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|Novodoparil

METHYLDOPA AND THIAZIDE DIURETICS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Aldoclor ¹
• Aldoril ²

In Canada—

• Novodoparil ²
• PMS Dopazide ²
• Supres ¹

Category

• Antihypertensive

Description

Combinations of methyldopa and a thiazide diuretic (chlorothiazide or hydrochlorothiazide) are used to treat high blood pressure (hypertension).

High blood pressure adds to the workload 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.

Methyldopa works by controlling nerve impulses along certain nerve pathways. As a result, it relaxes blood vessels so that blood passes through them more easily. Thiazide diuretics help reduce the amount of water in the body by increasing the flow of urine. These actions help to lower blood pressure.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Methyldopa and Chlorothiazide
  • Tablets (U.S. and Canada)
• Methyldopa 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 methyldopa and thiazide diuretics, the following should be considered:

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

Pregnancy—Studies in humans have not shown that methyldopa causes birth defects or other problems. However, when thiazide diuretics are used during pregnancy, they may cause side effects including jaundice, blood problems, and low potassium in the newborn infant. Thiazide diuretics have not been shown to cause birth defects.

Breast-feeding—This medicine passes into breast milk. Thiazide diuretics may decrease the flow of breast milk. Therefore, you should avoid use of thiazide diuretics during the first month of breast-feeding.

Children—Although there is no specific information comparing use of this medicine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Dizziness or light-headedness, drowsiness, or signs of too much potassium loss may be more likely to occur in the elderly, who are more sensitive to the effects of methyldopa and thiazide diuretics.

Other medicines—Although certain medicines should not be used together at all, in other cases two 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 methyldopa and thiazide diuretics, it is especially important that your health care professional know if you are taking any of the following:

• Digitalis glycosides (heart medicine)—Thiazide diuretics may cause low potassium in the blood, which can lead to symptoms of digitalis toxicity

• Lithium (e.g., Lithane)—Risk of lithium overdose, even at usual doses, may be increased

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking methyldopa while you are taking or within 2 weeks of taking MAO inhibitors may cause nervousness; headache, severe high blood pressure, and hallucinations have been reported

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

• Angina (chest pain)—Methyldopa may worsen the condition

• Type 2 diabetes mellitus—Thiazide diuretics may change the amount of diabetes medicine needed

• Gout (history of)—Thiazide diuretics may increase the amount of uric acid in the blood, which can lead to gout

• High cholesterol—Thiazide diuretics may raise cholesterol levels

• Kidney disease—Effects of methyldopa and thiazide diuretics may be increased because of slower removal from the body. If severe, thiazide diuretics may not work

• Liver disease—Effects of methyldopa may be increased because of slower removal from the body. If thiazide diuretics cause loss of too much water from the body, liver disease can become much worse

• Lupus erythematosus (history of)—Thiazide diuretics may worsen the condition

• Mental depression (history of)—Methyldopa can cause mental depression

• Pancreatitis (inflammation of the pancreas)

• Parkinson"s disease—Methyldopa may worsen the condition

• Pheochromocytoma—Methyldopa may interfere with tests for the condition; in addition, there have been reports of increased blood pressure

• If you have taken methyldopa in the past and developed liver problems

Proper Use of This Medicine

In addition to the use of the medicine your doctor has prescribed, appropriate 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 factors 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.

This 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 taking the medicine for a while, these effects should lessen. In general, 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.

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

Dosing—The dose of methyldopa 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 methyldopa and thiazide diuretic combinations. If your dose is different, do not change it unless your doctor tells you to do so:

• For methyldopa and chlorothiazide
• For oral dosage form (tablets):
  • Adults: Two to four tablets a day, taken as a single dose or in divided doses.
  • Children: Dose must be determined by your doctor.

• For methyldopa and hydrochlorothiazide
• For oral dosage form (tablets):
  • Adults: Two to four tablets a day, taken as a single dose or in divided doses.
  • 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 almost time for your next dose, 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 to make sure that this medicine is working properly.

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 tend to increase your blood pressure.

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.

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.

If you have a fever and there seems to be no reason for it, check with your doctor . This is especially important during the first few weeks you take this medicine since fever may be a sign of a serious reaction to methyldopa.

This medicine may cause some people to become drowsy or less alert than they are normally. This is more likely to happen when you begin to take it or when you increase the amount of medicine you are taking. 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 not alert .

Dizziness, light-headedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.

The dizziness, light-headedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. Drinking alcoholic beverages may also make the drowsiness worse. While you are taking this medicine, be careful in the amount of alcohol you drink . Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

For diabetic patients :

• This medicine may raise blood sugar levels. While you are using this medicine, be especially careful in testing for sugar in your urine. If you have any questions about this, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Thiazide diuretics 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.

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.

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 immediately if the following side effect occurs:

Check with your doctor as soon as possible if any of the following side effects occur, especially since some of them may mean that your body is losing too much potassium :

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:

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

Revised: 08/28/2000

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