Corzide 40/5

Corzide 40/5 (Nadolol (Corzide 40/5) and Corzide 40/5 Tablets) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk ononfatal 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 the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Corzide 40/5.

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 one 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.

Corzide 40/5 (Nadolol (Corzide 40/5) and Corzide 40/5 Tablets) is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient's needs, it may be more convenient than the separate components.

Corzide 40/5 is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Nadolol (Corzide 40/5) is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

The combination of Corzide 40/5 and Nadolol (Corzide 40/5) is used to treat high blood pressure (hypertension).

Corzide 40/5 and Nadolol (Corzide 40/5) may also be used for other purposes not listed in this medication guide.

DOSAGE MUST BE INDIVIDUALIZED. Corzide 40/5 MAY BE ADMINISTERED WITHOUT REGARD TO MEALS.

Corzide 40/5 is usually given at a dose of 5 mg daily. The usual initial dose of Nadolol (Corzide 40/5) is 40 mg once daily whether used alone or in combination with a diuretic. Corzide 40/5 in Corzide 40/5 is 30 percent more bioavailable than that of 5 mg Naturetin tablets. Conversion from 5 mg NATURETIN to Corzide 40/5 represents a 30 percent increase in dose of Corzide 40/5.

The initial dose of Corzide 40/5 (Nadolol (Corzide 40/5) and Corzide 40/5 Tablets) may therefore be the 40 mg/5 mg tablet once daily. When the antihypertensive response is not satisfactory, the dose may be increased by administering the 80 mg/5 mg tablet once daily.

When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure.

Dosage Adjustment in Renal Failure

Absorbed Nadolol (Corzide 40/5) is excreted principally by the kidneys and, although nonrenal elimination does occur, dosage adjustments are necessary in patients with renal impairment. The following dose intervals are recommended:

How supplied

Corzide 40/5 (Nadolol (Corzide 40/5) and Corzide 40/5 Tablets)

40 mg Nadolol (Corzide 40/5) combined with 5 mg Corzide 40/5 in bottles of 100 tablets (NDC 60793-283-01).

80 mg Nadolol (Corzide 40/5) combined with 5 mg Corzide 40/5 in bottles of 100 tablets (NDC 60793-284-01).

Round, biconvex tablets are white to bluish white with dark blue specks. Each tablet has a full bisect bar. Tablet identification numbers: 40 mg/5 mg combination embossed with KPI/283 on the scored side and Corzide 40/5/5 on the other; 80 mg/5 mg combination embossed with KPI/284 on the scored side and Corzide 40/5 80/5 on the other.

Storage

Keep bottle tightly closed. Store at room temperature; avoid excessive heat.

Distributed by: Pfizer Inc, New York, Ny 10017. Revised July 2013

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What is the most important information I should know about Corzide 40/5?

You should not use this medication if you have asthma, severe or uncontrolled heart failure, a serious heart condition such as "sick sinus syndrome" or "AV block," or if you are unable to urinate.

Before using this medication, tell your doctor if you have congestive heart failure, kidney or liver disease, cirrhosis, bronchospastic lung disease, a thyroid disorder, gout, lupus, diabetes, or if you are allergic to sulfa drugs.

If you are diabetic, check your blood sugar carefully. Using Nadolol (Corzide 40/5) can make it harder for you to tell when you have low blood sugar. Your insulin or diabetic medication needs may change while you are taking Corzide 40/5 and Nadolol (Corzide 40/5). Talk with your doctor before changing any doses.

Avoid drinking alcohol, which can lower your blood pressure and may add to the side effects of Corzide 40/5 and Nadolol (Corzide 40/5).

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

There are many other medicines that can interact with Corzide 40/5 and Nadolol (Corzide 40/5). Tell your doctor about all the prescription and over-the-counter medications you use.

Use Corzide 40/5 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Corzide 40/5 by mouth with or without food.
• Corzide 40/5 may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
• If you miss a dose of Corzide 40/5, take the missed dose if you remember the same day. Skip the missed dose if you do not remember the same day. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Corzide 40/5.

This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications, Nadolol (Corzide 40/5) and Corzide 40/5. Nadolol (Corzide 40/5) belongs to a class of drugs known as beta blockers. It works by keeping certain natural chemicals such as epinephrine from acting on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart. Corzide 40/5 is a "water pill" (diuretic) and causes your body to get rid of extra salt and water. This effect may increase the amount of urine you make when you first start the medication. It also helps relax the blood vessels so that blood can flow more easily.

How to use Nadolol (Corzide 40/5)-Corzide 40/5

Take this medication by mouth with or without food, usually once daily or as directed by your doctor.

If you take this drug too close to bedtime, you may need to wake up to urinate. Therefore, it is best to take this medication at least 4 hours before your bedtime. Consult your doctor or pharmacist if you have questions about when to take this medication.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

It may take several weeks before you get the full benefit of this medication. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Tell your doctor if your condition does not improve or if it worsens (for example, your routine blood pressure readings remain high or increase).

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What other drugs will affect Corzide 40/5?

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur: cisapride.

If you are currently using this medication, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (such as warfarin), dofetilide, fingolimod, lithium.

Cholestyramine and colestipol can decrease the absorption of Corzide 40/5. If you are taking either of these drugs, take them at least 4 hours before or after taking this product.

Check the labels on all your medicines (such as cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen for pain/fever reduction) because they may contain ingredients that could increase your blood pressure or heart rate. Ask your pharmacist about using those products safely.

This product may interfere with certain laboratory tests (including parathyroid, protein-bound iodide, tyramine, and phentolamine tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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What are the possible side effects of Corzide 40/5?

Dizziness, lightheadedness, slow heartbeat, tiredness, nausea, and vomiting may occur. Decreased sexual ability has been reported rarely. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The Corzide 40/5 in this product may cause your body to lose too much water and salt (dehydration). Tell your doctor right away if you have any of these unlikely but serious symptoms of dehydration: very dry mouth, extreme thirst, muscle cramps/weakness, fast heartbeat, severe dizziness, confusion, fainting, seizures.

Tell your doctor right away if any of these unlikely but serious side effects occur: very slow/irregular heartbeat, new or worsening symptoms of heart failure (such as swelling ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain), mental/mood changes (such as depression, mood swings), toe/joint pain.

Tell your doctor right away if any of these rare but very serious side effects occur: trouble breathing, blue fingers/toes, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, signs of kidney problems (such as change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

A thiazide diuretic with actions and uses similar to those of hydrochlorothiazide. It has been used in the treatment of familial hyperkalemia, hypertension, edema, and urinary tract disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p810)