Apo-Hydralazine

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|Apo-Hydralazine

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HYDRALAZINE (Systemic)

Some commonly used brand names are:

In the U.S.—

In Canada—

  • Apo-Hydral
  • Apo-Hydralazine
  • Apresoline
  • Novo-Hylazin

Generic name product may be available in the U.S. and Canada.

Category

  • Antihypertensive
  • Vasodilator, congestive heart failure

Description

Hydralazine (hye-DRAL-a-zeen) belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension). It is also used to control high blood pressure in the mother during pregnancy (pre-eclampsia or eclampsia) or in emergency situations when blood pressure is extremely high (hypertensive crisis).

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.

Hydralazine works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload.

Hydralazine may also be used for other conditions as determined by your doctor.

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

  • Oral
  • Oral solution (must be prepared by the pharmacist)
  • Tablets (U.S. and Canada)
  • Parenteral
  • Injection (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 hydralazine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to hydralazine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Although hydralazine often is used to reduce high blood pressure in pregnant women, extensive studies of hydralazine in pregnant women have not been done. However, blood problems and other problems have been reported in infants of mothers who took hydralazine during pregnancy. In addition, studies in mice have shown that high doses of hydralazine cause birth defects (cleft palate, defects in head and face bones). These birth defects also occurred in rabbits, but did not occur in rats. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Hydralazine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing use of hydralazine 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, the oral solution contains aspartame, which is converted to phenylalanine in the body. Children with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydralazine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 hydralazine, it is especially important that your health care professional know if you are taking the following:

  • Diazoxide (e.g., Proglycem)—Effect on blood pressure may be increased

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

  • Heart or blood vessel disease or
  • Stroke—Lowering blood pressure may make problems resulting from these conditions worse
  • Kidney disease—Effects may be increased because of slower removal of hydralazine from the body
  • Phenylketonuria—The oral solution of hydralazine contains aspartame, which is converted to phenylalanine in the body. Patients with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage

Proper Use of This Medicine

For patients taking this medicine for high blood pressure :

  • 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 hydralazine 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 oral solution form of hydralazine :

  • The oral solution may be mixed with fruit juice or applesauce. If mixed with fruit juice or applesauce, take immediately after mixing. Be sure to take all of the mixture to get the full dose of the medicine.

This medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same times each day.

Dosing—The dose of hydralazine 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 hydralazine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or teaspoonfuls of oral solution that you take depends on the strength of the medicine.

  • For oral dosage forms (oral solution and tablets):
    • For high blood pressure:
      • Adults—40 to 200 milligrams (mg) per day divided into two or four doses
      • Children—Dose is based on body weight. The usual dose is 0.75 to 7.5 mg per kilogram (kg) (0.34 to 3.4 mg per pound) of body weight a day. This is divided into two or four doses.
  • For injection dosage form:
    • For high blood pressure:
      • Adults—5 to 40 mg injected into a muscle or a vein. Your doctor may repeat the dose as needed.
      • Children—Dose is based on body weight. The usual dose is 1.7 to 3.5 mg per kg (0.77 to 1.6 mg per pound) of body weight a day. This is divided into four to six doses and injected into a muscle or a vein.
    • For high blood pressure during pregnancy:
      • Adults—5 mg injected into a vein every fifteen to twenty minutes.

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.
  • Store the oral solution form of hydralazine in the refrigerator because heat will cause this medicine to break down. However, keep the medicine from freezing.
  • 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.

Hydralazine may cause some people to have headaches or to feel dizzy. 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 .

The oral solution contains 1.4 milligrams (mg) of phenylalanine per teaspoonful (5 mL). Patients with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage.

For patients taking this medicine for high blood pressure :

  • 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.

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.

In general, side effects with hydralazine are rare at lower doses. However, check with your doctor as soon as possible if any of the following occur:

Less common

Blisters on skin; chest pain; general feeling of discomfort or illness or weakness; joint pain; muscle pain; numbness, tingling, pain, or weakness in hands or feet; skin rash or itching; sore throat and fever; swelling of feet or lower legs; swelling of lymph glands

Rare

Fever; general feeling of discomfort or illness; sore throat; weakness

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:

More common

Diarrhea; fast heartbeat; headache; loss of appetite; nausea or vomiting; pounding heartbeat

Less common

Constipation; dizziness or lightheadedness; redness or flushing of face; shortness of breath; stuffy nose; watery eyes

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not specifically included in product labeling, hydralazine is used in certain patients with the following medical condition:

  • Congestive heart failure

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 08/24/1998

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