Corzide

DRUG DESCRIPTION

CORZIDE (Nadolol and Bendroflumethiazide Tablets) for oral administration combines two antihypertensive agents: CORGARD® (nadolol), a nonselective beta-adrenergic blocking agent, and NATURETIN® (bendroflumethiazide), a thiazide diuretic-antihypertensive. Formulations: 40 mg and 80 mg nadolol per tablet combined with 5 mg bendroflumethiazide. Inactive ingredients: cellulose, colorant (FD&C Blue No. 2), lactose, magnesium stearate, povidone, sodium starch glycolate, and starch.

Nadolol

Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol is designated chemically as 1-(tert-butylamino)-3-{ (5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy} -2-propanol. Structural formula:

Nadolol Structural Formula Illustration

C17H27NO4     MW 309.40    CAS-42200-33-9

Bendroflumethiazide

Bendroflumethiazide is a white crystalline powder. It is soluble in alcohol and in sodium hydroxide, and insoluble in hydrochloric acid, water, and chloroform. Bendroflumethiazide is designated chemically as 3-benzyl-3,4-dihydro-6-(trifluoromethyl)-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Structural formula:


C15H14F3N3O4S2    MW 421.41    CAS-73-48-3

What are the precautions when taking nadolol and bendroflumethiazide (Corzide)?

Before taking this product, tell your doctor or pharmacist if you are allergic to nadolol or bendroflumethiazide; or to other thiazides (such as hydrochlorothiazide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block, sick sinus syndrome), an inability to make urine (anuria), breathing problems (such as asthma, chronic bronchitis, emphysema).

Before using this medication, tell your doctor...

Read All Potential Precautions of Corzide »


Corzide Consumer (continued)

SIDE EFFECTS: See also Warning and Precautions sections.

Dizziness, lightheadedness, slow heartbeat, tiredness, nausea, and vomiting may occur. Decreased sexual ability has been reported infrequently. 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 bendroflumethiazide in this product may cause your body to lose too much water and salt (dehydration). Tell your doctor immediately 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 immediately 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 immediately 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, change in the amount of urine (not including the normal increase in urine when you first start this drug).

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.

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

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to nadolol or bendroflumethiazide; or to other thiazides (such as hydrochlorothiazide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block, sick sinus syndrome), an inability to make urine (anuria), breathing problems (such as asthma, chronic bronchitis, emphysema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart failure, overactive thyroid (hyperthyroidism), pheochromocytoma, blood circulation problems (such as Raynaud's disease, peripheral vascular disease), mental/mood disorders (such as depression), gout, untreated salt imbalance (for example, high calcium, low potassium, low magnesium), loss of too much body water (dehydration), a certain muscle/nerve disease (myasthenia gravis), lupus, serious allergic reactions including those needing treatment with epinephrine.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To help prevent dizziness, drink plenty of fluids while taking this medication unless your doctor directs you otherwise. Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor.

This medication may reduce the potassium levels in your blood. Ask your doctor about adding potassium to your diet. Your doctor may prescribe a potassium supplement.

If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of a low blood sugar level, such as dizziness and sweating, are unaffected by this drug. This product may also make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your diabetes medication or diet may need to be adjusted.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Older adults may be more sensitive to the side effects of this drug, including dizziness.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

Nadolol and bendroflumethiazide pass into breast milk. Nadolol may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.



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