretic therapy should be considered.

Patients should take Lopressor HCT regularly and continuously, as directed, with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not discontinue Lopressor HCT without consulting their doctor.

Patients should (1) avoid operating automobiles or machinery or engaging in other tasks requiring alertness until the patients response to Lopressor HCT has been determined; (2) contact their doctor is any difficulty in breathing occurs; and (3) inform their doctor or dentist before any surgery that he or she is taking Lopressor HCT.

Drug/Drug Interactions

Lopressor:

Catecholamine-depleting drugs (e.g. reserpine) may have an additive effect when given with Lopressor HCT.

Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate, so use of both medicines together can increase the risk of bradycardia.

If you have a history of severe anaphylactic reaction to a variety of allergens and take Lopressor HCT, you may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic and you may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

If you are taking potent inhibitors of the CYP2D6 enzyme, exercise caution and speak with your doctors about using both medicines as CYP2D6 inhibitors increase plasma concentration of Lopressor HCT. Inhibors of the CYP2D6 enzyme include certain antidepressants such as fluoxetine, paraoxetine, or bupropion; antipsychotics such as thioridazine; antiarrhythmics such as quinidine or propafenone; antiretrovirals such as ritonavir; antihistimines such as diphenhydramine; antimalarials such as hydroxychloroquine or quinidine; antifungals such as terbinafine; and medications for stomach ulcers such as cimetidine.

If you are taking Lopressor HCT and clonidine treatment at the same time, and clonidine treatment is to be discontinued, the Lopressor HCT treatment should be withdrawn several days before discontinuing clonidine.

Hydrochlorothiazide:

Hydrochlorothiazide can exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability). Hypokalemia may develop during simultaneous use of steroids or ACTH. Insulin requirements in diabetic patients may change during Loressor HCT use. Thiazides may decrease the responsiveness of the heart to norepinephrine and increase responsiveness to tubocurarine. Lithium renal clearance is reduced by thiazides. Taking some nonsteroidal anti-inflammatory agents may reduce the diuretic, natriuretic, and antihypertensive effects of thiazide.

PREGNANCY CATEGORY C

There are no adequate and well-controlled studies of Lopressor HCT in pregnant women. Lopressor HCT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

ADVERSE REACTIONS

Fatigue or lethargy and flu syndrome, dizziness or vertigo, drowsiness or somnolence, and headache have been reported in 10% of patients. Hypokalemia has been reported in less than 10% of patients. Bradycardia has been reported in 6% of patients. Decreased exercise tolerance and dyspnea, and diarrhea; digestive disorder, dry mouth, nausea or vomiting, and constipation; edema, gout, and anorexia; blurred vision, tinnitus, and earache; and sweating, purpura, impotence, and muscle pain have been reported in 1% of patients.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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