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|Tenoretic 100

BETA-ADRENERGIC BLOCKING AGENTS AND THIAZIDE DIURETICS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Corzide 40/5 ⁴
• Corzide 80/5 ⁴
• Inderide ⁶
• Inderide LA ⁶
• Lopressor HCT ³
• Tenoretic 50 ¹
• Tenoretic 100 ¹
• Timolide 10-25 ⁷
• Ziac ²

In Canada—

• Corzide ⁴
• Inderide ⁶
• Tenoretic ¹
• Timolide ⁷
• Viskazide ⁵

Category

• Antihypertensive—Atenolol and Chlorthalidone; Bisprolol and Hydrochlorothiazide; Metoprolol and Hydrochlorothiazide; Nadolol and Bendroflumethiazide; Pindolol and Hydrochlorothiazide; Propranolol and Hydrochlorothiazide; Timolol and Hydrochlorothiazide

Description

Beta-adrenergic blocking agent (more commonly, beta-blockers) and thiazide diuretic combinations belong to the group of medicines known as antihypertensives (high blood pressure medicine). Both ingredients of the combination control high blood pressure, but they work in different ways. Beta-blockers (atenolol, bisoprolol, metoprolol, nadolol, pindolol, propranolol, and timolol) reduce the work load on the heart as well as having other effects. Thiazide diuretics (bendroflumethiazide, chlorthalidone, and hydrochlorothiazide) reduce the amount of fluid pressure in the body by increasing the flow of urine.

High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Beta-blocker and thiazide diuretic combinations are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Atenolol and chlorthalidone
  • Tablets (U.S. and Canada)
• Bisoprolol and hydrochlorothiazide
  • Tablets (U.S.)
• Metoprolol and hydrochlorothiazide
  • Tablets (U.S.)
• Nadolol and bendroflumethiazide
  • Tablets (U.S. and Canada)
• Pindolol and hydrochlorothiazide
  • Tablets (Canada)
• Propranolol and hydrochlorothiazide
  • Extended-release capsules (U.S.)
  • Tablets (U.S. and Canada)
• Timolol and hydrochlorothiazide
  • Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For the beta-blocker and thiazide diuretic combinations, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to beta-blockers, sulfonamides (sulfa drugs), bumetanide, furosemide, acetazolamide, dichlorphenamide, methazolamide, or any of the thiazide diuretics. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Use of some beta-blockers during pregnancy has been associated with low blood sugar, breathing problems, a slower heart rate, and low blood pressure in the newborn infant. Other reports have not shown unwanted effects in the newborn infant. Animal studies have shown some beta-blockers to cause problems in pregnancy when used in doses many times the usual human dose.

Studies with thiazide diuretics have not been done in pregnant women. However, use of thiazide diuretics during pregnancy may cause side effects such as jaundice, blood problems, and low potassium in the newborn infant. Animal studies have not shown thiazide diuretic medicines to cause birth defects even when used in doses several times the usual human dose.

Before taking a beta-blocker and thiazide diuretic combination, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Atenolol, metoprolol, nadolol, propranolol, pindolol, timolol, and thiazide diuretics pass into breast milk. It is not known whether bisoprolol passes into breast milk. Thiazide diuretics may decrease the flow of breast milk.

Children—Although there is no specific information comparing use of this combination medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. However, extra caution may be necessary in infants with jaundice, because these medicines can make the condition worse.

Older adults—Some side effects, especially dizziness or lightheadedness and signs and symptoms of too much potassium loss, may be more likely to occur in the elderly, who are usually more sensitive to the effects of this medicine. Also, beta-blockers may reduce tolerance to cold temperatures in elderly patients.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking beta-blocker and thiazide diuretic combinations, it is especially important that your health care professional know if you are taking any of the following:

• Allergy shots or
• Allergy skin tests—The beta-blocker contained in this medicine may increase the risk of a serious allergic reaction to these medicines

• Aminophylline (e.g., Somophyllin) or
• Caffeine (e.g., NoDoz) or
• Dyphylline (e.g., Lufylline) or
• Oxtriphylline (e.g., Choledyl) or
• Theophylline (e.g., Somophyllin-T)—The effects of these medicines and beta-blockers may be blocked; in addition, theophylline levels in the body may be increased, especially in patients who smoke

• Antidiabetics, oral (diabetes medicine you take by mouth) or
• Insulin—There is an increased risk of hyperglycemia (high blood sugar); the beta-blocker contained in this medicine may also cover up certain symptoms of hypoglycemia (low blood sugar), such as increases in pulse rate and blood pressure, and may make the hypoglycemia last longer

• Calcium channel blockers (amlodipine [e.g., Norvasc], bepridil [e.g., Bepadin], diltiazem [e.g., Cardizem], felodipine [e.g., Plendil], flunarizine [e.g., Sibelium], isradipine [e.g., DynaCirc], nicardipine [e.g., Cardene], nifedipine [e.g., Procardia], nimodipine [e.g., Nimotop], verapamil [e.g., Calan]) or
• Clonidine (e.g., Catapres) or
• Guanabenz (e.g., Wytensin)—Effects on blood pressure may be increased. In addition, unwanted effects may occur if clonidine, guanabenz, or a beta-blocker are stopped suddenly after use together. Unwanted effects on the heart may occur when beta-blocker and thiazide diuretic combinations are used with calcium channel blockers

• Cocaine—Cocaine may block the effects of beta-blockers; in addition, there is an increased risk of high blood pressure, fast heartbeat, and possibly heart problems if you use cocaine while taking a beta-blocker and thiazide diuretic combination

• Digitalis glycosides (heart medicine)—Use with beta-blocker and thiazide diuretic combinations may cause high blood levels of digoxin, which may increase the chance of side effects

• Lithium—The thiazide diuretic contained in this combination may cause high blood levels of lithium, which may increase the chance of side effects

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking a beta-blocker and thiazide diuretic combination while you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitors may cause severe high blood pressure

Other medical problems—The presence of other medical problems may affect the use of the beta-blockers and thiazide diuretics. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy, history of (asthma, eczema, hay fever, hives), or
• Bronchitis or
• Emphysema—This combination medicine may make allergic reactions to other substances more severe or make the reaction last longer; in addition, the beta-blocker contained in this combination can increase trouble in breathing

• Bradycardia (unusually slow heartbeat) or
• Heart or blood vessel disease—This combination medicine may make these heart problems worse; also, if treatment is stopped suddenly, unwanted effects may occur

• Type 2 diabetes mellitus—The beta-blocker contained in this medicine may cause hyperglycemia (high blood sugar) and circulation problems; in addition, if your diabetes medicine causes your blood sugar to be too low, beta-blockers may cover up some of the symptoms (fast heartbeat), although they will not cover up other symptoms such as dizziness or sweating; the thiazide diuretic contained in this medicine may increase the amount of sugar in the blood

• Gout (history of) or
• Lupus erythematosus (history of) or
• Pancreatitis (inflammation of the pancreas)—The thiazide diuretic contained in this medicine may make these conditions worse

• Kidney disease or
• Liver disease—Effects of this medicine may be increased because of slower removal from the body

• Mental depression (or history of) or
• Myasthenia gravis or
• Pheochromocytoma or
• Psoriasis or
• Raynaud"s syndrome—The beta-blocker contained in this medicine may make these conditions worse

• Overactive thyroid—Stopping this medicine suddenly may increase symptoms of overactive thyroid; the beta-blocker contained in this medicine may cover up fast heartbeat, which is a sign of overactive thyroid

Proper Use of This Medicine

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

For patients taking the extended-release tablet form of this medicine:

• Swallow the tablet whole.
• Do not crush, break, or chew before swallowing.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

Ask your doctor about checking your pulse rate before and after taking beta-blocking agents. Then, while you are taking this medicine, check your pulse regularly. If it is much slower than your usual rate (or less than 50 beats per minute), check with your doctor. A pulse rate that is too slow may cause circulation problems.

The thiazide diuretic (e.g., bendroflumethiazide, chlorthalidone, or hydrochlorothiazide) contained in this combination medicine may cause you to have an unusual feeling of tiredness when you begin to take it. You may also notice an increase in the amount of urine or in your frequency of urination. After you take the medicine for a while, these effects should lessen. To keep the increase in urine from affecting your sleep:

• If you are to take a single dose a day, take it in the morning after breakfast.
• If you are to take more than one dose a day, take the last dose no later than 6 p.m., unless otherwise directed by your doctor.

However, it is best to plan your dose or doses according to a schedule that will least affect your personal activities and sleep. Ask your health care professional to help you plan the best time to take this medicine.

Do not miss any doses . This is especially important when you are taking only one dose per day. Some conditions may become worse when this medicine is not taken regularly.

Dosing—The dose of beta-blocker and thiazide diuretic combinations will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of beta-blocker and thiazide diuretic combinations. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets that you take depends on the strength of the medicine.

• For atenolol and chlorthalidone combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 or 2 tablets once a day.
    • Children—Dose must be determined by your doctor.

• For bisoprolol and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 or 2 tablets once a day.
    • Children—Dose must be determined by your doctor.

• For metoprolol and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 or 2 tablets a day.
    • Children—Dose must be determined by your doctor.

• For nadolol and bendroflumethiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet once a day.
    • Children—Dose must be determined by your doctor.

• For pindolol and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 or 2 tablets once a day.
    • Children—Dose must be determined by your doctor.

• For propranolol and hydrochlorothiazide combination
• For regular (short-acting) oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 or 2 tablets two times a day.
    • Children—Dose must be determined by your doctor.
• For long-acting oral dosage form (capsules):
  • For high blood pressure:
    • Adults—1 capsule a day.
    • Children—Dose must be determined by your doctor.

• For timolol and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet two times a day or 2 tablets once a day.
    • Children—Dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is within 4 hours of your next dose (8 hours if you are using atenolol and chlorthalidone, bisoprolol and hydrochlorothiazide, nadolol and bendroflumethiazide, or extended-release propranolol and hydrochlorothiazide), skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits. This is to make sure the medicine is properly controlling your blood pressure and to allow the dosage to be changed if needed.

Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before stopping completely. Some conditions may become worse when the medicine is stopped suddenly, and the risk of heart attack is increased in some patients.

Make sure that you have enough medicine on hand to last through weekends, holidays, or vacations. You may want to carry an extra written prescription in your billfold or purse in case of an emergency. You can then have it filled if you run out of medicine while you are away from home.

Your doctor may want you to carry medical identification stating that you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor . This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems since they may increase your blood pressure.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine .

For diabetic patients :

• This medicine may increase your blood sugar levels . Also, this medicine may cover up signs of hypoglycemia (low blood sugar) , such as change in pulse rate. While you are taking this medicine, be especially careful in testing for sugar in your urine. If you have any questions about this, check with your doctor.

The thiazide diuretic contained in this medicine may cause a loss of potassium from your body .

• To help prevent this, your doctor may want you to:
  • eat or drink foods that have a high potassium content (for example, orange or other citrus fruit juices), or
  • take a potassium supplement, or
  • take another medicine to help prevent the loss of the potassium in the first place.
• It is very important to follow these directions. Also, it is important not to change your diet on your own. This is more important if you are already on a special diet (as for diabetes), or if you are taking a potassium supplement or a medicine to reduce potassium loss. Extra potassium may not be necessary and, in some cases, too much potassium could be harmful.

Check with your doctor if you become sick and have severe or continuing vomiting or diarrhea. These problems may cause you to lose additional water and potassium.

This medicine may cause some people to become dizzy, drowsy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert . If the problem continues or gets worse, check with your doctor.

The beta-blocker (atenolol, bisoprolol, metoprolol, nadolol, pindolol, propranolol, or timolol) contained in this medicine may make you more sensitive to cold temperatures, especially if you have blood circulation problems. Beta-blockers tend to decrease blood circulation in the skin, fingers, and toes. Dress warmly during cold weather and be careful during prolonged exposure to cold, such as in winter sports.

This medicine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor .

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

For patients with allergies to foods, medicines, or insect stings:

• There is a chance that this medicine will make allergic reactions worse and harder to treat. If you have a severe allergic reaction while you are being treated with this medicine, check with a doctor right away so that it can be treated.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Although not all of the above side effects have been reported for all of these medicines, they have been reported for at least one of the beta-blockers or thiazide diuretics. Since all of the beta-blockers are very similar and the thiazide diuretics are also very similar, any of the above side effects may occur with any of these medicines. However, they may be more common with some combinations than with others.

After you have been taking this medicine for a while, it may cause unpleasant or even harmful effects if you stop taking it too suddenly. After you stop taking this medicine or while you are gradually reducing the amount you are taking, check with your doctor right away if any of the following occur:

Chest pain; fast or irregular heartbeat; general feeling of discomfort, illness, or weakness; headache; shortness of breath (sudden); sweating; trembling

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/12/1998

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